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 29, the official website of the National Medical Products Administration (NMPA) announced that two imported innovative drugs have obtained marketing approval in China. The first is Naldemedine Tosylate (brand name: Symproic®), a new therapeutic agent for opioid-induced constipation…
On May 26, 2026, Henlius (2696.HK) announced that the first patient has been dosed in China in a randomized, double-blind, multicentre, parallel-controlled Phase 2/3 clinical trial evaluating its self-developed recombinant anti-EGFR mAb pimurutamab (HLX07) in combination with the anti-PD-1 mAb…
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 21, Boehringer-Ingelheim announced that a new indication for its lung cancer drug Zongertinib has been officially approved for use as a first-line monotherapy in adult patients with advanced non-small cell lung cancer harboring HER2 tyrosine kinase domain-activating mutations.…
On May 26, according to the latest announcement on the CDE official website, ALG-000184 tablets submitted by Fortrea were proposed for breakthrough therapy designation, with the indication being treatment‑naïve or untreated chronic hepatitis B virus (HBV) infection, aiming to achieve…