Guangdong Zhongsheng Pharmaceutical (002317.SZ) received a notification of the suitability investigation results of the Japanese pharmaceutical Paralofin API.

Guangdong Zhongsheng Pharmaceutical (002317.SZ) announced that its wholly-owned subsidiary Guangdong Xianqiang Pharmaceutical Co., Ltd. ("Xianqiang Pharmaceutical") recently received a Pralofan active pharmaceutical ingredient "Notification of Medicinal Product Suitability Investigation Results" issued by the independent administrative agency in Japan for pharmaceuticals and medical devices. Pralofan belongs to the propionic acid class of non-steroidal anti-inflammatory drugs, and its mechanism of action mainly involves inhibiting the activity of cyclooxygenase (COX), blocking the synthesis of arachidonic acid derivatives, inhibiting the synthesis of prostaglandins, and relieving inflammatory reactions. The indications for Pralofan eye drops include symptomatic treatment of inflammation in the external eye and anterior eye segment (eyelid inflammation, conjunctivitis, keratitis, scleritis, superficial scleritis, iridocyclitis, postoperative inflammation). The receipt of the "Notification of Medicinal Product Suitability Investigation Results" for the Pralofan active pharmaceutical ingredient in Japan signifies that Xianqiang Pharmaceutical has preliminarily established a foreign drug production quality management system. This active pharmaceutical ingredient meets the relevant drug quality standards in Japan and can be used and sold in formulations produced in Japan.