Shyndec subsidiary gets marketing nod for Agomelatine API

Shanghai Shyndec Pharmaceutical Co., Ltd. announced that its wholly-owned sub-subsidiary, Jiangsu Weiqida Pharmaceutical Co., Ltd., received marketing approval from the National Medical Products Administration for its Agomelatine active pharmaceutical ingredient (API). The API meets national drug registration requirements and is approved for marketing.

Agomelatine works by activating MT1 and MT2 melatonin receptors and antagonizing 5-HT2C, aiming to restore disrupted biological rhythms for its antidepressant effect. It is primarily used to treat major depressive episodes in adults. This approval allows Jiangsu Weiqida to domestically produce and sell Agomelatine, enriching the company's specialized API portfolio and positively impacting its future development.

According to the PDB database, global consumption of Agomelatine API in 2023 was 5,735.23kg. The company cautioned that while this approval is a significant milestone, API sales are subject to various factors including terminal formulation demand and market supply, presenting uncertainties. Investors are advised to exercise caution and be aware of investment risks.