Core Insights - Three innovative drugs have made significant progress, potentially stabilizing the Hang Seng Biotechnology Index and the Hang Seng Innovative Drug Index [1] Group 1: Drug Developments - Innovent Biologics announced that its drug IBI362 (Mastuzumab Injection) has achieved primary and all key secondary endpoints in a Phase III clinical trial for moderate to severe obesity in China, with plans to submit a new drug application for weight control [1] - Junshi Biosciences' PD-1 inhibitor, H drug (Surulitinib), has been officially included in the NMPA's list of breakthrough therapies for perioperative treatment of gastric cancer, marking it as the first drug recognized for this indication [2] - Peijia Medical's PB-119 has received approval from the NMPA for its new drug application, leveraging unique PEGylation technology to enhance efficacy while reducing immunogenicity and gastrointestinal side effects [3] Group 2: Industry Trends - The introduction of the innovative drug directory by commercial insurance is expected to address the accessibility and affordability of high-priced innovative drugs, with policies increasingly favoring the development of high-quality innovative drugs [3] - Chinese innovative pharmaceutical companies are increasingly focusing on internationalization, transitioning from imitation to innovation, supported by favorable policies and abundant clinical resources [2][3] - The ongoing drug review reforms are releasing dividends that are propelling the Chinese innovative drug industry into a new era of "innovation output" [2]

智通财经APP获悉，三款创新药发布公告取得有效进展，或引领恒生生物科技指数+恒生创新药指数企 稳。 1、11月20日，信达生物宣布，玛仕度肽注射液(IBI362)在中国中重度肥胖人群中开展的III期临床研究 (GLORY-2)达成主要终点和所有关键次要终点，信达生物将于近期向监管机构递交玛仕度肽9mg用于成 人体重控制的新药上市申请。 公开资料显示，玛仕度肽是信达生物与礼来制药共同推进的一款胰高血糖素(GCG)/胰高血糖素样 肽-1(GLP-1)双受体激动剂，也是全球首个获批的GCG/GLP-1双受体激动剂。该药已在国内获批两项适 应症，分别用于成人肥胖或超重患者的长期体重控制以及成人2型糖尿病患者的血糖控制。 2、2025年11月20日，复宏汉霖(02696)宣布，创新型PD-1抑制剂H药 汉斯状®(斯鲁利单抗，欧洲商品 名：Hetronifly®)被国家药品监督管理局(NMPA)药品审评中心(CDE)正式纳入突破性治疗品种名单，联 合化疗用于新辅助/辅助治疗胃癌，成为首个获CDE突破性疗法认定的胃癌围手术期治疗药物。 此次获得突破性疗法认定，标志着H药在胃癌围手术期治疗中的潜力与临床价值获得权威认可，有望 ...

每经AI快讯，派格生物医药-B(02565.HK)涨超5%，截至发稿，涨5.11%，报63.8港元，成交额2925.59万 港元。 ...

派格生物医药-B(02565)涨超5%，截至发稿，涨5.11%，报63.8港元，成交额2925.59万港元。 值得一提的是，今年10月，派格生物医药宣布与阿联酋领先医药研发机构PDC FZ-LLC("PDC")达成战 略合作，独家授予其在中东及非洲地区开发、分销、营销及商业化派格生物的核心产品 Visepegenatide(PB-119)。此次合作标志着派格生物全球商业化战略迈出关键一步。 消息面上，派格生物医药近日公告，中国国家药品监督管理局已批准公司核心产品PB-119的新药上市 申请。派达康(PB-119)为公司开发的新一代长效胰高血糖素样肽-1(GLP-1)受体激动剂，每周给药一次。 该产品为国家科技重大专项认定为"重大新药创制"的国家原创1类新药。 ...

Core Viewpoint - The approval of PB-119 by the National Medical Products Administration of China marks a significant milestone for the company, enhancing its market position and potential revenue streams [1] Company Developments - The company's stock price increased by 5.11%, reaching HKD 63.8, with a trading volume of HKD 29.2559 million [1] - PB-119 is a new generation long-acting GLP-1 receptor agonist, administered once a week, and recognized as a Class 1 new drug by the national major science and technology project [1] - The company has established a strategic partnership with PDC FZ-LLC, granting exclusive rights for the development, distribution, marketing, and commercialization of PB-119 in the Middle East and Africa [1] Industry Impact - The approval of PB-119 is expected to contribute to the advancement of innovative drug development within the biopharmaceutical industry in China [1] - The collaboration with PDC represents a critical step in the company's global commercialization strategy, potentially expanding its market reach [1]

Group 1 - The stock of Pagoda Biopharmaceuticals-B (02565.HK) opened nearly 15% higher and is currently up 14.94%, trading at HKD 72.7 [1] - The trading volume reached HKD 1.1269 million [1]

Core Viewpoint - The approval of PB-119 by the National Medical Products Administration of China is a significant milestone for the company, leading to a notable increase in its stock price [1]. Group 1: Company Developments - The company, Paig BioPharma-B (02565), saw its stock price rise by nearly 15%, reaching HKD 72.7, with a trading volume of HKD 1.1269 million following the announcement [1]. - PB-119, the company's core product, is a new generation long-acting GLP-1 receptor agonist that requires weekly administration [1]. - PB-119 has been recognized as a Class 1 new drug by the National Major Science and Technology Projects for its innovative drug creation [1]. Group 2: Product Efficacy - Clinical studies (Phase I to III) have shown that PB-119 achieves an optimal balance between effective blood sugar control and good tolerability [1]. - The product offers an efficient and safe treatment option for patients with type 2 diabetes in China, significantly improving β-cell function [1]. - PB-119 also manages blood pressure, blood lipids, and body weight, providing comprehensive benefits for patients [1].

Core Viewpoint - The approval of PB-119 by the National Medical Products Administration of China marks a significant milestone for the company, potentially enhancing its market position in the diabetes treatment sector [1] Company Summary - The stock of the company, Paigene Biopharmaceutical-B (02565), opened nearly 15% higher and is currently trading at 72.7 HKD, with a transaction volume of 1.1269 million HKD [1] - PB-119 is a new generation long-acting GLP-1 receptor agonist developed by the company, designed for weekly administration [1] - PB-119 has been recognized as a Class 1 new drug, categorized as a "major new drug creation" by the National Science and Technology Major Project [1] Product Summary - Clinical studies (Phase I to III) indicate that PB-119 achieves an optimal balance between effective blood sugar control and good tolerability, providing a high-efficiency and safe treatment option for type 2 diabetes patients in China [1] - PB-119 significantly improves β-cell function and offers comprehensive management of patients' blood pressure, blood lipids, and weight, achieving a "four highs co-management" approach for overall benefits [1]

根据第一期至第三期临床研究，PB-119在有效控制血糖与良好耐受性之间已达致最佳平衡，为中国2型 糖尿病患者提供高效、安全的治疗选择。PB-119可显著改善β细胞功能，除血糖外，兼具全面管理患者 的血压、血脂及体重，实现"四高共管，全面获益"。 派格生物医药-B(02565)发布公告，中国国家药品监督管理局(国家药监局)已批准本公司核心产品PB-119 的新药上市申请(新药上市申请)。 PB-119的差异化优势源自其独特的分子结构及其产生的药理特性。凭借创新的位点特异性聚乙二醇 (PEG)化技术，该药物能有效抵抗二肽基肽酶-4(DPP-4)的降解作用，并大幅延缓了肾脏清除率。这一结 构性修改使药物与GLP-1受体高效结合并发挥生物学效应。该结构特点亦使PB-119能在短时间内达到相 对较高的释放浓度。PB-119亦能将由此产生的免疫反应及胃肠道副作用降至最低，并避免体内累积的 风险，因此在临床治疗期间可维持较长的药效时间。 派达康(PB-119)为本公司开发的新一代长效胰高血糖素样肽-1(GLP-1)受体激动剂，每周给药一次。该产 品为国家科技重大专项认定为"重大新药创制"的国家原创1类新药。 ...

Core Viewpoint - The China National Medical Products Administration has approved the new drug application for PB-119, a novel long-acting GLP-1 receptor agonist developed by the company, providing an effective and safe treatment option for type 2 diabetes patients in China [1] Group 1: Product Details - PB-119 is recognized as a Class 1 new drug and is part of a major national science and technology project for "major new drug creation" [1] - The drug demonstrates an optimal balance between effective blood sugar control and good tolerability based on clinical studies [1] - PB-119 significantly improves β-cell function and manages blood pressure, blood lipids, and weight, achieving comprehensive benefits for patients [1] Group 2: Unique Features - The drug's differentiated advantages stem from its unique molecular structure and pharmacological properties [1] - Utilizing innovative site-specific PEGylation technology, PB-119 effectively resists DPP-4 degradation and significantly delays renal clearance [1] - This structural modification allows for efficient binding to GLP-1 receptors and biological effects, while minimizing immune responses and gastrointestinal side effects [1]