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.
Beijing Surgerii Technology Co. Ltd. completed a series C3 round to support the development of its robotic system for single-port laparoscopic surgery.
The growing number of people taking up more active sports in China is powering the global market for orthopedic trauma devices through a surge in demand and the emergence of new lines of surgical products, particularly ones that can improve patient outcomes and experience.
Biontech SE has tapped into two of Duality Biologics Co. Ltd.’s antibody-drug conjugate candidates (ADCs), paying Duality $170 million up front and agreeing on development, regulatory and commercial milestone fees of $1.5 billion or more.
Biontech SE has tapped into two of Duality Biologics Co. Ltd.’s antibody-drug conjugate candidates (ADCs), paying Duality $170 million up front and agreeing on development, regulatory and commercial milestone fees of $1.5 billion or more.
China’s NMPA granted conditional approval for a COVID-19 oral pill to treat adult patients with mild to moderate cases of the virus to a unit of Guangdong Zhongsheng Pharmaceutical Co. Ltd.
Triastek Inc., a digital pharmaceutical solutions company, is taking a unique approach by using 3D printing technology to develop a pipeline that spans rheumatoid arthritis (RA), clotting disorders, ulcerative colitis and pulmonary hypertension. Its technology was recently validated through a partnership with Boehringer Ingelheim GmbH. The company’s 3D printing products include T-19, T-20 and T-21, which have all received IND approval from the FDA.