Nicox's NCX 470 NDA Accepted for Review in China

Nicox SA, an ophthalmology company, has announced that its new formulation, NCX 470, has had its New Drug Application (NDA) accepted for review by China's National Medical Products Administration (NMPA). The treatment is aimed at reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension. This marks the beginning of the regulatory review process, which is expected to conclude within 12 to 18 months from the original submission in August 2026.

Ocumension Therapeutics, Nicox's licensee in China, has already paid €18 million in license fees to Nicox. The agreement includes tiered royalties on sales ranging from 6% to 12%. Ocumension is prepared for a rapid rollout, leveraging its existing sales force in China. NCX 470 has been successful in two Phase 3 trials and awaits similar decisions in the United States, with a target date set by the U.S. FDA for April 30, 2027.