Nicox SA announced that its exclusive Chinese licensee, Ocumension Therapeutics, has submitted a New Drug Application to China's National Medical Products Administration for NCX 470, a nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The submission uses the same Phase 3 data from the Mont Blanc and Denali trials that supported the recent U.S. filing, with Chinese clinical sites included in Denali. Ocumension has paid €18 million in license fees for rights in China, Korea, and Southeast Asia, funded 50% of the Denali trial costs, and is among Nicox's principal shareholders; Nicox will receive tiered royalties of 6% to 12% on Ocumension's sales. Approval in China is expected after the U.S. decision, with a typical review timeline of 12 to 18 months, while a Phase 3 program in Japan is underway and U.S. approval is anticipated in summer 2027.
NicOx S.A.Nicox's partner submitted NDA for NCX 470 in China, advancing its product and potential royalties.
Ocumension Therapeutics NDA submission for NCX 470 in China is a regulatory milestone for Ocumension, its licensee.
