China Medical System (0867) received NDA acceptance for its innovative drug Y-3 injection for acute ischemic stroke in China

CSPC Pharmaceutical Group Limited ("CSPC") is pleased to announce that the New Drug Application (NDA) for Class 1 new drug Y-3 for Injection (proposed Chinese generic name: Lobe Miliu for Injection) ("Y-3 for Injection" or "the Product") has been accepted by the National Medical Products Administration (NMPA) of China on December 11, 2025. The Product is a neuroprotective agent intended for acute ischemic stroke.

Y-3 for Injection has clear targets and mechanisms of action, enabling multiple therapeutic effects. As the world's first neuroprotective agent developed based on key stroke pathological targets PSD95-nNOS and MPO, Y-3 for Injection acts on multiple critical pathological processes in the ischemic cascade of ischemic stroke. Through highly selective multi-target synergy, it demonstrates superior neuroprotective effects. The Product shows excellent efficacy in treating ischemic stroke and potential benefits in preventing post-stroke depression and anxiety symptoms.

Y-3 for Injection demonstrates outstanding clinical data with excellent efficacy and good safety profile. Results from the Chinese Phase II clinical trial showed that in ischemic stroke patients within 48 hours of onset, treatment with Y-3 40mg once daily significantly increased the proportion of patients achieving good functional outcomes (mRS score 0-1) at 90 days compared to the placebo group, with a rate difference of 16%. The Chinese Phase III clinical study, led by Beijing Tiantan Hospital affiliated with Capital Medical University, enrolled nearly 1,000 acute ischemic stroke patients 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 acute ischemic stroke within 48 hours of onset. The Phase III study met its primary efficacy endpoint, demonstrating significant clinical benefits and good overall safety profile. Key results are planned to be presented at international academic conferences, with the full study to be published in international academic journals.

The Central Nervous System (CNS) represents one of CSPC's core therapeutic areas with gradually established comprehensive coverage. The product portfolio includes marketed innovative drug Vitucon (Diazepam Nasal Spray), original brand drug Deanxit (Flupentixol and Melitracen Tablets), and improved new drug ZUNVEYL (Galantamine Hydrobromide Enteric-coated Tablets) under NDA review, which have solidified market foundation. The addition of Y-3 for Injection will further strengthen the product matrix and create efficient synergy within the expert network and market resources. We look forward to the early launch of Y-3 for Injection to bring stroke patients in China a new-generation neuroprotective agent with excellent efficacy and comprehensive effects, while leveraging the Group's outstanding commercialization experience and compliant, efficient operation system to accelerate access to innovative therapies for more patients.

More about Y-3 for Injection

The pathological process of acute ischemic stroke is highly complex and interconnected, creating urgent clinical need for multi-target, multi-mechanism coordinated intervention to achieve more effective regulation of the complex ischemic cascade, thereby improving treatment outcomes and patients' quality of life. Y-3 for Injection can dissociate PSD95-nNOS coupling, inhibit MPO activity, and enhance α2-GABAA receptor (a GABAA receptor subtype with antidepressant and anxiolytic functions) activity. Through this highly selective multi-target synergistic mechanism, it is expected to achieve the technological breakthrough of simultaneous intervention in "stroke treatment and post-stroke depression/anxiety prevention," making Y-3 for Injection a promising new neuroprotective agent with excellent efficacy and comprehensive effects.

Results from the Phase II clinical trial of Y-3 for Injection in acute ischemic stroke, presented as an oral poster at the 10th European Stroke Organisation Conference (ESOC 2024), showed that in ischemic stroke patients within 48 hours of onset, treatment with Y-3 (20mg, 40mg, 60mg once daily) significantly increased the proportion of patients achieving good functional outcomes (mRS score 0-1) at 90 days compared to the placebo group (20mg: 67.8% vs 60.7%, 40mg: 76.7% vs 60.7%, 60mg: 70.0% vs 60.7%). The Product demonstrated safety comparable to placebo in the acute ischemic stroke population, with good tolerability.

On August 24, 2023, CSPC, through its wholly-owned subsidiary, entered into a collaboration agreement ("Agreement") with Nanjing Ningdan Pharmaceutical Technology Co., Ltd., a clinical demand-oriented, innovation and R&D-driven new drug company, for the Product. Under the Agreement, CSPC obtained exclusive promotion rights for the Product in Mainland China, Hong Kong SAR and Macau SAR. The term of the Agreement is perpetual.

About Stroke

According to the "Cerebrovascular Disease Prevention and Treatment Guidelines (2024 Edition)" issued by the National Health Commission, there are approximately 3.94 million new stroke cases annually in China, accounting for one-third of global new cases, with ischemic stroke representing about 72% and over 2.8 million new cases per year; the prevalent stroke patient population has exceeded 28 million [1]. China's cause of death surveillance data in 2021 showed that stroke deaths accounted for 23% of total deaths nationwide [1]. Over the past three decades, the disease burden of stroke-related disability in China has continued to increase, compounded by factors such as accelerated population aging, which will further increase future stroke prevention and control pressures, posing significant challenges to patients' families and society [1]. Additionally, post-stroke depression and anxiety are common complications of stroke, with incidence rates of approximately 30% and 25% respectively [2], which can affect patients' neurological recovery and even increase mortality risk, severely impacting prognosis. Y-3 for Injection holds significant potential value for long-term neurological improvement and overall prognosis in stroke patients, with broad market prospects.

About CSPC Pharmaceutical Group

CSPC Pharmaceutical Group is an open platform company that connects pharmaceutical innovation and commercialization, managing products throughout their lifecycle, committed to providing competitive products and services to meet unmet medical needs.

CSPC focuses on first-in-class (FIC) and best-in-class (BIC) innovative products, efficiently advancing clinical research, development and commercialization of innovative products, enabling continuous translation of scientific achievements into clinical practice to benefit patients.

CSPC concentrates on specialty areas with proven commercialization capabilities, extensive channel coverage and multi-therapeutic area expert resources. Core marketed products have achieved leading academic and market positions. CSPC continues to deepen development in key specialty areas to strengthen competitiveness in cardiovascular/cerebrovascular, digestive, ophthalmic and dermatology health businesses, bringing specialty scale efficiency. The dermatology health business (Dermavant Sciences) has become a leader in its segment and plans to list independently on the Stock Exchange. Meanwhile, CSPC continues to promote the operation and development of the entire R&D-production-sales industrial chain in Southeast Asia and the Middle East to capture incremental opportunities in emerging markets and support the Group's high-quality sustainable development.

References/Materials

1.National Health Commission of the People's Republic of China. Cerebrovascular Disease Prevention and Treatment Guidelines (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 Xingyu, Lyu Xiaohan, Li Ruina, et al. Post-stroke Anxiety [J]. International Journal of Cerebrovascular Diseases, 2022, 30(2): 129-133. DOI: 10.3760/cma.j.issn.1673-4165.2022.02.010.

CSPC Disclaimer and Forward-Looking Statements

This press release is not intended to promote any product and is not for advertising purposes. This press release does not recommend any drug, medical device and/or indication. For specific disease diagnosis and treatment information, please follow the advice or guidance of doctors or other healthcare professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient's specific circumstances and in accordance with the drug instructions.

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