On June 8, the CDE official website showed that Hengrui Medicine’s Ruikang Trastuzumab for Injection is proposed to be included in the priority review list for the treatment of adult patients with unresectable or metastatic HER2-low expressing (IHC 1+ or…
Hengrui Medicine, Innovent Biologics, and Haisco Pharmaceutical are among the Chinese biopharma leaders reshaping industry norms. In 2025, the total value of out-licensing deals for Chinese innovative drugs exceeded US$130 billion, reaching a record high. As of now in 2026,…
On June 8, Everest Medicines announced that it has entered into an agreement with箕星药业 (Jixing Pharmaceutical) to acquire the rights to develop, manufacture, and commercialize LNZ100 (1.44% aceclidine, US brand name VIZZ) in Greater China (including mainland China, Hong Kong,…
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…