Core Viewpoint - WuXi AppTec's CAR-T therapy, Relma-cel, has submitted Phase I study data for treating adult patients with active systemic lupus erythematosus (SLE) to the National Medical Products Administration (NMPA) in China, indicating significant potential for this innovative treatment in a challenging therapeutic area [1][4]. Group 1: Study Overview - The Phase I study is a multicenter, open-label, dose-exploration trial designed to assess the safety and efficacy of Relma-cel in SLE patients, with doses set at 50×10^6, 75×10^6, and 100×10^6 CAR+T cells [1]. - As of July 2025, a total of 12 female patients have been enrolled, with a median age of 27 years and a median disease history of 9.5 years [2]. Group 2: Patient Characteristics - All enrolled patients exhibited moderate to severe active SLE, with a median SELENA-SLEDAI score of 10 [2]. - 100% of patients had renal involvement, and other affected systems included skin (50%), hematologic (50%), and joints (16.7%) [2]. Group 3: Efficacy Results - Among the 12 patients evaluated for 6-month efficacy, 100% achieved SRI-4 response, and 50% met LLDAS criteria, indicating promising therapeutic effects [2]. - Various disease activity scales showed a downward trend, suggesting significant efficacy of Relma-cel in managing SLE [2]. Group 4: Safety Results - Initial safety results indicated that 11 out of 12 patients experienced grade 1 cytokine release syndrome (CRS), with one patient experiencing grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) [3]. - No dose-limiting toxicities (DLT) were reported, highlighting the favorable safety profile of Relma-cel in this patient population [3]. Group 5: Future Prospects - The ongoing study aims to gather longer follow-up data, with the potential for Relma-cel to advance to the biologics license application (BLA) stage [4]. - The company anticipates further discussions with regulatory authorities to expedite the Phase II pivotal study, aiming to provide a breakthrough treatment option for SLE patients [4].

Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has submitted Phase I study data for relma-cel in adult patients with active systemic lupus erythematosus (SLE) to the National Medical Products Administration (NMPA) in China, which has accepted the data and processed the meeting application [1] Group 1 - WuXi Biologics has initiated a Phase I clinical trial for relma-cel targeting SLE patients [1] - The submission to NMPA indicates progress in the regulatory process for relma-cel in China [1] - Acceptance of the data by NMPA is a significant step towards potential market entry [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 已向中國國家藥品監督管理局遞交瑞基奧侖賽在 （股份代號：2126） JW (Cayman) Therapeutics Co. Ltd 自願公告 藥明巨諾（開曼）有限公司* 研究及發展更新 （於開曼群島註冊成立的有限公司） 中國成人活動性系統性紅斑狼瘡患者中的I期研究數據 JW (Cayman) Therapeutics Co. Ltd （藥明巨諾（開曼）有限公司*）（「本公司」或「藥明 巨諾」，連同其附屬公司統稱「本集團」），一家獨立的、專注於研發、生產及商 業化細胞免疫治療產品的創新型生物科技公司，宣佈已向中國國家藥品監督 管理局（「NMPA」）遞交瑞基奧侖賽(relma-cel)在中國成人活動性系統性紅斑狼瘡 （「SLE」）患者中的I期研究數據，NMPA已接收數據，並受理會議申請。 瑞基奧侖賽在中國成人SLE患者中的安全性和療效數據更新 SLE是一種慢性自身免疫性疾病，可引起全身多臟器和組織受損。據 ...

Market Performance - The Hang Seng Index closed at 25,247.10 points, down 2.48%, with a weekly decline of 3.97% [1] - The Hang Seng Tech Index closed at 5,760.38 points, down 4.05%, with a weekly decline of 7.98% [1] Individual Stock Movements - ZTE Corporation fell over 12%, Huahong Semiconductor dropped nearly 7%, and SMIC declined over 6% [2] - Baidu, Alibaba, and Meituan all experienced declines of over 4%, while Xiaomi and JD.com fell over 3% [2] - On the positive side, Jiajie Ankang rose over 22%, and Chow Tai Fook increased by over 5% [2] Sector Performance - The Hang Seng Biotechnology Index closed at 15,783.20 points, down 3.60% [2] - The Hang Seng China Enterprises Index closed at 9,011.97 points, down 2.67% [2] - The Hang Seng Composite Index closed at 3,894.61 points, also down 2.67% [2]

Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has submitted a supplementary application for the domestic production of a viral vector for its CAR-T cell therapy product, Rikeolunai Injection, which targets blood cancers. This move aims to enhance the stability of supply and reduce production costs, thereby improving the product's market competitiveness and potential for insurance negotiations [3][6][7]. Group 1: Product Development and Approval - WuXi Biologics' Rikeolunai Injection has received approval for three indications in the domestic market, focusing on hematological malignancies [3]. - The number of CAR-T cell therapy products approved in China has reached seven, but high prices, such as Rikeolunai Injection's price of 1.29 million yuan per dose, limit accessibility [6]. Group 2: Cost and Supply Chain Challenges - The high cost of viral vectors, which are crucial for CAR-T cell therapy production, has been a significant barrier to market entry and insurance negotiations. The industry has faced multiple failures in price negotiations with national insurance [6][7]. - The company has developed a domestically produced viral vector (JWLV011) to mitigate supply chain issues and reduce costs associated with foreign suppliers [6][8]. Group 3: Clinical Research and Efficacy - A Phase II study has shown that the Rikeolunai Injection produced with the new domestic viral vector has comparable clinical efficacy to that produced with existing foreign vectors, with an overall response rate (ORR) of 66.67% and a complete response (CR) rate of 41.67% observed after three months [8].

Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has submitted a post-marketing supplementary application to the Chinese National Medical Products Administration for the use of domestically produced viral vectors in its CAR-T cell therapy product, Rikeo Lun Sai (BenoDa) [2] Group 1: Product Development and Approval - Rikeo Lun Sai is a CAR-T cell immunotherapy product targeting CD19, developed based on the CAR-T cell technology platform of WuXi Biologics [2] - The product has received approval for three indications in the blood cancer field in China [2] - Currently, there are seven CAR-T cell therapy products approved in China, but high prices limit accessibility, with Rikeo Lun Sai priced at 1.29 million yuan per injection [2] Group 2: Market Challenges - The high cost of CAR-T cell therapies has led to four failed negotiations with the national medical insurance, attributed to the pricing rules of "no negotiation below 500,000 yuan, and no entry below 300,000 yuan" [2] - Industry insiders indicate that due to production cost constraints, CAR-T drugs need to lower prices to enter insurance coverage, which will take time [2] Group 3: Production and Cost Efficiency - Lentiviral vectors are crucial for gene delivery in cell therapies and are among the most expensive production materials [3] - WuXi Biologics has developed a domestically produced lentiviral vector (JWLV011) to optimize production processes and enhance quality control, aiming to ensure stable supply and reduce costs for Rikeo Lun Sai [3] - The domestic replacement of lentiviral vectors is strategically significant for the company, potentially leading to lower costs and improved competitiveness in commercialization and insurance negotiations [3] Group 4: Clinical Research Findings - The application is based on a Phase II single-arm study assessing the comparability of Rikeo Lun Sai produced with the new JWLV011 vector against the existing product [4] - The study reported a 66.67% overall response rate (ORR) and a 41.67% complete response (CR) after at least three months of follow-up [4] - Common severe adverse events included cytopenia, with CAR-T related toxicities primarily at grade 1, and no grade 3 or higher cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported [4][5]

Core Viewpoint - The approval of the domestic viral vector for the production of the CAR-T cell therapy product, Brexucabtagene Autoleucel (brand name: Beinuoda), by WuXi AppTec is a significant step towards reducing production costs and improving supply stability, which may enhance the product's commercial viability and competitiveness in the market [1][4]. Group 1: Product Development and Approval - WuXi AppTec announced that the China National Medical Products Administration has officially accepted its supplementary application for the use of domestically produced viral vectors in the post-marketing phase for Beinuoda [1]. - Beinuoda is a CAR-T cell immunotherapy product targeting CD19, developed based on the CAR-T cell technology platform of WuXi AppTec's subsidiary, and has received approval for three indications in the blood cancer field [1]. Group 2: Market Context and Challenges - Currently, there are seven CAR-T cell therapy products approved in China, but their high prices, often exceeding one million yuan (approximately 129 million), limit accessibility [3]. - Previous attempts to negotiate inclusion in the national medical insurance have failed, attributed to strict pricing rules [3]. Group 3: Production Cost and Strategy - The use of lentiviral vectors is crucial in CAR-T cell therapy, being one of the most expensive raw materials, which has hindered the commercial production and clinical development of Beinuoda [3]. - The company has developed a new lentiviral vector (JWLV011) to optimize production processes and enhance quality control, aiming to ensure stable supply and reduce costs [3][4]. Group 4: Clinical Research and Efficacy - A Phase II study has been conducted to evaluate the comparability of Beinuoda produced with the new JWLV011 vector against the existing product, showing a 66.67% overall response rate and a 41.67% complete response rate after three months of follow-up [4][5]. - The study indicated that the safety profile of the JWLV011-produced product is comparable to that of the existing product, with no severe adverse events reported [5].

Core Viewpoint - WuXi AppTec (2126.HK) has announced that the National Medical Products Administration of China has officially accepted its supplementary application for the post-marketing use of Beiduo Da® with domestically produced viral vectors, which is strategically significant for the company [1] Group 1: Company Strategy - The use of lentiviral vectors is crucial as it is one of the most important and costly raw materials for cell therapy products [1] - The domestic substitution of lentiviral vectors is expected to stabilize the supply for commercial products and clinical development, leading to a significant reduction in production costs [1] - Lower costs will enhance the company's ability to compete in commercialization and insurance negotiations, potentially increasing the commercial value of Beiduo Da® [1]

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].

Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has received formal acceptance from the NMPA for a supplemental application to use domestically produced viral vectors for the production of its CAR-T therapy, Breyanzi, which aims to enhance supply stability and reduce costs [1][2]. Group 1: Product Development - The new application is based on a Phase II single-arm study that evaluates the comparability of Breyanzi produced with the new viral vector (JWLV011) against that produced with existing viral vectors [2]. - The study has shown a 3-month objective response rate (ORR) of 66.67% and a complete response (CR) rate of 41.67% [2]. Group 2: Safety and Efficacy - The most common severe adverse event reported was cytopenia, with CAR-T related toxicities primarily being grade 1, and no grade 3 or higher cytokine release syndrome (CRS) or any level of immune effector cell-associated neurotoxicity syndrome (ICANS) observed [2]. - Clinical data indicates that the Breyanzi produced with the domestically sourced viral vector (JWLV011) is clinically comparable to that produced with existing viral vectors [2]. Group 3: Strategic Importance - The CEO of WuXi Biologics emphasized that the domestic production of viral vectors is strategically significant, as it will stabilize supply and significantly reduce production costs [2]. - Lower costs will enhance the company's competitive position in commercialization and insurance negotiations, potentially leading to a substantial increase in the commercial value of Breyanzi [2].