Pharma and biotech opening moves from the foreign-investment action plan: segmented production, pilot expansion and the payment chain
- The Action Plan for Stabilising and Optimising the Utilisation of Foreign Investment (商资发〔2026〕97号, issued 16 June 2026 by MOFCOM, NDRC and MOF) commits the government to “expedite the study and issuance of implementation rules for segmented pharmaceutical production”, easing cross-border segmented manufacturing of biologics and chemical drugs by foreign marketing-authorisation holders.
商务部、国家发展改革委、财政部《利用外资固稳促优行动方案》（商资发〔2026〕97号，2026年6月16日印发）明确”抓紧研究出台药品分段生产实施细则”，便利境外药品上市许可持有人开展生物制品、化学药品跨境分段生产。
- The same plan moves to widen pilot geography: authorities will “expedite research and approval to further expand the pilot regions for biotechnology and wholly foreign-owned hospitals” — the two most-watched restricted-service openings of the current cycle.
同一方案还推动试点扩围：”抓紧研究报批进一步扩大生物技术、外商独资医院领域开放试点区域范围”——这是本轮最受关注的两项限制性服务业开放。
- The statutory base is already in place: the revised Drug Administration Law Implementation Regulations (published January 2026) turned segmented production from pilot into institution, letting marketing-authorisation holders commission qualified producers to segment-manufacture innovative drugs and clinically urgent drugs when genuinely needed, under a unified quality-assurance system covering all sites.
法定底座已经就位：修订后的《药品管理法实施条例》（2026年1月公布）把分段生产从试点推向制度——药品上市许可持有人确有需要的，可委托符合条件的企业分段生产创新药、临床急需药品等，并建立覆盖全部生产场地的统一质量保证体系。
- Commercial proof-of-concept has landed: in May 2026 Johnson & Johnson’s niccalimab injection became the first imported biologic to run domestic segmented production of drug substance in China, with the substance made by WuXi Bio in Wuxi and fill-finish completed in Germany.
商业验证已经落地：2026年5月，强生制药的尼卡利单抗注射液成为全国首个开展原液境内分段生产的进口生物制品——原液由无锡药明生物生产，制剂在德国完成。
- Biotech opening pilots are producing registrable outcomes: under the 2024 pilot allowing FIEs to develop and apply human stem-cell and gene diagnosis and therapy technologies in designated free trade zones, at least six foreign companies — including Merck, JW Therapeutics-related entities, Frontera Therapeutics and StarCellBio — have completed registration changes or new filings.
生物技术开放试点已产出可登记成果：在2024年允许外商投资企业于指定自贸区开展人体干细胞、基因诊断与治疗技术开发应用的试点下，至少6家外资企业（含默克、药明巨诺相关主体、芳拓生物、星奕昂等）已完成经营范围变更或新设登记。
- Payment and channel measures complete the chain: the plan supports insurers in covering more innovative drugs and devices under commercial health insurance, and calls for an industry collaboration platform to smooth foreign-made pharmaceuticals into retail channels — the “last mile” that has capped foreign pharma revenue in China.
支付与渠道措施补齐链条：方案支持保险公司将更多创新药械纳入商业保险保障范围，并搭建行业协作平台便利外资企业生产的药品进入零售渠道——这正是此前封顶外资药企中国收入的”最后一公里”。
Pharma and biotech opening moves from the foreign-investment action plan: segmented production, pilot expansion and the payment chain | 外资行动方案中的医药开放组合：分段生产、试点扩围与支付渠道
Overview
The Action Plan for Stabilising and Optimising the Utilisation of Foreign Investment (《利用外资固稳促优行动方案》, 商资发〔2026〕97号), issued on 16 June 2026 by the Ministry of Commerce, the National Development and Reform Commission and the Ministry of Finance with State Council consent, devotes one of its fifteen measures to pharmaceuticals. The measure assembles a “production — marketing-authorisation — payment — channel” package for foreign pharmaceutical and biotech companies: segmented production implementation rules, expanded pilot geography for biotechnology and wholly foreign-owned hospitals, commercial-insurance payment support, and retail-channel facilitation.
With September 2026 commentary from the Shanghai government’s weekly foreign-invested information service now tracking the package in detail, the measures are the clearest single statement of where foreign pharma market access in China is heading this cycle.
Segmented production: from pilot to statute to rules
Segmented production (分段生产) distributes a drug’s manufacturing process across sites or companies — globally common, but long restricted in China. The progression:
- October 2024: the National Medical Products Administration issued the pilot work plan for segmented production of biologics, allowing certain innovative and clinically urgent biologics to run segmented production at the pilot stage.
- January 2026: the State Council published the revised Drug Administration Law Implementation Regulations, moving segmented production into institution. Article 31 provides that where a marketing-authorisation holder genuinely needs it, the holder may commission qualified manufacturers to segment-manufacture (i) innovative drugs with special process, facility or equipment requirements, (ii) clinically urgent drugs and drugs needed for public-health response or reserves identified by the State Council departments, and (iii) other drugs specified by the drug regulator. The holder must build a unified quality-assurance system covering the whole production process and all sites; vaccines and blood products carry their own commissioning rules.
- Next step: the action plan’s commitment to issue implementation rules for segmented pharmaceutical production — the operational layer for application conditions, quality-responsibility allocation and regulatory coordination.
The commercial template already exists: in May 2026, Johnson & Johnson’s niccalimab injection became the first imported biologic to run domestic segmented production of drug substance — substance produced by WuXi Biologics in Wuxi, fill-finish completed by Vetter Pharma in Germany. For multinationals, the case demonstrates the operating model the rules will generalise: foreign marketing-authorisation holders placing upstream segments with qualified Chinese CDMOs while keeping downstream finishing abroad, or the reverse.
Biotechnology and wholly foreign-owned hospitals: pilot expansion pending approval
Biotechnology (human stem cells, gene diagnosis and therapy) has been open to FIEs only inside designated pilot areas since September 2024, when Beijing, Shanghai and Guangdong free trade zones and Hainan were authorised. The registry shows results: at least six foreign companies — including Merck, entities associated with JW Therapeutics (药明巨诺), Frontera Therapeutics (芳拓生物) and StarCellBio (星奕昂) — have completed business-scope changes or new registrations inside the pilot areas.
The action plan instructs authorities to expedite research and approval for expanding the pilot regions for both biotechnology and wholly foreign-owned hospitals — the same two openings that Shanghai’s 15th Five-Year plan and other provincial documents name as landing priorities. Neither expansion has been formally approved yet; the plan converts the expansion from discussion item into an official workstream with a deadline pressure attached.
Payment and channels: the last-mile package
Two measures address the revenue side that has historically capped foreign pharma’s China performance:
- Commercial insurance. The plan supports insurers in bringing more innovative drugs and devices into commercial health-insurance coverage — the payer channel that has grown fastest as national reimbursement negotiations compress prices.
- Retail channels. An industry collaboration platform will be built to facilitate foreign-produced pharmaceuticals entering drug retail channels — addressing the distribution friction that has kept foreign-manufactured drugs out of pharmacy chains even after approval.
What this means for foreign pharma and healthcare groups
- Map your product portfolio against segmented-production eligibility. The statutory categories are innovative drugs with special process/equipment requirements and clinically urgent or reserve drugs; groups with biologics or special-technology chemicals should identify candidates and pre-qualify Chinese CDMO partners under a unified quality system.
- Watch the implementation rules, not just the plan. Application conditions, quality-responsibility division and regulatory coordination sit in the forthcoming rules; the drafting is the moment to submit practical comments.
- Treat pilot expansion as a siting decision. If the biotech and wholly-owned-hospital pilots extend to new provinces, entity location inside a pilot area becomes a structuring variable; hold new China healthcare investments until the expanded map is published.
- Build the commercial-insurance and retail strategy now. Payment support and retail-channel facilitation are revenue-side measures; groups that prepare health-insurance dossiers and pharmacy distribution agreements can move when the platforms land.
- Benchmark against the niccalimab case. The first segmented-production precedent defines the documentation and quality-system expectations regulators will apply to the next applications.
Sources
- 济源产城融合示范区管理委员会（转载）— 商务部 国家发展改革委 财政部关于印发《利用外资固稳促优行动方案》的通知（商资发〔2026〕97号，2026年6月16日，政府官网全文）: https://zt.www.jiyuan.gov.cn/zsyz/wstz_zsyz/zcfb/t1008712.html
- 上海市人民政府外事办公室 — 《上海资讯周报》涉外资讯一站式服务（2026年9月第1期，总第157期，2026年9月2日，医药开放组合与分段生产制度演进综述）: https://wsb.sh.gov.cn/ztzl/shzxzb/20260902/d2eb54ce238e4d6d9f5bcac6e428f6e6.html
- 蒙城县人民政府（转载）— 中华人民共和国药品管理法实施条例（2026年修订版分段生产条款第31—33条全文）: https://www.mengcheng.gov.cn/XxgkContent/show/3008349.html
Related reading
- see also: segmented pharma production pilot mechanics (segmented-pharma-production)
- see also: wholly foreign-owned hospital pilot requirements (foreign-owned-hospital-pilot)
外资行动方案中的医药开放组合：分段生产、试点扩围与支付渠道
概述
《利用外资固稳促优行动方案》（商资发〔2026〕97号）由商务部、国家发展改革委、财政部经国务院同意于2026年6月16日印发，其十五条举措中专设一条指向医药。该条为外资医药与生物技术企业组装了一套”生产—上市许可—支付—渠道”组合：分段生产实施细则、生物技术与外商独资医院试点扩围、商业保险支付支持与零售渠道便利。
随着2026年9月上海市政府涉外资讯周报对该政策包作出详细追踪解读，这是本周期内中国外资药品准入走向最清晰的一份单项表述。
分段生产：从试点到法定再到细则
分段生产（分段生产）把药品生产过程分布在不同场地或企业之间——全球通行，但在中国长期受限。演进脉络：
- 2024年10月： 国家药监局印发生物制品分段生产试点工作方案，允许部分创新生物制品和临床急需生物制品在试点阶段开展分段生产。
- 2026年1月： 国务院公布修订后的《药品管理法实施条例》，把分段生产推向制度。第三十一条规定，药品上市许可持有人确有需要的，可以委托符合条件的药品生产企业分段生产：（一）生产工艺、设施设备有特殊要求的创新药；（二）临床急需药品、应对突发公共卫生事件急需或储备需要的药品；（三）国务院药品监督管理部门规定的其他药品。持有人须建立覆盖药品生产全过程和全部生产场地的统一质量保证体系；疫苗、血液制品另有委托生产规则。
- 下一步： 行动方案承诺出台药品分段生产实施细则——即申请条件、质量责任划分与监管协调的操作层。
商业模板已经出现：2026年5月，强生制药的尼卡利单抗注射液成为全国首个开展原液境内分段生产的进口生物制品——原液由无锡药明生物生产，制剂由德国Vetter Pharma完成。对跨国药企而言，该案例演示了细则将要推广的运营模式：境外持有人把上游环节放在中国合格CDMO、下游制剂留在境外，或反向操作。
生物技术与外商独资医院：扩围报批中
自2024年9月北京、上海、广东自贸区和海南获准试点以来，生物技术（人体干细胞、基因诊断与治疗）仅对试点区域内FIE开放。登记情况已有产出：至少6家外资企业——包括默克、药明巨诺相关主体、芳拓生物（Frontera Therapeutics）、星奕昂等——已在试点区域内完成经营范围变更或新设登记。
行动方案要求抓紧研究报批进一步扩大生物技术、外商独资医院领域开放试点区域范围——上海”十五五”规划等省级文件点名的同样是这两项开放。扩围尚未正式获批；方案把扩围从讨论事项转为带时限压力的正式工作流程。
支付与渠道：最后一公里
两项措施指向历史上封顶外资药企中国收入的收入端：
- 商业保险。 方案支持保险公司将更多创新药械纳入商业健康保险保障范围——在国家谈判压缩价格背景下增长最快的支付通道。
- 零售渠道。 将搭建行业协作平台，便利外资企业生产的药品进入药品零售渠道——解决获批外资药品难以进入连锁药店的流通摩擦。
对外资医药与医疗集团的启示
- 对照分段生产法定情形梳理产品组合。 法定类别是工艺设施有特殊要求的创新药与临床急需、储备药品；拥有生物制品或特殊工艺化学药的企业应识别候选产品，并按统一质量体系预审中国CDMO伙伴。
- 盯细则而不止于方案。 申请条件、质量责任划分与监管协调都在即将出台的实施细则中；起草阶段是提交实务意见的窗口。
- 把试点扩围当作选址变量。 若生物技术与独资医院试点扩展至新省份，主体落位在试点区域内就成为架构变量；新医疗投资可等扩围地图公布后再定。
- 现在就建商保与零售策略。 支付支持与渠道便利是收入端措施；提前准备健康险材料与药店分销协议的集团，可在平台落地时立即行动。
- 对标尼卡利单抗案例。 首个分段生产先例界定了监管对后续申请的单证与质量体系预期。
来源
- 济源产城融合示范区管理委员会（转载）— 《利用外资固稳促优行动方案》通知全文（商资发〔2026〕97号）: https://zt.www.jiyuan.gov.cn/zsyz/wstz_zsyz/zcfb/t1008712.html
- 上海市人民政府外事办公室 — 《上海资讯周报》涉外资讯一站式服务（2026年9月第1期）: https://wsb.sh.gov.cn/ztzl/shzxzb/20260902/d2eb54ce238e4d6d9f5bcac6e428f6e6.html
- 蒙城县人民政府（转载）— 中华人民共和国药品管理法实施条例（分段生产条款全文）: https://www.mengcheng.gov.cn/XxgkContent/show/3008349.html
相关阅读
- 见：药品分段生产试点机制要点（segmented-pharma-production）
- 见：外商独资医院试点要求（foreign-owned-hospital-pilot）