PROZIN PHARMACEUTICAL’s Category 1.2 New Traditional Chinese Medicine Drug Xiuqiu Zonggan Tablets and Extract Received CDE Clinical Trial Permission
Recently, the official website of the CDE (Center for Drug Evaluation, NMPA) indicates that Xiuqiu Zonggan Tablets and Xiuqiu Zonggan Extract, two Category 1.2 new TCM drugs co-developed by PROZIN PHARMACEUTICAL and the Institute of Materia Medica, Chinese Academy of Medical Sciences, obtain implied clinical trial approval.
Xiuqiu Zonggan Tablets and Xiuqiu Zonggan Extract are intended for the treatment of membranous nephropathy. As Category 1.2 new TCM drugs (natural plant extracts), their active ingredients derive from the roots or leaves of the traditional plant “Xiuqiu” (Hydrangea). Through modern extraction processes, they enrich the total saponin fraction. In early efficacy models, they show potential for repairing glomerular podocyte injury, thus promising to fill the gap of effective natural medicines in the field of membranous nephropathy.
The new drug first submitted a clinical trial application to the CDE in March 2026, which was accepted, and then received its first clinical approval in May 2026 — only two months from submission to approval. To date, PROZIN PHARMACEUTICAL has submitted four Category 1 new TCM drugs for clinical application, all of which have been accepted.
