On June 2, CSPC Pharmaceutical Group announced that its first dual-target chimeric antigen receptor (CAR)-T cell injection based on mRNA-LNP technology (SYS6063 Injection) has received clinical trial approval from China’s National Medical Products Administration (NMPA) for the indication of relapsed…
On June 2, the official website of the Drug Clinical Trial Registration and Information Disclosure Platform showed that NHWA Pharmaceutical and Shujing Biomedical have registered a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial (Registration No.: CTR20262177) evaluating the efficacy…
On June 2, the CDE official website showed that Zilebesiran Injection, a Category 1 new drug, is proposed to be granted Breakthrough Therapy designation for the treatment of adult patients with hypertension who have established cardiovascular disease or are at…
On June 1, the CDE official website announced that Merck’s Doravirine/Islatravir Tablets are proposed to be included in priority review for the following indication: as a complete dual-drug regimen for the treatment of HIV-1 infection in adults who are virologically…
On June 1, Changchun GeneScience Pharmaceutical announced that the New Drug Application (NDA) for its Leuprorelin Mesylate Injection (6M) has been accepted by the CDE for the proposed treatment of breast cancer. (Source: Company official website) Leuprorelin Mesylate Injection (development code: FP-001/Changchun…
On June 3, Livzon Pharmaceutical announced that the New Drug Application (NDA) for its Category 1 innovative biologic drug Laikangqita Monoclonal Antibody for the treatment of ankylosing spondylitis (AS) has been formally accepted by the National Medical Products Administration (NMPA).…
On June 4, Hansoh Pharma announced that the New Drug Application (NDA) for its innovative drug Olatorepatide Injection has been accepted by the NMPA for long-term weight management in adults who are obese or overweight. Olatorepatide is a glucagon-like peptide-1…
Sonefpeglutide (LAPS GLP-2 analogue), a drug candidate from Hanmi Pharmaceutical, was granted to Eli Lilly under a licensing agreement announced on May 31, granting Eli Lilly exclusive worldwide rights (excluding South Korea) to develop, manufacture, and commercialize the drug. The…
On June 2, Everest Medicines announced that it has entered into an exclusive licensing and collaboration agreement with Travere Therapeutics, granting Travere exclusive development and commercialization rights for EVER001 (civorebrutinib) in all markets outside Greater China and certain countries in…
On June 3, Yunnan Baiyao announced that its Investigational New Drug (IND) application for INB301 Injection has received clearance from the U.S. Food and Drug Administration (FDA) to conduct clinical trials, with the proposed indication being cancer cachexia. According to…