China’s NMPA has approved JW Therapeutics Co. Ltd.’s relmacabtagene autoleucel, an autologous chimeric antigen receptor T (CAR T) therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. It marks the first CAR T product to be independently developed in China and approved as a category I biologic product there, as well as the sixth approved CAR T product globally. The anti-CD19 therapy, sometimes called relma-cel, will be marketed as Carteyva.
Bristol Myers Squibb Co.’s Opdivo (nivolumab) is now the first and only immunotherapy for the first-line treatment of advanced gastric cancer in China.
An update from China’s NMPA clarifying registration requirements and classification methods for drug-device combination products has been welcomed by industry as the regulator seeks to keep pace with fast-moving developments in the sector.
An update from China’s NMPA clarifying registration requirements and classification methods for drug-device combination products has been welcomed by industry as the regulator seeks to keep pace with fast-moving developments in the sector.
China’s NMPA has given Belief Biomed Inc. the official go-ahead to start testing its investigational gene therapy, BBM-H901, for the potential treatment of hemophilia B in the country, marking the first time an I.V. gene therapy for a rare disease has been approved in China. The company plans to advance the phase I/II trial for the candidate shortly, it said.
China’s NMPA has given Belief Biomed Inc. the official go-ahead to start testing its investigational gene therapy, BBM-H901, for the potential treatment of hemophilia B in the country, marking the first time an I.V. gene therapy for a rare disease has been approved in China. The company plans to advance the phase I/II trial for the candidate shortly, it said.
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