On June 4, according to the latest announcement on the official website of the CDE, the New Drug Application (NDA) for IBI343, a Class 1 novel drug independently developed by Innovent Biologics, has been formally accepted. The proposed indication is…
Recently (on May 29), an announcement was issued stating that Pertuzumab Injection (brand name: POHERDY®), a product of its controlled subsidiary, has been approved for marketing. The product is indicated for neoadjuvant and adjuvant treatment of HER2-positive early breast cancer,…
Recently, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that two Category 1.2 traditional Chinese medicine novel drugs, Hydrangea Total Saponins Tablets and Hydrangea Total Saponins Extract, co-developed with the…
On June 2, the official website of the CDE announced that Bristol Myers Squibb’s (BMS) Mezigdomide capsules have been formally included in the priority review and approval procedure, which is expected to accelerate its approval for marketing in China. The…
On June 1, Haisco Pharmaceutical Group announced that its wholly-owned subsidiary, Haisco-USA Pharmaceuticals Inc., recently received a marketing approval notification from the U.S. Food and Drug Administration (FDA). The New Drug Application (NDA) for Cipepofol Injection (Cipepofol Injection, CYPSEDO), a…
On May 21, according to the NMPA official website, CSPC Pharmaceutical Group Limited obtained marketing approval for its two Category 4 generic drugs—budesonide enteric coated capsules (4 mg) and Lansoprazole enteric coated capsules—which are deemed to have passed the consistency…
Recently, good news keeps coming. According to the announcement published by the NMPA, Hunan Kelun-Biotech obtains the first generic approval for Siponimod tablets. In addition, Sichuan Kelun-Biotech’s Safinamide mesylate tablets also successfully gain approval, securing the first generic in China.…
On May 29, the NMPA official website shows that FOSUNPHARMA/Helsinn’s Class 5.1 imported new drug, AKYNZEO® concentrated solution for injection, obtains marketing approval in China for the prevention of chemotherapy‑induced nausea and vomiting. AKYNZEO® intravenous injection (NEPA) is a fixed‑dose…
Anbenitamab injection (KN026) is an anti-HER2 bispecific antibody independently developed by the Company using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). Anbenitamab can simultaneously bind two non-overlapping epitopes of HER2, resulting in HER2 signal blockade.…
On May 28, the NMPA website announced that Hengrui Pharma’s Class 1 new drug SHR4640 has been approved for marketing in patients with gout and hyperuricemia. SHR4640 (R&D code: SHR4640; also known as Ruzinurad) is a highly selective small-molecule inhibitor…