In January 2026, CSPC Pharmaceutical Group’s SYS6055 Injection received clinical trial approval for the treatment of relapsed/refractory aggressive B-cell lymphoma. According to the Insight database, this is the first in vivo CAR-T product approved by the CDE to enter registrational…
On June 11, the CDE official website showed that a new indication New Drug Application (NDA) for Biokin Pharmaceutical’s BL-B01D1 for Injection has been accepted. Based on clinical trial progress, the Insight database speculates that the indication is for unresectable…
On June 11, the CDE official website showed that a New Drug Application (NDA) for BrightGene Pharmaceutical’s BGM0504 Injection has been accepted. According to the Insight database, the proposed indication is for overweight or obesity. BGM0504 is a GLP-1 and…
On June 11, Kangning Jierui announced that the Phase III clinical study (KN026-003, NCT05838066) of Annitumumab (KN026) in combination with docetaxel (albumin-bound) (HB1801) as a first-line treatment for HER2-positive advanced breast cancer has met its primary endpoint of progression-free survival…
On June 11, the NMPA official website showed that Akeso’s Gumokimab has been approved for marketing for the first time in China for the treatment of moderate-to-severe plaque psoriasis. Notably, this is the second innovative drug in the autoimmune disease…
On June 11, the NMPA official website showed that Merck’s Clesrovimab (MK-1654) Injection has been approved for marketing in China. The indication is for the prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV) in neonates and…
On June 11, the NMPA official website showed that the Category 1 new drug Conteltinib Granules from Shouyao Holdings have been approved for marketing as a monotherapy for patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell…
On June 11, the NMPA official website showed that the first innovative drug from Langlai Technology, Lanocopan Hydrochloride Tablets, was granted marketing approval through the priority review and approval procedure for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria…
A few days ago, Johnson & Johnson announced the acquisition of Firefly Bio for $1 billion in cash, once again thrusting Degrader-Antibody Conjugates (DACs), a promising therapeutic field, into the spotlight. DACs, also known as “next-generation ADCs,” have seen increasing…
On June 10, DualityBio announced that the coaching for its RMB-denominated shares to be listed on the STAR Market has passed the acceptance inspection by the Shanghai Regulatory Bureau. Founded in 2019, DualityBio focuses on the research and development of innovative…