Akeso Inc. has received approval from China's National Medical Products Administration (NMPA) for a phase Ib/II trial of ivonescimab (AK-112) combined with drebuxelimab (AK-119) for the treatment of advanced solid tumors.
Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua.
Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua.
Innocare Pharma Ltd. has received IND approval from China's National Medical Products Administration (NMPA) to begin clinical trials of its B-cell lymphoma-2 (BCL2) inhibitor ICP-248.
China's National Medical Products Administration (NMPA) has cleared CSPC Pharmaceutical Group Limited to conduct clinical trials of TG-103 injection for the treatment of Alzheimer's disease and for the treatment of nonalcoholic steatohepatitis (NASH).
China’s NMPA has granted emergency use authorization for two COVID-19 vaccines as boosters, Cansino Biologics Inc.’s inhaled vaccine Convidecia Air and Livzon Pharmaceutical Group Inc.’s recombinant protein vaccine. Convidecia Air is an aerosolized adenovirus type 5 vector-based vaccine. It is the first inhaled COVID-19 vaccine to be approved globally, according to Cansino.
Genuine Biotech Co. Ltd.’s azvudine has been granted conditional approval by China’s NMPA for the treatment of COVID-19. The drug, first granted conditional approval from the NMPA to treat HIV-1-infected adults with high viral loads in July 2021, is the first domestically developed oral medicine approved to treat COVID-19 in China and was approved just 10 days after its application was submitted on July 15.
Genuine Biotech Co. Ltd.’s azvudine has been granted conditional approval by China’s NMPA for the treatment of COVID-19. The drug, first granted conditional approval from the NMPA to treat HIV-1-infected adults with high viral loads in July 2021, is the first domestically developed oral medicine approved to treat COVID-19 in China and was approved just 10 days after its application was submitted on July 15.
Venus Medtech (Hangzhou) Inc. received the green light in China for its transcatheter pulmonic valve replacement (TPVR) system Venusp-Valve. It is a self-expanding TPVR product for the treatment of severe pulmonary regurgitation (≥3+) in patients after a congenital heart defects procedure with native right ventricular outflow tract.
Infervision Medical Technology Co. Ltd. received approval from China’s NMPA for its radiological computer-assisted triage and notification software device Inferread CT Stroke. This is the first class III approval that the firm obtained in the cerebro-cardiovascular field. Class III approvals are for high-risk medical devices.
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