New Stock News | Binceuticals submits application to Hong Kong Stock Exchange to push BS001 into Phase III clinical trial for Chinese melanoma.

According to the disclosure by the Hong Kong Stock Exchange on September 30th, Wuhan Binhuibi Biotechnology Co., Ltd. (referred to as Binhuibi Biotechnology) submitted its listing application to the Main Board of the Hong Kong Stock Exchange, with Huatai International, CMB International, and BOCI Asia as joint sponsors. The prospectus shows that Binhuibi Biotechnology is a oncolytic virus therapy biotechnology company dedicated to the discovery, development, and commercialization of innovative cancer immunotherapy. The company aims to address the urgent unmet clinical needs globally by providing breakthrough oncolytic therapy that is superior in efficacy and safety than standard treatments. The company's work is led by Dr. Liu Binlei, the founder and chairman of the board, who has over 30 years of expertise in tumor immunology and oncolytic virology. Dr. Liu was a core member of the development team of the first FDA-approved oncolytic virus drug IMLYGIC (talimogene laherparepvec, or T-VEC) and played a key role in its development. As a pioneer in the field of oncolytic viruses and other areas, Binhuibi Biotechnology has established a rich and diversified pipeline, including five products in different stages of development, several of which have the potential to be the first of its kind globally. The company's core product BS001 (OH2 injection) is a novel oncolytic virus candidate drug based on type II herpes simplex virus (HSV-2), which has been biologically modified to selectively replicate within tumor cells, directly triggering oncolytic effects, and secreting human granulocyte-macrophage colony-stimulating factor (hGM-CSF) to activate systemic immune activity. The company is currently studying BS001 as monotherapy and in combination with other drugs (especially in combination with PD-1 inhibitors) for the treatment of various solid tumor indications, including melanoma, colorectal cancer, glioblastoma, soft tissue sarcoma, and cholangiocarcinoma, with promising safety and preliminary efficacy observed in early clinical trials. BS001 by Binhuibi Biotechnology is the first oncolytic virus candidate drug based on HSV-2 to reach the clinical stage and enter Phase III pivotal trials, with the potential to become the first globally approved oncolytic virus therapy based on HSV-2. BS001 is also the first oncolytic virus candidate drug to be granted breakthrough therapy designation by the Center for Drug Evaluation. Additionally, BS001 is the first and only oncolytic virus candidate drug to be granted orphan drug designation by the FDA for the treatment of stage III to stage IV melanoma in China and as the first oncolytic virus candidate drug based on HSV-2 for the treatment of malignant glioma. Furthermore, BS001 has been granted fast track designation by the FDA for the treatment of unresectable stage III or stage IV melanoma that is resistant to PD-1 therapy or has progressed after treatment. The company has advanced BS001 to a Phase III clinical trial for melanoma in China, which is a randomized controlled trial with overall survival as the primary endpoint. The completed Phase Ia/Ib trial showed a median overall survival of 31.06 months, with the final overall survival expected to continue to extend as treatment progresses. It also reported an objective response rate of 34.48% in late-stage melanoma patients, and a higher objective response rate of 42.1% in patients with PD-1 therapy resistance. In terms of finances, in the fiscal years of 2023, 2024, and the six months ending June 30, 2024, Binhuibi Biotechnology achieved revenues of 981,000 yuan, 1.725 million yuan, 250,000 yuan, and 140,000 yuan respectively, with net losses of approximately 110 million yuan, 113 million yuan, 43.748 million yuan, and 44.215 million yuan respectively during the same periods.