The Center for Drug Evaluation (CDE) website indicates that China-based Wuhan Binhui Biotechnology Co., Ltd’s GM-CSF oncolytic herpes simplex virus type II (OH2) for injection (Vero cells) has been awarded breakthrough therapy designation (BTD) status. This designation is for the treatment of patients with unresectable or metastatic melanoma who have failed at least the second line of standard treatment. Standard treatment includes chemotherapy/radiotherapy, immunotherapy, and targeted treatment for gene mutation.
Treatment Protocol and Progression
Within six months after the end of adjuvant treatment or during the period of adjuvant treatment, if the disease progresses to unresectable or metastatic melanoma, this adjuvant treatment can be counted as the first line of advanced treatment. This protocol is crucial for patients who have exhausted other treatment options and are in need of innovative therapeutic approaches.
Oncolytic Virus BS001 (OH2) Injection
The oncolytic virus BS001 (OH2) injection, the first oncolytic candidate drug approved for study combined with other drugs in China, is currently undergoing a multi-center, pivotal Phase III study in melanoma. This study is a significant step forward in the development of oncolytic viral therapies for the treatment of melanoma and other cancers.
Binhui Biotechnology’s Focus and Funding
Founded in 2010, Binhui Biotechnology focuses on tumor immunotherapies based on oncolytic viral therapies. The company has raised significant funding, including RMB 600 million (USD 87.4 million) in a Series C financing round in December 2021 and RMB 300 million (USD 43.7 million) in a Series B financing round in April 2022. This funding supports Binhui’s ongoing research and development efforts, positioning the company as a leader in the field of oncolytic viral therapies.-Fineline Info & Tech
