2024年9月8日，商务部公开了其与国家卫生健康委、国家药监局（下称" 三部门"）共同发布的《关于在医疗领域开展扩大开放试点工作的通知》（下称" 《通知》"），宣布 自即日起，在中国（北京）自由贸易试验区、中国（上海）自由贸易试验区、中国（广东）自由贸易试验区和海南自由贸易港，允许外商投资企业从事人体干细胞、基因诊断与治疗技术开发和技术应用，以用于产品注册上市和生产。
On September 8, 2024, the Ministry of Commerce, together with the National Health Commission and the National Medical Products Administration (hereinafter referred to as the "Three Departments"), publicly issued the Notice on Carrying Out Pilot Programs to Expand Opening-Up in the Healthcare Sector (hereinafter referred to as the "Notice"), announcing that, effective immediately, foreign-invested enterprises are permitted to engage in the development and application of human stem cells, gene diagnostic and therapy technologies for product registration and manufacturing in the China (Beijing) Pilot Free Trade Zone, China (Shanghai) Pilot Free Trade Zone, China (Guangdong) Pilot Free Trade Zone, and Hainan Free Trade Port.
这一振奋人心的消息令我们深感鼓舞，它标志着中国生物医药行业在开放发展的道路上再次迈出了重要一步。结合此前参与的立法建议征集工作，我们在第一时间分享对这一新政的见解，以供业界参考。
This exciting news is very encouraging, marking another significant step forward for China's biopharmaceutical industry on the path of open development. Drawing on our previous participation in legislative consultation work, we will share our insights on this new policy and provide a reference for the industry.
一、政策回望
Review of Policy Developments
我国《鼓励外商投资产业目录》和《外商投资准入特别管理措施（负面清单）》等文件为外商投资提供了重要的指引和规范。自2007年出台的《外商投资产业指导目录（2007年修订）》将"人体干细胞、基因诊断与治疗技术开发和应用"首次列入"禁止外商投资产业目录"后，该项特别管理措施沿用至今。
The Catalogue of Industries Encouraging Foreign Investment and the Special Administrative Measures for the Market Entry of Foreign Investment (Negative List) of China have provided key guidance and regulation for foreign investment. The restriction regarding foreign investment in "development and application of human stem cells, gene diagnostic and therapy technologies" has remained in place since the Catalogue for the Guidance of Foreign Investment Industries (Revised in 2007) was promulgated in 2007, where it was first listed as prohibited.
在确保我国生物安全的前提下，适度放宽外商投资干细胞及基因诊断与治疗技术开发与应用的政策限制，是长期以来行业和众多监管部门共同期盼和努力的方向。2019年以来，我国上海、北京、深圳、天津等多地监管部门发布文件，提议探索政策试点。
While ensuring the biosecurity of China, moderately relaxing the existing policy restrictions on foreign investment in development and application of human stem cells, gene diagnostic and therapy technologies has been a shared and long-awaited direction of the industry and regulatory authorities. Since 2019, regulatory authorities in Shanghai, Beijing, Shenzhen, Tianjin, and other cities have issued following documents proposing the exploration of pilot policies.
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上海：2019年8月13日发布的《上海市新一轮服务业扩大开放若干措施》中明确提出"推进医疗科技领域的项目合作和
取消外资准入限制，争取允许外商投资人体干细胞、基因诊断与治疗技术开发和应用"。于2022年1月1日起施行的《上海市浦东新区促进张江生物医药产业创新高地建设规定》同样提出，"在风险可控的前提下，支持符合条件的多元化投资主体开展人体细胞、基因技术研发和推进产业化进程"。
Shanghai: In Shanghai's Measures for Further Opening-Up of the Service Industry issued on August 13, 2019, it was explicitly stated "to promote collaboration in projects in the field of medical technology and remove restrictions on market entry of foreign investment, and to strive for allowing foreign investment in development and application of human stem cells, gene diagnostic and therapy technologies". The Regulations on Promoting the Development of Zhangjiang Biopharmaceutical Industry Innovation Hub in Pudong New Area, Shanghai, which came into effect on January 1, 2022, also proposed "to support qualified and diversified investors in conducting development and research on human cell and gene technology and promoting industrialization under the premise of controllable risks".
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北京：2023年11月18日发布的《支持北京深化国家服务业扩大开放综合示范区建设工作方案》和2024年7月3日印发的《北京市深化服务业扩大开放促进外商投资实施方案》提出，加大医疗领域开放力度，支持干细胞与基因研发国际合作，按照国家相关部署
在自由贸易试验区选择若干符合条件的外商投资企业在基因诊断与治疗技术开发和应用等领域进行扩大开放试点探索。
Beijing: The Work Plan for Supporting Beijing in Deepening the National Comprehensive Demonstration Zone for Expanding the Opening-Up of the Service Industry issued on November 18, 2023, and the Implementation Plan for Promoting the Expansion of Opening-Up in the Service Industry and Foreign Investment in Beijing issued on July 3, 2024, proposed to promote the opening development in the healthcare sector, support international cooperation in stem cell and gene research, and, in accordance with relevant national guidelines, to select several eligible foreign-invested enterprises in free trade zones to conduct pilot explorations of expanded openness in fields such as the development and application of gene diagnostic and therapy technologies.
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深圳：2024年5月18日发布的《深圳市人民政府关于印发进一步加大吸引和利用外资实施办法的通知》，提出鼓励外商投资企业依法在深圳开展境外已上市细胞和基因治疗药品临床试验...
允许符合条件的外商投资企业在基因诊断与治疗技术开发和应用等领域进行扩大开放试点。
Shenzhen: The Notice of the Shenzhen Government on Issuing Measures to Further Enhance the Attraction and Utilization of Foreign Investment, issued on May 18, 2024, encourages foreign-invested enterprises to conduct clinical trials in Shenzhen for cell and gene therapy drugs that have already been approved overseas, and to allow qualified foreign-invested enterprises to participate in pilot programs for expanding openness in the development and application of gene diagnostic and therapy technologies.
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天津：2024年8月5日发布的《扎实推进高水平对外开放更大力度吸引和利用外资行动方案落实工作清单》，提出积极争取放宽科技创新领域外商投资准入试点。鼓励外商投资企业依法在我市开展境外已上市细胞和基因治疗药品临床试验。
积极争取天津自由贸易试验区符合条件的外商投资企业在基因诊断与治疗技术开发和应用等领域先行先试。
Tianjin: The Work List for the Implementation of Actions to Promote High-Level Opening-Up and to Further Attract and Utilize Foreign Investment, issued on August 5, 2024, proposes actively seeking to relax the restrictions on market entry of foreign investment in the field of technological innovation through pilot programs. It encourages foreign-invested enterprises to conduct clinical trials in Tianjin for cell and gene therapy drugs that have already been approved overseas and to allow qualified foreign-invested enterprises in the Tianjin Free Trade Zone to engage in the development and application of gene diagnostic and therapy technology.
具有重要意义的是，国务院办公厅于2024年3月19日发布《扎实推进高水平对外开放更大力度吸引和利用外资行动方案》，宣布放宽科技创新领域外商投资准入试点。 将允许北京、上海、广东等自由贸易试验区选择若干符合条件的外商投资企业在基因诊断与治疗技术开发和应用等领域进行扩大开放试点。业界对此，期盼甚望。
Significantly, the General Office of the State Council issued the Action Plan for Promoting High-Level Opening-Up and Further Attracting and Utilizing Foreign Investment on March 19, 2024, announcing the relaxation of market entry of foreign investment in the field of technology innovation. It will allow free trade zones in Beijing, Shanghai, Guangdong, and others to select qualified foreign-invested enterprises to engage in pilot programs for development and application of gene diagnostic and therapy technology. The industry has been eagerly anticipating this progress.
2024年9月8日，国家发展和改革委员会、商务部对外公布最新一版负面清单《外商投资准入特别管理措施（负面清单）（2024年版）》（下称" 《2024年版负面清单》"）并将于2024年11月1日起施行，保留外商禁止投资人体干细胞、基因诊断与治疗技术开发和应用的规定。与此同时，三部门联合发布《通知》，宣布开放试点政策。至此，我国在外商投资干细胞及基因诊断与治疗技术的开发与应用上迎来了历史性的政策突破。
On September 8, 2024, the National Development and Reform Commission and the Ministry of Commerce publicly released the 2024 Edition of the Negative List (hereinafter referred to as the "2024 Negative List"), which will come into effect on November 1, 2024. Although the 2024 Negative List retains the restriction on foreign investment in the development and application of human stem cells, gene diagnostic and therapy technology, the Three Departments has meanwhile jointly issued the Notice, announcing the opening-up of pilot policies. This marks a historic policy breakthrough in foreign investment in the development and application of human stem cells and gene diagnostic and therapy technology in China.
二、新政解读
Policy Interpretation
尽管《2024年版负面清单》尚未在全国层面开放限制，但《通知》的出台确立了在中国（北京）自由贸易试验区、中国（上海）自由贸易试验区、中国（广东）自由贸易试验区和海南自由贸易港四地开展 先试先行，允许外商投资企业从事人体干细胞、基因诊断与治疗技术开发和技术应用的政策探索。未来，前述四地区内的外商投资企业有望从事干细胞及基因诊断与治疗技术的开发与应用业务。
Although the 2024 Negative List have not yet lifted restrictions nationwide, the issuance of the Notice establishes a policy framework for pilot programs in four regions: China (Beijing) Pilot Free Trade Zone, China (Shanghai) Pilot Free Trade Zone, China (Guangdong) Pilot Free Trade Zone, and Hainan Free Trade Port. Qualified foreign-invested enterprises in these regions may be allowed to engage in the development and application of stem cell and gene diagnostics and therapy technologies.
值得注意的是，《通知》特别提到，拟进行试点的外商投资企业应当遵守我国 人类遗传资源管理等法律法规的要求，并履行相应管理程序。由于外商投资监管政策的放宽，人类遗传资源监管对于保障该领域我国生物安全的重要性进一步上升。就人类遗传资源最新的监管政策和要求，可参见我们之前的文章，《汉坤 " 观点 | 重磅首发：〈人类遗传资源管理条例实施细则〉要点解读》和《汉坤 " 观点 | 解读新版人类遗传资源行政指南》。
It is worth noting that the Notice specifically mentions that foreign-invested enterprises participating in the pilot programs must comply with China's regulations on human genetic resources. As foreign investment regulations are relaxed, the human genetic resource regulations in ensuring national biosecurity will gain more importance. With regard to the latest regulatory developments and requirements on human genetic resources, please refer to our articles: Highlights on HGR Regulation Implementation Rules, and Key Takeaways of the New HGR Guidelines.
特别值得一提的是，笔者在此前参与外商投资负面清单相关立法建议征集工作中，即详细论述了我国在人类遗传资源方面卓有成效的监管工作，并将此作为放开基因诊断与治疗领域的外资准入限制的监管基础。就具体放开的措施及思路，笔者亦建议可以在若干自贸区内先试先行，后期再逐步在全国完全放开。 我们欣喜地看到本次《通知》的探索思路和措施与笔者此前的建议一致。
Notably, in our previous participation in legislative consultations regarding the Negative List, we discussed the effective regulatory framework in China for human genetic resources, which serves as the regulatory foundation for opening foreign investment in gene diagnostics and therapy. We also proposed piloting such reforms in certain free trade zones, with a gradual nationwide rollout to follow. We are pleased to see that the exploratory approach in the Notice coincide with our previous suggestions.
我们预计，新政策将对我国干细胞及基因诊断与治疗行业产生深远影响，具体包括并不限于以下方面.
We anticipate that the new policy will have a profound impact on the stem cell and gene diagnostics and therapy industry in China, including but not limited to in the following aspects:
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外资准入与产业发展：在历史性新政的鼓舞下，外资企业可以积极把握自由贸易区（港）四地干细胞及基因诊断与治疗产业发展的重要机遇，
通过投资、新设、并购、迁移企业或拓展业务范围等方式，推动产业集聚和创新发展。
Foreign Investment Access and Industry Development: Encouraged by this landmark new policy, foreign-invested enterprises can seize the significant opportunities for industrial development in the four free trade zones (ports) by investing, establishing new entities, engaging in mergers and acquisitions, relocating businesses, or expanding business scopes, thus promoting industrial clustering and innovation.
借此，国外企业/投资者将获得进入中国干细胞及基因诊断与治疗产业的机会，国内生物医药公司（如Biotech）亦在不需要搭建VIE架构情况下能够取得境外投资、深化国际合作。这将 惠及iPSC（诱导性多能干细胞），CAR-T、TCR-T、CAR-NK、TIL等细胞疗法、mRNA、基因测序、体外诊断（IVD/LDT）等众多产业的发展。就细胞与基因治疗领域（CGT）最新监管进展，可参见我们之前的文章：《汉坤·观点| CAR-T/NK监管路在何方 — 体细胞临床研究工作指引（征求意见稿）要点解读》）。
This policy will provide foreign companies and investors with access to China's stem cell and gene diagnostics and therapy industry, while domestic biopharmaceutical companies (e.g., Biotech) will be able to take foreign investment and enhance international cooperation without adopting the VIE structure. This will benefit the development of numerous industries, including iPSCs (induced pluripotent stem cells), CAR-T, TCR-T, CAR-NK, TILs, mRNA, gene sequencing, in vitro diagnostics (IVD/LDT), among others. With regard to the latest regulatory developments in the field of cell and gene therapy (CGT), please refer to our article in Chinese: 汉坤 " 观点 | CAR-T/NK监管靴子落地 — 解读《体细胞临床研究工作指引要点（试行）》).
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公司/集团结构调整：此前，为应对负面清单的监管限制，实践中有不少公司/集团采用了VIE架构从事人体干细胞、基因诊断与治疗技术开发和应用。在外资限制取消的情况下，
可以根据具体需要考虑调整为外商独资企业（WFOE）或合资企业（Joint
Venture）的架构，从而避免VIE架构带来的不稳定性。我们预计，新政发布后，行业内可能会兴起一波拆除VIE架构的热潮。我们将密切关注这一动向，并积极提供相应的协助。
Corporate/Group Restructuring: Previously, to circumvent restrictions in the Negative List, many companies/groups adopted the VIE structure to engage in the development and application of human stem cells and gene diagnostics and therapy technologies. With the removal of foreign investment restrictions, companies may consider reorganizing into wholly foreign-owned enterprises (WFOEs) or joint ventures, depending on their specific needs, thereby avoiding the instability associated with the VIE structure. We anticipate that, following the release of the new policy, there may be a wave of VIE structure dismantling across the industry. We will closely monitor this trend and actively provide corresponding assistance.
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人类遗传资源监管强化：如《通知》明确提到的试点企业应遵守人类遗传资源等监管要求，预计未来卫健委对人类遗传资源监管态度可能更加谨慎。
企业在拥抱利好政策的同时，也将面临更为严格的人类遗传资源监管压力，需要审慎对待，搭建好相应的合规制度体系（SOP），积极履行可能适用的国际合作科学研究等行政许可、备案、事先报告程序。
Enhanced Regulation of Human Genetic Resources: As the Notice explicitly states that pilot enterprises must comply with regulations on human genetic resources, we expect that the National Health Commission will adopt a more cautious approach to the regulation of human genetic resources in the future. While companies embrace the favorable policies, they may also face stricter regulatory pressure. Companies need to carefully establish compliance standard operating systems (SOPs) and actively fulfill applicable administrative approval, filing, and prior reporting requirements for international collaborative scientific research.
三、结语
Conclusion
我们理解，《通知》出台后，各试点自贸区（港）内的配套和具体措施有待进一步出台，例如 可能涉及试点企业的申请资质与申请程序等多方面的监管要求。我们将持续关注这些动向，并积极陪同行业共同探索前进。未来是否会有更多试点地区的开放，以促进全国范围内干细胞与基因诊断行业的蓬勃发展，亦值得进一步期待
We understand that after the issuance of the Notice, supplementary and specific measures in the pilot free trade zones (ports) are yet to be introduced, such as the qualifications and application procedures for pilot enterprises. We will continue to monitor these developments. It remains to be seen whether more pilot regions will open up in the future to promote the robust development of the stem cell and gene diagnostics industry nationwide.
随着我国医药行业的深化改革开放以及创新药物研发的国际化步伐加快，我们见证了国家监管部门与国内创新医药企业携手并进的努力。我们满怀期待地看到，我国干细胞与基因诊断治疗行业即将迎来新的发展机遇。我们共同期盼，通过不断提升中国生物医药产业的国际竞争力，中国向创新药大国行列前行，让创新药物与疗法早日惠及广大患者，为全球健康事业贡献中国力量。
As China's healthcare industry undergoes deeper reform and opening-up and the pace of internationalization of innovative drug development accelerates, we have witnessed the joint efforts of national regulatory authorities and domestic innovative pharmaceutical companies. We look forward with great anticipation to the new development opportunities that await China's stem cell and gene diagnostics and therapy industry. Together, we hope China's biopharmaceutical industry could enhance the international competitiveness, and China could advance into an innovative drug powerhouses, allowing innovative drugs and therapies to benefit patients worldwide and contribute to global health.
Originally Published 9 September 2024
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