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]