来源：市场资讯 （来源：药闻社） 今天一早，港股创新药企和铂医药发布公告，与阿斯利康基于3月21日的合作协议共同修订合作协议， 共同发现和开发包括抗体偶联药物（ADC）和T细胞衔接器（TCE）在内的新一代生物疗法，这是阿斯 利康与和铂医药的进一步深度绑定。 阿斯利康已经多次出手和铂医药了： 1）2022年Claudin18.2/CD3双抗的全球授权（2500万美元预付款+3.25亿美元里程碑+外加销售分成）； 2）2024年5月一款临床前单抗项目的授权（1900万美元预付款+1000万美元近期里程碑+5.75亿美元里程 碑+外加销售分成）； 3）2025年3月21日两项临床前免疫学项目的授权许以及多个项目的选择权（1.75亿美元首付款、近期里 程碑付款及选择权行权费，最高达44亿美元的里程碑付款以及销售分成）。同时，阿斯利康以1.05亿美 元认购和铂医药9.15%的新发行股份，当天收盘价溢价37.2%。 今天的重新修订的合作协议将合作范围扩大到抗体偶联药物（ADC）和T细胞衔接器（TCE），必然是 基于对和铂研发平台的高度认可，和铂医药也表示将有资格获得选择权费、开发与商业里程碑付款，以 及未来的销售分成。 ...

先是诺华以30亿美元与Dren Bio达成合作，利用后者开发的靶向髓系细胞衔接器和吞噬平台开发双抗疗法；紧接着赛诺菲直接以6亿美元首付款 买下Dren Bio的DR-0201，这个CD20靶向MCE在难治性红斑狼疮患者身上出现18个月无治疗缓解期，正在加速进击自免市场。而继与礼来达成 合作后，泽安生物又与GSK签下4个MCE项目合作协议…… 尽管在交易金额层面还难与TCE相比，但从如今的交易及临床推进情况上看，MCE这条新的免疫疗法赛道，正在快速成形。 机制上，MCE疗法靶向髓样细胞能降低CRS的风险，在适应症范围上可能应用更广，这也是MCE获得大药企青睐的关键。 当然，MCE能否成为"下一个TCE"，甚至超越之，还需要更多的临床数据来证明。 TCE自去年以来相当火热，诞生了多笔重磅交易。而在结构上与其类似的髓系细胞衔接器（MCE），也突然从小众机制分子,跃升为多家MNC 争抢的战略资产。 / 01 / 大药企开始加注 作为一项新兴的技术，MCE的入局者并不算多，但多笔大药企主导的重磅交易已经提示,MCE正成为免疫疗法赛道中最受关注的技术之一。而 这些密集交易背后，也是各家药企不同却明确的战略诉求。 最先引爆 ...

自2024年下半年以来，TCE（T细胞衔接器，T cell-engager）逐渐成为MNC的BD心头好。诸多重磅TCE交易相继授出，出海盛况丝毫不逊于当年的ADC技 术。 所谓TCE是一种特殊双抗，一端（或两端）连接TAA（肿瘤相关抗原）定位肿瘤细胞，另一端连接T细胞的CD3表位，激活T细胞，发挥T细胞的肿瘤杀伤 作用。相比ADC用细胞毒素杀伤，TCE双抗本质是激活T细胞的免疫疗法，对靶点表达量要求更低、但肿瘤特异性要求更高。 与个性化、定制化的CAR-T疗法相比，"现货"型TCE双抗在便利性、可及性和生产成本上都具备优势。因此，我们看到，TCE双抗正在作为下一代免疫治 疗的核心方向重构肿瘤与自免疾病治疗格局。 这一潜力赛道中，国内药企百花齐放，进入规模化竞争阶段，形成差异化竞争梯队，既有技术平台驱动的管线深耕，也有全球化BD合作的价值释放。 一场技术革新风暴即将到来，谁会从众多参与者中杀出重围？这一过程中又会否诞生中国创新药的新王呢？ 01 TCE为何起风？ 过去的几十年中，治疗性抗体早已成为肿瘤治疗的关键组成部分，显著提高了疗效。如曲妥珠单抗治疗晚期HER2阳性乳腺癌，利妥昔单抗治疗B细胞淋 巴瘤。然而， ...

Core Viewpoint - The treatment goal for late-stage lung cancer has shifted towards extending survival, with overall survival (OS) becoming the core clinical focus [2] Group 1: Early Detection and Treatment Advances - Increasing numbers of lung cancer patients are being detected early and receiving timely interventions, leading to improved five-year survival rates [1] - Innovative immunotherapy options are rapidly developing, providing long-term survival hope for late-stage lung cancer patients and moving towards early and mid-stage patients [1] - The early stage of lung cancer is identified as the "golden window" for treatment, where patients have the potential for clinical cure through radical surgery [1] Group 2: Post-Surgery Treatment and Management - Despite surgery, many patients face recurrence or metastasis risks, necessitating more effective adjuvant treatment methods [1] - The maturity of perioperative immunotherapy models has significantly improved patient prognosis, with multiple phase III clinical studies confirming reduced recurrence risks and increased five-year survival rates [1] Group 3: Late-Stage Lung Cancer Management - The application of immunotherapy has led to a historic breakthrough in the five-year survival rate for late-stage non-small cell lung cancer (NSCLC) patients [2] - In the small cell lung cancer (SCLC) field, immunotherapy combined with chemotherapy has shown long-term survival benefits in first-line treatment [2] - Late-stage lung cancer patients are gradually entering a chronic disease management phase, achieving longer and higher quality of life [2]

Core Insights - Xu Ruihua, a professor at Sun Yat-sen University Cancer Prevention and Treatment Center, was elected as an academician of the Chinese Academy of Engineering for his work in developing immunotherapy and understanding gastrointestinal cancers [2][4] - Xu was also featured in Cell Press's "50 Scientists that Inspire" series, highlighting his contributions to cancer research and personalized treatment [2][4] Group 1: Scientific Innovation - Scientific innovation is a multi-dimensional process that involves not only the discovery of new knowledge but also the application of this knowledge to solve real-world problems [5][6] - Key dimensions of scientific innovation include meeting clinical needs, advancing scientific frontiers, and promoting interdisciplinary collaboration [6] - The future of cancer treatment is moving towards precision, personalization, and intelligence, emphasizing the importance of understanding molecular characteristics and biological mechanisms of tumors [6][9] Group 2: Personal Motivation and Challenges - Xu's initial motivation to become a scientist was to save lives, which was reinforced by his clinical experiences and the challenges faced by cancer patients [7][8] - The high incidence and mortality rates of gastrointestinal cancers in China, with 2 million new cases annually, drive Xu's commitment to finding effective treatments [7][8] Group 3: Research Achievements - A significant discovery was made regarding the benefit of immunotherapy for patients with MSI-H/dMMR advanced colorectal cancer, leading to a new treatment method combining HDAC inhibitors, immunotherapy, and anti-angiogenic drugs [8][9] - This research represents a clinical milestone and has the potential to redefine treatment models for advanced colorectal cancer [9] Group 4: Future Outlook - In the next 50 years, precision medicine is expected to dominate cancer treatment, with the integration of big data and artificial intelligence [12] - Immunotherapy will be applied to more cancer types, and liquid biopsy technology will mature, facilitating early detection and monitoring of cancer [12] - A multidisciplinary approach to cancer treatment will become standard, promoting global health through international collaboration [12]

Core Viewpoint - The company Fuhong Hanlin (2696.HK) announced that its innovative PD-1 inhibitor, H drug (Han's Zhuang®), has been officially included in the National Medical Products Administration (NMPA) breakthrough therapy list for use in combination with chemotherapy for new adjuvant/adjuvant treatment of gastric cancer, marking it as the first drug recognized by the NMPA for perioperative treatment of gastric cancer [1] Group 1 - The H drug has achieved significant clinical milestones, including reaching the primary endpoint in its Phase III clinical study, which demonstrated a significant reduction in recurrence risk and an increase in cure opportunities for gastric cancer patients [1] - This therapy is the first in the world to replace postoperative adjuvant chemotherapy with a single-agent immunotherapy for perioperative treatment of gastric cancer, potentially offering dual benefits of survival improvement and enhanced quality of life for patients [1] - The inclusion in the breakthrough therapy program allows the company to apply for conditional approval and priority review during the drug listing application process, which could accelerate the review and market launch of the H drug [1] Group 2 - Currently, there are no approved immunotherapies for perioperative treatment of gastric cancer globally, highlighting the potential market opportunity for the H drug [1] - The recognition of the H drug as a breakthrough therapy underscores its clinical value and potential in the field of gastric cancer treatment, filling a significant gap in immunotherapy options [1] - Following the announcement, the company's stock rose by 4.89% to HKD 67.6, marking a 185% increase year-to-date and a rebound of over 3.4 times from its year-to-date low on January 23 [1]

Novartis (NYSE:NVS) Update / Briefing November 20, 2025 04:15 AM ET Company ParticipantsNaresh Chouhan - PrincipalDianne Auclair Rocha - U.S. Therapeutic Area Head for CRMBob Baloh - Global Head of Neuroscience Biomedical ResearchReshema Kemps-Polanco - Chief Commercial Officer of the U.S. UnitVictor Bulto - President of the U.S. UnitRuchira Glaser - Global Head of CRM DevelopmentShaun Coughlin - Global Head of Cardiovascular and Metabolism Biomedical ResearchHarry Kirsch - CFOMukul Mehta - Head of Business ...

Core Viewpoint - The company emphasizes the importance of innovation in drug development for oncology, autoimmune diseases, and neurobiology, highlighting unmet clinical needs and market demand in these areas [1] Group 1: Oncology - Oncology remains a key focus in innovative drug development, with increasing resistance leading to ongoing breakthroughs in immunotherapy, targeted therapy, and personalized medicine [1] - There is a persistent unmet clinical demand in the oncology sector, indicating potential investment opportunities [1] Group 2: Autoimmune Diseases - Autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease are significant areas of interest for biopharmaceutical companies [1] - These diseases predominantly affect the younger workforce, and there is a high demand for effective treatments due to poor treatment outcomes and medication adherence [1] Group 3: Neurobiology - Neurodegenerative diseases like Alzheimer's, Parkinson's, and diabetic neuropathy are gaining attention from global pharmaceutical companies and research institutions [1] - The aging global population is contributing to a rapid increase in the number of patients with neurodegenerative diseases, creating substantial market demand [1] Group 4: Company Performance - For the period from January to September 2025, the company reported revenue of 510 million yuan, a year-on-year decrease of 29.33% [1] - The net profit attributable to the parent company was 6 million yuan, reflecting a significant year-on-year decline of 95.68% [1] Group 5: Drug Development Pipeline - The company has established multiple self-developed drug pipelines in neurobiology, autoimmune diseases, and oncology [1] - It has obtained three IND approvals for Class I new drugs and ten IND approvals for Class II new drugs, indicating progress in its drug development efforts [1]

Verrica Pharmaceuticals (NasdaqGM:VRCA) Q3 2025 Earnings Call November 17, 2025 08:30 AM ET Company ParticipantsJayson Rieger - President and CEOStacy Ku - Biotechnology Equity ResearchKevin Gardner - Managing DirectorJohn Kirby - Interim CFOConference Call ParticipantsDennis Ding - VP and Equity Research AnalystNone - AnalystNone - AnalystOperatorGood morning, ladies and gentlemen, and welcome to the Verrica Pharmaceuticals Third Quarter 2025 Corporate Update Conference Call. At this time, all participants ...

Core Insights - The article discusses the transformative potential of in vivo CAR-T cell therapy, which aims to overcome the limitations of traditional CAR-T therapies by generating CAR-T cells directly within the patient, thus eliminating complex manufacturing and logistics challenges [2][3][6]. Group 1: In Vivo CAR-T Technology - In vivo CAR-T technology leverages advancements in virology, RNA therapeutics, and nanomedicine to deliver genetic material encoding CAR into endogenous T cells, enhancing clinical efficacy and simplifying the treatment process [2][3][9]. - The technology aims to expand the applicability of CAR-T therapies beyond hematological malignancies to include autoimmune diseases like systemic lupus erythematosus [3][7]. Group 2: Clinical Development and Platforms - The article highlights two main in vivo CAR platforms: engineered viral vectors (such as lentiviruses) that integrate payloads into the host genome, and lipid nanoparticles (LNPs) that enable transient expression of the payload within host cells [9][11]. - Several companies are developing in vivo CAR-T therapies, with various targeting mechanisms and therapeutic payloads aimed at treating conditions like B cell malignancies and solid tumors [10][11]. Group 3: Future Directions and Challenges - The review emphasizes the need for innovation in delivery and engineering technologies to fully realize the potential of CAR-T therapies, addressing current limitations in accessibility and clinical performance [7][15]. - The transition from ex vivo to in vivo CAR-T therapies is expected to redefine the scalability and accessibility of immunotherapies, significantly reducing production costs and enhancing the socio-economic impact of these life-saving treatments [23].