SHENZHEN, CHINA – China Medical System Holdings Limited (the “Group” or “CMS”) is pleased to announce that on 11 December 2025, the New Drug Application (NDA) of Class 1 Innovative Drug Y-3 for Injection (proposed English generic name: Loberamisal for Injection) (“Y-3 for Injection” or the “Product”) has been accepted by National Medical Products Administration of the People’s Republic of China (NMPA). The Product is a brain cytoprotectant indicated for the treatment of acute ischemic stroke.

With well-defined targets and clear mechanism of action, Y-3 for Injection is able to exert multiple therapeutic effects. As the world’s first brain cytoprotectant developed based on the important targets PSD95-nNOS and MPO, in the pathological processes of stroke, Y-3 for Injection acts on multiple key pathological processes of the ischemic cascade in ischemic stroke. Through multi-target, highly selective synergy, it is more conducive to exerting brain cytoprotective effects. The Product has an excellent therapeutic effect on ischemic stroke and the potential to prevent post-stroke depression and anxiety symptoms.

Y-3 for Injection demonstrates excellent clinical data with excellent efficacy and a favorable safety profile. The results of Phase II clinical trial of the Product in China indicated that among patients with ischemic stroke within 48 hours of onset, patients in the Y-3 group (40mg, qd) demonstrated a significantly higher proportion of patients achieving an excellent functional outcome (mRS of 0-1) at 90 days than those in the placebo group, with a rate difference of 16%. The Phase III clinical trial of the Product in China was conducted by Beijing Tiantan Hospital, Capital Medical University as the leading site. It has enrolled nearly 1,000 patients with acute ischemic stroke within 48 hours of onset across approximately 40 research centers nationwide, aiming to evaluate the efficacy and safety of Y-3 for Injection in treating patients with acute ischemic stroke within 48 hours of onset. The Phase III clinical study met the primary efficacy endpoint, with patients achieving significant clinical benefits and an overall favorable safety profile. The key study results are planned to be presented at international academic conferences, and the full study will be published in international academic journals.

The Central Nervous System (CNS) is one of the core advantageous fields of CMS, where a deeply integrated layout has been progressively established. The product portfolio has solidified the market foundation, including the marketed innovative drug VALTOCO (Diazepam Nasal Spray), the original brand drug Deanxit (Flupentixol and Melitracen Tablets), and the improved new drug ZUNVEYL (Benzgalantamine Gluconate Enteric-coated Tablets), which is currently under NDA review. The addition of Y-3 for Injection will further strengthen the product portfolio, generating highly efficient synergies in terms of expert networks and market resources. It is expected that if approved for marketing, Y-3 for Injection will bring a new generation of brain cytoprotectant with excellent efficacy and more comprehensive therapeutic effects to Chinese patients with ischemic stroke. Leveraging the successful commercialization experience and compliant and efficient operation system, the Group will accelerate the accessibility of innovative therapies to benefit more patients.

More Information about Y-3 for Injection

The pathological processes of acute ischemic stroke are highly complex and interconnected. There is an urgent clinical need for multi-target, multi-mechanism coordinated interventions to achieve more effective regulation of the complex ischemic cascade, thereby improving treatment outcomes and enhancing patients’ quality of life. Y-3 for Injection is able to uncouple PSD95-nNOS, inhibit MPO activity, and enhance the activity of α₂-GABA_A receptor (a subtype of GABA_A receptor with antidepressant and anxiolytic effects). With this multi-target, highly selective synergistic mechanism, it is expected to achieve a technological breakthrough in the simultaneous intervention of “stroke treatment and prevention of post-stroke depression and anxiety”, making Y-3 for Injection a promising novel brain cytoprotectant with excellent efficacy and more comprehensive therapeutic effects.

The results of Phase II clinical trial of Y-3 for Injection for the treatment of acute ischemic stroke were presented as an oral poster at the 10th European Stroke Organisation Conference in 2024 (ESOC 2024). It indicated that among patients with ischemic stroke within 48 hours of onset, patients in the Y-3 group (20mg, 40mg, 60mg, qd) demonstrated a significantly higher proportion of patients achieving an excellent functional outcome (mRS of 0-1) at 90 days than those in the placebo group (20mg: 67.8% vs 60.7%, 40mg: 76.7% vs 60.7%, 60mg: 70.0% vs 60.7%). Moreover, the Product showed comparable safety to placebo in acute ischemic stroke patients, exhibiting good tolerability.

On 24 August 2023, the Group through its wholly-owned subsidiary entered into a Collaboration Agreement (the “Agreement”) with Neurodawn Pharmaceutical Co., Ltd. (“NeuroDawn”), a clinical needs-oriented pharmaceutical company driven by innovation and R&D. In accordance with the Agreement, the Group obtains an exclusive promotion right in mainland China, the Hong Kong Special Administrative Region, and the Macau Special Administrative Region. The term of the Agreement is permanent.

About Stroke

According to the Guideline for Prevention and Treatment of Cerebrovascular Disease (2024 Edition) issued by the National Health Commission, approximately 3.94 million new stroke cases occur in China each year, accounting for one-third of the global new cases^[1]. Among these, ischemic stroke accounts for about 72%, with over 2.8 million new cases annually; the number of existing stroke patients in China has exceeded 28 million^[1]. Data from China’s cause-of-death monitoring in 2021 shows that stroke-related deaths accounted for 23% of the national total deaths^[1]. Over the past three decades, the disease burden of stroke-related disabilities in China has continued to increase^[1]. Coupled with factors such as the accelerating aging of the population, the pressure of stroke prevention and control will further intensify in the future, posing enormous challenges to patients’ families and society^[1]. In addition, post-stroke depression and anxiety are common complications of stroke, with incidence rates of approximately 30% and 25% respectively^[2]. They can hinder the recovery of patients’ neurological functions, even increase the risk of death, and severely affect patients’ prognosis. Y-3 for Injection holds significant potential value for the long-term neurological function improvement and overall prognosis of a vast number of stroke patients, indicating broad market prospects.

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development in its advantageous specialty fields, strengthening the competitiveness of the cardio-cerebrovascular/ gastroenterology/ ophthalmology/ skin health businesses, bringing economies of scale in specialty fields. Among them, the skin health business (Dermavon) has become a leading enterprise in its field, and is proposed to be listed independently on the SEHK. Meanwhile, CMS continuously promotes the operation and development of its integrated R&D, manufacturing and commercialization chain in Southeast Asia and the Middle East, capturing growth opportunities in emerging markets to support the high-quality and sustainable development of the Group.

Reference

1. National Health Commission of the People’s Republic of China. Guideline for Prevention and Treatment of Cerebrovascular Disease (2024 Edition) [J]. Chinese Journal of Magnetic Resonance Imaging, 2025, 16(1): 1-8. DOI: 10.12015/issn.1674-8034.2025.01.001.
2. Chen Xinyu, Lyu Xiaohan, Li Ruina, et al. Post-Stroke Anxiety [J]. International Journal of Cerebrovascular Disease, 2022, 30(2): 129-133. DOI: 10.3760/cma.j.issn.1673-4165.2022.02.010.

CMS Disclaimer and Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

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