Statistics on Weekly Drug Approvals, Market Applications, Clinical Applications, and Review Status (2025.10.18-2025.10.24)Note: The weekly statistics cutoff date is set for every Friday, and data from Saturday and Sunday will be included in the next week's statistics, and so on.This Week's Huadong Medicine SubsidiaryHangzhou Zhongmei HuadongAnother innovative drug secured! Mefanertinib Maleate Tablets approved for marketing,For adult patients with locally advanced or metastatic non-small cell lung cancer,Huadong Medicine Co., Ltd. has just been approved for an innovative drug last week, maintaining a strong momentum of one innovative drug approval per week.Another subsidiary of Huadong Medicine, Doer Biologics, also made significant moves this week. On October 21, Huadong MedicineAnnouncement: DR10624 Injection has been approved by the U.S. FDA to commence clinical trials for the indication of severe hypertriglyceridemia.The clinical trial of DR10624 Injection in China is currently underway.
This drug is the world's first GLP-1/GCGR/FGF21 triple agonist. With just this one GLP-1 target, two generations of blockbuster drugs are about to emerge, and Huadong Medicine is at the forefront of extended research on this target.Hengrui Obtains Another Innovative Hypoglycemic Drug This WeekThe sustained-release tablets (I)(II) of Hengge Sodium-Glucose Co-Transporter 2 Inhibitor and Metformin have been approved for marketing. This is Hengrui's fifth innovative hypoglycemic drug, the other four being: Proline Hengge Sodium-Glucose Co-Transporter 2 Inhibitor Tablets, Rengliptin Phosphate Tablets, Hengge Sodium-Glucose Co-Transporter 2 Inhibitor and Metformin Sustained-Release Tablets, and Rengliptin and Metformin Tablets. Hengrui seems to be fully committed to hypoglycemic drugs.In terms of generic drugs, another company has started producing a generic version of Safinamide Mesylate Tablets this week. Although the original drug by Zambon was approved in China just a year ago, 20 companies have already applied to produce generics, indicating the upcoming emergence of another highly competitive drug variety.
The well-known "competitive" variety, Vonoprazan Fumarate Tablets, has gained two more approvals this week. Takeda's patent has not yet expired, but the number of generic drug approvals has already reached 29, with over a hundred in the pipeline. Once the original patent expires, it is expected that approvals will exceed 50, reaching an incredibly intense level of competition.
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