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]

智通财经APP获悉，创新药投资主线GLP-1赛道再度迎来标志性事件——派格生物(02565)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)。这不 仅是一则新药获批消息，更可能是派格生物投资价值的关键转折点，值得投资者高度关注。 当前市场对GLP-1赛道的认知正在经历一场深刻的迭代。最初约500亿美元的市场规模预测，在重新评 估其覆盖的庞大患者群体、长期用药特性及持续拓展的临床获益后，正被全面上修至1500亿美元量级， 约合人民币超1万亿元量级。 这一认知升级主要基于三个维度：其一，目标患者群体的规模远超早期预测;其二，慢性疾病需要长期 管理的特点确保了持续的治疗需求;其三，药物在降糖、减重之外的额外临床价值不断得到验证。这三 个因素共同构成了市场空间被大幅重估的核心逻辑。 在全球范围内，这一赛道正展现出前所未有的增长动能。派格生物所对标的美股企业——礼来 (LLY.US)，正是这一趋势的绝佳例证。礼来专注于以研发为基础，致力于创新药物的开发，业务覆盖 糖尿病、体重管理、肿瘤和神经科学等多个关键治疗领域。作为一家全球领先制药公司，礼来在代谢疾 病 ...

每经AI快讯，派格生物医药-B(02565.HK)最高涨超15%，截至发稿，涨6.29%，报56.65港元，成交额 994.16万港元。 ...

Company Highlights - The stock of Pag Pharmaceutical-B (02565) rose over 15% at its peak and is currently up 6.29%, trading at HKD 56.65 with a transaction volume of HKD 9.9416 million [1] - Pag Pharmaceutical announced a licensing agreement with PDC FZ-LLC for the exclusive development, distribution, marketing, and commercialization of its core product Visepegenatide (PB-119) in the Middle East and Africa [1] - Visepegenatide (PB-119) is a self-developed GLP-1 receptor agonist designed for weekly subcutaneous injection, aimed at treating type 2 diabetes and weight management [1] - The company believes that this collaboration will leverage PDC's local advantages to expedite the development, registration, and commercialization of Visepegenatide (PB-119) in the targeted regions, creating long-term value and hope for global metabolic disease patients [1] Industry Insights - According to the International Diabetes Federation (IDF), the diabetes prevalence rate among adults in the Middle East and North Africa is 16.2%, the highest globally [2] - The digestive and metabolic drug market, which includes diabetes treatment medications, is the largest therapeutic area in the region, accounting for 20.4% of the market share, with a significant growth of 22.1% expected in Q1 2025 [2] - The global weight management drug market has grown from USD 99.7 billion in 2020 to an estimated USD 112.8 billion by 2024, with a compound annual growth rate (CAGR) of 3.1%, projected to reach USD 277.4 billion by 2034 [2] - The demand for weight management drugs in the Middle East and Africa is expected to be the highest globally, potentially reaching a scale of USD 10 billion by 2034 [2]

Company Overview - Pagoda Biopharma-B (02565) experienced a maximum increase of over 15%, currently up 6.29% at HKD 56.65, with a trading volume of HKD 9.9416 million [1] - The company granted exclusive licensing rights to PDC FZ-LLC for the development, distribution, marketing, and commercialization of its core product Visepegenatide (PB-119) in the Middle East and Africa [1] - Visepegenatide (PB-119) is a weekly subcutaneous GLP-1 receptor agonist designed for the treatment of type 2 diabetes and weight management [1] Industry Insights - The adult diabetes prevalence rate in the Middle East and North Africa is as high as 16.2%, the highest globally [2] - The digestive and metabolic drug market, including diabetes treatment drugs, is the largest therapeutic area in the region, accounting for 20.4% market share, with a significant growth of 22.1% expected in Q1 2025 [2] - The global weight management drug market is projected to grow from USD 99.7 billion in 2020 to USD 112.8 billion by 2024, with a compound annual growth rate of 3.1%, and is expected to reach USD 277.4 billion by 2034 [2] - The demand for weight management drugs in the Middle East and Africa is anticipated to be the highest globally, potentially reaching a scale of USD 10 billion by 2034 [2]

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 派格生物醫藥 ( 杭州 ) 股份有限公司 呈交日期: 2025年11月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02565 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 279,164,339 | RMB | | 1 RMB | | 279,164,339 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 279,164,339 | RMB | | 1 RMB | | 279,164,339 | | 2. 股份分類 | 普 ...