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Guangdong's new drug BYS10 was approved by the US FDA for drug clinical trials

2022-06-06

Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., a subsidiary of Guangzhou Pharmaceutical Group, a Fortune 500 company, issued an announcement on the evening of the 30th, and its subsidiary Baiyunshan Pharmaceutical Factory received the US FDA (ie US Food and Drug Administration) on May 29. The approval of BYS10 tablets Letter to clinical trials for the treatment of advanced solid tumors with RET fusions or mutations. Baiyunshan Pharmaceutical General Factory plans to conduct an open-ended, multi-center Phase I clinical trial of the new drug for the above indications when conditions are met in the near future.

According to reports, BYS10 is a class 1 new drug of selective RET small molecule inhibitor chemical drug independently developed by Baiyunshan Pharmaceutical General Plant, a subsidiary of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., and is indicated for advanced solid tumors with RET fusion or mutation (including non-small molecule drugs). lung cancer, thyroid cancer, medullary thyroid cancer, etc.).

It is understood that the BYS10 project plans to solve major scientific problems that need to be solved urgently in clinical practice, such as low selectivity of multi-target drugs, significant off-target effects and clinical drug resistance.

In addition, GPHL is carrying out the research and development of small-molecule antiviral generic drugs, and has completed the industrialized trial production. It is carrying out research work in accordance with the generic drug research and development process, and is expected to provide more clinical drug options for the treatment of respiratory diseases.


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