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]

Core Viewpoint - The approval of PB-119 by the National Medical Products Administration of China marks a significant milestone for the company, positioning it as a new treatment option for type 2 diabetes patients in China [1] Group 1: Product Information - PB-119 is a next-generation long-acting GLP-1 receptor agonist that requires weekly administration [1] - It is recognized as a "major new drug creation" under a national science and technology major project, classified as a category 1 original drug [1] - 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] Group 2: Therapeutic Benefits - PB-119 significantly improves β-cell function and manages blood pressure, blood lipids, and weight, achieving comprehensive management of "four highs" [1] - The drug's unique molecular structure and pharmacological properties contribute to its differentiated advantages [1] Group 3: Mechanism of Action - The innovative site-specific PEGylation technology allows PB-119 to effectively resist degradation by DPP-4 and significantly delay renal clearance [1] - This structural modification enables efficient binding to GLP-1 receptors and biological effects, allowing for a relatively high release concentration in a short time [1] - PB-119 minimizes immune responses and gastrointestinal side effects, avoiding the risk of accumulation in the body, thus maintaining a longer duration of efficacy during clinical treatment [1]

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 中國國家藥監局批准PB-119新藥上市申請 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。 本公司欣然宣佈，中國國家藥品監督管理局（「國家藥監局」）已批准本公司核心產 品PB-119的新藥上市申請（「新藥上市申請」）。 關於PB-119 根據第一期至第三期臨床研究，PB-119在有效控制血糖與良好耐受性之間已達致 最佳平衡，為中國2型糖尿病患者提供高效、安全的治療選擇。PB-119可顯著改 善β細胞功能，除血糖外，兼具全面管理患者的血壓、血脂及體重，實現「四高共 管，全面獲益」。 派達康®(PB-119)為本公司開發的新一代長效胰高血糖素樣肽-1(GLP-1)受體激動 劑，每週給藥一次。該產品為國家科技重大專項認定為「重大新藥創製」的國家原 創 ...

每经AI快讯，派格生物医药-B(02565.HK)尾盘涨超12%，截至发稿，涨12.59%，报63.5港元，成交额 2820.11万港元。 ...

消息面上，由派格生物自主研发的周制剂GLP-1RA维培那肽(派达康)正式获中国国家药监局批准上市， 用于治疗2型糖尿病(T2DM)。根据弗若斯特沙利文数据，2018年至2023年，全球T2DM药物市场规模复 合年增长率约为29.3%。GLP-1受体激动剂的市场份额显著增长，从2018年的约8.4%增长至2023年的约 29.3%。长效GLP-1受体激动剂因其更高的依从性，预计将在2032年占据中国GLP-1受体激动剂市场80% 以上的份额。 派格生物医药-B(02565)尾盘涨超12%，截至发稿，涨12.59%，报63.5港元，成交额2820.11万港元。 ...

Core Viewpoint - The approval of PegBio's GLP-1RA drug, Weipinaitai (派达康®), for the treatment of type 2 diabetes (T2DM) by the National Medical Products Administration of China has led to a significant increase in the company's stock price, reflecting positive market sentiment and potential growth in the diabetes treatment sector [1] Company Summary - PegBio's stock surged over 12%, reaching HKD 63.5, with a trading volume of HKD 28.2 million following the drug approval announcement [1] - The company's GLP-1RA drug is expected to capture a significant share of the growing diabetes treatment market in China [1] Industry Summary - The global T2DM drug market has experienced a compound annual growth rate (CAGR) of approximately 29.3% from 2018 to 2023 [1] - The market share of GLP-1 receptor agonists has increased from about 8.4% in 2018 to approximately 29.3% in 2023 [1] - Long-acting GLP-1 receptor agonists are projected to dominate the Chinese market, expected to account for over 80% of the market share by 2032 [1]