Nicox's NCX 470 NDA Submitted in China

Nicox SA announced that Ocumension Therapeutics, its partner in China, has submitted a New Drug Application (NDA) for NCX 470. This application aims to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The NDA was submitted to China's National Medical Products Administration (NMPA) and mirrors the U.S. submission data.

Ocumension, with an established ophthalmology sales force across China, is set for a rapid launch following approval. The NDA includes data from both Mont Blanc and Denali trials, the latter having Chinese clinical sites. Approval is anticipated within 12 to 18 months, post submission.

Both Gavin Spencer, CEO of Nicox, and Victor Liu, CEO of Ocumension, emphasize the longstanding partnership and its role in advancing NCX 470 in China. Ocumension has invested significantly in this venture, with €18 million in license fees and shared clinical trial costs. Nicox will receive tiered royalties from sales.