According to the Hong Kong Stock Exchange disclosure on September 30, Wuhan Binhua Biosciences Co., Ltd. (Binhua Biosciences) has submitted a listing application to the main board of the Hong Kong Stock Exchange, with Huatai International, China Merchants Bank International, and Bank of China International serving as joint sponsors.

The prospectus shows that Binhua Biosciences is an oncolytic virus therapy biotechnology company dedicated to the discovery, development, and commercialization of innovative cancer immunotherapies. The company aims to address urgent unmet global clinical needs by providing breakthrough oncolytic therapies that demonstrate superior efficacy and safety compared to standard treatments.

The company's work is led by founder and Chairman Dr. Liu Binlei, who possesses over 30 years of expertise in tumor immunology and oncolytic virology. Dr. Liu was a core member of the original development team for IMLYGIC® (talimogene laherparepvec, or T-VEC), the first oncolytic virus drug approved by the FDA, and played a key role in its development.

As a pioneer in the oncolytic virus field and beyond, Binhua Biosciences has established a rich and diversified pipeline comprising five products at different stages of development, with multiple products having first-in-class global potential.

The company's independently developed core product BS001 (OH2 injection) is a novel oncolytic virus candidate based on herpes simplex virus type 2 (HSV-2). Its biological modifications enable selective replication within tumor cells, directly inducing oncolytic effects while secreting human granulocyte-macrophage colony-stimulating factor (hGM-CSF) to activate systemic immune activity.

The company is currently investigating BS001 as both monotherapy and in combination therapies (particularly with PD-1 inhibitors) for treating various solid tumor indications, including melanoma, colorectal cancer, glioblastoma, soft tissue sarcoma, and biliary tract cancer. The company has observed favorable safety profiles and preliminary efficacy in early-stage clinical trials.

Binhua Biosciences' BS001 is the world's first HSV-2-based oncolytic virus candidate to reach clinical stage and advance to Phase III pivotal trials, with potential to become the world's first approved HSV-2-based oncolytic virus therapy. BS001 is also the first oncolytic virus candidate to receive breakthrough therapy designation from China's Center for Drug Evaluation.

Additionally, BS001 is the first and only China-originated oncolytic virus candidate to receive FDA orphan drug designation for treating Stage III to IV melanoma, as well as the first China-originated HSV-2-based oncolytic virus candidate to receive FDA orphan drug designation for treating malignant gliomas. Furthermore, BS001 has received FDA fast track designation for treating unresectable Stage III or IV melanoma that is resistant to or has progressed after anti-PD-1 therapy.

The company has advanced BS001 to a Phase III clinical trial in China for melanoma, which is a randomized controlled trial significantly employing overall survival—the gold standard efficacy endpoint in oncology recognized by competent regulatory authorities—as the primary endpoint. The completed Phase Ia/Ib trials demonstrated median overall survival extension to 31.06 months; however, as treatment continues, final overall survival has not been reached and is expected to continue extending. The trials also reported an objective response rate of 34.48% in advanced melanoma patients, with an even higher objective response rate of 42.1% in patients with PD-1 therapy resistance.

Financially, for the years 2023 and 2024, and the six-month periods ended June 30, 2024 and 2025, Binhua Biosciences achieved revenues of RMB 981,000, RMB 1.725 million, RMB 250,000, and RMB 140,000 respectively. During the same periods, annual/period losses were approximately RMB 110 million, RMB 113 million, RMB 43.748 million, and RMB 44.215 million respectively.