Burning Rock Biotech Ltd. wants to significantly change the way cancers are detected and the biotech is sailing ahead with the latest breakthrough device designation received from China’s NMPA for its multi-cancer detection blood test (MCDBT), Overc.
China’s National Medical Products Administration (NMPA) has largely completed its development of overarching regulations for medical devices and is now drilling down into more granular matter, such as a guidance on assessments of benefits and risks for medical devices. Grace Fu Palma, CEO of China Med Device LLC, told BioWorld that this new guidance is a much more detailed version of the 2019 edition, but added that China’s anticorruption efforts will be ramped up with an eye toward health care, just one of several current and impending developments of interest in this massive market.
China’s National Medical Products Administration (NMPA) has given the green light to Gloria Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody, zimberelimab (Yutuo, GLS-010), for treating second-line cervical cancer, making it the first immune checkpoint inhibitor approved in China for treating the disease.
Wuhan Endoangel Medical Technology Co. Ltd.’s artificial intelligence (AI)-assisted real-time quality control and auxiliary diagnosis system for lower gastrointestinal endoscopy has been approved by China’s NMPA.
Grand Pharmaceutical Group Ltd. obtained China’s NMPA approval for an intravascular dual-mode imaging system for coronary artery imaging, tapping into a potentially huge but very undeveloped market for imaging in percutaneous coronary interventions (PCI).
Anhui Happiness Workshop Medical Equipment Co. Ltd.'s single use ureteroscope was approved by China’s NMPA, becoming the first domestically developed electronic soft ureteroscope to monitor intrarenal pressure during procedures.
China’s NMPA gave the nod to Roche Diagnostics (Shanghai) Ltd.’s anti-preferentially expressed antigen in melanoma (PRAME) (EPR 20330) that could help to speed up melanoma diagnosis and improve survival rates.
Acotec Scientific Holdings Ltd. received Chinese marketing approval for its microcatheter Vericor-14 to assist in percutaneous coronary interventions and percutaneous peripheral interventions, taking a step forward in a competitive market that is poised to grow eightfold by the end of the decade.
China’s NMPA gave the nod to Roche Diagnostics (Shanghai) Ltd.’s anti-preferentially expressed antigen in melanoma (PRAME) (EPR 20330) that could help to speed up melanoma diagnosis and improve survival rates.
Meio Medical Inc.’s Titian, a surgical robot for navigation in cardiac electrophysiology, has been included in a Green Pathway for approval of medical devices in China, meaning it could get to market faster. Inclusion in the Green Pathway gives the medical device priority for reviewing and shortens the average registration time. Currently, Meio Medical is running a trial of Titian in multiple hospitals in China.
