Jiangxi Puzheng Pharmaceutical Co., Ltd：CXZL2600028/7 received CDE clinical trial approval
Recently, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that two Category 1.2 traditional Chinese medicine novel drugs, Hydrangea Total Saponins Tablets and Hydrangea Total Saponins Extract, co-developed with the Institute of Materia Medica, Chinese Academy of Medical Sciences, have received tacit clinical trial approval.
Hydrangea Total Saponins Tablets and Hydrangea Total Saponins Extract are intended for the treatment of membranous nephropathy and belong to Category 1.2 novel traditional Chinese medicine drugs (natural plant extracts). Their active ingredients are derived from the roots or leaves of the traditional plant “Hydrangea”, and the total saponin fraction is enriched through modern extraction processes. In early pharmacological models, they have shown potential for repairing glomerular podocyte injury, offering promise to fill the gap in effective natural medicines for membranous nephropathy.
The investigational new drug submitted its clinical trial application to the CDE for the first time in March 2026, and the application was accepted. It received its first clinical trial approval in May 2026, taking only two months from submission to approval. To date, PuZheng Pharmaceutical has filed clinical trial applications for four Category 1 novel traditional Chinese medicine drugs, all of which have been accepted.
In 2025, the market size of urogenital system drugs in domestic terminal hospitals exceeded 38 billion RMB. Among them, the nephrology sub-segment has solid clinical unmet needs, limited existing treatment options, and a significant therapeutic gap, leaving ample commercial space for innovative natural extract-based traditional Chinese medicines. Developing novel nephrology drugs through plant-derived approaches is becoming a popular direction in current TCM innovation.
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