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Betta Pharmaceuticals (300558.SZ): The approval process for the new drug listing of Esmotrine hydrochloride capsules has been initiated with the European Medicines Agency.
On February 13, Gelonghui reported that Betta Pharmaceuticals (300558.SZ) announced that today, its holding subsidiary Xcovery Holdings, Inc. (referred to as "Xcovery") submitted a letter of intent to the European Medicines Agency (EMA), officially starting the上市 approval process for the hydrochloride ensartinib capsules (trade name: Baimena, hereinafter referred to as "ensartinib") "intended for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for anaplastic lymphoma kinase (ALK)" (i.e., first-line indication).
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Betta Pharmaceuticals (300558.SZ): BPI-452080 tablets have been approved for clinical drug trials.
Betta Pharmaceuticals (300558.SZ) announced that the company has received the "Pharmaceutical Clinical Trial" issued by the National Medical Products Administration...
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