On June 26, the CDE official website showed that the New Drug Application (NDA) for Vcare PharmaTech’s Category 1 antithrombotic novel drug Vicagrel Capsules has been formally accepted. Vicagrel is an industry-academia collaboration project between Vcare PharmaTech and China Pharmaceutical…
Ionis Pharmaceuticals recently announced that the U.S. FDA has approved, under Priority Review, a supplemental New Drug Application (sNDA) for its antisense oligonucleotide (ASO) therapy, Olezarsen. The approval is for reducing triglyceride (TG) levels and the risk of acute pancreatitis…
On June 26, the CDE official website showed that the NDA for Lerodalcibep Injection, co-filed by LIB Therapeutics and Everest Medicines, has been accepted. It is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with…
On June 25, Merck announced that its PD-1 inhibitor pembrolizumab has been approved by the NMPA for use in combination with paclitaxel (with or without bevacizumab) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary…
On June 25, the NMPA official website showed that Tonghua Jinma’s Category 1 new drug “Octahydroaminoacridine Succinate” has been approved for marketing in China for the treatment of mild-to-moderate Alzheimer’s disease (AD). Octahydroaminoacridine Succinate (formerly known as Octahydroaminoacridine Succinate) is a…
On June 24, the CDE official website showed that the New Drug Application (NDA) for HB0017 Injection, filed by Huahai Pharmaceutical and its subsidiary Huaota Biopharmaceutical, has been accepted. According to clinical trial progress, the Insight database speculates that the…
On June 24, the CDE official website showed that the New Drug Application (NDA) for Encorafernib Capsules, filed by Pierre Fabre, has been accepted for the first-line treatment of adult patients with BRAF V600E-mutant metastatic colorectal cancer (CRC) in combination…
On June 24, Gensci Pharmaceutical announced that its Category 2.2 new drug, Triptorelin Acetate for Injection (II), has recently received approval from the NMPA for the treatment of central precocious puberty (CPP) in children weighing 20 kg and above. Central…
On June 22, CARsgen’s “Satricabtagene Autoleucel Injection” was approved for marketing in China for the treatment of CLDN18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy. Notably, this is the world’s…
On June 24, the CDE official website announced that CSPC Pharmaceutical Group’s Category 1 new drug SYS6043 has been proposed for Breakthrough Therapy designation, with the indication being platinum-resistant ovarian cancer, primary peritoneal cancer, and fallopian tube cancer. SYS6043 is…