Dec 8, 2025 – SIM0811 Injection, an investigational drug developed by Simcere Pharmaceutical, has obtained implied clinical trial approval from the National Medical Products Administration (NMPA). It is intended for the treatment of acute ischemic stroke. According to the public information of acceptance number CXHL2501035, SIM0811 Injection is classified as a Class 1 new chemical drug.
Previously, Simcere Pharmaceutical’s Sanbexin® Edaravone and Dexborneol Concentrated Solution for Injection was launched in 2020, benefiting numerous patients; Sanbexin® Sublingual Tablets also received NMPA approval for marketing in 2024. The clinical trial approval of SIM0811 Injection demonstrates Simcere Pharmaceutical’s in-depth strategic layout in the field of acute ischemic stroke treatment.
About Acute Ischemic Stroke
Stroke is one of the leading causes of death in China and worldwide, characterized by high mortality and disability rates. Approximately 2 million new stroke cases occur in China each year, among which acute ischemic stroke (AIS) accounts for 69.6%–72.8% of all new cases, making it the most common type of stroke. It severely impairs patients’ quality of life and imposes a heavy disease burden. Its prevention and treatment remain a major urgent issue to be addressed in the medical field.
About Simcere Pharmaceutical
Simcere Pharmaceutical (2096.HK) is an innovation and R&D-driven pharmaceutical company, home to the National Key Laboratory of Neurological and Oncological Drug Research and Development. The company focuses on the therapeutic areas of neuroscience, oncology, autoimmune diseases and anti-infectives, while proactively and foresightedly expanding into disease areas with significant unmet clinical needs in the future, fulfilling its corporate mission of "Born for Patients". Driven by the dual engines of independent R&D and collaborative innovation, Simcere has established strategic partnerships with multiple innovative enterprises, research institutes and universities.
KylinLab
CNSxplore | Pioneering CNS Drug Discovery--In vitro and in vivo, Beyond limits
Kylin Lab is a preclinical CRO company specializing in central nervous system (CNS) diseases, dedicated to offering one stop solutions for CNS drug discovery. With a portfolio of fully-validated cellular and animal disease models, combined with comprehensive research and analytical capabilities, we empower clients to accelerate the development of innovative therapies and reduce clinical trial risks.
Kylin Lab boasts an experienced technical team well-versed in international regulations, along with high-standard experimental platforms. Our core technologies include AI-driven phenotypic screening, humanized stem cells and organoids, electrophysiology, high-throughput electroencephalography (EEG), histology, and molecular biology. Our expertise spans a broad range of areas including Alzheimer’s disease, Parkinson’s Since its establishment, Kylin Lab has adhered to the philosophy of “Pioneering R&D, Leading in technology Quality-first, Customer-centric.” We have served hundreds of clients, successfully completed numerous thematic research projects and IND submissions, and established a high-quality, stable, and forward-looking efficacy evaluation system.
