Shanghai Pharmaceuticals Holding (02607): Doxycycline Capsules Obtains Approval Number from US FDA.

Shanghai Pharmaceuticals Holding (02607) announced that its subsidiary, Changzhou Pharmaceutical Factory Co., Ltd. (hereinafter referred to as "Changzhou Pharmaceutical Factory"), has received notification from the US Food and Drug Administration (hereinafter referred to as "FDA") that its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules (hereinafter referred to as "the drug") has been approved. Doxycycline Capsules (40mg) contain two types of doxycycline microspheres (30mg immediate-release microspheres and 10mg delayed-release microspheres), mainly used for the inflammatory lesions of adult patients with rosacea (erythematotelangiectatic rosacea and papulopustular rosacea). The original research was developed by GALDERMA LABORATORIES LP and was launched in the United States in 2006. In September 2024, Changzhou Pharmaceutical Factory submitted the ANDA application to the FDA for the drug and recently received approval for marketing. As of the date of this announcement, the company has invested approximately RMB 10.8333 million in research and development expenses for this drug.