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.
Shanghai Junshi Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody toripalimab showed positive interim event-free survival (EFS) results in a phase III study to treat patients with resectable non-small-cell lung cancer (NSCLC). This is the world’s first phase III trial that shows perioperative treatment with an anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable NSCLC, according to Shanghai-based Junshi Biosciences.
Zephyrm Biotechnologies Co. Ltd. raised ¥200 million (US$29 million) in a series B financing to support phase I and II trials of the company’s human pluripotent stem cell candidates to treat lung diseases, degenerative joint diseases such as osteoarthritis, CNS diseases, inherited retinal degenerations and retinal degenerative diseases. The money will also be used for the construction of its technology platform and cell manufacturing bases.
Xian Janssen Pharmaceutical Ltd. obtained marketing approval in China for Spravato (esketamine hydrochloride nasal spray) in combination with an oral antidepressant to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Unlike existing antidepressants on the market, which can take weeks to take effect, the newly approved nasal spray shows effects right away.
Shanghai Junshi Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody toripalimab showed positive interim event-free survival (EFS) results in a phase III study to treat patients with resectable non-small-cell lung cancer (NSCLC). This is the world’s first phase III trial that shows perioperative treatment with an anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable NSCLC, according to Shanghai-based Junshi Biosciences.
Beijing Surgerii Technology Co. Ltd. completed a series C3 round to support the development of its robotic system for single-port laparoscopic surgery.
Zephyrm Biotechnologies Co. Ltd. raised ¥200 million (US$29 million) in a series B financing to support phase I and II trials of the company’s human pluripotent stem cell candidates to treat lung diseases, degenerative joint diseases such as osteoarthritis, CNS diseases, inherited retinal degenerations and retinal degenerative diseases. The money will also be used for the construction of its technology platform and cell manufacturing bases.
