Latanoprost

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CYHB2501209联苯乙酸凝胶上海鼎辉医药有限公司————2025年07月10日2CYHB2501211注射用艾司奥美拉唑钠上海旭东海普药业有限公司————2025年07月10日3CYHB2501219乙酰半胱氨酸颗粒河北万龙药业有限公司————2025年07月10日4CYHB2501220腺苷钴胺胶囊烟台万润药业有限公司————2025年07月10日5CYHB2501232呋塞米注射液海鸿恒隆（海南）生物科技有限公司————2025年07月10日6CYSB2400132ACYW135群脑膜炎球菌多糖疫苗成都康华生物制品股份有限公司————2025年07月08日7CYZB2501188山香圆片百安制药（赣江新区）有限公司————2025年07月10日8JTH2500102拉坦前列素滴眼液深圳市康哲生物科技有限公司————2025年07月10日9JTH2500105Tasurgratinib片赛生医药（中国）有限公司————2025年07月10日10JTS2500047达依泊汀α注射液协和麒麟（中国）制药有限公司————2025年07月10日

June 30, 2025 – release at 7:30 am CET Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that the last patient has completed the Denali Phase 3 trial, evaluating the efficacy and safety of NCX 470, its lead compound, in patients with open-angle glaucoma or ocular hypertension. With this milestone reached, all patients have now completed their treatment and follow-up visits. A total of 696 patients were enrolled in the trial and topline results are expected mid-August to mid-September 2025. “Reaching the milestone of the last patient last visit in the Denali Phase 3 trial is a great achievement by our clinical sites, our partner Ocumension and the Nicox development team who have continued to drive this trial. I would like to thank everyone who has been involved in the conduct of the Denali trial including our patients, investigators and their staff.” said Doug Hubatsch, Chief Scientific Officer of Nicox “We look forward to announcing the topline results in the near future, which we expect will further consolidate the profile of NCX 470 and confirm its potential in the glaucoma market. We remain fully focused on completing the clinical development program and preparing for regulatory submissions.” NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The Denali trial is evaluating the IOP lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension. It is a multi-country (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea and Southeast Asia. The Denali trial, together with the already completed Mont Blanc trial, was designed to fulfil the clinical regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in the U.S. and China. All remaining NDA-enabling pharmacokinetic and non-clinical studies necessary to support the U.S. NDA filing are on track. Subject to securing a U.S. partner, or obtaining the necessary funding, the Company estimates that a NDA for this country NCX 470 could potentially be submitted in H1 2026. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Topline results are expected mid-August to mid-September 2025 NCX 470 Phase 3 clinical efficacy and long-term safety trials in Japan: Initiation expected in H2 2025 NCX 470 NDA filing in the United States: expected in H1 2026, subject to securing a U.S. partner, or obtaining the necessary funding Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa for Japan. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. The content above comes from the network. if any infringement, please contact us to modify.