Multiple Drug and Therapy Advances from Novartis, Hengrui Medicine, and Novo Nordisk

According to announcements from various companies and news from the CDE official website, several drugs/therapies have made new progress! These include Novartis' CAR-T therapy Kymriah, Hengrui Medicine's compound sustained-release tablets of Henglietin and metformin, and Novo Nordisk's oral semaglutide.

Novartis: CAR-T Therapy Secures Third Indication

Novartis announced that the U.S. FDA granted accelerated approval for its CAR-T therapy Kymriah (tisagenlecleucel) to treat patients with relapsed or refractory follicular lymphoma who have received two or more lines of systemic therapy. The press release noted that this is the third indication for which the FDA has approved Kymriah.

The approval was based on data from the Phase II ELARA trial, a single-arm, open-label study that evaluated the efficacy in 90 patients. With a median follow-up of approximately 17 months, 86% of treated patients achieved a response, with 68% achieving complete response. Among those achieving complete response, 85% remained relapse-free 12 months after their initial response.

Kymriah is a CAR-T immunotherapy and also the first CAR-T therapy to receive FDA approval.

Hengrui Medicine: Marketing Application for Henggeliejing Metformin Compound Sustained-Release Tablets Accepted

According to Hengrui Medicine's official WeChat, the marketing authorization application for HR20033 Tablets (a compound sustained-release tablet of proline hengliptin and metformin) developed by its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. has been accepted by the National Medical Products Administration. In conjunction with diet control and exercise, this product is suitable for adult patients with type 2 diabetes who are appropriate candidates for treatment with proline hengliptin and metformin hydrochloride, to improve glycemic control in these patients.

Hengrui Pharmaceutical's Henggeleijing Metformin Sustained-Release Tablets are a fixed-dose combination sustained-release formulation of Hengrui's self-developed sodium-glucose co-transporter 2 (SGLT2) inhibitor Henggeleijing and metformin. This product achieves blood glucose reduction through two different mechanisms of action. Additionally, as a sustained-release formulation, it simplifies the hypoglycemic therapy by reducing the frequency of administration, which is expected to improve patient treatment compliance.

Novo Nordisk: Oral Semaglutide Submits Marketing Application in China

CDE Official Website Announcement: Novo Nordisk Submits and Receives Approval for the Market Application of Oral Semaglutide in China. Public information indicates that semaglutide is a long-acting glucagon-like peptide-1 receptor (GLP-1R) agonist, with its injectable form having already been approved in China.

Semaglutide tablets are a compound preparation of semaglutide and the absorption enhancer (SNAC). SNAC can increase local pH, reduce pepsin degradation, and help semaglutide achieve transcellular absorption in the stomach, thereby increasing the bioavailability of oral administration.

Source Integration: WuXi AppTec, Hengrui Medicine, CDE, Medicinal Observer

Editor: Qijin

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