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China Grants Breakthrough Therapy Designation for Keymed Biosciences' Gastric Cancer Treatment

MT Newswires ·  {{timeTz}}

02:33 AM EDT, 09/19/2022 (MT Newswires) -- China 's medical products regulator granted breakthrough therapy designation for Keymed Biosciences' (HKG:2162) CMG901 treatment for Claudin 18.2-positive advanced gastric cancer, a Monday stock filing said.

The designation will allow the government to prioritize the treatment in communications and guidance to promote the drug development process, the pharmaceutical company said.

The US Food and Drug Administration granted CMG901 an orphan drug designation and fast track designation for the treatment of relapsed or refractory gastric cancer and gastroesophageal junction adenocarcinoma.

Shares of the biotechnology company fell nearly 2% in Monday's afternoon trading.

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