格隆汇10月9日｜药明巨诺(2126.HK)在港公告，布中国国家药品监督管理局已正式受理其倍诺达®新增 使用国产病毒载体的上市后补充申请。药明巨诺董事长兼首席执行官刘敏先生表示：慢病毒载体不仅是 细胞治疗产品最重要的生产原材料之一，也是成本最高的生产原材料。慢病毒载体的国产替代，对于公 司有著重要的战略意义。在成功完成病毒载体替代后，我们的商业化商品及临床开发的供货将更为稳 定，产品成本也将实现大幅度的下降，较低的成本将使得公司能够更好地应对商业化的竞争以及保险谈 判，这使得我们有机会实现倍诺达®商业化价值的巨大提升。 ...

药明巨诺-B(02126)发布公告，中国国家药品监督管理局(NMPA)已正式受理其倍诺达新增使用国产病毒 载体的上市后补充申请。 慢病毒载体作为目的基因递送工具，在细胞治疗产品中起着重要的作用，可以实现嵌合抗原受体基因的 转导和整合。慢病毒载体是瑞基奥仑赛注射液的重要的生产原材料之一，当前生产中所使用的慢病毒载 体由国外生产商供货，价格贵且供货存在不稳定性，较大地限制了瑞基奥仑赛的商业化生产及临床开 发。药明巨诺研发并新增了自主生产的慢病毒载体(JWLV011)，旨在实现病毒生产工艺优化、品质控制 加强的前提下，确保瑞基奥仑赛注射液的稳定持续供应以及降低成本。 本次申请是基于一项II期单臂研究，目的是评估和论证使用新工艺病毒载体(JWLV011)生产的瑞基奥仑 赛注射液，与使用现有病毒载体生产的瑞基奥仑赛注射液产品可比。目前本研究已完成至少3个月随 访：观察到的3个月最佳客观缓解率(ORR)为66.67%，疾病完全缓解率(CR)为41.67%。最常见的严重不 良事件为血细胞减少;CAR-T相关毒性如细胞因子释放综合征(CRS)，多为1级，无≥3级CRS发生，无任 何级别免疫效应细胞相关神经毒性综合征(ICAN ...

消息面上，国家医保局近日公告，2025年国家基本医保目录及商保创新药目录调整专家评审工作已结 束，包括药明巨诺的倍诺达在内的5款CAR-T药物均通过了专家评审。据悉，CAR-T治疗由于"一针超百 万元"的高昂定价始终未能进入基本医保目录。截至目前，CAR-T疗法已经基本形成了以商业医疗保险 为主体、特病特药保险为补充、金融分期及各类救助方案为辅的多元支付格局。 药明巨诺-B(02126)盘中涨近7%，截至发稿，涨6.1%，报4.35港元，成交额728.67万港元。 公开资料显示，药明巨诺的倍诺达已被70余款商业医疗险产品纳入，公司也对外回应称，公司CAR-T产 品会积极参加2025年医保和商保创新药目录申报工作。业内人士普遍认为，此次5款CAR-T产品集体通 过专家评审，释放出积极信号，显示监管层在提高前沿疗法可及性上的决心。 ...

智通财经APP获悉，药明巨诺-B(02126)盘中涨近7%，截至发稿，涨6.1%，报4.35港元，成交额728.67万 港元。 消息面上，国家医保局近日公告，2025年国家基本医保目录及商保创新药目录调整专家评审工作已结 束，包括药明巨诺的倍诺达在内的5款CAR-T药物均通过了专家评审。据悉，CAR-T治疗由于"一针超百 万元"的高昂定价始终未能进入基本医保目录。截至目前，CAR-T疗法已经基本形成了以商业医疗保险 为主体、特病特药保险为补充、金融分期及各类救助方案为辅的多元支付格局。 公开资料显示，药明巨诺的倍诺达已被70余款商业医疗险产品纳入，公司也对外回应称，公司CAR-T产 品会积极参加2025年医保和商保创新药目录申报工作。业内人士普遍认为，此次5款CAR-T产品集体通 过专家评审，释放出积极信号，显示监管层在提高前沿疗法可及性上的决心。 ...

Core Viewpoint - The approval of five CAR-T products, including WuXi AppTec's Benauda, by the National Healthcare Security Administration (NHSA) is seen as a positive signal indicating the regulatory body's commitment to improving access to cutting-edge therapies [1] Group 1: Company Specifics - WuXi AppTec's stock price increased by over 7% in the afternoon session, reaching 4.22 HKD with a trading volume of 19.47 million HKD [1] - The company's CAR-T product, Benauda, has been included in over 70 commercial health insurance products, indicating strong market acceptance [1] - WuXi AppTec has stated that it will actively participate in the application process for the 2025 National Basic Medical Insurance and commercial insurance innovative drug directories [1] Group 2: Industry Insights - The recent approval of CAR-T therapies reflects a shift towards a multi-faceted payment structure, primarily driven by commercial health insurance, supplemented by special disease insurance and various financial assistance programs [1] - Despite the high cost of CAR-T treatments, which can exceed one million yuan per injection, the industry is adapting to ensure broader access through innovative insurance solutions [1]

Core Viewpoint - WuXi AppTec's stock price increased by over 7% following the announcement that five CAR-T therapies, including its product Benodda, passed expert review for inclusion in the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory, indicating a positive regulatory signal for advanced therapies [1] Group 1: Company Performance - WuXi AppTec's stock price rose by 5.76% to HKD 4.22, with a trading volume of HKD 19.47 million [1] - The company is actively participating in the application process for the 2025 medical insurance and commercial insurance innovative drug directories [1] Group 2: Industry Insights - The approval of five CAR-T products, including WuXi AppTec's Benodda, reflects a commitment from regulators to enhance the accessibility of cutting-edge therapies [1] - CAR-T therapies have not yet entered the basic medical insurance directory due to their high costs, often exceeding one million yuan per treatment [1] - The current payment structure for CAR-T therapies is diverse, primarily relying on commercial health insurance, supplemented by special disease insurance, financial installment plans, and various assistance programs [1]

Core Viewpoint - The National Healthcare Security Administration (NHSA) has completed the expert review for the 2025 National Basic Medical Insurance (BMI) catalog and the commercial insurance innovative drug catalog, marking the eighth adjustment since its establishment and the first inclusion of a commercial insurance innovative drug catalog [1][2]. Group 1: CAR-T Products Approval - Five CAR-T products have successfully passed the expert review and will be included in both the basic medical insurance and commercial insurance innovative drug catalogs, laying the groundwork for future negotiations and access [1][2]. - The approval of these CAR-T products is seen as a positive signal, indicating the regulatory body's commitment to improving access to cutting-edge therapies [1][3]. - The review process emphasized the innovation level, efficacy, and the ability to fill treatment gaps, with CAR-T therapies receiving unanimous approval [2][5]. Group 2: Impact on Patients and Companies - The introduction of the commercial insurance innovative drug catalog is expected to significantly reduce out-of-pocket expenses for patients, making high-cost CAR-T treatments more accessible [3][4]. - Companies view the catalog as a "second channel" for innovative drugs, alleviating pricing pressure during negotiations with basic medical insurance and potentially expanding market share [4][5]. - The collaboration between pharmaceutical companies and insurance providers is anticipated to evolve towards deeper cooperation, exploring mechanisms like outcome-based payments and risk-sharing [4][5]. Group 3: Future Outlook - Companies express cautious optimism regarding the inclusion of CAR-T products in the commercial insurance innovative drug catalog, supported by policy direction, clinical value, and practical experience [5][6]. - The ongoing expansion and optimization of the commercial insurance catalog are expected to further benefit patients in need of CAR-T therapies [6].

Core Viewpoint - The company reported better-than-expected reduction in operating losses for 1H25, driven by cost control and licensing agreements [1][2] Financial Performance - Revenue for 1H25 reached 106 million yuan, a year-on-year increase of 22.5% - The net loss attributable to shareholders was 267 million yuan, with an operating loss of 114 million yuan after excluding impairment impacts, showing a reduction in losses of 126.5 million yuan compared to the same period last year [1] - The gross margin for product sales improved to 51.1%, up 0.7 percentage points year-on-year, while the sales expense ratio decreased by 15.7 percentage points to 72.0% [1] Development Trends - The company achieved stable sales for its main product, Benodac, in 1H25, and entered a licensing agreement with Juno for JW sLVV production technology, with a payment of up to 10 million USD expected to enhance performance [1] - The company disclosed a new CD19/20 dual-target CAR-T pipeline, with data expected by the end of the year, and initiated IIT research for JWCAR201 in hematological malignancies and autoimmune diseases [1] Clinical Trials - The company started a Phase I clinical trial for systemic lupus erythematosus (SLE) in May 2024, with patient enrollment completed by 1Q25, indicating a first-mover advantage in CAR-T treatment for SLE in China [2] Profit Forecast and Valuation - Due to the better-than-expected reduction in operating losses, the company raised its 2025 net profit forecast from a loss of 609 million yuan to a loss of 427 million yuan, and introduced a 2026 forecast of a loss of 320 million yuan [2] - The target price was increased by 151.7% to 6.04 HKD, indicating a potential upside of 19.6% from the current stock price [2]

中金主要观点如下： 上半年经营性利润减亏良好，主因降本控费和达成授权许可合作 （原标题：中金：维持药明巨诺-B(02126)跑赢行业评级 上调目标价至6.04港元） 智通财经APP获悉，中金发布研报称，由于上半年药明巨诺-B(02126)经营性利润减亏较好，维持跑赢行 业评级，考虑到公司减亏、SLE和早期管线进展，叠加行业估值中枢上行，基于DCF模型，上调目标价 151.7%至6.04港币，较当前股价有19.6%的上行空间。公司公布1H25业绩，收入1.06亿元，同比 +22.5%，减亏情况好于该行预期，主要由于降本控费良好。 新增披露CD19/20双靶点CAR-T管线，年底有望数据读出 根据公司公告，2H24公司启动JWCAR201在血液瘤和自免的IIT研究，目前正在入组中。该产品公司具 备全球权益，通过结合双靶向，公司认为该产品有望具备更广泛的疗效、更高的信号阈值。根据公司公 告，血液瘤已经获得令人鼓舞的初步数据，计划在2025年12月美国血液学会年会公布IIT数据。 期待CD19 CAR-T的系统性红斑狼疮SLE数据更新 根据公司公告，公司2024年5月启动SLE的I期临床试验，截至1Q25患者入组完成 ...

Core Viewpoint - 中金维持药明巨诺-B的跑赢行业评级，基于DCF模型上调目标价151.7%至6.04港币，预计有19.6%的上行空间 [1] Group 1: Financial Performance - 1H25公司收入为1.06亿元，同比增加22.5%，减亏情况好于预期，主要得益于降本控费 [1][2] - 1H25公司产品销售毛利率提升至51.1%，同比增加0.7个百分点，销售费用率下降至72.0%，同比减少15.7个百分点，行政和研发开支分别减少45.7%和39.0% [2] Group 2: Strategic Developments - 2025年4月，公司与Juno达成授权合作，授予JW sLVV生产工艺及相关技术知识的非独家许可，Juno支付的对价不超过1千万美元 [2] - 2H24公司启动JWCAR201在血液瘤和自免的IIT研究，计划在2025年12月美国血液学会年会公布初步数据 [3] Group 3: Clinical Trials - 公司于2024年5月启动系统性红斑狼疮SLE的I期临床试验，截至1Q25患者入组完成，预计未来将有潜在数据读出 [4]