Zhen Shiming's New Class 4 Sodium Hyaluronate Eye Drops Approved for Market Launch

Text | Vernacular Chinese

On April 10, the new Class 4 sodium hyaluronate eye drops submitted by Jiangxi Zhenshiming Pharmaceutical Co., Ltd. (ZSM) were approved by the National Medical Products Administration (NMPA), deemed as having passed the consistency evaluation. This makes ZSM the second company in China to achieve consistency evaluation for this product, following Chengdu Pushi Pharmaceutical.

Sodium Hyaluronate Eye Drops are a major product in the ophthalmic market, indicated for dry eye disease to alleviate dry eye symptoms. Currently, there are 15 domestic manufacturers and 3 importers holding production approvals for this product in China. Santen Pharmaceutical’s Sodium Hyaluronate Eye Drops from Japan reported sales of JPY 18.902 billion (equivalent to USD 175 million) in 2018.

Chengdu Pushi Pharmaceutical’s New Drug Application (NDA) for its sodium hyaluronate eye drops, filed under the new Class 4 category, was approved by the National Medical Products Administration (NMPA) in November 2018, making it the first company in China to obtain approval for this product through the consistency evaluation. Yangtze River Pharmaceutical Group’s sodium hyaluronate eye drops were approved for marketing in July 2019; currently, the company’s application for consistency evaluation of this product is under review. In addition, three other companies—Xingqi Eye Medicine, Shandong Haishan Pharmaceutical, and Zhongshan Wanhan Pharmaceutical—have also submitted NDAs for this product under the new Class 4 category.

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