Ocumension Therapeutics

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Nicox partner Ocumension submits NDA for NCX 470 in China

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.

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Biotech & Genomic Medicine▼

Qilu Pharmaceutical's atropine sulfate eye drops application accepted, intensifying competition in children's myopia drug market

Qilu Pharmaceutical's marketing application for atropine sulfate eye drops, filed under chemical drug registration category 2.2, was accepted by the Center for Drug Evaluation of the National Medical Products Administration on July 24. The indication is to slow the progression of myopia in children. Currently, only Xingqi Pharmaceutical's 0.01% atropine sulfate eye drops have been approved for marketing in this field, in March 2024, with nationwide sales reaching 603.6 million yuan in 2025, a year-on-year increase of 212%. Similar products from companies such as Hengrui Medicine's subsidiary Shengdi Pharmaceutical and Zhaoke Ophthalmology have also entered the marketing application stage, while Ocumension Therapeutics, Shapuaisi, and JMD Biomed are in late-stage clinical trials. Qilu Pharmaceutical stated that it is currently only an application, and the specific launch time is uncertain.

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Biotech & Genomic Medicine

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Zhaoke Ophthalmology Acquires Global Rights to Atropine Sulfate Eye Drops

Zhaoke Ophthalmology announced it has acquired the global rights to NVK002 atropine sulfate eye drops, a product designed to slow the progression of myopia in children. Under the agreement, Zhaoke Ophthalmology will obtain global ownership of all intellectual property, trademarks, regulatory filings, clinical data, manufacturing capabilities, and other assets related to NVK002. Previously, the company only held exclusive licenses for Greater China, South Korea, and some Southeast Asian countries. As part of the transaction, Zhaoke Ophthalmology granted the seller a perpetual, royalty-free exclusive license for development and commercialization in the United States. After the acquisition, the company will have full control over the global development, manufacturing, and commercialization of the product. Currently, only Xingqi Ophthalmology has received approval for atropine sulfate eye drops in China. Zhaoke Ophthalmology has submitted marketing applications for two strengths of NVK002 as a modified new drug and a generic drug respectively, with approval expected within the year. Several other pharmaceutical companies, including Hengrui Medicine and Ocumension Therapeutics, are also developing similar products.

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Nicox Submits NDA to FDA for NCX 470 in Treating Ocular Hypertension

Nicox has submitted a new drug application to the U.S. FDA for NCX 470 in the treatment of open-angle glaucoma and ocular hypertension. The submission was made via its U.S. licensee Kowa and triggered a €3 million milestone payment. NCX 470 is a novel nitric oxide-donating bimatoprost eye drop that demonstrated reduced intraocular pressure and a favorable safety profile in the Phase 3 Mont Blanc and Denali trials. The FDA review is expected to take up to a year, with a response anticipated by mid-2027 and a potential U.S. launch before the end of 2027. Kowa holds exclusive development and commercialization rights in the U.S., Japan, South Korea, and Southeast Asia, while Ocumension Therapeutics is the licensee in China.

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Nicox : demande d’autorisation de mise sur le marché de NCX 470 soumise aux États-Unis par Kowa

Nicox annonce que son licencié exclusif Kowa a soumis une demande d’autorisation de mise sur le marché pour NCX 470 auprès de la FDA américaine, déclenchant un paiement d’étape de 3 millions d’euros. Ce dépôt repose sur les résultats positifs des études de phase 3 Mont Blanc et Denali et vise la réduction de la pression intraoculaire chez les patients atteints de glaucome à angle ouvert ou d’hypertension oculaire. Un paiement supplémentaire est prévu en cas d’approbation, attendue mi-2027 après une période d’examen standard de 12 mois, avec un lancement commercial aux États-Unis avant fin 2027. NCX 470 est également licencié à Ocumension Therapeutics pour la Chine, la Corée du Sud et l’Asie du Sud-Est, et à Kowa pour le Japon et le reste du monde.

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Nicox partner Ocumension gets positive pre-NDA feedback in China for NCX 470

Nicox SA announced that its exclusive Chinese licensee Ocumension Therapeutics has received positive pre-submission regulatory feedback from the Chinese Center for Drug Evaluation for NCX 470, an innovative nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Based on this feedback, Ocumension plans to file a New Drug Application in China shortly after the U.S. NDA submission, which is expected in summer 2026 by Nicox's exclusive U.S. partner Kowa. NCX 470 is licensed to Kowa worldwide except for China, South Korea, and Southeast Asia, where it is licensed to Ocumension. Nicox is eligible for regulatory and sales milestone payments as well as royalties on global sales, with all regulatory and commercialization costs borne by Kowa and Ocumension.

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