The med-tech market in China has lured many device makers and investors into doing business there despite concerns about intellectual property (IP) theft. While some of those IP theft worries have eased, China’s National Medical Products Administration (NMPA) is still implementing an order that came into force June 1, creating an environment of massive regulatory uncertainty that will force device makers to navigate carefully when attempting to access the world’s largest med-tech market.
Minhai Biotechnology Co. Ltd. has won approval from the NMPA for its 13-valent pneumococcal conjugate vaccine, which makes it the third company with such a vaccine to be greenlighted in China.
Minhai Biotechnology Co. Ltd. has won approval from the NMPA for its 13-valent pneumococcal conjugate vaccine, which makes it the third company with such a vaccine to be greenlighted in China.
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.
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.
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