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OH2 injection approved by CDE for inclusion in breakthrough treatment varieties

Source:Shohui Organism

Page View:41

Release Time:2023-10-11 18:30:49

On February 25, 2023, Wuhan Binhui Biotechnology Co., Ltd.'s first candidate drug for oncolytic virus, recombinant human GM-CSF oncolytic type II herpes simplex virus (OH2) injection (Vero cells), was approved by the Drug Evaluation Center (CDE) of the National Medical Products Administration and included in the breakthrough treatment variety.


01 "High Speed Channel" for Drug Marketing

On July 1, 2020, the newly revised Measures for the Administration of Drug Registration were officially implemented, with a special section on accelerating the registration process for drugs on the market. Four drug evaluation fast channels were established, including breakthrough therapeutic drugs, conditional approval, priority review approval, and special approval, to encourage innovation and meet urgent clinical needs. The Work Procedure for Breakthrough Therapy Drug Evaluation (Trial) also specifies that the Drug Review Center shall communicate and exchange priority allocation resources for drugs included in the Breakthrough Therapy Drug Program, strengthen guidance and promote drug research and development; If the applicant meets the relevant conditions after evaluation, they can also apply for conditional approval and priority evaluation when applying for a drug marketing license.

  02 Approved Gold Standard | Outstanding Clinical Data

The overall approach of the breakthrough treatment drug review process is in line with international standards, benchmarking against FDA Fast Track and Breakthrough Therapy. It is suitable for the prevention and treatment of diseases that seriously endanger life or seriously affect quality of life, and there is no effective prevention and treatment method or sufficient evidence to show significant clinical advantages compared to existing treatment methods for innovative drugs or improved new drugs. Clinical trial drugs must have significant clinical advantages and significant improvements in one or more clinically significant endpoints in order to apply for breakthrough treatment drug programs.

03 OH2 Injection | First breakthrough therapeutic variety for oncolytic viruses

The Binhui Biooncolytic Virus (oHSV2) immunotherapy platform, with independent intellectual property rights and industry-leading capabilities, 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 on the platform, was the first Chinese independently developed oncolytic virus to obtain FDA orphan drug certification; It is the first national major new drug development project for oncolytic viruses to enter confirmatory phase III clinical research; It is also the first oncolytic virus to be included in breakthrough treatment varieties.

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