translation
China's pharmaceutical industry plan for 2026-2030, side by side
The full text of 医药工业发展“十五五”规划 (工信部联规〔2026〕210号), the Chinese quoted above every English paragraph. Unofficial. Every number, threshold, and negation machine-matched to the characters; one cross-family adversarial review; two source-internal inconsistencies left visible.
工信部联规〔2026〕210号 -- the 15th Five-Year Plan for pharmaceutical industry development, MIIT and nine other ministries, signed 2026-08-28, published 2026-09-18 · 2026-09-25 · 2 sources
医药工业发展“十五五”规划
15th Five-Year Plan for Pharmaceutical Industry Development
UNOFFICIAL side-by-side translation. The Chinese text is the sole authoritative version.
Cite the original: Ministry of Industry and Information Technology and nine other departments,
《医药工业发展"十五五"规划》, 工信部联规〔2026〕210号, signed 2026-08-28, published 2026-09-18.
Authority page1Ministry of Industry and Information Technology, notice publishing 工信部联规〔2026〕210号, 2026-09-18 -- authority page. https://www.miit.gov.cn/zwgk/zcwj/wjfb/tz/art/2026/art_9463adac4db040159f6cbf482675eeea.html (T1 -- issuing ministry); original PDF2Ministry of Industry and Information Technology, 《医药工业发展"十五五"规划》 (original PDF, 18 pages, sha256 e4ba3a4c737f9ed1deafde79fb0d7cf63b4bd47aac93f68502aadaa95a25da8e). https://www.miit.gov.cn/cms_files/filemanager/1226211233/attach/20269/c9ef9c990ec84347a7a87999e23e26e0.pdf (T1 -- issuing ministry, primary document)
(sha256 e4ba3a4c737f9ed1deafde79fb0d7cf63b4bd47aac93f68502aadaa95a25da8e, 18 pages).
The ministry's server is slow to answer from outside China, so the same file is served here:
miit-pharma-15th-fyp-plan-2026-210.pdf,
byte-identical to the original (same sha256).
English rendering by BigBio's Claude-based pipeline, 2026-09-25; method and review ledger in Chapter, verse and checksum. Each Chinese paragraph is
quoted (>) immediately above its English rendering so any quotation can be checked against
the source characters. Terms follow common policy-translation usage (new quality productive
forces, manufacturing powerhouse, Healthy China, first-in-class / best-in-class, above
designated size).
Issuing bodies: Ministry of Industry and Information Technology; National Development and Reform Commission; Ministry of Natural Resources; Ministry of Agriculture and Rural Affairs; Ministry of Commerce; National Health Commission; Ministry of Emergency Management; National Healthcare Security Administration; National Administration of Traditional Chinese Medicine; National Medical Products Administration.
为贯彻落实党中央、国务院决策部署，落实制造强国和健康中国建设战略任务，推动医药工业高质量发展，根据《中华人民共和国国民经济和社会发展第十五个五年规划纲要》，制定本规划。
In order to implement the decisions and arrangements of the Party Central Committee and the State Council, carry out the strategic tasks of building a manufacturing powerhouse and a Healthy China, and promote the high-quality development of the pharmaceutical industry, this Plan is formulated in accordance with the "Outline of the 15th Five-Year Plan for the National Economic and Social Development of the People's Republic of China."
一、总体要求
1. General Requirements
坚持以习近平新时代中国特色社会主义思想为指导，深入贯彻党的二十大和二十届历次全会精神，认真落实四中全会部署，完整准确全面贯彻新发展理念，加快构建新发展格局，锚定基本实现新型工业化目标， 统筹发展和安全，以推动高质量发展为主题，以人民健康为中心，以培育发展新质生产力为重点，激活创新核心动力，构筑韧性安全根基，深化数智融合赋能，引领精准诊疗范式，推进效率变革提升，增强价值创造能力， 提高普惠可及水平，拓展开放互利合作，为全方位满足全生命周期健康需求、全面推进健康中国建设构筑强大物质技术基础。
Adhere to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era; thoroughly implement the spirit of the 20th National Congress of the Party and of all plenary sessions of the 20th Central Committee; conscientiously implement the arrangements of the Fourth Plenary Session; fully, accurately, and comprehensively implement the new development philosophy; accelerate the building of the new development pattern; anchor on the goal of basically achieving new-type industrialization; and coordinate development and security. Take promoting high-quality development as the theme, people's health as the center, and cultivating and developing new quality productive forces as the focus; activate the core driving force of innovation, build a resilient and secure foundation, deepen digital and intelligent integration and empowerment, lead the paradigm of precision diagnosis and treatment, advance efficiency transformation and improvement, strengthen value-creation capacity, raise the level of inclusive accessibility, and expand open and mutually beneficial cooperation, so as to build a strong material and technological foundation for comprehensively meeting whole-life-cycle health needs and comprehensively advancing the building of a Healthy China.
到 2030 年，生物医药研发应用稳居世界前列，创新驱动效能充分释放，重点领域关键核心技术实现系统性突破。全产业链数智赋能成效彰显，精准医药体系高效助力重大疾病综合防治。要素协同生态日趋成熟， 产业发展空间不断拓展。生产供应保障坚实有力，核心竞争力与国际影响力大幅跃升，深度嵌入全球医药创新协作网络。生物医药产业加速成为国家新兴支柱产业，持续守护增进人民生命健康福祉，有力支撑制造强国、健康中国战略落地实施， 为筑牢国家安全屏障、携手构建人类卫生健康共同体贡献坚实产业力量。
By 2030, biomedical R&D and application will rank firmly among the world's leaders, the effectiveness of innovation-driven development will be fully unleashed, and systematic breakthroughs will be achieved in key core technologies in priority fields. The results of digital and intelligent empowerment across the entire industrial chain will be evident, and the precision medicine system will efficiently support the comprehensive prevention and treatment of major diseases. The ecosystem of coordinated factors [of production] will grow increasingly mature, and the space for industrial development will continue to expand. Production and supply assurance will be solid and strong, core competitiveness and international influence will leap substantially, and [the industry] will be deeply embedded in the global pharmaceutical innovation collaboration network. The biomedicine industry will accelerate in becoming a new national pillar industry, continuously safeguarding and enhancing the well-being of people's lives and health, powerfully supporting the implementation of the manufacturing powerhouse and Healthy China strategies, and contributing solid industrial strength to fortifying the national security barrier and jointly building a global community of health for all.
专栏 1 “十五五”时期医药工业发展预期性指标
Box 1 Anticipatory Indicators for Pharmaceutical Industry Development During the 15th Five-Year Plan Period
| 序号 No. | 指标 | Indicator | 2030 年 | 2030 | 年均/累计 | Annual average / cumulative |
|---|---|---|---|---|---|---|
| 1 | 规模以上医药工业企业营业收入（万亿元） | Operating revenue of pharmaceutical industry enterprises above designated size (trillion yuan) | ≥3.5 | ≥3.5 | — | -- |
| 2 | 医药工业上市企业平均研发投入强度（%） | Average R&D investment intensity of listed pharmaceutical industry enterprises (%) | — | -- | ≥10 | ≥10 |
| 3 | 首次开展临床试验在研新药研发管线数量 | Number of R&D pipelines of new drugs under development entering clinical trials for the first time | 世界前列 | Among the world's leaders | — | -- |
| 4 | 首创新药（FIC）占全球比例（%） | First-in-class (FIC) new drugs as a share of the global total (%) | ≥25 | ≥25 | — | -- |
| 5 | 创新药上市数量 | Number of innovative drugs approved for market | 世界前列 | Among the world's leaders | — | -- |
| 6 | 创新医疗器械上市数量（个） | Number of innovative medical devices approved for market (units) | — | -- | 〔≥200〕 | 〔≥200〕 |
| 7 | 创新药产业规模增速（%） | Growth rate of the scale of the innovative drug industry (%) | — | -- | ≥20 | ≥20 |
| 8 | 年营业收入超过 100 亿元的医药工业企业数量（家） | Number of pharmaceutical industry enterprises with annual operating revenue exceeding 10 billion yuan (enterprises) | 50 | 50 | — | -- |
| 9 | 千亿级医药产业园区数量（个） | Number of pharmaceutical industrial parks at the 100-billion-yuan level (units) | 20 | 20 | — | -- |
| 10 | 全球年销售额超 10 亿美元的品种数量（个） | Number of products with global annual sales exceeding US$1 billion (units) | ≥5 | ≥5 | — | -- |
注：①〔〕为 5 年累计数。②首创新药（FIC）占全球创新药比例统计范围包含临床Ⅰ期、Ⅱ期、Ⅲ期、新药上市申请（NDA/BLA）、已获批上市药物，不包含临床前、终止研发、撤项的品种。
Notes: (1) 〔〕 denotes a 5-year cumulative figure. (2) The statistical scope of the share of first-in-class (FIC) new drugs among global innovative drugs includes products in Phase I, Phase II, and Phase III clinical trials, new drug applications (NDA/BLA), and drugs already approved for marketing; it does not include products that are preclinical, whose R&D has been terminated, or that have been withdrawn.
二、重点任务
2. Key Tasks
（一）引领产业向新向优，锻造创新驱动新引擎
(1) Lead the industry toward the new and the superior, and forge a new engine of innovation-driven development
1.增强原始创新能力。聚焦重大传染病、重大慢性病、罕见病、儿童用药等重点领域，强化企业创新主体地位，加快推动我国创新药械研发向首创性、突破性、颠覆性升级。支持医药工业企业瞄准医药前沿科技，开发一批新靶点、新机制、新药物类型的首创新药（FIC）和同类最优药物（BIC）。加快研发应用一批前沿性、引领性高端医疗器械。
1. Strengthen original innovation capacity. Focus on priority fields such as major infectious diseases, major chronic diseases, rare diseases, and pediatric medicines; strengthen the principal position of enterprises in innovation; and accelerate the upgrading of China's R&D of innovative drugs and devices toward first-of-its-kind, breakthrough, and disruptive innovation. Support pharmaceutical industry enterprises in targeting frontier pharmaceutical science and technology to develop a batch of first-in-class (FIC) new drugs and best-in-class (BIC) drugs with new targets, new mechanisms, and new drug modalities. Accelerate the R&D and application of a batch of cutting-edge, leading high-end medical devices.
专栏 2 重点创新领域和产品
Box 2 Key Innovation Fields and Products
| 中文 | English |
|---|---|
| 1.化学药 | 1. Chemical drugs |
| 新靶点和新作用机制药物。重点开发针对传统不可成药靶点的干预药物，基于基因组学、蛋白质组学、空间组学等新靶点药物，针对重大疾病相关宿主因子的干预药物，变构调节机制药物，表观遗传及转录调控机制药物，RNA 功能调控机制药物和微环境重塑机制药物等。 | Drugs with new targets and new mechanisms of action. Focus on developing interventional drugs against traditionally undruggable targets; new-target drugs based on genomics, proteomics, spatial omics, etc.; interventional drugs against host factors associated with major diseases; drugs with allosteric modulation mechanisms; drugs with epigenetic and transcriptional regulation mechanisms; drugs with RNA function regulation mechanisms; and drugs with microenvironment remodeling mechanisms, etc. |
| 新模态药物。重点开发 siRNA/ASO 等寡核苷酸药物，靶向蛋白降解药物（PROTAC、分子胶），新型多肽及口服环肽药物，多肽偶联药物（PDC），多肽或小分子放射性核素偶联药物等。 | New-modality drugs. Focus on developing oligonucleotide drugs such as siRNA/ASO; targeted protein degradation drugs (PROTACs, molecular glues); novel peptide and oral cyclic peptide drugs; peptide-drug conjugates (PDCs); peptide or small-molecule radionuclide conjugate drugs, etc. |
| 新型递送系统与成药性优化技术。重点开发脑靶向化学药物递送系统，病理微环境响应型递送系统（pH、酶特异性释放）等。重点发展脂质体和聚合物纳米粒等纳米药物技术，口服吸收增强技术和缓控释及长效化技术等。 | New delivery systems and druggability optimization technologies. Focus on developing brain-targeted chemical drug delivery systems, pathological-microenvironment-responsive delivery systems (pH-specific, enzyme-specific release), etc. Prioritize the development of nanomedicine technologies such as liposomes and polymer nanoparticles, oral absorption enhancement technologies, and sustained/controlled-release and long-acting technologies, etc. |
| 2.中药 | 2. Traditional Chinese medicine (TCM) |
| 中药新药。针对中医具有优势的疾病领域和环节，加大创新药开发力度，将医疗机构制剂或名老中医经验方，通过现代技术赋能，转化为运用现代剂型的创新中药。结合新技术、新方法，重点开发兼具整体调节与靶向干预、组分明确、机制清楚的天然药物。 | New TCM drugs. Targeting disease areas and stages in which TCM has advantages, intensify the development of innovative drugs, and, through empowerment by modern technology, convert medical institution preparations or empirical formulas of renowned veteran TCM practitioners into innovative TCM using modern dosage forms. Combining new technologies and new methods, focus on developing natural medicines that combine holistic regulation with targeted intervention and have well-defined components and clear mechanisms. |
| 经典名方。以《古代经典名方目录》为基础，开展“药材饮片—基准样品—制剂”全链条研究，开发古代经典名方中药复方制剂。 | Classical famous formulas. On the basis of the "Catalogue of Ancient Classical Famous Formulas," carry out whole-chain research on "medicinal materials and decoction pieces -- reference samples -- preparations," and develop TCM compound preparations of ancient classical famous formulas. |
| 民族药。聚焦藏、蒙、维等少数民族医学特色和优势病种，挖掘民族药特色药材资源与验方，重点开发创新药、特色复方制剂与专科专用制剂。 | Ethnic medicines. Focusing on the distinctive features and advantageous disease types of the medicine of ethnic minorities such as the Tibetan, Mongolian, and Uyghur, tap the distinctive medicinal material resources and proven formulas of ethnic medicines, and focus on developing innovative drugs, distinctive compound preparations, and specialty-specific preparations. |
| 3.生物制品 | 3. Biologics |
| 抗体及重组蛋白药物。重点开发针对新靶点的抗体药物及双/多特异性抗体药物，具有增强肿瘤靶向性与免疫激活协同效应的创新产品，长效化抗体及重组蛋白药物，重组融合蛋白药物，重组酶替代治疗用蛋白药物，肿瘤微环境特异性解离遮蔽肽的高靶向性双/多特异性抗体药物，靶向补体系统的抗体及重组蛋白药物等。 | Antibody and recombinant protein drugs. Focus on developing antibody drugs and bispecific/multispecific antibody drugs against new targets; innovative products with synergistic effects of enhanced tumor targeting and immune activation; long-acting antibody and recombinant protein drugs; recombinant fusion protein drugs; recombinant protein drugs for enzyme replacement therapy; highly targeted bispecific/multispecific antibody drugs with masking peptides that dissociate specifically in the tumor microenvironment; antibody and recombinant protein drugs targeting the complement system, etc. |
| 新一代偶联药物。重点开发双/多特异性抗体偶联药物（ADC），基于新型载荷（含双载荷）、肿瘤微环境特异性释放连接子的高靶向性抗体偶联药物，抗体/蛋白类放射性核素偶联药物（RDC），抗体寡核苷酸偶联药物（AOC）等。 | Next-generation conjugate drugs. Focus on developing bispecific/multispecific antibody-drug conjugates (ADCs); highly targeted antibody-drug conjugates based on novel payloads (including dual payloads) and linkers with tumor-microenvironment-specific release; antibody/protein radionuclide drug conjugates (RDCs); antibody-oligonucleotide conjugates (AOCs), etc. |
| 细胞与基因治疗药物。针对实体瘤、自身免疫性疾病及遗传性疾病等，重点开发靶向新靶点的新型 CAR-T 细胞治疗产品、通用型 CAR-T 细胞治疗产品，体内基因编辑 CAR-T 细胞治疗产品，多功能诱导干细胞（iPSC）治疗产品等。重点发展用于体内基因递送的腺相关病毒（AAV）载体及用于体内核酸药物递送的脂质纳米颗粒（LNP）等递送系统。 | Cell and gene therapy drugs. Targeting solid tumors, autoimmune diseases, genetic diseases, etc., focus on developing novel CAR-T cell therapy products directed at new targets, universal CAR-T cell therapy products, in vivo gene-edited CAR-T cell therapy products, multifunctional induced stem cell (iPSC) therapy products [tr: rendered as written; 多功能 = multifunctional, though iPSC normally abbreviates induced pluripotent stem cell -- an inconsistency in the source], etc. Prioritize the development of delivery systems such as adeno-associated virus (AAV) vectors for in vivo gene delivery and lipid nanoparticles (LNPs) for in vivo nucleic acid drug delivery. |
| 新型疫苗。重点开发针对呼吸道合胞病毒（RSV）、带状疱疹等新适应症的 mRNA 疫苗，替代传统疫苗的基因重组疫苗新品种，联合疫苗，新给药途径疫苗，新疫苗佐剂等。 | Novel vaccines. Focus on developing mRNA vaccines for new indications such as respiratory syncytial virus (RSV) and herpes zoster; new varieties of recombinant vaccines to replace traditional vaccines; combination vaccines; vaccines with new routes of administration; new vaccine adjuvants, etc. |
| 4.医疗器械 | 4. Medical devices |
| 植介入器械。重点开发降解速率可控的冠脉支架、心脏起搏器、神经介入微导管/微导丝、药物洗脱外周动脉支架等产品。重点发展突破钛合金/氮化钛表面纳米改性、快速精密 3D 打印等技术，应用于 3D 打印植入物、组织修复材料等再生医学材料。 | Implantable and interventional devices. Focus on developing products such as coronary stents with controllable degradation rates, cardiac pacemakers, neurointerventional microcatheters/microguidewires, and drug-eluting peripheral arterial stents. Prioritize achieving breakthroughs in technologies such as titanium alloy/titanium nitride surface nano-modification and rapid precision 3D printing, applied to regenerative medicine materials such as 3D-printed implants and tissue repair materials. |
| 体外诊断器械。重点发展新型分子诊断、单细胞测序、肿瘤早筛、罕见病基因检测等技术和产品。 | In vitro diagnostic devices. Prioritize the development of technologies and products such as novel molecular diagnostics, single-cell sequencing, early cancer screening, and genetic testing for rare diseases. |
| 智能医疗器械。重点发展高端计算机断层扫描（CT）、磁共振、多模态 AI 病理系统等 AI 辅助诊断产品及关键零部件。重点发展高端放射治疗系统、多模态 AI 手术导航定位系统、专科化和轻量化微创介入手术机器人等治疗设备。重点发展 AI 驱动的闭环胰岛素泵、无创连续血压/血糖监测设备、多参数居家心衰管理系统等家用医疗器械。重点发展外骨骼机器人、脑机接口驱动外骨骼、AI 步态分析系统等康复医疗器械。 | Intelligent medical devices. Prioritize the development of AI-assisted diagnostic products and key components such as high-end computed tomography (CT), magnetic resonance, and multimodal AI pathology systems. Prioritize the development of therapeutic equipment such as high-end radiotherapy systems, multimodal AI surgical navigation and positioning systems, and specialized and lightweight minimally invasive interventional surgical robots. Prioritize the development of home medical devices such as AI-driven closed-loop insulin pumps, non-invasive continuous blood pressure/blood glucose monitoring devices, and multi-parameter home heart failure management systems. Prioritize the development of rehabilitation medical devices such as exoskeleton robots, brain-computer-interface-driven exoskeletons, and AI gait analysis systems. |
2.充分发挥产业创新平台作用。支持医药工业企业与国家实验室，以及国家技术创新中心、国家制造业创新中心、国家产业技术工程化中心、国家临床医学研究中心等创新载体深化合作，加强临床应用验证与评价， 贯通医药基础研究与成果转化。发展专业化医药服务型制造，加强医药研发及生产服务平台建设，加速新型抗体药物、偶联药物、小核酸药物、多肽药物等新模态药物关键技术验证、转化与产业化应用。加强新发突发重大传染性疾病疫苗和治疗药物的技术储备。
2. Give full play to the role of industrial innovation platforms. Support pharmaceutical industry enterprises in deepening cooperation with national laboratories, as well as with innovation vehicles such as national technology innovation centers, national manufacturing innovation centers, national industrial technology engineering centers, and national clinical medical research centers; strengthen clinical application validation and evaluation; and link basic pharmaceutical research with the translation of research results. Develop specialized pharmaceutical service-oriented manufacturing, strengthen the construction of pharmaceutical R&D and production service platforms, and accelerate the validation, translation, and industrial application of key technologies for new-modality drugs such as novel antibody drugs, conjugate drugs, small nucleic acid drugs, and peptide drugs. Strengthen technology reserves for vaccines and therapeutic drugs against emerging and sudden-onset major infectious diseases.
3.积极培育壮大创新药械产业。聚焦肿瘤、自身免疫性疾病、代谢性疾病、心血管系统疾病、神经系统疾病等重点领域，加大创新药械研发、生产、应用推广力度，加速形成一批拉动产业规模扩容的重磅产品。搭建儿童、老年、罕见病患者等人群用药供需对接平台，加快推动适宜剂型、规格的产品研发应用。鼓励开展真实世界研究用于药品全生命周期评价，加强临床综合评价力度，加强评价结果分析转化。
3. Actively cultivate and grow the innovative drug and device industry. Focusing on priority fields such as oncology, autoimmune diseases, metabolic diseases, cardiovascular diseases, and nervous system diseases, intensify the R&D, production, and application promotion of innovative drugs and devices, and accelerate the formation of a batch of blockbuster products that drive the expansion of the industry's scale. Build supply-demand matching platforms for medicines for populations such as children, the elderly, and rare disease patients, and accelerate the R&D and application of products in suitable dosage forms and strengths. Encourage real-world studies for use in whole-life-cycle drug evaluation, strengthen comprehensive clinical evaluation, and strengthen the analysis and translation of evaluation results.
4.加快布局前沿技术和产品。强化跨学科交叉融合与前沿技术供给，支持医药工业企业、高校、科研院所、医疗机构等联合攻关。加快人工智能、量子计算、超级计算、计算医学等新技术赋能药物研发， 探索超限制造、太空制药、生物制造等药械生产新模式，深化基因编辑、分子精准递送、细胞编程与调控、先进组学、新一代脑机接口等前沿技术应用，突破人工生命体系合成、类器官与器官芯片、通用型细胞治疗、复杂再生器官、诊疗一体化放射性药物、异种移植器官等关键技术， 培育若干新增长点。
4. Accelerate the deployment of frontier technologies and products. Strengthen interdisciplinary convergence and the supply of frontier technologies, and support pharmaceutical industry enterprises, universities, research institutes, medical institutions, etc. in jointly tackling key problems. Accelerate the empowerment of drug R&D by new technologies such as artificial intelligence, quantum computing, supercomputing, and computational medicine; explore new models of drug and device production such as beyond-limit manufacturing [tr: 超限制造; also rendered "extreme manufacturing" in some press English], space-based pharmaceutical manufacturing, and biomanufacturing; deepen the application of frontier technologies such as gene editing, precise molecular delivery, cell programming and regulation, advanced omics, and next-generation brain-computer interfaces; achieve breakthroughs in key technologies such as the synthesis of artificial life systems, organoids and organs-on-chips, universal cell therapy, complex regenerative organs, integrated diagnostic-therapeutic (theranostic) radiopharmaceuticals, and xenotransplant organs; and cultivate a number of new growth points.
专栏 3 重点前沿技术
Box 3 Key Frontier Technologies
| 中文 | English |
|---|---|
| 1.基础研究阶段。量子生成式 AI 药物分子设计技术、生物大分子结构—序列双模态预测技术、RNA 三维结构预测与功能解析技术、DNA 数字存储技术、医药领域全场景数字孪生技术、基于精准基因编辑的中药育种技术、生物分子相分离与凝聚体靶向干预技术、新型基因编辑系统开发及体内递送技术、仿生纳米疫苗技术、微环境响应型遮蔽肽与前药激活技术、低丰度高纯度医用放射性前置核素提取及纯化技术等。 | 1. Basic research stage. Quantum generative AI drug molecule design technology; structure-sequence bimodal prediction technology for biological macromolecules; RNA three-dimensional structure prediction and functional analysis technology; DNA digital storage technology; full-scenario digital twin technology for the pharmaceutical field; TCM breeding technology based on precise gene editing; biomolecular phase separation and condensate-targeted intervention technology; development of novel gene editing systems and in vivo delivery technology; biomimetic nanovaccine technology; microenvironment-responsive masking peptide and prodrug activation technology; extraction and purification technology for low-abundance, high-purity medical radioactive precursor nuclides, etc. |
| 2.技术转化阶段。基于多组学大数据的临床队列数据分析与药物靶标发现技术、AI 驱动的类器官/器官芯片药物评价技术、珍稀濒危药用资源生物替代技术与可持续利用技术、基于中医药“证候”动态演化的精准药效评价技术、中药多靶点作用机制的时空动态解析技术、中药和天然药物活性分子高效发现技术、基因治疗病毒载体规模化制备技术、大分子偶联降解剂技术、人诱导多能干细胞衍生细胞药物技术、大功率多核素靶系统技术等。 | 2. Technology translation stage. Clinical cohort data analysis and drug target discovery technology based on multi-omics big data; AI-driven organoid/organ-on-chip drug evaluation technology; biological substitution technology and sustainable utilization technology for rare and endangered medicinal resources; precision efficacy evaluation technology based on the dynamic evolution of TCM "syndromes" (zhenghou); spatiotemporal dynamic analysis technology for the multi-target mechanisms of action of TCM; high-efficiency discovery technology for active molecules of TCM and natural medicines; large-scale preparation technology for gene therapy viral vectors; macromolecular conjugate degrader technology; human induced pluripotent stem cell-derived cell drug technology; high-power multi-nuclide target system technology, etc. |
| 3.产业熟化阶段。协同催化合成技术与连续流生产技术、药物共晶与晶型工程技术、RNA 药物（mRNA、siRNA、ASO）化学修饰技术、合成生物学驱动的天然药物规模化生产技术、全自动高灵敏分子诊断技术、β核素放射性药物自动化合成与 GMP 生产技术、创新性α类放射性药物全流程质量控制与评价技术、原创性放射性药物化学标记与生物评价技术等。 | 3. Industrial maturation stage. Cooperative catalytic synthesis technology and continuous-flow production technology; drug co-crystal and crystal form engineering technology; chemical modification technology for RNA drugs (mRNA, siRNA, ASO); synthetic-biology-driven large-scale production technology for natural medicines; fully automated high-sensitivity molecular diagnostic technology; automated synthesis and GMP production technology for beta-nuclide radiopharmaceuticals; whole-process quality control and evaluation technology for innovative alpha-class radiopharmaceuticals; chemical labeling and biological evaluation technology for original radiopharmaceuticals, etc. |
（二）着力强基础扬优势，构建韧性安全新体系
(2) Strive to strengthen the foundation and leverage advantages, building a new system of resilience and security
5.夯实产业基础。完善医药产业链供应链安全风险评估和应对机制，加强对重点产品、产业链关键环节监测预警。支持相关医药工业企业开展上下游协同攻关，突破药用辅料、高端制药设备及耗材、仪器试剂、原材料和工业软件等环节关键技术。加强产业中试平台建设，加速科技成果转化与技术迭代升级，贯通创新产品技术研发、功能验证与规模化应用。支持建设生物信息中心、生命健康大数据产业基础设施等关键数据平台。
5. Consolidate the industrial foundation. Improve the security risk assessment and response mechanisms for the pharmaceutical industry chain and supply chain, and strengthen monitoring and early warning for key products and key links of the industry chain. Support relevant pharmaceutical industry enterprises in carrying out upstream-downstream collaborative tackling of key problems, achieving breakthroughs in key technologies in links such as pharmaceutical excipients, high-end pharmaceutical manufacturing equipment and consumables, instruments and reagents, raw materials, and industrial software. Strengthen the construction of industrial pilot-scale platforms, accelerate the transformation of scientific and technological achievements and technology iteration and upgrading, and connect the technology R&D, functional validation, and scaled application of innovative products. Support the construction of key data platforms such as bioinformatics centers and life-and-health big data industrial infrastructure.
| 专栏 4 产业基础技术和产品 | Box 4 Industrial Foundation Technologies and Products |
|---|---|
| 1.高端药用辅料与包装材料 | 1. High-end pharmaceutical excipients and packaging materials |
| 高端药用辅料。重点发展口服缓控释制剂用骨架材料、新型刺激响应与主动靶向新材料、生物药及核酸药物等高端制剂专用药用辅料、新型透皮制剂辅料、吸入制剂药用辅料、中药特色辅料等。 | High-end pharmaceutical excipients. Focus on developing matrix materials for oral sustained- and controlled-release formulations, new stimuli-responsive and active-targeting new materials, dedicated pharmaceutical excipients for high-end formulations such as biologics and nucleic acid drugs, excipients for new transdermal formulations, pharmaceutical excipients for inhalation formulations, distinctive excipients for traditional Chinese medicine (TCM), etc. |
| 医药包装材料。重点发展环状聚烯烃（COC、COP 等）、含氟聚合物覆膜材料、热缩性弹性体（TPE）等材料，适合传统中药制剂的包装材料和形式、自我给药装置、可穿戴医药包装与装置、铝/玻璃等药品容器/组件的内/外喷涂及表面处理材料等。 | Pharmaceutical packaging materials. Focus on developing materials such as cyclic polyolefins (COC, COP, etc.), fluoropolymer film-coating materials, and heat-shrinkable elastomers (TPE) [tr: rendered as written; 热缩性 = heat-shrinkable, though TPE normally abbreviates thermoplastic elastomer -- an inconsistency in the source]; packaging materials and forms suited to traditional TCM formulations; self-administration devices; wearable pharmaceutical packaging and devices; and internal/external spray-coating and surface-treatment materials for drug containers/components made of aluminum/glass, etc. |
| 2.原材料 | 2. Raw materials |
| 高端植介入医疗器械原材料。重点发展医用级聚氨酯、聚四氟乙烯、聚醚醚酮、聚砜/聚醚砜、钛镍超薄带材/丝材、铂合金丝材、锆铌合金、可降解医用镁合金/锌合金、高纯氧化锆、亲水润滑涂层/抗菌涂层/抗凝涂层等。 | Raw materials for high-end implantable and interventional medical devices. Focus on developing medical-grade polyurethane, polytetrafluoroethylene, polyether ether ketone, polysulfone/polyethersulfone, ultra-thin nickel-titanium strip/wire, platinum alloy wire, zirconium-niobium alloy, degradable medical magnesium alloy/zinc alloy, high-purity zirconia, hydrophilic lubricious coatings/antibacterial coatings/anticoagulant coatings, etc. |
| 生物药生产用原料及耗材。重点发展新型无血清培养基、不同类型生物制品分离纯化用层析填料，深层过滤、超滤、纳滤等膜过滤材料等。 | Raw materials and consumables for biologics production. Focus on developing new serum-free culture media, chromatography resins for the separation and purification of different types of biological products, and membrane filtration materials for depth filtration, ultrafiltration, nanofiltration, etc. |
| 3.生产工艺系统 | 3. Production process systems |
| 原料药及制剂生产工艺系统。重点发展微通道反应器、核酸合成仪、新型结晶器、高密闭性隔离器、膜分离系统、高端生物反应器及核心部件、碟片离心机、全自动一次性层析/多柱连续层析系统、微纳米制剂和透皮贴片等高端制剂生产设备、高速无菌吹灌封（BFS）一体化生产线等。 | Production process systems for active pharmaceutical ingredients (APIs) and formulations. Focus on developing microchannel reactors, nucleic acid synthesizers, new crystallizers, high-containment isolators, membrane separation systems, high-end bioreactors and core components, disc-stack centrifuges, fully automated single-use chromatography/multi-column continuous chromatography systems, production equipment for high-end formulations such as micro/nano formulations and transdermal patches, high-speed aseptic blow-fill-seal (BFS) integrated production lines, etc. |
| 医疗器械生产工艺系统。重点发展高端五轴联动加工中心、介入器械专用四轴精密成型机床、3D 生物打印定制装备、表面改性专用等离子喷涂设备、微流控芯片精密刻蚀机、高精度光学装调与检测系统等。 | Production process systems for medical devices. Focus on developing high-end five-axis simultaneous machining centers, four-axis precision forming machine tools dedicated to interventional devices, customized 3D bioprinting equipment, plasma spraying equipment dedicated to surface modification, precision etching machines for microfluidic chips, high-precision optical alignment and inspection systems, etc. |
| 4.医药工业软件 | 4. Pharmaceutical industrial software |
| 药物研发类。重点发展实验室信息管理系统、计算机辅助药物设计、人工智能药物发现与设计等。 | Drug R&D category. Focus on developing laboratory information management systems, computer-aided drug design, artificial intelligence drug discovery and design, etc. |
| 生产控制类。重点开发与药品生产质量管理规范（GMP）相结合的制造执行系统、高级计划与排程系统、过程分析系统，数据采集与监控系统、分散控制系统等工业控制系统。 | Production control category. Focus on developing manufacturing execution systems, advanced planning and scheduling systems, and process analysis systems integrated with Good Manufacturing Practice (GMP) for drugs, and industrial control systems such as supervisory control and data acquisition systems and distributed control systems. |
| 质量保障类。重点开发药品和医疗器械质量管理系统、质量回顾系统、电子批记录系统、工艺趋势预测和偏差分析系统等。 | Quality assurance category. Focus on developing quality management systems for drugs and medical devices, quality review systems, electronic batch record systems, process trend prediction and deviation analysis systems, etc. |
6.巩固竞争优势。实施专利过期药物高效替代行动，推进通用名药（即仿制药）、生物类似药系统开发和推广应用，支持新技术、新剂型、新工艺快速迭代升级，大幅提升高价值临床用药可及性。增强化学原料药市场竞争力和产业控制力， 提高连续化、智能化、绿色化生产水平。支持中药工业企业加强传承创新，强化中药大品种的质量优势和品牌优势。积极发展创新中药，健全符合中医药规律特点的评价体系，畅通经典名方、医疗机构制剂向规模化产品转化路径。
6. Consolidate competitive advantages. Implement an action for the efficient substitution of off-patent drugs, advance the systematic development and promotion and application of generic-name drugs (i.e., generic drugs) and biosimilars, support the rapid iteration and upgrading of new technologies, new dosage forms, and new processes, and substantially improve the accessibility of high-value clinical medications. Enhance the market competitiveness and industrial control of chemical APIs, and raise the level of continuous, intelligent, and green production. Support TCM industrial enterprises in strengthening inheritance and innovation, and reinforce the quality advantages and brand advantages of major TCM varieties. Actively develop innovative TCM, improve an evaluation system consistent with the laws and characteristics of TCM, and smooth the pathways for converting classical famous formulas and medical institution preparations into scaled products.
| 专栏 5 优势工艺技术 | Box 5 Advantageous Process Technologies |
|---|---|
| 1.原料药绿色生产技术。重点发展酶催化、电化学反应、光化学合成、生物合成、连续合成等技术，贵金属催化剂替代或再利用技术，有毒有害、高 VOCs 含量、高光化学反应活性原料替代技术，废水高级氧化、膜生物反应等处理技术，高浓度难降解废水处理技术，挥发性有机废气高效处理技术，废液废渣资源化、无害化处理与评价技术等。 | 1. Green production technologies for APIs. Focus on developing technologies such as enzymatic catalysis, electrochemical reactions, photochemical synthesis, biosynthesis, and continuous synthesis; technologies for the substitution or reuse of precious metal catalysts; technologies for substituting raw materials that are toxic and hazardous, high in VOCs content, or highly photochemically reactive; wastewater treatment technologies such as advanced oxidation and membrane bioreactors; technologies for treating high-concentration, refractory wastewater; technologies for the efficient treatment of volatile organic waste gases; technologies for the resource recovery, harmless treatment, and evaluation of waste liquids and waste residues; etc. |
| 2.中药关键技术工艺。重点发展濒危药材人工繁育、中药材品种选育、中药材生态种植养殖、中药炮制智能制造、中药连续制造、中药全产业链质量控制等技术。突破天然活性分子成药性优化技术、中药复方物质基础解析、质量标志物识别、质量—药效关联评价及批间一致性控制技术等。 | 2. Key TCM technologies and processes. Focus on developing technologies such as artificial breeding of endangered medicinal materials, variety selection and breeding of TCM medicinal materials, ecological cultivation and farming of TCM medicinal materials, intelligent manufacturing for TCM processing (paozhi), continuous manufacturing of TCM, and quality control across the entire TCM industry chain. Achieve breakthroughs in technologies for optimizing the druggability of natural active molecules, analysis of the material basis of TCM compound formulas, identification of quality markers, quality-efficacy correlation evaluation, and batch-to-batch consistency control, etc. |
| 3.高端化学药复杂制剂工艺。重点发展脂质体靶向递送、微球/植入剂长效缓释、纳米晶增溶、透皮微针、刺激响应性释药、口服缓控释、黏膜给药、3D 打印制剂、连续化智能制造等工艺。 | 3. Processes for high-end complex formulations of chemical drugs. Focus on developing processes such as liposomal targeted delivery, long-acting sustained release via microspheres/implants, nanocrystal solubilization, transdermal microneedles, stimuli-responsive drug release, oral sustained and controlled release, mucosal delivery, 3D-printed formulations, and continuous intelligent manufacturing. |
| 4.高端生物药制备工艺。重点发展细胞株构建、灌流培养、连续流层析、病毒载体生产、ADC 定点偶联、小核酸药物肝外靶向递送、mRNA-LNP 包封、CAR-T 扩增、全封闭自动化细胞处理、环状 RNA 制备、外泌体递送等工艺。 | 4. Preparation processes for high-end biologics. Focus on developing processes such as cell line construction, perfusion culture, continuous-flow chromatography, viral vector production, ADC site-specific conjugation, extrahepatic targeted delivery of small nucleic acid drugs, mRNA-LNP encapsulation, CAR-T expansion, fully closed automated cell processing, circular RNA preparation, and exosome delivery. |
| 5.医疗器械先进制造工艺技术。重点发展医疗器械超精密微纳加工、介入产品一体化成型、仿生结构高精度复刻等核心制造工艺，高生物相容性表面改性、抗凝血与抗感染涂层制备等功能化处理工艺，突破微创介入器械柔性成型、薄壁管材高精度拉拔、复杂内腔精密抛光等工艺瓶颈。 | 5. Advanced manufacturing process technologies for medical devices. Focus on developing core manufacturing processes such as ultra-precision micro/nano machining of medical devices, integrated forming of interventional products, and high-precision replication of biomimetic structures, as well as functionalization processes such as highly biocompatible surface modification and the preparation of anticoagulant and anti-infective coatings; and break through process bottlenecks such as flexible forming of minimally invasive interventional devices, high-precision drawing of thin-walled tubing, and precision polishing of complex internal cavities. |
7.培育发展新动能。打造生物类似药、多肽药物、小核酸药物、高端制剂、体外诊断产品等重点优势产业链。推动重点品种产业化，培育细分领域国际龙头企业，推动形成若干产业集群。鼓励医药工业企业聚焦缓控释、靶向给药、新给药途径等高端制剂，打造一批市场认可度高、临床价值突出的卓越产品。加快体外诊断产品迭代升级，拓展应用场景，完善检验检测服务体系。
7. Cultivate and develop new growth drivers. Build key advantageous industry chains in biosimilars, peptide drugs, small nucleic acid drugs, high-end formulations, in vitro diagnostic (IVD) products, etc. Promote the industrialization of key varieties, cultivate internationally leading enterprises in niche fields, and promote the formation of several industrial clusters. Encourage pharmaceutical industry enterprises to focus on high-end formulations such as sustained and controlled release, targeted drug delivery, and new routes of administration, and create a batch of outstanding products with high market recognition and prominent clinical value. Accelerate the iteration and upgrading of IVD products, expand application scenarios, and improve the testing and inspection service system.
（三）持续提质增效赋能，树立数智转型新标杆
(3) Continuously improve quality, raise efficiency, and empower, setting new benchmarks for digital and intelligent transformation
8.深化人工智能赋能升级。支持医药工业企业联合医疗机构、科研院所、医药研发服务机构建设医药行业高质量数据集，打造医药健康可信数据空间，促进医药健康数据流通和使用，加快研发医药垂类大模型与智能体。围绕药物发现、临床研究、工艺优化、质量管理、流通使用、智慧监管等环节，打造 AI 制药高价值应用场景，加速人工智能驱动的医药研发和生产管理范式变革。
8. Deepen AI empowerment and upgrading. Support pharmaceutical industry enterprises in joining with medical institutions, research institutes, and pharmaceutical R&D service organizations to build high-quality datasets for the pharmaceutical sector, create trusted data spaces for pharmaceuticals and health, promote the circulation and use of pharmaceutical and health data, and accelerate the R&D of pharmaceutical vertical large models and intelligent agents. Focusing on links such as drug discovery, clinical research, process optimization, quality management, distribution and use, and smart regulation, create high-value application scenarios for AI in pharmaceuticals, and accelerate the AI-driven paradigm shift in pharmaceutical R&D and production management.
9.推动数智化转型。以高价值应用场景为切入点，推动医药数智化系统解决方案及技术产品协同攻关，加速检测用高端传感器、在线分析仪等核心零部件产业化。强化标准规范引领，健全数智化转型公共服务体系， 依托医药工业数智化转型促进中心、制造业数字化转型促进中心等服务平台，推进共性技术攻关和推广应用，面向全行业提供软硬件适配验证测试、计算机化系统验证（CSV）等技术服务，加快提升医药工业企业质量管理水平和发展效能。
9. Promote digital and intelligent transformation. Taking high-value application scenarios as the entry point, promote collaborative tackling of key problems for digital and intelligent pharmaceutical system solutions and technology products, and accelerate the industrialization of core components such as high-end sensors for testing and online analyzers. Strengthen guidance by standards and specifications, improve the public service system for digital and intelligent transformation, and, relying on service platforms such as pharmaceutical industry digital and intelligent transformation promotion centers and manufacturing digital transformation promotion centers, advance the tackling of key problems in, and the promotion and application of, common technologies; provide technical services such as software-hardware adaptation verification testing and computerized system validation (CSV) to the whole industry; and accelerate improvement in the quality management level and development efficiency of pharmaceutical industry enterprises.
10.加快绿色化提升。鼓励医药工业企业运用大数据、人工智能、工业互联网等技术，加强药品生产全过程能源资源利用精准监测与智能调控，持续提升数字化绿色化协同发展能力。引导医药工业企业落实绿色工厂、绿色园区和绿色供应链创建要求，鼓励原料药等领域开展碳足迹评价。支持涉及易燃易爆危险化学品和爆炸性粉尘的医药工业企业加快数字化改造，提升本质安全水平。
10. Accelerate green upgrading. Encourage pharmaceutical industry enterprises to use technologies such as big data, artificial intelligence, and the industrial internet to strengthen precise monitoring and intelligent regulation of energy and resource use across the entire drug production process, and continuously improve capabilities for coordinated digital and green development. Guide pharmaceutical industry enterprises to implement the requirements for building green factories, green parks, and green supply chains, and encourage carbon footprint evaluation in fields such as APIs. Support pharmaceutical industry enterprises that involve flammable and explosive hazardous chemicals and explosive dust in accelerating digital retrofitting and raising their level of intrinsic safety.
| 专栏 6 AI 制药高价值应用场景培育 | Box 6 Cultivating High-Value Application Scenarios for AI in Pharmaceuticals |
|---|---|
| 1.智能靶点筛选与药物发现。重点开发应用 AI 赋能靶点筛选、药物分子设计与优化、化合物虚拟筛选、候选药物特性分析、动物模型数据挖掘、中医药人用经验数据挖掘和决策模型研究、实验室数据集成管理、辅助临床试验方案审评与科学评估等应用场景。 | 1. Intelligent target screening and drug discovery. Focus on developing and applying AI-empowered application scenarios such as target screening, drug molecule design and optimization, virtual compound screening, candidate drug property analysis, animal model data mining, data mining of TCM human-use experience and decision-model research, integrated management of laboratory data, and assisted review and scientific assessment of clinical trial protocols. |
| 2.智能制药与质量管理。重点开发应用一批基于 AI 技术的制药全流程数据自动采集与全流程追溯系统，开发面向关键质量属性的实时预警与闭环控制 AI 智能化平台。 | 2. Intelligent pharmaceutical manufacturing and quality management. Focus on developing and applying a batch of AI-based systems for automated data collection and full-process traceability across the entire pharmaceutical manufacturing process, and develop AI intelligent platforms for real-time early warning and closed-loop control oriented to critical quality attributes. |
| 3.智能医药使用及健康管理。重点开发应用一批智能用药指导与处方辅助审核场景，结合数字孪生与 AI 预测模型，探索建立高仿真虚拟患者模型与疾病演进模型体系，赋能临床诊疗、真实世界研究与个性化健康管理应用。 | 3. Intelligent medicine use and health management. Focus on developing and applying a batch of scenarios for intelligent medication guidance and assisted prescription review; combining digital twins and AI predictive models, explore establishing a system of high-fidelity virtual patient models and disease progression models, empowering applications in clinical diagnosis and treatment, real-world research, and personalized health management. |
| 4.智慧药械生产流通监管。重点开发应用“两品一械”（药品、化妆品和医疗器械）审评审批检查大模型与智能体，高效赋能产品智能分类、任务分配、资料审查、知识检索、问题识别、报告生成及制证送达等高频业务场景。整合研发、生产、流通、使用等全生命周期数据，实现药械产品质量安全全程受控。 | 4. Smart regulation of drug and device production and distribution. Focus on developing and applying large models and intelligent agents for the review, approval, and inspection of the "two products and one device" (drugs, cosmetics, and medical devices), efficiently empowering high-frequency business scenarios such as intelligent product classification, task assignment, dossier review, knowledge retrieval, issue identification, report generation, and certificate issuance and delivery. Integrate full-lifecycle data across R&D, production, distribution, and use to achieve full-process control of the quality and safety of drug and device products. |
| 5.智能真实世界研究及上市后评价。建设真实世界数据研究与应用平台。支持利用人工智能等技术，系统、规范收集药械临床真实世界应用数据，纳入可信数据空间进行深度关联和挖掘分析，为依法依规开展产品全生命周期临床评价提供支持。 | 5. Intelligent real-world research and post-marketing evaluation. Build real-world data research and application platforms. Support the use of technologies such as artificial intelligence to systematically and in a standardized manner collect clinical real-world application data on drugs and devices, incorporate them into trusted data spaces for in-depth correlation and mining analysis, and provide support for conducting full-lifecycle clinical evaluation of products in accordance with laws and regulations. |
（四）顺应技术演进态势，培育精准诊疗新范式
(4) Follow the Trend of Technological Evolution and Cultivate a New Paradigm of Precision Diagnosis and Treatment
**11.发展精准预防药械产品。**推动基因检测、生物遗传技术与疾病预防体系深度融合。支持医药工业企业开发新型疫苗、精准营养素、靶向干预产品及智能化预防方案，完善产品研发和生产质控体系。加强需求牵引，推动强化遗传病、出生缺陷、肿瘤、心血管疾病等重大疾病早期筛查预防，引导医药工业企业与健康管理专业机构合作，加大健康管理相关产品开发力度。
11. Develop precision prevention drug and device products. Promote the deep integration of genetic testing and biological genetic technologies with the disease prevention system. Support pharmaceutical industry enterprises in developing novel vaccines, precision nutrients, targeted intervention products, and intelligent prevention solutions, and improve product R&D and production quality control systems. Strengthen demand pull; promote stronger early screening and prevention of major diseases such as genetic diseases, birth defects, tumors, and cardiovascular diseases; guide pharmaceutical industry enterprises to cooperate with professional health management institutions; and step up the development of health-management-related products.
**12.壮大精准诊断产业规模。**重点发展高通量基因测序、微流控、高灵敏生物检测等技术，推动体外诊断、医学影像、病理诊断、分子诊断、多组学检测等领域融合升级，加快创新诊断产品产业化。 完善精准诊断产品质量控制、临床评价及标准体系。推动有条件的医疗机构发展精准诊断中心，加强与相关企业合作，促进诊疗数据互联互通、共享共用，加快精准诊断技术与数字健康、人工智能深度融合， 提升罕见病、肿瘤、遗传病等精准诊断水平。
12. Expand the scale of the precision diagnostics industry. Focus on developing technologies such as high-throughput gene sequencing, microfluidics, and high-sensitivity biological detection; promote the integration and upgrading of fields such as in vitro diagnostics, medical imaging, pathological diagnosis, molecular diagnostics, and multi-omics testing; and accelerate the industrialization of innovative diagnostic products. Improve the quality control, clinical evaluation, and standards systems for precision diagnostic products. Promote the development of precision diagnosis centers by qualified medical institutions, strengthen their cooperation with relevant enterprises, promote the interconnection, sharing, and common use of diagnosis and treatment data, accelerate the deep integration of precision diagnostic technologies with digital health and artificial intelligence, and raise the level of precision diagnosis for rare diseases, tumors, genetic diseases, etc.
| 专栏 7 精准医药重点技术和产品 | Box 7 Key Technologies and Products for Precision Medicine |
|---|---|
| 1.肿瘤精准早筛和诊断产品。重点发展基因组、代谢组、蛋白组等多组学联合检测，聚焦多癌种早期筛查，突破数字液体活检、甲基化检测等关键技术的普适化瓶颈，提升早期检出率。重点发展肿瘤分子分型及特异性靶点检测产品，推动基于循环肿瘤 DNA（ctDNA）、循环肿瘤细胞（CTC）、外泌体等多靶标联合检测技术的临床应用。重点发展 AI 辅助影像诊断与多模态影像融合技术，实现病灶精准定位和性质鉴别。加强核医学分子影像探针研发，开发新型正电子发射断层显像（PET）和单光子发射计算机断层显像（SPECT）示踪剂，推动核素诊疗一体化产品的开发与应用。 | 1. Precision early screening and diagnostic products for tumors. Focus on developing combined multi-omics testing such as genomics, metabolomics, and proteomics; focus on early screening for multiple cancer types; break through the bottlenecks to broad applicability [tr: pushihua, i.e., making the technology widely usable and accessible] of key technologies such as digital liquid biopsy and methylation detection; and raise early detection rates. Focus on developing tumor molecular typing and specific target detection products, and promote the clinical application of multi-target combined detection technologies based on circulating tumor DNA (ctDNA), circulating tumor cells (CTC), exosomes, etc. Focus on developing AI-assisted imaging diagnosis and multimodal image fusion technologies to achieve precise localization and characterization of lesions. Strengthen R&D of nuclear medicine molecular imaging probes, develop novel positron emission tomography (PET) and single-photon emission computed tomography (SPECT) tracers, and promote the development and application of integrated radionuclide diagnosis-and-therapy products. |
| 2.重点慢性疾病精准诊断产品。针对心脑血管、代谢异常、神经退行性等慢性疾病早期发现与精准诊断，重点开发基于微针传感、汗液传感等新型在体检测技术，实现生理指标的连续、无创监测。重点开发血脂精准分型检测产品及易感基因检测产品，聚焦帕金森病、阿尔茨海默症等神经退行性疾病，发展基于生物标志物的靶向干预产品与早期筛查技术，实现早预警、早干预。 | 2. Precision diagnostic products for key chronic diseases. Targeting the early detection and precision diagnosis of chronic diseases such as cardiovascular and cerebrovascular, metabolic, and neurodegenerative diseases, focus on developing novel in vivo detection technologies based on microneedle sensing, sweat sensing, etc., to achieve continuous, non-invasive monitoring of physiological indicators. Focus on developing precision blood lipid typing test products and susceptibility gene test products; focusing on neurodegenerative diseases such as Parkinson's disease and Alzheimer's disease, develop biomarker-based targeted intervention products and early screening technologies to achieve early warning and early intervention. |
| 3.母婴与儿童精准检测产品。重点开发 NIPT2.0（新一代无创产前筛查技术）、遗传病携带者筛查产品及广谱预防型疫苗，推动新一代基因测序产品在出生缺陷防控领域的应用。发展基于高通量测序技术的单基因遗传病无创产前检测新方法，扩大筛查病种覆盖范围。开发针对新生儿遗传代谢病、基因缺失性疾病等重点出生缺陷疾病的快速精准检测产品，实现遗传病精准诊断与早期预防，降低出生缺陷风险，提升母婴健康保障水平。 | 3. Precision testing products for mothers, infants, and children. Focus on developing NIPT2.0 (next-generation non-invasive prenatal screening technology), genetic disease carrier screening products, and broad-spectrum preventive vaccines, and promote the application of next-generation gene sequencing products in the prevention and control of birth defects. Develop new methods of non-invasive prenatal testing for monogenic genetic diseases based on high-throughput sequencing technology, and expand the range of diseases covered by screening. Develop rapid precision testing products for key birth defect diseases such as neonatal inherited metabolic diseases and gene-deletion diseases, achieve precision diagnosis and early prevention of genetic diseases, reduce the risk of birth defects, and raise the level of maternal and infant health protection. |
| 4.公共卫生感染精准预防与诊断产品。重点开发感染早期预警与免疫干预产品，构建公共卫生防控体系，提升对传染病、感染性疾病的全链条防控能力。重点发展即时检测（POCT）产品，突破核酸快速扩增、微流控芯片、CRISPR 等病原体精准识别核心技术，实现现场快速检测。开发普适化多病原体联检产品及耐药基因快速检测产品，提升新发突发传染病的早期发现与快速响应能力。 | 4. Precision prevention and diagnostic products for public health infections. Focus on developing infection early-warning and immune intervention products, build a public health prevention and control system, and enhance whole-chain prevention and control capabilities for communicable diseases and infectious diseases. Focus on developing point-of-care testing (POCT) products, break through core technologies for precise pathogen identification such as rapid nucleic acid amplification, microfluidic chips, and CRISPR, and achieve on-site rapid testing. Develop broadly applicable multi-pathogen combined testing products and rapid drug-resistance gene testing products, and enhance capabilities for the early detection of and rapid response to emerging and sudden-onset infectious diseases. |
**13.构建精准治疗产业生态。**支持医药工业企业向“检测—诊断—治疗”全链条延伸，建立基于靶点、分型的精准治疗产品组合。鼓励医药工业企业与医疗机构、科研院所等加强产学研用协同合作，加快重大疾病领域靶向药物、抗体药物、细胞与基因治疗药物、创新中药制剂及微创介入器械等精准治疗产品的研发与产业化。
13. Build a precision therapy industrial ecosystem. Support pharmaceutical industry enterprises in extending along the full "testing -- diagnosis -- treatment" chain and establishing precision therapy product portfolios based on targets and subtypes. Encourage pharmaceutical industry enterprises to strengthen industry-academia-research-application collaboration with medical institutions, research institutes, etc., and accelerate the R&D and industrialization of precision therapy products in major disease areas, such as targeted drugs, antibody drugs, cell and gene therapy drugs, innovative traditional Chinese medicine preparations, and minimally invasive interventional devices.
（五）释放要素生态潜能，实现效率提升新突破
(5) Unleash the Potential of the Factor Ecosystem and Achieve New Breakthroughs in Efficiency Improvement
**14.畅通临床高效转化通道。**支持医药工业企业联合高校、科研院所和医疗机构组建转化医学联合体和临床资源共享网络，推动靶点发现、药物筛选与临床需求高效衔接。依托重点园区布局转化医学中心和非临床研究平台， 提供药效评价、毒理研究等服务。支持研究型医院牵头建设高水平临床试验机构，优化临床试验方案和伦理审查等相关流程，进一步压缩临床试验启动周期。支持推行统一的医院信息系统（HIS）标准， 鼓励临床试验数字化改造与审评、检查联网。支持企业建设技术转移机构和专业化服务团队，提升创新成果由实验室向临床阶段转化效率。
14. Unblock efficient clinical translation channels. Support pharmaceutical industry enterprises in joining with universities, research institutes, and medical institutions to form translational medicine consortia and clinical resource sharing networks, and promote the efficient linking of target discovery and drug screening with clinical needs. Relying on key industrial parks, lay out translational medicine centers and non-clinical research platforms that provide services such as pharmacodynamic evaluation and toxicology research. Support research-oriented hospitals in taking the lead in building high-level clinical trial institutions, optimize related processes such as clinical trial protocols and ethics review, and further shorten clinical trial start-up cycles. Support the implementation of unified hospital information system (HIS) standards, and encourage the digital transformation of clinical trials and their networking with review and inspection. Support enterprises in building technology transfer institutions and specialized service teams, and raise the efficiency with which innovation results are translated from the laboratory to the clinical stage.
**15.完善工程化高效放大体系。**聚焦抗体药物、重组蛋白药物、细胞与基因治疗药物等领域生产工艺验证需求，支持医药工业企业和专业机构建设概念验证、中试验证平台。鼓励第三方机构建设中试车间， 向中小企业开放关键设备与生产线资源。支持医药工业企业围绕细胞培养、纯化分离、制剂工艺等关键环节开展工艺优化与放大验证，提升产品稳定性和批次间一致性。引导上游设备、原辅料企业与制药企业协同攻关， 提升工程化放大和规模生产支撑能力。
15. Improve the efficient engineering scale-up system. Focusing on production process validation needs in fields such as antibody drugs, recombinant protein drugs, and cell and gene therapy drugs, support pharmaceutical industry enterprises and specialized institutions in building proof-of-concept and pilot-scale validation platforms. Encourage third-party institutions to build pilot-scale workshops and open key equipment and production line resources to small and medium-sized enterprises. Support pharmaceutical industry enterprises in carrying out process optimization and scale-up validation around key steps such as cell culture, purification and separation, and formulation processes, to improve product stability and batch-to-batch consistency. Guide upstream equipment and raw and auxiliary materials enterprises to tackle key problems jointly with pharmaceutical manufacturers, and enhance the capacity to support engineering scale-up and large-scale production.
**16.打造产业高效协同格局。**充分发挥龙头医药工业企业引领作用，带动中小企业专精特新发展，培育细分领域制造业单项冠军企业。鼓励通用名药、生物类似药、原料药生产向具备规模优势、生产质量水平领先的企业集中。 依托重点园区推动研发、中试和生产功能集聚布局，建设公共服务平台和专业化孵化载体，为中小企业提供检测认证、注册申报等服务。开展国家高新区新赛道培育行动，培育一批生物医药重点新赛道。推动京津冀、长三角、粤港澳大湾区等区域形成世界级医药产业集群， 建设若干国内一流和特色突出的医药产业集聚区，提升产业整体效率和规模化发展水平。发挥沿海地区资源优势，统筹加强“资源链+科技链+产业链+应用链”全链条创新体系建设，打造海洋药物和功能制品产业集群。
16. Build an efficient industrial collaboration pattern. Give full play to the leading role of leading pharmaceutical industry enterprises, drive the specialized, refined, distinctive, and innovative development of small and medium-sized enterprises, and cultivate manufacturing single-item champion enterprises in niche fields. Encourage the concentration of the production of generic drugs, biosimilars, and active pharmaceutical ingredients (APIs) in enterprises with scale advantages and leading levels of production quality. Relying on key industrial parks, promote the clustered layout of R&D, pilot-scale, and production functions, and build public service platforms and specialized incubation vehicles to provide small and medium-sized enterprises with services such as testing and certification and registration filing. Carry out the action to cultivate new tracks in national high-tech zones, and cultivate a batch of key new biomedicine tracks. Promote the formation of world-class pharmaceutical industry clusters in regions such as Beijing-Tianjin-Hebei, the Yangtze River Delta, and the Guangdong-Hong Kong-Macao Greater Bay Area, build a number of domestically first-class pharmaceutical industry agglomeration zones with outstanding distinctive features, and raise the overall efficiency and scaled development level of the industry. Leverage the resource advantages of coastal regions, coordinate and strengthen the construction of a whole-chain innovation system of "resource chain + science and technology chain + industrial chain + application chain," and build marine drug and functional product industrial clusters.
| 专栏 8 优势产业集群培育 | Box 8 Cultivation of Advantageous Industrial Clusters |
|---|---|
| 1.京津冀及其他环渤海地区生物医药产业集群。立足北京、天津、河北、山东、辽宁等环渤海省份资源禀赋的互补优势，构建“京津研发策源、区域协同转化、腹地规模制造”的产业新格局，重点发展小分子创新药、细胞与基因治疗、高端医疗器械、脑机接口、现代中药、高端原料药、海洋药物及高端医药服务型制造等领域。 | 1. Beijing-Tianjin-Hebei and other Bohai Rim region biomedicine industrial cluster. Based on the complementary advantages of the resource endowments of Bohai Rim provinces such as Beijing, Tianjin, Hebei, Shandong, and Liaoning, build a new industrial pattern of "Beijing-Tianjin as the source of R&D, regional collaborative translation, and large-scale manufacturing in the hinterland," focusing on developing fields such as small-molecule innovative drugs, cell and gene therapy, high-end medical devices, brain-computer interfaces, modern traditional Chinese medicine, high-end APIs, marine drugs, and high-end pharmaceutical service-oriented manufacturing. |
| 2.长三角创新药械产业集群。发挥长三角地区药物研发和临床资源丰富、制造体系完备等优势，挖掘发展潜力，形成高效协同，打造全球创新药械首发地、科学家创业首选地，实现全球首创、中国首发、临床首用创新产品持续涌现。加快发展小分子创新药、新型抗体、细胞与基因治疗、高端医疗器械等。加快发展重组蛋白药物、高端原料药、药用辅料等。加快发展海洋药物和功能制品、放射性药物等。 | 2. Yangtze River Delta innovative drugs and devices industrial cluster. Leverage the advantages of the Yangtze River Delta region, such as abundant drug R&D and clinical resources and a complete manufacturing system; tap development potential and form efficient collaboration; build a global first-launch location for innovative drugs and devices and a preferred destination for scientists to start businesses; and achieve a continuous stream of innovative products that are world-first, first launched in China, and first used in the clinic. Accelerate the development of small-molecule innovative drugs, novel antibodies, cell and gene therapy, high-end medical devices, etc. Accelerate the development of recombinant protein drugs, high-end APIs, pharmaceutical excipients, etc. Accelerate the development of marine drugs and functional products, radiopharmaceuticals, etc. |
| 3.粤港澳创新药械产业集群。依托产业集群优势、“港澳药械通”等制度优势、粤港澳三地联动及大湾区国际资源汇聚的开放合作优势，建设全球知名的高端医疗器械研发中心和国内领先、国际一流的医药产业集聚发展高地，重点发展高端医疗器械、高端原料药、创新药、脑科学与脑机接口产品、现代中药、海洋药物和功能制品等。 | 3. Guangdong-Hong Kong-Macao innovative drugs and devices industrial cluster. Relying on industrial cluster advantages, institutional advantages such as the "Hong Kong and Macao Drugs and Medical Devices Connect" policy, and the open-cooperation advantages of the three-way linkage among Guangdong, Hong Kong, and Macao and the convergence of international resources in the Greater Bay Area, build a globally renowned high-end medical device R&D center and a domestically leading, internationally first-class highland for the agglomerated development of the pharmaceutical industry, focusing on developing high-end medical devices, high-end APIs, innovative drugs, brain science and brain-computer interface products, modern traditional Chinese medicine, marine drugs and functional products, etc. |
| 4.成渝生物医药产业集群。立足成渝地区双城经济圈生物医药资源互补、产业协同优势，发挥成都前沿研发与临床转化、重庆高端器械制造与物流枢纽的双核联动作用，形成“成都研发、双城制造”的协作格局，重点发展抗体药物、基因治疗、高端影像设备、核医药、现代中药及 CXO 服务平台等细分领域。 | 4. Chengdu-Chongqing biomedicine industrial cluster. Based on the complementary biomedicine resources and industrial collaboration advantages of the Chengdu-Chongqing Twin-City Economic Circle, give play to the dual-core linkage of Chengdu's frontier R&D and clinical translation and Chongqing's high-end device manufacturing and logistics hub, form a collaboration pattern of "R&D in Chengdu, manufacturing in both cities," and focus on developing niche fields such as antibody drugs, gene therapy, high-end imaging equipment, nuclear medicine, modern traditional Chinese medicine, and CXO service platforms. |
| 5.中部医药制造产业集群。依托长江中游城市群与中原城市群的区位交通、产业基础与成本优势，综合发挥化学药、中药、生物制品、医疗器械制造集聚区和医药物流中心的辐射带动作用，深化“研发—制造—流通”全链协同。重点发展高端原料药、高端化学制剂、血液制品、医疗器械、医用耗材、现代中药及医药冷链物流等。 | 5. Central region pharmaceutical manufacturing industrial cluster. Relying on the location and transportation, industrial base, and cost advantages of the Middle Yangtze River urban agglomeration and the Central Plains urban agglomeration, give comprehensive play to the radiating and driving role of the chemical drug, traditional Chinese medicine, biological product, and medical device manufacturing agglomeration zones and pharmaceutical logistics centers, and deepen whole-chain "R&D -- manufacturing -- distribution" collaboration. Focus on developing high-end APIs, high-end chemical formulations, blood products, medical devices, medical consumables, modern traditional Chinese medicine, pharmaceutical cold-chain logistics, etc. |
| 6.边疆地区中药（民族药）产业集群。发挥西藏、内蒙古、新疆、云南、广西、海南、吉林等在药材种植、民族医学与特色诊疗等方面的特色优势，强化“资源保护—标准制定—品牌培育—跨境合作”全链条建设，形成“药材道地化、生产标准化、应用国际化”的融合发展格局，打造一批高标准中药原料生产基地、民族药传承创新转化基地，重点发展高品质中药饮片、民族药独家品种、药食同源健康产品、热带海洋药物等。 | 6. Border region traditional Chinese medicine (ethnic medicine) industrial cluster. Give play to the distinctive advantages of Tibet, Inner Mongolia, Xinjiang, Yunnan, Guangxi, Hainan, Jilin, etc. in medicinal material cultivation, ethnic medicine, and distinctive diagnosis and treatment; strengthen whole-chain construction of "resource protection -- standard-setting -- brand cultivation -- cross-border cooperation"; form an integrated development pattern of "genuine-region (daodi) medicinal materials, standardized production, and internationalized application"; build a batch of high-standard production bases for traditional Chinese medicine raw materials and bases for the inheritance, innovation, and translation of ethnic medicines; and focus on developing high-quality traditional Chinese medicine decoction pieces, exclusive ethnic medicine varieties, health products based on substances that are both food and medicine, tropical marine drugs, etc. |
（六）推动量质协同跃升，拓展价值创造新空间
(6) Promote a coordinated leap in quantity and quality, and expand new space for value creation
**17.深化医药工业健康价值。**发挥产业溢出效应，构建医药健康产业生态圈。积极推动医药工业与健康养老、健康旅游、慢病康养、健身休闲、健康食品等融合，催生医药健康新产品、新业态、新模式。 支持医药工业企业布局药食同源产品、智能健康穿戴设备、保健食品、特殊医学用途配方食品等健康消费品。推动跨界新技术在健康管理相关场景应用，发展远程医疗、个性化健康管理等服务。支持零售药店扩展专业服务、健康促进等功能， 打造更好服务群众的“健康驿站”，拓展多元化健康消费市场。挖掘中药资源优势，围绕抗衰老、养老护理、康复、健康管理等需求，开拓中医药新消费场景。
17. Deepen the health value of the pharmaceutical industry. Leverage the industry's spillover effects and build a pharmaceutical and health industry ecosystem. Actively promote the integration of the pharmaceutical industry with health and elderly care, health tourism, chronic disease rehabilitation and wellness, fitness and leisure, health foods, etc., spawning new pharmaceutical and health products, new business formats, and new models. Support pharmaceutical industry enterprises in positioning themselves in health consumer goods such as medicine-food homology products [tr: 药食同源, substances traditionally used as both food and medicine], smart health wearable devices, health foods, and foods for special medical purposes. Promote the application of new cross-sector technologies in health management-related scenarios, and develop services such as telemedicine and personalized health management. Support retail pharmacies in expanding functions such as professional services and health promotion, building "health stations" that better serve the public, and expanding a diversified health consumption market. Tap the advantages of traditional Chinese medicine (TCM) resources and, centering on needs such as anti-aging, elderly care and nursing, rehabilitation, and health management, open up new consumption scenarios for TCM.
**18.提升医药工业社会价值。**加快慢性病、传染病、老年病、罕见病等领域创新药械推广应用，强化全生命周期健康防护产品供给和重点人群健康保障。大力发展智慧健康服务，强化职业人群健康防护与健康干预。提升生物安全管控能力，指导医药工业企业完善安全管理体系，分级分类强化风险评估、风险辨识、风险预警，支持医药工业企业开发应用先进技术工艺，提升安全保障水平。
18. Enhance the social value of the pharmaceutical industry. Accelerate the promotion and application of innovative drugs and devices in fields such as chronic diseases, infectious diseases, geriatric diseases, and rare diseases, and strengthen the supply of full-life-cycle health protection products and health security for key populations. Vigorously develop smart health services, and strengthen health protection and health interventions for occupational populations. Enhance biosafety control capabilities; guide pharmaceutical industry enterprises in improving their safety management systems; strengthen risk assessment, risk identification, and risk early warning by level and by category; and support pharmaceutical industry enterprises in developing and applying advanced technologies and processes to raise the level of safety assurance.
**19.培育医药工业文化价值。**推动中医药文化传承创新，加强中医药古籍整理与经典名方开发，展示中医药传统文化与发展成就。鼓励中药原料生产基地、中药企业开展农文旅融合的科普研学活动。培育现代医药产业文化，开发权威科普资源，强化公众对医药产业创新、科技创新的认知与了解。提升文化软实力，推动医药文化融入国民教育，在中小学开展中医药文化、生命科学教育，支持医药题材文艺创作，讲好医药领域中国故事。
19. Cultivate the cultural value of the pharmaceutical industry. Promote the inheritance and innovation of TCM culture, strengthen the collation of ancient TCM texts and the development of classical famous formulas, and showcase TCM traditional culture and development achievements. Encourage TCM raw material production bases and TCM enterprises to carry out popular-science study-tour activities that integrate agriculture, culture, and tourism. Cultivate a modern pharmaceutical industry culture, develop authoritative popular-science resources, and strengthen public awareness and understanding of pharmaceutical industry innovation and scientific and technological innovation. Enhance cultural soft power, promote the integration of pharmaceutical culture into national education, carry out TCM culture and life science education in primary and secondary schools, support literary and artistic creation on pharmaceutical themes, and tell China's story well in the pharmaceutical field.
（七）优化生产保供效能，筑牢普惠健康新基石
(7) Optimize the effectiveness of production and supply assurance, and build a solid new cornerstone for inclusive health
**20.完善多元保障体系。**加强重点药品生产供应信息监测，健全重点医药物资生产保供体系。强化常见病、慢性病等非处方药推广应用，重点加强儿童、老年、罕见病患者等人群用药保障。健全国家医药储备管理体系，科学调整储备品种、规模和结构，充分发挥产能储备和技术储备效用。
20. Improve the diversified assurance system. Strengthen the monitoring of production and supply information for key drugs, and improve the production and supply-assurance system for key medical supplies. Strengthen the promotion and application of over-the-counter drugs for common diseases, chronic diseases, etc., with a focus on strengthening medication assurance for populations such as children, the elderly, and rare disease patients. Improve the national pharmaceutical reserve management system, scientifically adjust the varieties, scale, and structure of reserves, and give full play to the utility of production capacity reserves and technology reserves.
**21.强化基本药物与医疗器械优质供给。**深入实施制造业卓越质量提升工程，引导医药工业企业参与制造业企业质量管理能力评价，提升企业质量管理能力。加强药品与医疗器械质量提升与全生命周期监管， 支持医药工业企业落实新修订药品生产质量管理规范（GMP）相关要求，提升我国药品整体质量水平。围绕基本医疗服务需求，持续提升超声诊断仪、生化分析仪、心电图机等医疗器械的性能品质。动态优化基本药物目录， 优先增补临床必需、安全有效、价格合理的品种。
21. Strengthen the high-quality supply of essential medicines and medical devices. Thoroughly implement the Manufacturing Excellence Quality Improvement Project, guide pharmaceutical industry enterprises to participate in quality management capability evaluations for manufacturing enterprises, and raise enterprises' quality management capabilities. Strengthen quality improvement and full-life-cycle regulation of drugs and medical devices, support pharmaceutical industry enterprises in implementing the relevant requirements of the newly revised Good Manufacturing Practice for drugs (GMP), and raise the overall quality level of China's drugs. Centering on the needs of basic medical services, continuously improve the performance and quality of medical devices such as ultrasound diagnostic instruments, biochemical analyzers, and electrocardiographs. Dynamically optimize the National Essential Medicines List, giving priority to adding varieties that are clinically necessary, safe and effective, and reasonably priced.
**22.持续提升用药可及性。**充分发挥全产业链成本效率优势，持续提高通用名药、生物类似药、创新药、医疗器械等统筹供应能力。强化国际供需对接，支持疫苗、诊断试剂、抗感染药物等重点产品纳入世界卫生组织（WHO）预认证和全球采购体系。加强国际医药供应协作，提升突发疫情、重大灾害等场景下的医药产品快速调配与供应能力。加强国际医药援助，支持发展中国家提升疾病防控和医疗救治能力。
22. Continuously improve access to medicines. Give full play to the cost-efficiency advantages of the entire industrial chain, and continuously raise the coordinated supply capacity for generic drugs [tr: 通用名药, lit. "generic-name drugs"], biosimilars, innovative drugs, medical devices, etc. Strengthen international supply-demand matching, and support key products such as vaccines, diagnostic reagents, and anti-infective drugs in gaining inclusion in World Health Organization (WHO) prequalification and global procurement systems. Strengthen international pharmaceutical supply cooperation, and raise capabilities for the rapid allocation and supply of pharmaceutical products in scenarios such as sudden epidemics and major disasters. Strengthen international pharmaceutical aid, and support developing countries in improving their capabilities in disease prevention and control and in medical treatment.
| 专栏 9 重点医药物资保供效能提升 | Box 9: Enhancing the Effectiveness of Supply Assurance for Key Medical Supplies |
|---|---|
| 1.重点人群用药生产供应保障 | 1. Production and supply assurance of medicines for key populations |
| 罕见病药物开发应用。针对血友病、白化病、渐冻症、苯丙酮尿症、线粒体病、多发性硬化病、肺泡蛋白沉积症、库欣综合征、戈谢病、庞贝病、黏多糖贮积症等罕见病，全力推动细胞治疗、基因治疗、小核酸药物、多肽药物、生长抑素类似物等前沿技术攻关，加快罕见病诊疗药物创新研发和转化应用。 | Development and application of rare disease drugs. Targeting rare diseases such as hemophilia, albinism, amyotrophic lateral sclerosis (ALS) [tr: 渐冻症, lit. "gradual-freezing disease"], phenylketonuria, mitochondrial disease, multiple sclerosis, pulmonary alveolar proteinosis, Cushing's syndrome, Gaucher disease, Pompe disease, and mucopolysaccharidosis, make all-out efforts to promote breakthroughs in cutting-edge technologies such as cell therapy, gene therapy, small nucleic acid drugs, peptide drugs, and somatostatin analogs, and accelerate the innovative R&D and translational application of drugs for the diagnosis and treatment of rare diseases. |
| 儿童用药适宜剂型和适配规格开发。针对儿童的生理特点和药物接受度，研发口服制剂、经皮给药制剂、鼻腔给药制剂、吸入制剂、直肠给药制剂等儿童适宜剂型、适配规格及专用辅料。 | Development of suitable dosage forms and adapted strengths for pediatric medicines. Targeting children's physiological characteristics and drug acceptability, research and develop child-appropriate dosage forms such as oral preparations, transdermal preparations, nasal preparations, inhalation preparations, and rectal preparations, as well as adapted strengths and dedicated excipients. |
| 2.储备管理 | 2. Reserve management |
| 产能储备。根据供应保障需求，结合实物储备规模及产品属性、生产周期、安全属性等，制定国家医药储备应急保供生产企业名单，推动产能储备建设。 | Production capacity reserves. Based on supply-assurance needs, and taking into account the scale of physical reserves as well as product attributes, production cycles, safety attributes, etc., formulate a list of emergency supply-assurance production enterprises for national pharmaceutical reserves, and promote the building of production capacity reserves. |
| 技术储备。针对未知疾病风险、新发突发传染病防控、重大突发事件保障等场景，制定国家医药储备战略前沿技术目录，加强医药技术储备。 | Technology reserves. Targeting scenarios such as unknown disease risks, the prevention and control of emerging and sudden-onset infectious diseases, and assurance for major emergencies, formulate a national pharmaceutical reserve catalog of strategic frontier technologies, and strengthen pharmaceutical technology reserves. |
（八）深化国际产业合作，塑造开放共赢新格局
(8) Deepen international industrial cooperation, and shape a new pattern of openness and win-win outcomes
**23.增强产业竞争力。**加快构建化学原料药、高端制剂、疫苗、抗体药物、中药、医疗器械等领域优势。完善医药领域跨境技术与服务体系，提升面向国际市场的全链条医药研发生产服务（CRO/CDMO）专业能力。 支持国内企业通过共同研发、共同商业化等方式积极参与全球医药创新分工合作，强化知识产权保护与运用，助力创新药械走向国际市场。加强药品监管国际合作，推动国内外监管规则、标准等有效衔接， 强化监管协调，提升我国医药产品的国际认可度与影响力。
23. Enhance industrial competitiveness. Accelerate the building of advantages in fields such as chemical active pharmaceutical ingredients (APIs), high-end formulations, vaccines, antibody drugs, TCM, and medical devices. Improve the cross-border technology and service system in the pharmaceutical field, and raise professional capabilities in full-chain pharmaceutical R&D and manufacturing services (CRO/CDMO) oriented to international markets. Support domestic enterprises in actively participating in the global division of labor and cooperation in pharmaceutical innovation through means such as co-development and co-commercialization, strengthen the protection and use of intellectual property, and help innovative drugs and devices go to international markets. Strengthen international cooperation in drug regulation, promote the effective alignment of domestic and foreign regulatory rules, standards, etc., strengthen regulatory coordination, and raise the international recognition and influence of China's pharmaceutical products.
**24.提升产业合作能级。**加快打造医药健康产业合作生态，加强与共建“一带一路”国家合作，以医疗领域国际交流带动国产先进诊疗技术、药品和医疗器械推广使用。强化海外发展布局指引，鼓励行业协会、专业服务机构等拓展研发、注册、融资、生产等海外服务网络。支持医药工业企业开展创新药国际多中心临床试验和国际注册，拓展海外研发中心、生产基地和销售网络。
24. Raise the level of industrial cooperation. Accelerate the building of a pharmaceutical and health industry cooperation ecosystem, strengthen cooperation with countries jointly building the "Belt and Road," and use international exchanges in the medical field to drive the promotion and use of domestically produced advanced diagnostic and therapeutic technologies, drugs, and medical devices. Strengthen guidance on overseas development layout, and encourage industry associations, professional service institutions, etc., to expand overseas service networks for R&D, registration, financing, production, etc. Support pharmaceutical industry enterprises in conducting international multicenter clinical trials and international registration of innovative drugs, and in expanding overseas R&D centers, production bases, and sales networks.
**25.提高市场吸引力。**以国内大市场吸引国外医药企业扩大在华业务，加大投资力度，开展从产品研发、临床转化到生产制造的全链条布局。发挥自由贸易试验区、海南自由贸易港、粤港澳大湾区等政策优势， 探索跨境数据流动、跨境监管协作等制度创新，构建高效便捷的跨境医药服务体系。加速临床急需进口药械上市并引进在境内生产，带动高端原辅料、设备耗材、仪器试剂等配套产业链发展。支持有条件的地方加快推进国际化创新合作枢纽建设， 扩展国际创新合作的深度和广度。
25. Increase market attractiveness. Use the large domestic market to attract foreign pharmaceutical enterprises to expand their business in China, increase their investment, and carry out full-chain layouts spanning product R&D and clinical translation through to manufacturing. Leverage the policy advantages of pilot free trade zones, the Hainan Free Trade Port, the Guangdong-Hong Kong-Macao Greater Bay Area, etc., explore institutional innovations such as cross-border data flows and cross-border regulatory collaboration, and build an efficient and convenient cross-border pharmaceutical service system. Accelerate the market launch of urgently needed clinical imported drugs and devices and bring them in for domestic production, driving the development of supporting industrial chains such as high-end raw materials and excipients, equipment and consumables, and instruments and reagents. Support qualified localities in accelerating the construction of international innovation cooperation hubs, expanding the depth and breadth of international innovation cooperation.
三、加强组织实施
3. Strengthen Organization and Implementation
发挥相关部际协调机制作用，统筹战略规划、重大项目、重大工程、支持政策等，推动产业、科技、监管、医疗、医保、金融、人才等政策协同。做好规划实施情况动态监测、评估等工作。优化审评审批机制， 建立健全与我国医药研发生产能力相匹配、与国际先进标准接轨的高水平监管体系，运用人工智能等技术提升智慧监管水平。完善价格、支付及使用政策，落实好全周期药品价格形成机制，大力发展商业健康保险。 加快临床急需的创新药械入院应用，优化进院流程与激励措施，支持各地开展医疗机构与医药工业企业对接活动，促进更多创新药械及时惠及临床患者。加强医药健康产业科普宣传，支持行业组织与相关媒体深度合作， 联合打造面向公众的专业化、多元化、立体化的产业科普传播矩阵，提升公众医药健康素养。强化人才支撑，加强“高精尖缺”医药人才引进，依托国家学院、国家卓越工程师实践基地和学院等加强复合型人才培养。 发挥行业组织作用，加强行业自律管理，规范医药工业企业生产经营管理行为，实现有序竞争、集约发展，提升品牌影响力。
Give play to the role of the relevant inter-ministerial coordination mechanisms; coordinate strategic planning, major projects, major engineering programs, supporting policies, etc.; and promote policy coordination across industry, science and technology, regulation, medical care, medical insurance, finance, talent, etc. Do a good job of dynamic monitoring and evaluation of the implementation of the plan. Optimize review and approval mechanisms, establish and improve a high-level regulatory system that matches China's pharmaceutical R&D and production capabilities and is aligned with advanced international standards, and use technologies such as artificial intelligence to raise the level of smart regulation. Improve pricing, payment, and use policies, properly implement the full-cycle drug price formation mechanism, and vigorously develop commercial health insurance. Accelerate the hospital admission and use of urgently needed clinical innovative drugs and devices, optimize hospital-entry processes and incentive measures, and support localities in holding matchmaking activities between medical institutions and pharmaceutical industry enterprises, so that more innovative drugs and devices benefit clinical patients in a timely manner. Strengthen popular-science publicity for the pharmaceutical and health industry, support in-depth cooperation between industry organizations and relevant media, and jointly build a professional, diversified, and multi-dimensional industry popular-science communication matrix oriented to the public, raising the public's pharmaceutical and health literacy. Strengthen talent support, strengthen the recruitment of "high-end, precision, cutting-edge, and scarce" pharmaceutical talent, and strengthen the training of interdisciplinary talent by relying on national colleges [tr: 国家学院, unspecified; possibly the national colleges for excellent engineers], national excellent engineer practice bases and colleges, etc. Give play to the role of industry organizations, strengthen industry self-regulatory management, regulate the production, operation, and management conduct of pharmaceutical industry enterprises, achieve orderly competition and intensive development, and raise brand influence.
Lost in translation
The literal text above is the record. This section is where intent is rendered, with the characters kept in view so an intent reading can always be checked against the source.
The eight task headings: what a Chinese policy reader hears
Each heading is a pair of parallel phrases. The first names the move, the second names the result. Rank order matters: task (1) is what gets funded first.
| Heading (zh) | Literal (above) | What it signals operationally |
|---|---|---|
| （一）引领产业向新向优，锻造创新驱动新引擎 | Lead the industry toward the new and the superior, forge a new innovation-driven engine | Innovation is the FIRST priority and the growth engine. "向新向优" = novel (FIC/BIC) over incremental, quality over volume. Expect funding, approval and reimbursement preference for first-in-class. |
| （二）着力强基础扬优势，构建韧性安全新体系 | Strengthen the foundation and leverage advantages, build a new system of resilience and security | Supply-chain security: APIs, excipients, packaging, equipment, software. "韧性安全" is the national-security frame applied to pharma inputs; import substitution without saying so. |
| （三）持续提质增效赋能，树立数智转型新标杆 | Improve quality, raise efficiency, empower; set new benchmarks for digital and intelligent transformation | "数智" (digital + intelligent) is the AI mandate. Box 6 names the AI-for-pharma use cases the state wants demonstrated. |
| （四）顺应技术演进态势，培育精准诊疗新范式 | Follow the trend of technological evolution, cultivate a new paradigm of precision diagnosis and treatment | Precision medicine as an INDUSTRY (diagnostics, sequencing, companion products), not just a clinical practice. |
| （五）释放要素生态潜能，实现效率提升新突破 | Unleash the potential of the factor ecosystem, achieve new breakthroughs in efficiency | "要素" = factors of production: clinical sites, capital, land, talent. Faster clinical translation, scale-up, cluster policy (Box 8 names the regions). |
| （六）推动量质协同跃升，拓展价值创造新空间 | Promote a coordinated leap in quantity and quality, expand new space for value creation | Growth AND upgrading together; the industry's health, social and cultural "value" beyond revenue. |
| （七）优化生产保供效能，筑牢普惠健康新基石 | Optimize production and supply assurance, build a solid new cornerstone for inclusive health | Strategic reserves, essential medicines, shortages, rare disease and pediatric supply. "普惠" = affordable and reachable for everyone. |
| （八）深化国际产业合作，塑造开放共赢新格局 | Deepen international industrial cooperation, shape a new pattern of openness and win-win | Going out: multi-regional trials, overseas approvals, licensing deals, and attracting foreign investment. "共赢" is the standard diplomatic formulation. |
Units and currencies (every scaled figure in the document)
| zh | Literal arithmetic | Rendering used |
|---|---|---|
| 3.5 万亿元 | 3.5 x 10^12 yuan | 3.5 trillion yuan |
| 100 亿元 | 100 x 10^8 = 10^10 yuan | 10 billion yuan |
| 千亿级 | 10^11 yuan scale | 100-billion-yuan level |
| 10 亿美元 | 10 x 10^8 = 10^9 USD | US$1 billion |
The document itself makes no currency conversion and none is added. 亿 (10^8) has no English unit; every 亿 figure is re-based to million/billion, which is where translation errors in press coverage usually occur.
Threshold conventions: ≥ in Box 1 = 达到或超过 ("reach or exceed"); 超过 = "exceed"; 〔 〕 = five-year cumulative total (Box 1 note 1), all other Box 1 figures are 2030 point values or annual averages as the column header states.
Terms with no clean English equivalent
| zh | Rendering | What is lost |
|---|---|---|
| 新质生产力 | new quality productive forces | A Xi-era term of art (2023) meaning innovation-led, high-tech, high-efficiency productivity. "Productive forces" is Marxist vocabulary; the English sounds odd because the Chinese is doctrinal. |
| 数智 | digital and intelligent | A coined compound (数字 + 智能); in practice it means AI-enabled digitalization. |
| 制造强国 / 健康中国 | manufacturing powerhouse / Healthy China | Named national strategies, capitalized programs, not adjectives. |
| 规模以上 | above designated size | Statistical term: industrial enterprises with annual revenue at or above 20 million yuan. The 3.5 trillion target counts only these. |
| 首发地 / 首创 | first-launch site / world-first | The Yangtze cluster slogan 全球首创、中国首发 means originated for the world, launched first in China. Not the same as the defined term 首创新药 (FIC). |
| 药食同源 | medicine-food homology | Substances traditionally used as both food and medicine; a regulatory category in China. |
| 渐冻症 | ALS | Literal "gradual freezing disease", the colloquial Chinese name for amyotrophic lateral sclerosis. |
| 两品一械 | "two products, one device" | Shorthand for drugs, cosmetics, and medical devices, the NMPA's three regulated categories. |
| 普惠 | inclusive | Carries both "affordable" and "universally reachable"; neither English word alone covers it. |
| 人类卫生健康共同体 | global community of health for all | Official Xinhua rendering of a diplomatic formulation; a literal "community of common health for mankind" is also seen. |
| 部署 | arrangements | Literally "deployment"; used for Party decisions handed down to be implemented. "Arrangements" is the standard official rendering and is kept. |
Two inconsistencies inside the source itself
- 热缩性弹性体（TPE）: the characters say heat-shrinkable, the abbreviation says thermoplastic. Rendered as written, noted inline.
- 多功能诱导干细胞（iPSC）: the characters say multifunctional, the abbreviation says pluripotent. Rendered as written, noted inline.
A translation that "fixed" either would be more readable and less faithful. Both are left for the reader to see.
Footnotes
-
Ministry of Industry and Information Technology, notice publishing 工信部联规〔2026〕210号, 2026-09-18 -- authority page. https://www.miit.gov.cn/zwgk/zcwj/wjfb/tz/art/2026/art_9463adac4db040159f6cbf482675eeea.html (T1 -- issuing ministry) ↩
-
Ministry of Industry and Information Technology, 《医药工业发展"十五五"规划》 (original PDF, 18 pages, sha256 e4ba3a4c737f9ed1deafde79fb0d7cf63b4bd47aac93f68502aadaa95a25da8e). https://www.miit.gov.cn/cms_files/filemanager/1226211233/attach/20269/c9ef9c990ec84347a7a87999e23e26e0.pdf (T1 -- issuing ministry, primary document) ↩