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

Regulation
โดย GlobeNewswire·Read original
Summary · why it matters

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.

Impact on stocks 3

Aging Population▲ · 2 stocks
KOWA CO. LTD.
7807
▲ PositiveRegulationrelevance

Kowa is Nicox's exclusive U.S. partner for NCX 470; positive regulatory progress in China supports global development.

Health Care▲ · 1 stocks
NicOx S.A.
ALCOX
▲ PositiveRegulationrelevance

Nicox's licensee Ocumension received positive pre-NDA feedback in China for NCX 470, advancing regulatory pathway.

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