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 - Huazhan Biotechnology (Qingdao) Co., Ltd. has submitted an application for listing on the Hong Kong Stock Exchange, with Huatai International and CITIC Securities as joint sponsors [1][3]. Company Overview - Established in 2012, Huazhan Biotechnology is a biopharmaceutical company based in China, focusing on developing therapies for medical needs and market opportunities, particularly in protein drugs [3]. - The company's main focus is on discovering, developing, and commercializing wound healing therapies, with two core products: Pro-101-1 for burn treatment and Pro-101-2 for diabetic foot ulcers [3][4]. Product Development - As of the last feasible date, 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 [3][4]. - 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 [3]. Market Position and Competitive Advantage - Pro-101-1 is reported to be the fastest-developing PDGF candidate drug for burn treatment in China, according to Frost & Sullivan [4]. - PDGF drugs have a history of over 20 years in clinical use for diabetic foot ulcers, primarily in the United States, and are the only recombinant growth factors approved by the FDA for topical use in this indication [4]. Intellectual Property and Collaboration - 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 [5][6]. - The company has independent rights to the technology and patents related to PDGF, having taken over the relevant technical data from the Academy of Military Medical Sciences [6]. Financial Performance - For the fiscal years 2023 and 2024, the company reported revenues of approximately RMB 472,000 and RMB 261,000, respectively, with total comprehensive losses of RMB 105.2 million and RMB 212.2 million for the same periods [7][8]. - The company has incurred significant administrative and research and development expenses, contributing to its overall losses [8].