CMS (00867) announced that the New Drug Application (NDA) for its Class 1 innovative drug Y-3 Injection (proposed Chinese generic name: Lobe Miliu Injection) has been accepted by China's National Medical Products Administration (NMPA) on December 11, 2025. The product is a neuroprotective agent intended for acute ischemic stroke.
As the world's first neuroprotective agent targeting key pathological pathways in stroke—PSD95-nNOS and MPO—Y-3 Injection acts on multiple critical pathological processes in the ischemic cascade of stroke. Its multi-target, highly selective synergistic mechanism enhances neuroprotection, offering superior efficacy in treating ischemic stroke and potential benefits in preventing post-stroke depression and anxiety symptoms.
The Phase III clinical trial in China, led by Beijing Tiantan Hospital, Capital Medical University, enrolled nearly 1,000 acute ischemic stroke patients within 48 hours of onset across approximately 40 research centers. The study aimed to evaluate the efficacy and safety of Y-3 Injection. The trial met its primary efficacy endpoint, demonstrating significant clinical benefits and favorable overall safety. Key findings will be presented at international academic conferences and published in peer-reviewed journals.
Acute ischemic stroke involves highly complex and interconnected pathological processes, necessitating multi-target, multi-mechanism interventions for effective regulation of the ischemic cascade. Y-3 Injection dissociates PSD95-nNOS coupling, inhibits MPO activity, and enhances α2-GABAA receptor activity—a subtype linked to antidepressant and anxiolytic effects. This multi-target approach may achieve a breakthrough in simultaneous stroke treatment and post-stroke mood disorder prevention, positioning Y-3 as a comprehensive neuroprotective agent.
According to China's "Cerebrovascular Disease Prevention and Treatment Guidelines (2024 Edition)," the country reports approximately 3.94 million new stroke cases annually, accounting for one-third of global incidence. Ischemic stroke constitutes 72% of cases, with over 2.8 million new patients each year. Existing stroke patients exceed 28 million, and stroke-related deaths represent 23% of total fatalities in China. With rising disability burdens and an aging population, stroke prevention and treatment face growing challenges.
Post-stroke depression and anxiety, affecting about 30% and 25% of patients respectively, hinder neurological recovery and increase mortality risks. Y-3 Injection holds significant potential for long-term neurological improvement and prognosis in stroke patients, presenting substantial market opportunities.
On August 24, 2023, CMS's wholly-owned subsidiary entered a permanent exclusive promotion agreement with Nanjing Ningdan New Drug Technology Co., Ltd. for Y-3 Injection in mainland China, Hong Kong, and Macau.
As a core therapeutic area for CMS, the Central Nervous System (CNS) portfolio will be further enriched by Y-3 Injection, complementing existing products like Vetac (diazepam nasal spray) and Deanxit (flupentixol and melitracen tablets), as well as the NDA-stage improved drug ZUNVEYL (galantamine hydrobromide enteric-coated tablets). Leveraging CMS's commercialization expertise, Y-3 Injection—if approved—could provide a new treatment option for ischemic stroke patients in China, addressing unmet clinical needs while positively impacting the company's performance.
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