- Y-3, a Class 1 Innovative Drug injection, is used to alleviate neurological symptoms and dysfunction of daily activities caused by acute ischemic stroke. The Product has a clear mechanism of action, which is conducive to exerting brain cytoprotection effects. Meanwhile, the Product has a rapid anti-depression and anti-anxiety function, and is expected to become the first new type of brain cytoprotectant that treats both stroke and post-stroke depression.
- The product will enrich the cardio-cerebrovascular (including the central nervous system) pipeline of the Group. After approved for marketing in China, it is expected to meet the clinical needs of drug with both safety and efficacy, providing new treatment options to ischemic stroke patients in China.
On August 24, China Medical System Holdings Limited (“CMS” or the “Group”) announced that the Group entered into a Collaboration Agreement (the “Agreement”) with Nanjing NeuroDawn Pharmaceutical Co. Ltd. (“NeuroDawn Pharmaceutical”), for anti-ischemic stroke brain cytoprotectant and class 1 innovative drug Y-3 injection (“Y-3 injection” or the “Product”), and gained an exclusive promotion right of the Product in Mainland China, Hong Kong Special Administrative Region and Macao Special Administrative Region. The term of the Agreement is permanent.
Y-3 Injection is a Class 1 innovative drug – small molecule compound, which is used to alleviate neurological symptoms and dysfunction of daily activities caused by acute ischemic stroke. The mechanism of action of the Product is to dissociate PSD-95 and nNOS coupling and activate α2-GABAA receptors. With dual-target intervention at the same time and its clear mechanism of action, the Product is conducive to exerting brain cytoprotection effects. Meanwhile, the Product has a rapid anti-depression and anti-anxiety function, and is expected to become the first new type of brain cytoprotectant that treats both stroke and post-stroke depression.
Stroke is a major non-communicable disease that seriously endangers the health of Chinese people. The overall lifetime risk of stroke in China is 39.9%, ranking the first in the world. The number of new cases of ischemic stroke in China was approximately 2.87 million in 2019, and the incidence rate substantially increased by 226.5% from 1990 to 2019, with a large patient population. Stroke has the characteristics of high disability rate and heavy economic burden. There is an urgent clinical need for evidence-based drugs to reduce family and social burdens.
In January 2023, The Phase I clinical trial of the Product in China has been completed and the results showed a good overall safety. The Product is currently in the Phase II clinical trial in China. If approved for marketing in China, it will bring new treatment options to ischemic stroke patients in China, meet the clinical needs of drug with both safety and efficacy, and thus benefit the patients.
CMS has been deeply engaged in the cardio-cerebrovascula/central nervous system therapeutic fields for years and possesses XinHuoSu (recombinant human brain natriuretic peptide for injection), Deanxit (flupentixol and melitracen tablets) and VALTOCO (the first diazepam nasal spray approved in China), etc. The Group has also established a compliant and efficient commercialization system in the cardio-cerebrovascular and central nervous system fields. In the future, the Group will continue to prioritize patients and clinical needs, strategically deploy more differentiated innovative drugs, and consistently expand the product portfolio in the Group’s advantageous specialty fields, benefiting a greater number of patients.
For further detailed information, please visit the following link for the announcement issued by CMS on August 24, “Voluntary and Business Update Announcement Gaining Exclusive License of an Anti-Ischemic Stroke Class 1 Innovative Drug” issued by CMS on August 24 2023.