Targetingone Corp. Ltd.’s new testing kit based on digital polymerase chain reaction (dPCR) techniques has received approval from China’s NMPA. It is the first dCPR-based testing kit to receive the country’s class III medical device registration certificate. The Beijing-based company collaborated with Tsinghua University, several hospitals and the Chinese Center for Disease Control and Prevention (CDC) participated to research and develop the testing kit.
Cansino Biologics Inc. has received marketing approval from the NMPA for its ACYW-135 meningococcal conjugate vaccine, Menhycia, making it the first of its kind to be authorized in China. The approval marks “an important step in accelerating the development of China’s meningococcal vaccine immunization strategy,” the company said.
Cansino Biologics Inc. has received marketing approval from the NMPA for its ACYW-135 meningococcal conjugate vaccine, Menhycia, making it the first of its kind to be authorized in China. The approval marks “an important step in accelerating the development of China’s meningococcal vaccine immunization strategy,” the company said.
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.
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.
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