PDGF药物

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新股消息 华芢生物三度递表港交所 用于治疗烧烫伤的Pro-101-1已在中国完成IIb期临床试验
Jin Rong Jie· 2025-08-17 09:18
Core Viewpoint - Huazhang Biotechnology (Qingdao) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with Huatai International and CITIC Securities as joint sponsors [1] Company Overview - Established in 2012, Huazhang Biotechnology is a biopharmaceutical company based in China, focusing on developing therapies for medical needs and market opportunities, particularly in protein drugs [2] - The company is primarily engaged in discovering, developing, and commercializing wound healing therapies, with a focus on platelet-derived growth factor (PDGF) drugs [2] - As of the latest feasible date, the company has two core products: Pro-101-1 for treating burns and Pro-101-2 for diabetic foot ulcers, along with eight other candidate products [2] Clinical Development - Pro-101-1 has completed Phase IIb clinical trials in China and is in the process of finalizing the clinical trial report, while Pro-101-2 is undergoing Phase II clinical trials in China [2] - The company anticipates that once its PDGF candidate products are commercialized, the primary market will be in China, with plans to launch Pro-101-1 in the United States [2] Product Details - PDGF is a growth factor secreted by platelets after injury, promoting new blood vessel formation, regulating inflammation, and stimulating cell proliferation and migration, ultimately leading to wound healing [3] - Pro-101-1 is reported to be the fastest-developing PDGF candidate drug for treating burns in China, with other PDGF candidates sharing the same active ingredient, rhPDGF-BB [3] Market Landscape - PDGF drugs have been used for over 20 years in clinical settings for diabetic foot ulcers, primarily in the United States, and are the only recombinant growth factors approved by the FDA for topical use in treating diabetic foot ulcers [3] Intellectual Property - The company has submitted five patent applications related to its core products, with two PDGF-related patents obtained from the Academy of Military Medical Sciences and the Institute of Bioengineering [4] - The company has exclusive rights to use and commercialize these patents, with no involvement from the Academy in the clinical development of Pro-101-1 or other PDGF candidates since July 2021 [5] Financial Performance - For the fiscal years 2023 and 2024, the company reported revenues of approximately CNY 472,000 and CNY 261,000, respectively, with total comprehensive losses of CNY 105.2 million and CNY 212.1 million for the same periods [6][7] - The company incurred significant administrative and research expenses, contributing to its overall financial losses [7]
新股消息 | 华芢生物三度递表港交所 用于治疗烧烫伤的Pro-101-1已在中国完成IIb期临床试验
智通财经网· 2025-08-17 08:38
智通财经APP获悉,据港交所8月15日披露,华芢生物科技(青岛)股份有限公司(简称:华芢生物)向港交所主板递交上 市申请,华泰国际和中信证券为联席保荐人。该公司曾分别于2024年4月29日、2024年11月22日递表港交所。 招股书显示,华芢生物成立于2012年,是一家总部位于中国的生物制药公司,致力于开发疗法,重点是针对有医疗 需求及市场机会的适应症开发蛋白质药物。公司的主攻方向是发现、开发和商业化伤口愈合的疗法,目前为血小板 衍生生长因子("PDGF")药物。截至最后实际可行日期,公司的管线包含两款核心产品,即用于治疗烧烫伤的Pro-101- 1及用于治疗糖尿病足溃疡("糖足")的Pro-101-2,以及八款其他候选产品。截至最后实际可行日期,公司用于治疗烧 烫伤的Pro-101-1已在中国完成IIb期临床试验,并正处于确定临床试验报告的阶段;且公司用于治疗糖足的Pro-101-2 正在中国进行II期临床试验。公司预期,一旦公司的PDGF候选产品实现商业化,其主要市场将在中国。此外,公司 计划在美国推出Pro-101-1。 华芢生物于招股书中提示,公司或许不能成功开发及╱或推广公司的核心产品。PDGF是血 ...
华芢生物招股书解读:研发投入大增250%,净利润亏损扩大230%
Xin Lang Cai Jing· 2025-08-15 23:27
来源:新浪港股-好仓工作室 主营业务与商业模式 华芢生物成立于2012年,作为一家总部位于中国的生物制药公司,专注于开发针对有医疗需求及市场机 会适应症的蛋白质药物,主攻方向为伤口愈合疗法,目前聚焦于血小板衍生生长因子(PDGF)药物。 公司商业模式围绕PDGF药物的研发、临床试验及未来商业化展开。截至最后实际可行日期,其管线包 含两款核心产品,即用于治疗烧烫伤的Pro - 101 - 1及用于治疗糖尿病足溃疡("糖足")的Pro - 101 - 2, 以及八款其他候选产品。 研发管线进展 候选产品治疗靶点适应症剂型临床试验地区开发阶段预计完成时间主管机构商业权益研发方式Pro - 101 - 1烧烫伤外用凝胶中国已完成IIb期临床试验,处于确定临床试验报告阶段预计2025年第四季度完成II期 国家药监局全球自主研发美国预计2026年第一季度提交IND申请FDA全球Pro - 101 - 2糖足外用凝胶中国 正在进行II期临床试验预计2027年第二季度完成II期,并于2027年第三季度启动III期国家药监局全球与 军科院生物工程研究所联合研发Pro - 101 - 3新鲜创面外用凝胶中国预计2025年第四季度 ...