Key Industry Catalyst: Beijing's Comprehensive Support Policies Launch a National Industrial Cycle
On August 14, 2026, Beijing released a draft opinion on high-quality development in cell and gene therapy, introducing nine support measures across five dimensions: innovation, clinical application, platforms, regulation, and industry. This creates a leading policy ecosystem for CGT in China. Two breakthrough benefits are set to remove industry bottlenecks: first, the payment system is being proactively addressed, with medical insurance agencies providing early pricing guidance and establishing a multi-tier "medical insurance + commercial insurance" payment framework. This resolves the commercialization challenge of high cell therapy drug costs and limited patient affordability. Second, a dedicated fast-track approval channel is being implemented, offering case-by-case guidance throughout the process to significantly shorten new drug registration and industrial deployment timelines. Additionally, foreign investment in stem cell and gene therapy services is being liberalized in free trade zones, accelerating the inflow of global technology and capital.
These policy advantages are likely to be replicated nationwide, supported by complementary national measures. In May of this year, China's first CGT-specific administrative regulation took effect, and in July, the National Medical Products Administration introduced a 30-day expedited review pathway for CGT innovative drugs. This creates a complete top-down support system. The industry's growth potential is vast, with the domestic CGT market exceeding 500 billion yuan in 2025, a 45% year-on-year increase, and a global compound annual growth rate of 35.6%. Domestically, 354 cell therapy IND applications have been approved, accounting for 68.5% of all CGT clinical applications, and five CAR-T drugs have been included in commercial insurance catalogs, signaling a commercial tipping point. Secondary market funds are also flowing in, with sector stocks averaging a 2.69% gain in August. Avis Budget, 百普赛斯, and 睿智医药 have attracted significant net capital inflows, creating a synergy between industry fundamentals and capital flows. This policy package covers the entire value chain, from upstream equipment and reagents, to midstream CDMO/CRO services and self-developed cell drugs, to downstream cell storage. All segments can benefit from the policy tailwinds, driving a triple upward cycle of accelerated R&D filings, commercial scaling, and capacity expansion.
Midstream Self-Developed CGT Innovative Drug Companies: Directly Benefiting from Faster Approvals and Improved Payment, with Strongest Commercialization Flexibility
复星医药 (600196) is a domestic CAR-T commercialization leader. Its product, Yikaida, was the first approved CAR-T in China, has been included in the first edition of commercial insurance innovative drug catalogs, and leads in the number of treated patients. The Beijing policy's push for dual medical and commercial insurance channels will significantly reduce patient out-of-pocket costs, directly boosting clinical usage. The case-by-case approval mechanism will accelerate the company's subsequent pipeline of next-generation CAR-T and universal cell therapies. With its integrated platform for antibodies, ADCs, and cell therapies, coupled with solid progress in solid tumor cell therapy programs, the company is poised to capitalize on both commercialization and pipeline development.
安科生物 (300009) has invested in博生吉安科 to develop a CD7-CAR-T pipeline. Its PA3-17 injection has been designated a breakthrough therapy by the CDE and is in a pivotal Phase II trial. This status allows it to prioritize access to Beijing's full-process application guidance and expedited market pathway. The company is also advancing a globally first-in-class in vivo CAR-T technology targeting both hematological and solid tumors. With abundant clinical resources at top-tier hospitals in Beijing, the new policy encourages medical institutions to conduct CGT clinical research, giving the company's pipeline priority access to these resources, shortening clinical trial timelines, and boosting its valuation.
中源协和 (600645) is a domestic leader in stem cell therapy, holding 11 IND approvals for stem cell drugs, the most in the country, and has a history of deep clinical collaboration with Beijing's top-tier hospitals. The new policy focuses on commercializing stem cell technology and liberalizing foreign cooperation channels in free trade zones. The company's international BD cooperation strategy aligns with these policy directions, with ongoing overseas product licensing and joint R&D deals. Its cell storage business also benefits from local industry support, allowing its stem cell drug development, storage, and overseas licensing segments to all gain from the policy tailwinds.
Midstream CGT CXO (CDMO/CRO): Surge in R&D Filings Drives Continued Outsourcing Orders
和元生物 (688238) is the only pure-play CGT vertical CDMO listed on the A-share market. It operates a comprehensive GMP manufacturing platform for plasmids, viral vectors, and cell preparations, having served over 300 CGT R&D projects with dual China-US filing capabilities. The new 30-day expedited review pathway will create a rush of drug companies filing INDs. To compress R&D timelines, these companies will prioritize professional CDMOs with mature, compliant systems. The company's viral vector manufacturing is a necessary step in cell therapy, ensuring its capacity utilization continues to rise. With Beijing encouraging local CGT industry platform construction, the company is well-positioned to secure manufacturing orders from the capital's drug companies and innovative institutes, offering leading performance flexibility across the sector.
Avis Budget is a global integrated CRDMO leader. Its subsidiary,药明生基, has a global-scale CGT production base offering full-service manufacturing for CAR-T and gene therapies, while also holding stakes in self-developed CAR-T pipelines. As domestic and international cell therapy R&D investment intensifies, and with Beijing liberalizing foreign investment in CGT, cross-border drug companies are seeking to conduct clinical trials and production in China, generating dual domestic and international outsourcing orders for the company. In August, it attracted significant capital inflows, with institutional investors showing long-term confidence in the CGT outsourcing space.
博济医药 (300404) is a key player in the CGT clinical CRO subsector, offering a full-cycle clinical service platform for CAR-T and CAR-NK therapies, covering preclinical, Phase I-III trials, and regulatory filings. The new policy accelerates clinical translation of cell drugs, leading to a surge in pipelines entering clinical stages and a growing boom in solid tumor CAR-T R&D. The company's clinical project pipeline is expanding. Amidst the sector's momentum, the stock hit a 20cm daily limit, with its small-cap nature offering greater price flexibility, allowing it to fully benefit from the wave of clinical filings.
昭衍新药 (603127) is a domestic leader in CGT non-clinical safety evaluation, handling over 45% of all cell and gene therapy drug safety assessment work in the country. All CGT IND filings require a completed safety evaluation. With the rising number of IND applications and the simplified Beijing filing process adding project volume, the company's safety evaluation orders maintain stable, high growth. As a necessary R&D step, preclinical evaluation is insulated from drug commercialization cycles, providing strong earnings stability.
Upstream Equipment, Reagents, and Consumables: The "Shovel Sellers" in CGT, with Capacity Expansion Sustaining Demand
东富龙 (300171) is a supplier of integrated equipment for the entire cell therapy process, covering cell culture, purification, and cryopreservation, along with related consumables, offering complete solutions for CGT facilities and drug manufacturing plants. The Beijing policy encourages building standardized CGT industrialization platforms, prompting drug companies nationwide to accelerate the construction of their own cell production lines and CDMOs to expand capacity. This releases sustained equipment procurement demand. The company's equipment has been commercially validated by leading cell therapy companies, and with industry capacity expansion, it continues to secure large-scale equipment orders.
百普赛斯 (301080) is a leading supplier of core raw materials for CAR-T R&D, independently producing recombinant proteins and anti-idiotypic antibodies for targets like CD19, BCMA, and HER2. These are essential reagents for in vitro screening and activity testing of cell drugs. As downstream CAR-T pipelines grow in clinical and commercial scale, raw material consumption increases proportionally. Beijing's support for local CGT innovation has led to a surge in startup cell therapy companies, steadily boosting reagent procurement demand. This high-barrier raw material subsector maintains long-term high gross margins.
开能健康 (300272) is deepening its presence in the cell storage and cell preparation equipment space through its affiliate, Yaneng Cell, focusing on fully automated, ultra-low temperature cell storage systems and complete cell bank solutions. The Beijing policy strengthens the entire CGT industrial chain and encourages the construction of cell resource banks, leading to the continued expansion of cell storage operations at hospitals and biotech companies. Cell storage equipment is a fundamental infrastructure need, and its growth will steadily accompany the development of the stem cell and immune cell industry.
Investment Thesis for the Full Sector Over the Long Term
Beijing's new CGT policy, combined with national-level approval and payment reforms, marks a shift for the cell and gene therapy industry away from concept speculation and into a long-term cycle of regulated commercialization. The investment thesis is clear, with three distinct layers. The primary core thesis centers on self-developed cell therapy drug companies, where the integration of medical and commercial insurance payment systems, coupled with accelerated approvals, will drive product commercialization and pipeline launches, offering the strongest earnings visibility. The second, more flexible thesis focuses on CGT vertical CDMO and clinical CRO companies, where a surge in industry R&D filings will lead to an explosion in outsourcing orders, particularly for companies focused on this subsector. The third, more stable thesis involves upstream equipment, reagent, and consumable suppliers, where the expansion of the entire industry chain will continue to drive essential procurement, offering stable, cross-cycle growth characteristics. As Beijing's policies are gradually replicated nationwide, the commercial scale of cell therapy drugs will continue to expand, driving parallel growth in upstream capacity and midstream R&D services. The entire CGT value chain presents long-term, sustainable investment value, with the sector's valuation facing a systematic reassessment opportunity.
Comments