On November 17, the official website of NMPA released the latest batch of notifications, involving a total of 77 acceptance numbers (65 varieties), which is quite a substantial amount, including several blockbuster varieties.

Screenshot source: NMPA

Eli LillyTheTirzepatideIn this notification, an indication for marketing application was not approved. Based on its clinical registration information,CTR20211863 speculates that the indication likely to have encountered setbacks this time is heart failure with preserved ejection fraction complicated by obesity. Data from MaxEntropy Pharma shows that the drug's global sales exceeded $11.54 billion in 2024.

Screenshot source: Mosentropy Global Drug R&D Database

Screenshot source: Mosan Medicine All-Terminal Hospital Sales Database

Qilu PharmaceuticalThis time, there are also two well-known drugs on the list. One of them isPalonosetron Hydrochloride Soft Capsules, November 14Kunming Jida PharmaceuticalJust successfully secured the first generic drug approval, but this week Qilu Pharmaceutical received news of failure. AnotherAripiprazole for Injection, Qilu Pharmaceutical's attempt to secure the first generic approval also ended in failure. The reviews for these two drugs took over three hundred days each, and they were not given the opportunity for supplementary submission, ultimately resulting in an unfortunate setback.

In addition, there areThree High-Difficulty Formulations Fail to Achieve First Generic StatusNusinersen Sodium Injection、Estradiol Tablets / Estradiol Dydrogesterone Tablets Compound PackagingAndIron Sucrose InjectionThese three drugs have extremely high process requirements, and the industry is eagerly awaiting the approval of the first generic drug. However, what they have waited for time and time again is a failed outcome, which is truly lamentable.

Complete Information Table of This Notification:

END

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