新股消息 | 滨会生物递表港交所 已将BS001推进至中国黑色素瘤III期临床试验

Core Viewpoint - Wuhan Binhui Biotechnology Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange and has advanced its core product BS001 to Phase III clinical trials for treating melanoma, showcasing its innovative approach in oncolytic virus therapy [1][2]. Company Overview - Binhui Biotechnology is a biotech company focused on the discovery, development, and commercialization of innovative cancer immunotherapies, particularly oncolytic virus therapies [1]. - The company is led by Dr. Liu Binlei, who has over 30 years of expertise in tumor immunology and oncolytic virology, and was a key member of the original development team for the FDA-approved oncolytic virus drug IMLYGIC [1]. Product Pipeline - The company has established a diverse pipeline with five products at various stages of development, including BS001, which is a novel oncolytic virus candidate based on HSV-2 [2]. - BS001 is designed to selectively replicate within tumor cells, induce oncolytic effects, and activate systemic immune responses by secreting hGM-CSF [2]. - The product is being studied as a monotherapy and in combination with other therapies, particularly PD-1 inhibitors, for various solid tumor indications, including melanoma, colorectal cancer, glioblastoma, soft tissue sarcoma, and biliary cancer [2]. Clinical Development - BS001 is the first oncolytic virus candidate based on HSV-2 to reach clinical stage and enter Phase III trials globally, with the potential to be the first approved HSV-2 based oncolytic virus therapy [3]. - It has received breakthrough therapy designation from the drug evaluation center and orphan drug status from the FDA for treating advanced melanoma and glioblastoma [3]. - The ongoing Phase III trial for melanoma uses overall survival as the primary endpoint, with previous trials showing a median overall survival of 31.06 months and an objective response rate of 34.48% in advanced melanoma patients [3]. Financial Performance - For the fiscal years 2023 and 2024, the company reported revenues of RMB 0.981 million and RMB 1.725 million, respectively, while incurring losses of approximately RMB 110 million and RMB 113 million [4]. - The financial results for the six months ending June 30, 2024, and 2025, showed revenues of RMB 0.25 million and RMB 0.14 million, with losses of RMB 43.748 million and RMB 44.215 million, respectively [4].