Renhe Yikang Gains Approval for Topiramate Oral Solution, a RMB 200M+ Anti-Epileptic Drug
Johnson & Johnson
Medical Device R&D and Manufacturer
On May 29, according to the public notice on the NMPA official website,Renhe Yikang GroupDeclaredTopiramate Oral Solution(Class 3 Generic Drugs)Officially approved for marketing, and deemed to have passed the consistency evaluation. Data from PharmCube shows that there are currently five domestic enterprises holding production approval documents for this product.
Screenshot source: NMPA official website
TopiramateOriginally developed byJohnson & JohnsonInnovative Drug Development is a small-molecule antiepileptic drug with diverse mechanisms of action. It inhibits carbonic anhydrase, blocks sodium channels, and antagonizes gamma-aminobutyric acid type A (GABAA) receptors, AMPA receptors, and kainate receptors. The drug was first approved in the United Kingdom in 1995 and entered the Chinese market in 2001, with its approved indication in China being epilepsy.
Data from Mosent Pharma shows that,Topiramate(Tablets + Capsules)In 2025, the total sales revenue in the all-channel hospital market exceeded RMB 200 million, of whichTopiramate TabletsHolds an absolute dominant position, with a market share exceeding 91%.
Across the overall market, annual sales of antiepileptic drugs in hospitals across all tiers in China have exceeded RMB 5.9 billion, with the industry size growing steadily. Leveraging its clinical value, Topiramate Tablets consistently rank among the top 10 antiepileptic drugs by sales volume. As a core product widely used in clinical practice, their diverse pharmacological actions provide reliable treatment options for patients with epilepsy.
Screenshot source: Hospital Sales Database Across All Channels (Data Inquiry via Moseeker)
As of now, in ChinaTopiramate Oral SolutionFive pharmaceutical companies hold production approval documents,In addition to the current approvalRenhe YikangIn addition, the other four companies are respectivelyHuayi Pharmaceutical, Hangzhou Hekang Pharmaceutical, Hainan Sida Pharmaceutical, Kebeyuan (Beijing) Pharmaceutical, among whichHUAYI is the first in China。
Meanwhile, a large number of companies continue to file applications for this dosage form. The marketing authorization applications of more than 10 pharmaceutical enterprises, including Shandong Lukang Pharmaceutical, Hunan Kelun Pharmaceutical, and Hunan Jiudian Pharmaceutical, are currently under review, which will further intensify market competition in the future.
2026 to Present, Renhe Yikang Group(including subsidiaries)Eleven products have been approved and passed the consistency evaluation, with the generic drug pipeline continuing to gain momentum.
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