CMS(00867) Y-3, a heavyweight innovative drug for the treatment of stroke, has been accepted for NDA in China for injection use.

On December 11, 2025, CMS (00867) announced that the new drug application (NDA) for injection Y-3, an innovative drug for the treatment of acute ischemic stroke, has been accepted by the National Medical Products Administration (NMPA) of China. Injection Y-3 is the world's first brain cell protector developed based on the important targets PSD95-nNOS and MPO in the pathological process of stroke. It acts on multiple key pathological processes in ischemic stroke cascade reactions, and through high selective synergy of multiple targets, it is more conducive to exerting brain cell protection. The product has excellent therapeutic potential for ischemic stroke and potential prevention of post-stroke depression and anxiety symptoms. The Phase III clinical study of injection Y-3 in China has met the primary efficacy endpoint, with patients showing significant clinical benefits and overall good safety. The main study results are planned to be announced at international academic conferences, and the overall study will be published in international academic journals. China sees approximately 3.94 million new cases of stroke each year, accounting for one-third of global new cases, with ischemic strokes accounting for about 72%, with over 2.8 million new cases. Data from China's Cause of Death Surveillance in 2021 show that stroke deaths account for 23% of the total deaths in the country. Over the past thirty years, the burden of stroke-related disabilities in China has continued to increase, compounded by factors such as rapid population aging, further increasing the pressure on stroke prevention and control, posing significant challenges to patients, families, and society. In addition, post-stroke depression and anxiety are common complications of stroke, with incidence rates reaching approximately 30% and 25%, respectively, affecting neurologic function recovery and even increasing the risk of death, significantly impacting patient prognosis. Injection Y-3 has significant potential value for long-term neurological function improvement and overall prognosis for a large number of stroke patients, with broad market prospects. CMS stated that the central nervous system is one of its core strengths, gradually forming a deep product layout to strengthen its market base. If approved for market, injection Y-3 will synergize effectively with the innovative drugs currently on sale such as Vituker (cluster epilepsy), the original brand medicine Dalixin (anxiety, depression), and the improved new drug ZUNVEYL (Alzheimer's disease) that is currently under NDA review, within the expert network and market resources. Leveraging CMS's outstanding commercial experience and efficient compliance operations system, accelerating the promotion of innovative therapies to benefit more patients, bringing a new generation of brain cell protectors with superior efficacy and a more comprehensive effect for Chinese ischemic stroke patients. On August 24, 2023, CMS signed a cooperation agreement with its wholly-owned subsidiary and Nanjing Ningdan New Drug Technology Co., Ltd. to obtain the exclusive promotion rights for the product in mainland China, the Hong Kong Special Administrative Region, and the Macau Special Administrative Region. The agreement is permanent.