Shanghai Pharma (02607): Qiwei Fangji Huangqi Granules Receives Clinical Trial Approval Notice

Stock News
01/29

Shanghai Pharmaceuticals Holding Co., Ltd. (02607) announced that recently, the "Qiwei Fangji Huangqi Granules" (referred to as "the project"), developed by its subsidiary Zhengda Qingchunbao Pharmaceutical Co., Ltd. ("Qingchunbao"), has received the "Drug Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration (NMPA). The prescription for Qiwei Fangji Huangqi Granules was developed by Tianjin University of Traditional Chinese Medicine by modifying and refining the classic formula "Fangji Huangqi Decoction," based on TCM classical theory and clinical practice. This project was collaboratively developed by Qingchunbao and Tianjin University of Traditional Chinese Medicine, among other institutions, which holds the core intellectual property rights. As of the date of this announcement, the cumulative R&D investment for this project amounts to approximately RMB 13.8 million. Qiwei Fangji Huangqi Granules is a Class 1.1 innovative traditional Chinese medicine developed by the company, and as of this announcement, the product has not been marketed in China or internationally. The marketed application for Qiwei Fangji Huangqi Granules submitted by the company requires the completion of clinical trials and subsequent approval from the NMPA before it can be launched. New drug development involves long cycles and substantial investment, with uncertainties inherent in disease-related diagnostic and therapeutic advancements, trial results, and approval timelines; potential scenarios include project delays or clinical trial outcomes not meeting expectations. The receipt of the clinical trial approval notice for Qiwei Fangji Huangqi Granules is not expected to have a significant impact on the company's current operating performance.

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