PEGBIO CO(02565)
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港股公告掘金 | 舜宇光学科技:9月手机摄像模组出货量为4852.4万件 环比增加15.3% 同比增加32%
Zhi Tong Cai Jing· 2025-10-12 12:21
Major Events - Yuan Da Zhu Gong (02163) plans to apply for bankruptcy reorganization at Changsha Intermediate People's Court [1] - Yi Li Holdings (00076) subsidiary intends to issue blockchain vouchers V76, redeemable for bulk commodities on the platform [1] - Peijia Medical-B (09996): National Medical Products Administration accepts registration application for GeminiOne® transcatheter edge-to-edge repair system [1] - Paggen Biopharmaceutical-B (02565) proposes to grant exclusive license for VISEPEGENATIDE (PB-119) in the Middle East and Africa [1] - Beijing Enterprises Environment Group (00154) bids for Hong Kong I·PARK 2 project [1] - Fangda Holdings (01521) plans to acquire Shanghai Guanhua Medical Technology Co., Ltd. for 270 million yuan to enhance global laboratory service capabilities [1] - Lianzhong (06899) focuses on female user value, driving new entertainment through content [1] - Global New Materials International (06616) increases stake in CQV to 50.75%, strengthening global business collaboration [1] - Qianxin Biotechnology-B (02509): Qianxin's industrialization base successfully passes EU QP audit [1] - China Energy Construction (03996) subsidiary signs three new energy general contracting agreements, totaling approximately 19.554 billion yuan [1] - Yongyi International (01218) plans to sell all issued shares of Zhuoyi to Gaoshan (00616) [1] - Bohai Bank (09668) plans to list high capital-occupying debt assets for sale, with an initial pricing of no less than 48.883 billion yuan [1] - Chuangsheng Holdings (02680) plans to receive a premium of about 6% for full acquisition offer, resuming trading on October 13 [1] - Kelun-Botai Biopharmaceutical (06990): Core product TROP2ADC, Lukan-Satuzi (SAC-TMT) approved by National Medical Products Administration for third indication, treating EGFR mutation non-small cell lung cancer after EGFR-TKI progression [1] Operating Performance - Zhaojin Mining (01818) reports net profit of approximately 2.117 billion yuan for the first three quarters, a year-on-year increase of 140.43% [2] - Sunny Optical Technology (02382): September mobile phone camera module shipments reach 48.524 million units, a month-on-month increase of 15.3% and a year-on-year increase of 32% [2] - Yuexiu Property (00123) reports cumulative contract sales of approximately 79.812 billion yuan for the first nine months, a year-on-year increase of about 2.8% [2] - Qiu Tai Technology (01478) reports September camera module sales of 46.654 million units, a month-on-month decrease of 7.6% but a year-on-year increase of 45.1% [2]
派格创新药Visepegenatide借力PDC掘金万亿市场,中东非洲迎来减重新希望!
Zhi Tong Cai Jing· 2025-10-10 13:22
Core Insights - The collaboration between Paige Biopharma and PDC grants exclusive rights for the development, distribution, marketing, and commercialization of Visepegenatide (PB-119) in the Middle East and Africa [1] Market Opportunity - The Middle East and North Africa (MENA) region has a high diabetes prevalence rate of 16.2%, the highest globally, driven by dietary and lifestyle factors [2] - The pharmaceutical market for digestive and metabolic drugs, including diabetes treatments, holds a 20.4% market share in the region, with a significant growth of 22.1% in Q1 2025 [2] - The number of diabetes patients in Africa is projected to increase by nearly 142% by 2050, indicating substantial market potential for diabetes and obesity treatment drugs [2] - The global weight management drug market is expected to grow from $99.7 billion in 2020 to $112.8 billion by 2024, with a compound annual growth rate (CAGR) of 3.1%, potentially reaching $277.4 billion by 2034 [2] - The demand for weight management drugs in the MENA region is anticipated to be the highest globally, potentially reaching a scale of $10 billion by 2034 [2] Product Overview - Visepegenatide (PB-119) is a once-weekly subcutaneous GLP-1 receptor agonist developed by Paige Biopharma for the treatment of type 2 diabetes and weight management [3] - The product demonstrates superior clinical characteristics compared to some existing products, including good safety, tolerability, and significant effects on blood sugar reduction and weight loss [3] - The innovative molecular design and long-acting mechanism of Visepegenatide (PB-119) provide patients with a more convenient and stable treatment option, representing the future direction of GLP-1 therapies [3] - The partnership with PDC is expected to leverage local advantages to expedite the development, registration, and commercialization of Visepegenatide (PB-119) in the MENA region, creating long-term value for the company and hope for patients with metabolic diseases globally [3]
派格(02565)创新药Visepegenatide借力PDC掘金万亿市场,中东非洲迎来减重新希望!
智通财经网· 2025-10-10 09:27
Core Insights - The collaboration between Paige Biopharma and PDC grants exclusive rights for the development, distribution, marketing, and commercialization of Visepegenatide (PB-119) in the Middle East and Africa [1] Market Opportunity - The Middle East and North Africa (MENA) region has a high diabetes prevalence rate of 16.2%, the highest globally, driven by dietary and lifestyle factors [2] - The therapeutic area of digestive and metabolic drugs, including diabetes treatments, holds a 20.4% market share in the MENA pharmaceutical market, with a significant growth of 22.1% in Q1 2025 [2] - The number of diabetes patients in Africa is projected to increase by nearly 142% by 2050, indicating substantial market potential for diabetes and obesity treatment drugs [2] - The global weight management drug market is expected to grow from $99.7 billion in 2020 to $112.8 billion in 2024, with a compound annual growth rate (CAGR) of 3.1%, potentially reaching $277.4 billion by 2034 [2] - The demand for weight management drugs in the MENA region is anticipated to be the highest globally, reaching a scale of $10 billion by 2034 [2] Product Overview - Visepegenatide (PB-119) is a once-weekly subcutaneous GLP-1 receptor agonist developed by Paige Biopharma for the treatment of type 2 diabetes and weight management [3] - The product demonstrates superior clinical characteristics compared to some existing products, including good safety, tolerability, and significant effects on blood sugar reduction and weight loss [3] - The innovative molecular design and long-acting mechanism of Visepegenatide (PB-119) provide patients with a more convenient and stable treatment option, representing the future direction of GLP-1 therapies [3] - The partnership with PDC is expected to leverage local advantages to expedite the development, registration, and commercialization of Visepegenatide (PB-119) in the MENA region, creating long-term value for the company and hope for patients with metabolic diseases globally [3]
派格生物医药-B(02565.HK)拟向阿联酋PDC授出Visepegenatide (PB-119)于中东及非洲的独家许可
Ge Long Hui· 2025-10-10 09:15
Core Viewpoint - The company has entered into a non-binding term sheet with PDC in the UAE for the exclusive licensing of its product Visepegenatide (PB-119), a GLP-1 receptor agonist for type 2 diabetes and weight management, marking a significant milestone in its global commercialization strategy [1][2] Group 1 - The agreement grants PDC exclusive rights to develop, distribute, market, and commercialize PB-119 in the Middle East and Africa, including local production and comprehensive technology transfer [1] - The partnership is strategically important as PDC's extensive regional expertise and infrastructure can accelerate market access and penetration, validating the company's asset output strategy [1][2] - The Middle East and Africa represent a large and growing market for diabetes and obesity treatment, highlighting the unmet medical needs and commercial potential for innovative therapies like PB-119 [1] Group 2 - PDC is a leading pharmaceutical R&D institution in the region with a strong track record in clinical trials, providing end-to-end innovative solutions for clinical studies and life sciences [2] - The collaboration with PDC reinforces the company's proprietary R&D capabilities and the clinical characteristics of Visepegenatide (PB-119), showcasing its significant market potential [2] - This partnership is a crucial step in expanding the global footprint of PB-119 and aligns with the overall interests of the company and its shareholders [2]
派格生物医药-B:建议授出VISEPEGENATIDE (PB-119) 于中东及非洲的独家许可
Zhi Tong Cai Jing· 2025-10-10 09:08
Core Viewpoint - The company has entered into a non-binding term sheet with PDC FZ-LLC for the exclusive licensing of its product Visepegenatide (PB-119), a GLP-1 receptor agonist for treating type 2 diabetes and weight management, in the Middle East and Africa [1][2] Group 1: Licensing Agreement - The agreement grants PDC exclusive rights to develop, distribute, market, and commercialize PB-119 in the Middle East and Africa [1] - This partnership is a significant milestone in the global commercialization strategy for PB-119, covering regional development, product registration, local production with full technology transfer, and exclusive commercialization rights [1] Group 2: Strategic Importance - The collaboration is strategically important as PDC's extensive regional expertise and infrastructure can accelerate market access and penetration [1] - The partnership validates the company's asset output strategy and contributes significantly to the global positioning of PB-119 and the long-term value creation for the company [1] Group 3: Market Potential - The Middle East and Africa represent a large and continuously growing market for diabetes and obesity treatment drugs, highlighting the unmet medical needs and commercial potential for innovative therapies like PB-119 [1][2] - The high prevalence and rising trend of these diseases underscore the significant market opportunity for PB-119 in these regions [1]
派格生物医药-B(02565):建议授出VISEPEGENATIDE (PB-119) 于中东及非洲的独家许可
智通财经网· 2025-10-10 09:07
Core Viewpoint - The company has entered into a non-binding term sheet with PDC FZ-LLC for the exclusive licensing of its product Visepegenatide (PB-119), a GLP-1 receptor agonist for the treatment of type 2 diabetes and weight management, in the Middle East and Africa [1][2] Group 1: Licensing Agreement - The agreement grants PDC exclusive rights to develop, distribute, market, and commercialize PB-119 in the Middle East and Africa [1] - The licensing includes regional development, product registration, local production involving comprehensive technology transfer, and exclusive commercialization rights [1] - The product will be marketed under a trademark owned by PDC in the specified regions [1] Group 2: Strategic Importance - This partnership is a significant milestone in the global commercialization strategy for PB-119, leveraging PDC's extensive regional expertise and infrastructure to accelerate market access and penetration [1][2] - The collaboration validates the company's asset output strategy and contributes significantly to the global positioning of the product and the long-term value creation for the company [1] Group 3: Market Potential - The Middle East and Africa represent a large and continuously growing market for diabetes and obesity treatment drugs, highlighting the unmet medical needs and commercial potential for innovative therapies like PB-119 [1] - The high prevalence and rising trends of these diseases underscore the importance of PB-119 in addressing significant healthcare demands in the region [1]
派格生物医药(02565) - 自愿公告 - 建议授出VISEPEGENATIDE (PB-119)...
2025-10-10 09:00
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) 根據建議條款,PDC將獲授獨家許可,以於中東及非洲地區(「該地區」)開發、分 銷、營銷及商業化該產品。是次合作為本公司PB-119全球商業化戰略的重要里程 碑。該許可涵蓋區域開發、產品註冊、涉及全面技術轉讓的本地生產,以及全面 商業化的獨家權利。該產品將以PDC擁有的商標於該地區內銷售。 該合作夥伴關係具有重要的戰略意義,憑藉PDC廣泛的區域專業經驗及基礎設 施,可加速市場准入及滲透,印證本公司的資產輸出戰略,並為該產品的全球佈 局及本公司的長期價值創造作出重大貢獻。 中東及非洲地區為糖尿病及肥胖症治療藥物提供龐大且持續增長的市場。該等疾 病的高發病率及不斷上升的趨勢凸顯PB-119等創新療法存在巨大的未滿足醫療需 求及商業潛力。 1 PDC為中東及非洲地區首屈一指的製藥研發機構,於進行臨床試驗 ...
派格生物医药(02565) - 截至二零二五年九月三十日止之股份发行人的证券变动月报表
2025-10-06 10:28
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9月30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10月6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 | 普通 ...
派格生物医药(02565) - 2025 - 中期财报
2025-09-29 08:30
Drug Development and Pipeline - As of June 30, 2025, PegBio has developed a pipeline of six candidate drugs targeting chronic diseases, with a focus on metabolic diseases and their complications[9] - PB-119, a long-acting GLP-1 receptor agonist, entered the review phase with the National Medical Products Administration on May 22, 2025, with expectations for new drug approval in Q3 2025[10] - The company has three projects in clinical trials and one that has received IND approval, demonstrating its commitment to advancing innovative therapies for chronic diseases[18] - Core product PB-119 is a long-acting GLP-1 receptor agonist nearing commercialization, primarily for T2DM and obesity treatment[21] - PB-1902 is a potential first-in-class oral selective opioid receptor antagonist for treating opioid-induced constipation (OIC), with plans to initiate Phase II clinical trials in China by 2025[31] - PB-722, a GCG receptor agonist for congenital hyperinsulinism, received IND approval in China in May 2023, with a Phase I trial expected to start in 2026[32] - PB-2301, a GLP-1/GIP dual receptor agonist for T2DM, NASH, and obesity, is undergoing preclinical studies, with an IND application planned for 2026[35] - PB-2309, a GLP-1/GIP/GCG triple receptor agonist for T2DM, NASH, and obesity, is also in preclinical studies, with an IND application expected in 2025[36] Financial Performance - The company reported an operating loss of RMB 92,135 thousand for the six months ended June 30, 2025, compared to a loss of RMB 154,330 thousand for the same period in 2024, representing a 40.3% improvement[15] - The total loss for the six months ended June 30, 2025, was RMB 937 million, a decrease of RMB 618 million compared to RMB 1,555 million for the six months ended June 30, 2024[54] - The basic and diluted loss per share for the six months ended June 30, 2025, was RMB 0.25, an improvement from RMB 0.42 in the same period of 2024[15] - Adjusted net loss for the six months ended June 30, 2025, was RMB 51.1 million, a decrease from RMB 67.8 million for the same period in 2024[57] - The company's net assets increased to RMB 260,449 thousand from RMB 57,470 thousand, showing a growth of 353% year-over-year[135] - The company reported a total comprehensive loss of RMB 93,672 thousand, compared to a loss of RMB 155,490 thousand for the same period in 2024, representing a 39.7% improvement year-over-year[132] Market Access and Commercialization Strategy - The company has established a comprehensive market access strategy, including hospital access and tendering processes, to enhance patient accessibility[11] - PegBio's strategy includes exploring innovative payment solutions to alleviate the financial burden on patients[11] - The company is preparing for commercial production to ensure stable supply post-approval[25] - The company has established a systematic commercial preparation system to ensure the successful launch of PB-119 in the Chinese market[44] - The company plans to accelerate the commercialization process of PB-119 to benefit patients in China[51] - The company is actively exploring potential collaborations for the commercialization of PB-119 and is considering new arrangements following the termination of a previous agreement[48] Research and Development - As of June 30, 2025, the company's R&D expenses were RMB 26.3 million and RMB 64.0 million for the six months ending June 30, 2025, and 2024, respectively[39] - The company has a dedicated R&D team with over 13 years of experience in candidate product improvement and drug discovery[37] - Research and development expenses decreased to RMB 26,294 thousand from RMB 64,038 thousand, indicating a reduction of 59% compared to the previous year[132] - The company aims to enhance its R&D capabilities by increasing its investment in new technologies by 20% in the upcoming fiscal year[184] Financial Position and Capital Structure - The total assets increased to RMB 383,347 thousand as of June 30, 2025, up from RMB 218,357 thousand as of December 31, 2024, reflecting a growth of 75.7%[15] - The total equity of the company increased to RMB 260,449 thousand as of June 30, 2025, compared to RMB 57,470 thousand as of December 31, 2024, marking a significant increase of 352.5%[15] - Cash and cash equivalents at the end of June 30, 2025, were RMB 264.5 million, an increase of RMB 236.1 million from RMB 28.4 million at the end of 2024[68] - The company's debt-to-equity ratio as of June 30, 2025, was 32.3%, a significant decrease from 176.6% at the end of 2024[70] - The company raised approximately HKD 231.8 million (equivalent to RMB 212.6 million) from the global offering after deducting underwriting fees and related expenses[103] Employee and Governance - The company had a total of 58 employees as of June 30, 2025, down from 64 employees as of December 31, 2024[80] - The company has appointed Dr. Michael Min Xu as both Chairman and CEO, which the board believes enhances internal leadership consistency and decision-making efficiency[90] - The Audit Committee, consisting of three directors, has reviewed and approved the accounting principles adopted by the group, ensuring compliance with relevant accounting standards[92] - The company has established an Audit Committee in accordance with listing rules, ensuring proper governance and oversight of financial reporting[92] Strategic Partnerships and Market Expansion - PegBio is exploring strategic partnerships to enhance its market presence, targeting a 10% increase in market share by 2025[184] - The company aims to expand its global cooperation network and is preparing for market entry in the Middle East and other countries along the Belt and Road Initiative[53] - The company is also considering acquisitions to bolster its product pipeline, with a budget of $100 million allocated for potential deals[184] Risks and Challenges - The company faces risks related to competition, technology changes, and the successful commercialization of its candidate drugs, which could adversely affect its financial condition[83] - The company acknowledges the uncertainty in successfully developing and commercializing PB-119 and PB-718[28]
派格生物医药-B午前涨超5% GLP-1多靶点领域临床进度靠前 PB-718为公司旗下重磅品种
Zhi Tong Cai Jing· 2025-09-23 04:02
Group 1 - The core viewpoint of the articles highlights the significant growth potential in the global GLP-1 drug market, primarily dominated by Novo Nordisk and Eli Lilly, with other multinational corporations (MNCs) accelerating their presence in this sector [1][2] - The stock price of Paig BioPharma-B (02565) has increased over 3.1 times since its listing, with a current rise of 5.25% to HKD 54.15, and a trading volume of HKD 19.87 million [1] - Zhejiang Securities emphasizes that the GLP-1 market has substantial room for growth in terms of patient base and market size, making it a critical area for MNCs in the metabolic disease sector [1] Group 2 - PB-718, a key product of Paig BioPharma, is a novel long-acting GLP-1/GCG dual receptor agonist targeting MASH treatment, showing promising clinical progress [2] - The Phase Ib/IIa clinical trial results for PB-718 indicate a significant reduction in liver fat content, with a mean percentage change of -57.14% after 18 weeks at a dosage of 1.6mg, achieving a maximum reduction of 62%, outperforming semaglutide in a shorter treatment duration [2] - The domestic pipeline in the multi-target GLP-1 field is advancing, with expectations for major business development (BD) events to emerge [2]