Konya once again authorized to go abroad; Oral Simeglutide Tablets Fully Launched | Medical Early Reference

January 14, 2025  Source: drugdu 38

Novo Nordisk announced that the world's first oral glucagon like peptide-1 receptor agonist (GLP-1 RA), Novohexidine (semaglutide tablets), has been fully launched in China. Novosim helps patients benefit from GLP-1RA drugs earlier by convenient oral administration, bringing an innovative category for clinical treatment of type 2 diabetes in China.

Comment: The oral administration of GLP-1RA, a biopeptide drug, has always been a technical challenge for scientists. Novohexin has broken through multiple absorption barriers in the stomach and pushed GLP-1 RA drugs into a new stage of oral administration. The launch of oral preparations in China will also make new contributions to the sales performance of Novo Nordisk's "Smeaglutide Family".

NO.2 Conova CD38 monoclonal antibody "CM313" achieves external authorization

Konya announced that its subsidiary has partnered with Timberlyne Therapeutics, Timberlyne, Inc. has reached an exclusive licensing agreement. Based on the licensing agreement, Konya grants Timberlyne exclusive rights to develop, produce, and commercialize the humanized monoclonal antibody CM313 targeting CD38 worldwide (excluding China). In return, Connaught will receive a down payment of $30 million and recent payments, as well as acquire Timberlyne equity, becoming the largest shareholder of the company. After achieving several sales and development milestones, Konya can receive up to $337.5 million in additional payments and tiered royalties for net sales.

Comment: Including this transaction, Konya has repeatedly achieved "authorized overseas" through the "NewCo form" (referring to authorizing newly established companies). The company retains traditional authorization based income in the transaction consideration, which allows for cash to be received in the short term, and potential income from future transactions or acquisitions by the new company.

NO.3 Hengrui Pharmaceutical PCSK 9 monoclonal antibody approved for market launch

Hengrui Pharmaceutical disclosed that its subsidiary has received approval from the National Medical Products Administration to issue a "Drug Registration Certificate" for the injection of Rexacinan, which is the company's first Class 1 innovative drug in the field of cardiovascular disease. Ruika Xidan antibody for injection is a humanized monoclonal antibody developed by Hengrui Pharmaceutical against "human pre protein convertase subtilisin 9" (PCSK 9). It can inhibit the binding of PCSK 9 to "low-density lipoprotein receptor" (LDLR), increase the number of LDLR that can clear low-density lipoprotein in the blood, and thus reduce low-density lipoprotein cholesterol levels.

Comment: According to the introduction, compared with other PCSK 9 inhibitors, Rekaxidan can also be used as a monotherapy for adult patients with non familial hypercholesterolemia and mixed dyslipidemia to meet the actual treatment needs and wishes of different patients, bringing new choices for the long-term management of dyslipidemia patients in China.

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