China’s NMPA granted conditional approvals to two COVID-19 drugs under a special examination and approval procedure aimed at addressing urgent needs. The approvals are both for oral small-molecule drugs for adult patients with mild to moderate COVID-19 infections. One of the approved drugs is Simcere Pharmaceutical Group Ltd.’s Xiannuoxin (simnotrelvir/ritonavir). The other is Shanghai Junshi Biosciences Co. Ltd.’s VV-116 (deuremidevir hydrobromide).
China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time.
China’s NMPA granted conditional approvals to two COVID-19 drugs under a special examination and approval procedure aimed at addressing urgent needs. The approvals are both for oral small-molecule drugs for adult patients with mild to moderate COVID-19 infections. One of the approved drugs is Simcere Pharmaceutical Group Ltd.’s Xiannuoxin (simnotrelvir/ritonavir). The other is Shanghai Junshi Biosciences Co. Ltd.’s VV-116 (deuremidevir hydrobromide).
China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time.
Bio-Thera Solutions Ltd. has obtained NMPA approval for BAT-1806 to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis and cytokine release syndrome. BAT-1806 is the world’s first tocilizumab biosimilar approved for marketing, according to Guangzhou, China-based Bio-Thera.
Shanghai Henlius Biotech Inc. scored NMPA approval for its self-developed anti-PD-1 monoclonal antibody Hansizhuang (serplulimab). It can be used for the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide.
Nervtex Co. Ltd.’s diagnostic assessment software Modas for movement disorders such as Parkinson’s disease has been given NMPA approval in China. Using smart mobile devices, Modas can process video data collected from people with potential or existing movement disorders when they are in any specific motion state.
Skynor Medical (Shanghai) Co. Ltd. has raised ¥100 million (US$15 million) in a financing round to step up its efforts in product development and market expansion. More specifically, the Shanghai-based company intends to use the funds to develop its interventional treatment solutions for neuro and peripheral vascular diseases, as well as expand them to markets at home and abroad.
CSPC Pharmaceutical Group Ltd. has received clearance from China's National Medical Products Administration (NMPA) to conduct clinical trials in China of the highly selective novel protein arginine methyltransferase 5 (PRMT5) inhibitor SYH-2045 for the treatment of advanced malignant tumors.
Zylox-Tonbridge Medical Technology Co. Ltd. has obtained marketing approval for its retrievable inferior vena cava (IVC) filter Zylox Octoplus in China. “Zylox Octoplus is approved for the prevention of pulmonary embolism (PE) and deep vein thrombosis (DVT) in the peripheral vasculature,” a spokesperson at Zylox-Tonbridge told BioWorld. The approval is based on a multi-center, randomized and positive control clinical trial in China. The trial was conducted in nine peripheral vascular intervention centers in China.
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