China’s National Medical Products Administration (NMPA) awarded Akeso Inc. breakthrough therapy designation for its PD-1 checkpoint inhibitor/VEGF bispecific antibody, ivonescimab (AK-112), combined with docetaxel for locally advanced or metastatic non-small-cell lung cancer (NSCLC) in patients who failed to respond to prior PD-(L)1 inhibitors combined with chemotherapy.
Luye Pharma Group has received marketing approval from China’s NMPA for the triple monoamine reuptake inhibitor Ruoxinlin (toludesvenlafaxine hydrochloride) to treat patients with major depressive disorder, a condition that “has become one of the most prevalent mental disorders in China, causing a heavy burden on patients, their families and the entire society,” said Luye President Yang Rongbing.
Shanghai’s State Medical Products Administration announced that GSK plc has been banned from participating in volume-based procurement tenders until April 29, 2024, after failing a good manufacturing practices (GMP) inspection at a contract manufacturing plant in Poland that makes products for China.
China’s National Medical Products Administration (NMPA) established new medical device regulations earlier in the year aimed at spurring innovation and creating regulatory incentives, and although the regulation has shortened review and approval timelines, other benefits are less clear, experts said.
CSPC Pharmaceutical Group Ltd. announced that the National Medical Products Administration of the People’s Republic of China has granted approval to conduct clinical trials of the company’s antibody-drug conjugate candidate, SYS-6002.
Sino Medical Sciences Technology Inc. received marketing approval from China’s NMPA for its drug eluting stent system to improve vascular stenosis in patients with localized ischemic heart disease. The product is designed to improve the speed of wound healing and accelerate the recovery of vascular endothelium after stent implantation. It fits vessels with a diameter of 2.25 mm to 4.00 mm and a lesion length of less than or equal to 40 mm.
China's National Medical Products Administration (NMPA) has cleared an IND application for a clinical trial of Shanghai Henlius Biotech Inc.'s HLX-60 for the treatment of solid tumors and lymphomas.
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.
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