OCUMENSION-B (01477) saw its shares rally more than 3% in early trading, last up 1.78% at HK$5.435 with turnover reaching HK$1.3189 million. The surge comes after the company announced a significant regulatory milestone.
In a recent filing, OCUMENSION-B disclosed that its New Drug Application (NDA) for OT-301 (NCX 470, Gebreprostasil), a therapy designed to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, has been accepted for review by the Center for Drug Evaluation under China's National Medical Products Administration. The application is supported by data from the Mont Blanc and Denali clinical trials.
OT-301 (NCX 470, Gebreprostasil) is one of the company's key drug candidates and represents a novel nitric oxide (NO)-donating prostaglandin analog developed jointly with Nicox S.A. The company secured an exclusive license from Nicox in December 2018 to develop, manufacture, commission manufacturing, import, export, and sell OT-301 in Greater China. This exclusive right was subsequently expanded in March 2020 to include South Korea and 12 additional countries across Southeast Asia.