收管线、押项目、兑里程碑，把别人的"失败药"变成自己的"现金牛"。 XOMA Royalty这家仅有29个员工的企业在2025H1完成了6起收购，人均年创收200万美元，远超行业平均水平。它不像传统药企那样埋头研发，而是 像"当铺"一样，接受Biotech用其最宝贵的资产（药物管线未来收益权）作为"抵押品"，来换取眼下救急的现金。 到了2017年，XOMA终于确定了自己新的战略方向，即以收集整合管线知识产权为核心，通过向MNC或Biotech授权管线资产，绑定未来潜在里程碑的经 济权益，构建一个低研发风险、且具有稳定现金流的资产组合。 简单来说，XOMA希望通过自己数十年对研发药物的理解来评估管线资产，收购处于临床阶段或已上市药物的未来里程碑付款和销售分成权益。通过一 次性支付现金，XOMA 获得这些资产未来产生的现金收益，而卖方Biotech既可以获得非稀释性融资并负责继续推进项目，也可以选择停业回收部分成 本。 截至2025H1，XOMA已经拥有超过120条管线资产，涵盖肿瘤、自免以及罕见病等多个领域。由于自身早期发展因为研发问题导致濒临破产，因此在新的 商业模式中，XOMA自身并不去做研发，不去承担临床 ...

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 - TianTan Biological announced that its subsidiary Chengdu Rongsheng Pharmaceutical has received the GMP compliance inspection notice and the updated drug production license from the Sichuan Provincial Drug Administration, allowing for an expansion in the production scale of "Recombinant Human Coagulation Factor VIII" [1] Group 1 - Chengdu Rongsheng has completed the site change for the production of "Recombinant Human Coagulation Factor VIII" [1] - The GMP compliance inspection was conducted from August 18 to August 21, 2025, and concluded that the company meets the relevant regulations [1] - The updated drug production license allows for the production of therapeutic biological products (Recombinant Human Coagulation Factor VIII) at the new address in Chengdu, Sichuan Province [1]

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].

Core Insights - WuXi AppTec's subsidiary, WuXi Biologics, has received formal acceptance from the National Medical Products Administration (NMPA) for its supplemental application for the post-marketing use of its domestically produced viral vector, JWLV011, for the production of its CAR-T therapy, Ruili Kelong [1][2] Group 1: Product Development - The application is based on a Phase II single-arm study aimed at evaluating the comparability of Ruili Kelong produced with the new viral vector JWLV011 against that produced with existing viral vectors [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] Group 2: Safety and Efficacy - The most common severe adverse event reported was cytopenia, with CAR-T related toxicities such as cytokine release syndrome (CRS) primarily at grade 1, and no occurrences of grade 3 or higher CRS or any grade of immune effector cell-associated neurotoxicity syndrome (ICANS) [2] - Clinical data indicates that the Ruili Kelong produced with the domestically sourced JWLV011 is clinically comparable to that produced with existing viral vectors [2] Group 3: Strategic Importance - The chairman and CEO of WuXi AppTec emphasized that the domestically produced viral vector is not only a crucial raw material for cell therapy products but also the most expensive, making its domestic substitution strategically significant for the company [2] - Successful completion of the viral vector substitution is expected to stabilize supply for commercial products and clinical development while significantly reducing costs, enhancing the company's competitive position in commercialization and insurance negotiations [2]

复宏汉霖(02696)公布，近日，一项比较公司自主开发的汉斯状® (斯鲁利单抗注射液)或安慰剂联合化疗 (奥沙利铂+替吉奥)新辅助/辅助治疗胃癌的3期临床研究在计划的期中分析中，经独立数据监查委员会 (Independent Data Monitoring Committee，"IDMC")评估达到了无事件生存期(EFS)的主要研究终点，可 支持提前申报上市。 本研究为一项在早期胃癌患者中开展的随机、双盲、多中心的3期临床研究，旨在比较汉斯状®联合化 疗对比安慰剂联合化疗新辅助/辅助治疗早期胃癌患者的临床有效性及安全性。基于IDMC进行的预设期 中分析结果显示，汉斯状®联合化疗对比安慰剂联合化疗显示出明显的无事件生存期(EFS)改善，达到 预设的优效性标准，病理完全缓解(pCR)率为对照组的3倍以上，患者复发风险显著降低，同时安全性良 好，未发现新的安全性信号。 ...

截至发稿，药康生物市值为72亿元。 每经头条（nbdtoutiao）——与美元脱钩后，暴涨102倍，揭秘黄金疯涨背后神秘的"无形之手"！专家： 推动金价上涨的逻辑没有变 每经AI快讯，药康生物（SH 688046，收盘价：17.64元）10月9日晚间发布公告称，截至2025年9月30 日，公司通过上海证券交易所交易系统以集中竞价交易方式累计回购公司股份约155万股，占公司总股 本4.1亿股的比例为0.3776%，回购成交的最高价为17.76元/股，最低价为10.52元/股，支付的资金总额为 人民币约2209万元。 2024年1至12月份，药康生物的营业收入构成为：科学研究和技术服务占比99.92%，其他业务占比 0.08%。 （记者 张明双） ...

Core Insights - 百奥泰与Intas Pharmaceuticals达成合作，Intas将独占BAT2506在加拿大市场的商业化权益 [1][2] - BAT2506是基于戈利木单抗开发的生物类似药，已获得中国NMPA、美国FDA和欧洲EMA的上市许可申请受理 [1][2] Company Overview - 百奥泰是一家位于中国广州的全球性生物制药企业，专注于开发新一代创新药和生物类似药，涵盖肿瘤、自身免疫性疾病等多个领域 [3] - 公司已推动多款药物获批上市，包括贝塔宁、阿达木单抗、托珠单抗等，且在抗体药物开发方面处于全球领先地位 [3] Strategic Importance - Accord BioPharma的高管表示，此次独家商业化协议将丰富其生物类似药产品管线，并对北美市场的业务增长具有重要战略意义 [2] - Accord致力于提升加拿大患者对生物类似药的可及性，并通过与百奥泰的合作推动生物类似药的引入 [2] Product Development - BAT2506是针对TNF-α的抗体，能够阻断TNF-α与其受体的结合，从而抑制其活性 [1][2] - 百奥泰在生物类似药的研发中遵循中国、美国和欧洲的相关指导原则，确保产品的高质量和安全性 [1][2]

本研究为一项在早期胃癌患者中开展的随机、双盲、多中心的3期临床研究，旨在比较汉斯状联合化疗 对比安慰剂联合化疗新辅助/辅助治疗早期胃癌患者的临床有效性及安全性。基于IDMC进行的预设期中 分析结果显示，汉斯状联合化疗对比安慰剂联合化疗显示出明显的无事件生存期(EFS)改善，达到预设 的优效性标准，病理完全缓解(pCR)率为对照组的3倍以上，患者复发风险显著降低，同时安全性良好， 未发现新的安全性信号。 智通财经APP讯，复宏汉霖(02696)公布，近日，一项比较公司自主开发的汉斯状 (斯鲁利单抗注射液)或 安慰剂联合化疗(奥沙利铂+替吉奥)新辅助/辅助治疗胃癌的3期临床研究在计划的期中分析中，经独立 数据监查委员会(Independent Data Monitoring Committee，"IDMC")评估达到了无事件生存期(EFS)的主 要研究终点，可支持提前申报上市。 ...

Core Viewpoint - The company, Fuhong Hanlin (02696), has announced that its self-developed drug, Hanshu (Sru Li Antibody Injection), has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for the treatment of early gastric cancer, supporting an early application for market approval [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshu combined with chemotherapy against a placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) conducted a pre-specified interim analysis, which showed significant improvement in EFS for the Hanshu combination therapy compared to the placebo group [1] Group 2: Efficacy and Safety Results - The pathological complete response (pCR) rate for the Hanshu group was more than three times that of the control group, indicating a substantial efficacy advantage [1] - The risk of recurrence for patients receiving Hanshu was significantly reduced, and no new safety signals were identified, demonstrating good safety [1]