China’s NMPA has given thumbs up to Cstone Pharmaceuticals Co. Ltd.’s Cejemly (sugemalimab), an anti-PD-L1 monoclonal antibody. It was approved for use in treatment-naïve metastatic (stage IV) non-small-cell lung cancer (NSCLC) patients in combination with chemotherapy.
Antengene Corp. Ltd. received marketing approval from China’s NMPA for ATG-010 (selinexor), a drug that was in-licensed from Karyopharm Therapeutics Inc. It was approved for use in combination with dexamethasone to treat adults with relapsed or refractory multiple myeloma, specifically those who have received prior therapies and whose disease is refractory to at least a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
China is making some advances in approving and reimbursing drugs to treat or prevent rare diseases. More than 60 rare disease drugs have been approved for marketing in China, with more than 40 of those included in the national medical insurance system, according to figures released at a national conference on rare diseases held in Beijing Dec. 18.
China is making some advances in approving and reimbursing drugs to treat or prevent rare diseases. More than 60 rare disease drugs have been approved for marketing in China, with more than 40 of those included in the national medical insurance system, according to figures released at a national conference on rare diseases held in Beijing Dec. 18.
A cocktail of monoclonal neutralizing antibodies developed by Brii Biosciences Ltd. has become “the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomized, double-blind and placebo-controlled trial,” Rogers Luo, president and general manager of greater China at the company, told BioWorld.
A cocktail of monoclonal neutralizing antibodies developed by Brii Biosciences Ltd. has become “the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomized, double-blind and placebo-controlled trial,” Rogers Luo, president and general manager of greater China at the company, told BioWorld. The NMPA approved a combination of Brii’s amubarvimab and romlusevimab as a treatment for both adults and pediatric patients, ages 12 to 17, with mild and “normal type” COVID-19 at high risk for progression to severe disease, including hospitalization or death.
Shanghai Henlius Biotech Inc.’s self-developed Hanbeitai (bevacizumab biosimilar) has received marketing approval from China’s NMPA. It was approved for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent, or metastatic non-squamous non-small-cell lung cancer.
Beigene Ltd. has received approval from China’s NMPA to market Sylvant (siltuximab) for the treatment of patients with multicentric Castleman disease, including HIV-negative and human herpes virus-8-negative disease. The green light comes at a good time as the Beijing-headquartered company is preparing for a $3.5 billion listing on Shanghai’s STAR Market, its third listing. The monoclonal antibody siltuximab previously received regulatory approval in the U.S. and Europe.
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