NCX 470 NDA submitted in China

NicOx announced that its exclusive licensee in China, Paragon Therapeutics, has submitted a New Drug Application (NDA) to the Chinese China — National Medical Products Administration (NMPA) for NCX 470, a novel nitric oxide-donating bimatoprost eye drop intended to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The NDA is based on the same clinical data package as the recent U.S. submission, including results from the Mont Blanc and Denali Phase 3 trials, with Denali including Chinese clinical sites. Ocumension, which already markets NicOx's ZERVIATE in China and has an established ophthalmology sales force, is well-positioned for a rapid launch following approval. NicOx will receive tiered royalties on sales ranging from 6% to 12%. Approval in China is typically granted within 12 to 18 months, with U.S. approval expected in summer 2027. This submission follows the U.S. NDA submitted by partner Kowa (company) and marks a significant step toward commercialization in major markets.