On February 25, 2023, Wuhan Binhui Biotechnology reported its first oncolytic virus candidate drug recombinant human GM-CSF oncolytic herpes simplex virus type II (OH2) injection (Vero cells) was approved by the State Drug Administration (Press release, Binhui Biotechnology, FEB 25, 2023, View Source [SID1234633513]). Approved by the Center for Evaluation (CDE), included in breakthrough therapy varieties.
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01 "High-speed channel" for drug listing
On July 1, 2020, the newly revised "Measures for the Administration of Drug Registration" was officially implemented. In particular, a chapter on accelerated drug market registration procedures was added, and four fast-track drug reviews were established: breakthrough therapy drugs, conditional approval, priority review and approval, and special approval. Channels to encourage innovation and meet urgent clinical needs. The "Breakthrough Therapy Drug Review Work Procedures (Trial)" also clarified: the Center for Drug Evaluation shall communicate and exchange resources for the priority allocation of drugs included in the breakthrough therapy drug program, strengthen guidance and promote drug research and development; applicants that meet the relevant conditions after evaluation , and may also submit a conditional approval application and a priority review application when applying for a drug marketing authorization.
02 Approved gold standard | Outstanding clinical data
The general idea of the breakthrough therapy drug review process is in line with international standards, and it is benchmarked against FDA Fast Track (FastTrack) and Breakthrough Therapy (Breakthrough Therapy). It is suitable for the prevention and treatment of diseases that are seriously life-threatening or seriously affect the quality of life, and there is no effective treatment Methods or innovative drugs or improved new drugs that have sufficient evidence to show that they have obvious clinical advantages compared with existing treatments. Drugs in clinical trials must have obvious clinical advantages and significant improvement in one or more clinically meaningful endpoints before they can apply for the breakthrough therapy drug program.
03 OH2 Injection | The first oncolytic virus breakthrough treatment product
Owning independent intellectual property rights, the industry-leading Binhui Bio-oncolytic virus (oHSV2) immunotherapy platform is the only industry-university-research integrated research platform in China that develops oncolytic virus products in a fully closed loop. OH2 injection, as the first candidate drug developed by the platform, is the first oncolytic virus independently developed in China to obtain FDA orphan drug designation; it is the first national major new drug creation project of oncolytic virus to enter confirmatory phase III clinical research and the first oncolytic virus to be included in a breakthrough therapy category.