NMPA Approves 130 Drug Products in a Single Batch: A Surge in Both Innovative and Generic Approvals

Note: The data statistics for this week are set to end on Friday, and the data will be carried over to next week.

On May 21, the NMPA released a large number of approvals, with a total of 130 varieties approved (excluding additional indications). Both innovative drugs and generic drugs saw gains, with the number being very rare.

Yangtze River Pharmaceutical's Subsidiary Jiangsu Haian's Fazaner Sheng Tablets Successfully ApprovedThe third product to be launched in ChinaDual orexin receptor antagonist, and also the first domestically developed drug of its kind in China.

Johnson & Johnson's Nicarelimab Approved for the First Time in China, for Treating Adult Patients with Generalized Myasthenia Gravis (gMG) Who Are Autoantibody-Positive and Adolescent Patients Over 12 Years Old. In August 2020, Johnson & Johnson Acquired Momenta Pharmaceuticals for $6.5 Billion, Securing This Blockbuster New Drug.

Nicarlimab is Johnson & Johnson's new autoimmune drug. However, another autoimmune drug from Johnson & Johnson, ustekinumab injection, has already faced competition from domestic companies in China.Three biosimilar companies approved in one day: Bio-Thera, CSPC, and Sinopharm East China (with added indications). Ustekinumab is mainly used for Crohn's disease. In recent years, Chinese companies have shifted their focus from chemical generic drugs to biosimilars, achieving fruitful results.

Bayer's well-known new drugNerifrolim tablets have made remarkable progress this week, gaining approval in China for use in adult heart failure. The new indication for type 1 diabetes-related chronic kidney disease has been accepted by the FDA.And it has been granted priority review status. Finerenone tablets were listed in China as a Class 1 innovative drug, and with the patent term plus data protection period, it will take a long time for domestically produced generic drugs to enter the competition.

In terms of generic drugs, Kelun got approval for 4 drugs in one day, including 1 powder-liquid dual-chamber bag, and 2 are the first of their kind.Siponimod Tablets and Qilu were approved on the same day, both considered as the first. Although Qilu is often not the first, its follow-up speed is astonishing. Just a few days after Qingfeng Pharmaceutical's Abemaciclib Tablets were approved, Qilu got approval this week. Kelun was just approved as the first.Safinamide Mesylate Tablets, as expected, Qilu will also get approval soon. Qilu strives to be not the first but at least among the top three for such varieties.

Other generic varieties,Sildenafil Citrate Orally Disintegrating Tablets,Maribavir Tablets,Budesonide Enteric-Coated Capsules,Flurbiprofen Gel Patches are well-known varieties and were both successfully approved on May 21.

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