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

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]