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 Insights - Huasheng 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, Huasheng Biotechnology is a biopharmaceutical company based in China, focusing on developing protein drugs for medical needs and market opportunities [3] - The company's primary focus is on discovering, developing, and commercializing therapies for wound healing, with two core products: Pro-101-1 for burn treatment and Pro-101-2 for diabetic foot ulcers [3][4] Product 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 [3][4] - The company anticipates that its PDGF candidate products will primarily target the Chinese market, with plans to launch Pro-101-1 in the United States [3] Market Position - Pro-101-1 is noted as the fastest clinical development PDGF candidate 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 FDA-approved recombinant growth factors for topical use in this indication [4] 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 [5][6] - The Academy has transferred relevant technical data to the company, granting it exclusive rights to the patents and commercialization [6] Financial Performance - For the fiscal years 2023 and 2024, the company reported revenues of approximately RMB 472,000 and RMB 261,000, respectively [7][8] - The total comprehensive losses for the same periods were RMB 105.2 million and RMB 212.1 million, indicating significant financial challenges [7][8]