Investment Rating - The industry investment rating is maintained at "Overweight" [5] Core Insights - The management change at WuXi AppTec is seen as a strategic move to leverage the expertise of both commercial and technical leaders to navigate the evolving payment landscape for CAR-T therapies. The new CEO, Tian Feng, brings over 20 years of experience in oncology commercialization, while the new chairman, Dr. Liu Cheng, is a leading scientist in the CAR-T field [5][7] - The establishment of the first national commercial health insurance innovation drug directory marks a significant shift in China's multi-tiered payment system, providing new payment channels for high-cost therapies like CAR-T. This policy change indicates a transition in market focus from "technical validation" to "payment capability and market access" [7] - The management aims to capitalize on this policy window by enhancing collaborations with insurance companies and optimizing costs, such as reducing core material costs by over 90% through self-developed lentiviral vectors. This strategic adjustment signals a broader industry shift from research-driven to a dual focus on research and commercialization [7] Summary by Sections Recent Industry Performance - The industry has shown relative returns of -3.06% over the past month, -9.84% over the past three months, and -7.91% over the past year compared to the CSI 300 index. Absolute returns were 0.49% for the last month, -7.88% for the last three months, and 9.5% for the last year [3] Management Changes - WuXi AppTec announced significant changes in its core management team, appointing Tian Feng as the new CEO and Dr. Liu Cheng as the chairman. This change is crucial as the company seeks to enhance its market performance amid evolving industry challenges [5][7] Investment Recommendations - The report suggests focusing on companies within the A-share market that have a strong position in the cell therapy industry, such as WuXi AppTec, Fosun Pharma, and others, due to the anticipated opportunities arising from the breakthrough in CAR-T therapy payment bottlenecks [7]

Core Viewpoint - WuXi AppTec's management restructuring aims to enhance operational stability and drive growth in the competitive CAR-T therapy market, particularly following the inclusion of its CAR-T product in the national commercial health insurance directory [1][2][5]. Management Changes - Tian Feng will officially become the CEO and Executive Director on December 29, 2025, while Dr. Liu Cheng will assume the role of Chairman of the Board from December 12, 2025 [1]. - The current CEO, Liu Min, will resign on December 12, 2025, due to personal career development plans, and his previously approved stock options will be canceled [1][2]. - The existing management team will temporarily take over the CEO responsibilities to ensure smooth operations during the transition period [1]. New Leadership Background - Tian Feng has over 20 years of experience in the biopharmaceutical industry, with a strong background in commercialization, marketing, and strategic management [2]. - Dr. Liu Cheng has more than 20 years of experience and holds over 300 patents in the biopharmaceutical field, ranking highly in global CAR-T patents [3]. Financial Performance - In the first half of the year, WuXi AppTec reported revenues of 106 million yuan, a year-on-year increase of 22.5%, but also recorded a loss of 267 million yuan, with the loss margin widening by 11.24% [3]. - The company's core product, the CAR-T therapy, has been approved for treating specific types of lymphoma [3]. Strategic Partnerships - WuXi AppTec has entered into several business collaborations, including a technology licensing agreement with Juno Therapeutics valued at up to 10 million USD and a strategic cooperation agreement with Regeneron worth up to 50 million USD [4]. Market Context - The inclusion of WuXi AppTec's CAR-T product in the national commercial health insurance directory is a significant breakthrough, with five CAR-T therapies listed, including WuXi's product priced at 1.29 million yuan per dose [5][6]. - The price reduction for these therapies is expected to range between 15% and 50%, which may facilitate better access to these innovative treatments [6]. Challenges and Opportunities - The new management faces the challenge of improving market penetration for core products and accelerating pipeline development amid intense competition in the new drug development landscape [5][7]. - The company must also navigate hospital access issues to ensure the successful implementation of its products in the healthcare system [6][7].

药明巨诺建有三个经国家药监局批准的CAR-T生产模块，其中模块三为国内唯一获批传染病阳性患者 CAR-T生产车间，保障了产品的可及性与安全性。 2025年10月，倍诺达®新增使用国产病毒载体的上市后补充申请获药监局正式受理，标志着核心物料自 主可控，预计慢病毒载体的物料成本将显著下降。其自建的高规格慢病毒载体生产车间采用悬浮生产工 艺，突破传统贴壁工艺的限制。相较于后者单批次仅能供应约100人份的产能，药明巨诺的单批次产量 可提升至1500人份CAR-T治疗需求，显著提高了生产效率和供应能力。 2025年4月，药明巨诺将其自研的慢病毒载体生产工艺授权予美国Juno公司，实现中国细胞治疗技术的 反向出口，展现出中国创新的国际竞争力。 04 多管线研发并行，全球化布局加速 政策引领与产业创新双轮驱动，助力"健康中国2030" 2025年12月7日，国家医保局正式发布《商业健康保险创新药品目录》。药明巨诺（2126.HK）的倍诺 达®（瑞基奥仑赛注射液）凭借突出的临床价值与创新性，成功纳入首批创新药目录。这标志着中国创 新药可及性改革迈出关键一步，细胞免疫治疗正式进入"商保+创新药"协同新阶段，为更多中国患者使 用 ...

Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has received formal acceptance from the National Medical Products Administration (NMPA) for a supplemental application to use domestically produced viral vectors in the production of its CAR-T therapy, Breyanzi (JWLV011) [1][2]. Group 1 - The application is based on a Phase II single-arm study aimed at evaluating the comparability of Breyanzi produced with the new viral vector (JWLV011) versus the existing viral vector [2]. - The study has completed at least three months of follow-up, showing an objective response rate (ORR) of 66.67% and a complete response (CR) rate of 41.67% [2]. - The most common severe adverse event reported was cytopenia, with no grade 3 or higher cytokine release syndrome (CRS) events and no immune effector cell-associated neurotoxicity syndrome (ICANS) reported [2]. Group 2 - The domestic production of the viral vector is strategically significant for the company, as it aims to stabilize supply and reduce costs, which are currently high due to reliance on foreign suppliers [1][2]. - The successful transition to domestic viral vectors is expected to enhance the commercial viability and clinical development of Breyanzi, allowing the company to better compete in the market and negotiate with insurers [2].

Summary of Weekly Review on Pharmaceutical Sector Industry Overview - The pharmaceutical sector in A-shares showed a positive performance with the index (CITIC) increasing by 2.21% while the CSI 300 index decreased by 1.08% and the ChiNext index fell by 1.40% [1][2] - In H-shares, the Hang Seng Index for healthcare increased by 3.43%, contrasting with a decline of 1.32% in the Hang Seng Index and a drop of 1.46% in the Hang Seng Technology Index [1][2] Market Performance - The CSI 300 pharmaceutical index rose by 0.61% and the CSI 500 pharmaceutical index increased by 1.83% [3] - The overall daily trading volume for the market remained between 9,900 million and 12,000 million, with the pharmaceutical sector's market trading share fluctuating between 7.3% and 10.1% [3] - The pharmaceutical sector outperformed both the CSI 300 index and the ChiNext index during the week [3] Key Announcements and News - **WuXi AppTec**: The NMPA has accepted the application for the new indication of its cell immunotherapy product, Beiduo® (Regorafenib Injection), for second-line treatment of relapsed or refractory adult B-cell lymphoma patients [4] - **Hengrui Medicine**: The company received approval from the National Medical Products Administration for the clinical trial of SHR-4712 injection, which targets tumor-associated antigens and activates immune cells in the tumor microenvironment [4] - **Junshi Biosciences**: The company's HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) has been granted orphan drug designation for gastric cancer treatment by the European Commission [4] - **Kejia Pharmaceutical**: The candidate product targeting Claudin18.2 protein, "Shu Rui Ji Ao Lun Sai Injection," has been included in priority review by the NMPA for treating Claudin18.2 positive patients with advanced gastric and gastroesophageal junction adenocarcinoma who have failed at least second-line treatment [4] - **Rongchang Biologics**: The company announced that its dual-target fusion protein, Tai Ta Xi Pu, has been approved for listing in China for the treatment of acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG), showing significant improvement in patient symptoms after 24 weeks of treatment [5]

Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has received acceptance from the National Medical Products Administration (NMPA) for its cell immunotherapy product, Brexucabtagene Autoleucel (Ruxolitinib Injection), for a new indication in the second-line treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) patients [1][2] Group 1 - The application for Brexucabtagene Autoleucel is the fourth submission for this product by WuXi Biologics [1] - The NMPA granted breakthrough therapy designation for Brexucabtagene Autoleucel in January 2025 for the second-line treatment of r/r LBCL [1] - LBCL is a highly aggressive form of non-Hodgkin lymphoma and is the most common subtype of lymphoma in adults, with 30-40% of patients experiencing relapse or refractory disease after first-line treatment [1] Group 2 - The sBLA is based on a pivotal, single-arm, multi-center clinical study that evaluated Brexucabtagene Autoleucel in adult r/r LBCL patients who were not suitable for autologous stem cell transplantation (ASCT) after first-line treatment failure [2] - The Phase II open-label study in China included patients who had failed prior treatment with targeted CD20 antibodies and anthracycline-based regimens [2] - As of January 21, 2025, 49 patients had undergone cell infusion with at least 3 months of follow-up, showing significant clinical efficacy with an overall response rate (ORR) of 81.3% and a complete response rate (CRR) of 54.2% [2]