On Dec 1,2022，Simcere Pharmaceutical Group Ltd (2096.HK), announced that, a multi-center, randomized, double-blind, parallel and placebo-controlled phase III clinical study (the “Study”) of Sanbexin sublingual tablets for the treatment of Acute Ischemic Stroke (“AIS”), which was jointly developed by Simcere and Nanjing Neurodawn Pharmaceutical Co., Ltd., has completed Database Lock (DBL) recently.
Preliminary analysis shows that, compared with placebo, Sanbexin sublingual tablets have significantly improved the recovery of neurological function and ability to live independently following treatment in AIS patients, achieving expected efficacy endpoints with an excellent safety profile. The results of this Study are expected to be published in academic journals and/or conferences in the near future.
The Study，led by Peking University Third Hospital, enrolled a totally number of more than 900 AIS patients within ≤ 48 hours of onset from nearly 40 research centers nationwide. The aim of the study is to evaluate the efficacy and safety of Sanbexin sublingual tablets for the treatment of AIS patients.
On June 28, 2021, the Study enrolled the first patient (FPI) for clinical trial. After about 10 months, all intended enrollments had been completed on May 4, 2022. All treatments and visits were completed by August 2022. The success of this Study has demonstrated the clinical value of Sanbexin sublingual tablets in the treatment of AIS, which is expected to bring new treatment options for AIS patients.
About Sanbexin sublingual tablets
Sanbexin sublingual tablets (formerly known as Y-2 sublingual tablets) are oral solid formulation containing edaravone and dexborneol as active ingredients. The tablet given sublingually can be disintegrated and absorbed rapidly into the bloodstream, and exert anti-inflammation and anti-free radicals functions in the central nervous system, to protect the blood-brain barrier,and minimizing neuron damage or impairment during AIS. Such unique dosage form is expected to increase the availability and flexibility of stroke regimen and improve medication compliance. Sequential therapy consisting of Sanbexin sublingual tablets and the marketed Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) is expected to enable patients to receive more timely and complete treatment.
About Neurodawn
Neurodawn is an innovative company focusing on the development and industrialization of new drugs in the field of central nervous system diseases, and has been named as a Nanjing Cultivated Unicorn Enterprise. The company’s project pipeline mainly involves stroke, glioma, cognitive disorders, affective disorders, neuropathic pain, cerebral small vessel disease and other related diseases, which are currently in the clinical and pre-clinical stages respectively.
About Simcere
Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future, aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world leading innovative companies and research institutes.
For more information, please visit: http://en.simcere.com/
Media contact: simcere.mediarelations@simcere.com