Hengrui Pharma secures NMPA green light for China’s first 0.1% water-free cyclosporine eye-drop

Bulletin Express06-25

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) announced that its subsidiary Chengdu Suncadia Medicine has received National Medical Products Administration (NMPA) approval to launch Cyclosporine Ophthalmic Solution (IV), the country’s first and only 0.1% water-free cyclosporine formulation for dry-eye disease (DED).

The prescription product, introduced from Novaliq GmbH and developed on the EyeSol® platform, offers a 17.6-fold increase in bioavailability versus conventional 0.05% water-based cyclosporine. The water-free semifluorinated alkane carrier prolongs corneal residence time, enhances stromal penetration and simultaneously reduces tear evaporation, targeting both inflammatory and tear-film-instability pathways of DED.

Dry-eye prevalence in China stands at 21.0%–52.4%, underlining a sizeable patient pool. Comparable cyclosporine therapies on the U.S. market include Allergan’s Restasis (0.05%) and Sun Pharma’s Cequa (0.09%), while Xingqi Pharmaceutical’s 0.05% generic entered China in 2020. Combined global sales of similar products reached USD 2.11 billion in 2025.

Hengrui Pharma has invested a cumulative RMB 102.60 million in the Cyclosporine Ophthalmic Solution (IV) project (unaudited). The company notes that post-approval production and sales remain subject to market and operational uncertainties.

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(Hengrui Pharma) announced that its subsidiary Chengdu Suncadia Medicine has received National Medical Products Administration (NMPA) approval to launch Cyclosporine Ophthalmic Solution (IV), the country’s first and only 0.1% water-free cyclosporine formulation for dry-eye disease (DED).</p>\n<p>The prescription product, introduced from Novaliq GmbH and developed on the EyeSol® platform, offers a 17.6-fold increase in bioavailability versus conventional 0.05% water-based cyclosporine. The water-free semifluorinated alkane carrier prolongs corneal residence time, enhances stromal penetration and simultaneously reduces tear evaporation, targeting both inflammatory and tear-film-instability pathways of DED.</p>\n<p>Dry-eye prevalence in China stands at 21.0%–52.4%, underlining a sizeable patient pool. Comparable cyclosporine therapies on the U.S. market include Allergan’s Restasis (0.05%) and Sun Pharma’s Cequa (0.09%), while Xingqi Pharmaceutical’s 0.05% generic entered China in 2020. 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