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的內容概不負責，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。 PegBio Co., Ltd. 派格生物醫藥（杭州）股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2565） 自願公告 有關基石投資者作出自願延長禁售期的通知 本公告由派格生物醫藥（杭州）股份有限公司（「本公司」）自願刊發。 茲提述本公司日期為2025年5月19日的招股章程及本公司日期為2025年5月26日 的最終發售價及配發結果公告，內容有關（其中包括）(i)本公司與益澤康瑞醫藥 （香港）有限公司（「基石投資者」）訂立的基石投資協議；及(ii)基石投資者就合共 9,584,500股本公司H股作出自上市日期（包括該日）起計六個月期間（「原禁售期」） 的禁售承諾。原禁售期的最後一天為2025年11月26日。截至本公告日期，基石投 資者合共持有9,584,500股H股，佔本公司已發行H股總數約3.43%（「相關H股」）。 近日，本公司接獲基石投資者的通知，據此，基石投資者同意自原禁售 ...

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]

Group 1 - Three innovative drugs have made significant progress, potentially stabilizing the Hang Seng Biotechnology Index and the Hang Seng Innovative Drug Index [1] - Innovent Biologics announced that its drug IBI362 has achieved primary and all key secondary endpoints in a Phase III clinical trial for obesity, with plans to submit a new drug application for weight control [1] - The drug IBI362 is a dual receptor agonist for glucagon and GLP-1, and is the first of its kind approved globally for obesity and type 2 diabetes management [1] Group 2 - Junshi Biosciences' PD-1 inhibitor, H drug, has been officially included in the breakthrough therapy list by the NMPA for use in perioperative treatment of gastric cancer, marking a significant recognition of its clinical value [2] - This breakthrough designation is expected to accelerate the review and approval process for H drug, filling a gap in immune therapy for gastric cancer [2] - The approval of PB-119 by the NMPA highlights the competitive advantage of the drug based on solid clinical data and innovative PEGylation technology, which balances efficacy and reduces side effects [1][3] Group 3 - The introduction of the innovative drug directory by commercial insurance is expected to address the accessibility and affordability of high-priced innovative drugs [3] - The National Healthcare Security Administration is encouraging the high-quality development of innovative drugs, indicating a warming trend in payment policies for innovative drugs [3] - Domestic pharmaceutical companies are actively transitioning towards innovation, supported by ongoing reforms in drug approval processes [3] Group 4 - Relevant Hong Kong stocks in the innovative drug sector include Heng Rui Medicine, Kelun-Botai Biopharmaceutical, and others, indicating a growing interest in the market [4]

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。 ...