On January 27, 2023, Canton Pertowers' self-developed IND application for oral anticoagulant 505(b)(2) drug was approved by the United States Food and Drug Administration (FDA) for formal clinical trials.
About anticoagulant oral preparations
The oral anticoagulant preparation approved this time is a 505 (b) (2) new drug independently developed by Guangzhou Positao on the basis of the already listed heavy anticoagulant drugs. Clinically available for stroke, the product significantly reduces the risk of stroke and embolic disease, including hemorrhagic stroke, and the incidence of hemorrhage, including fatal and intracranial hemorrhage, resulting in a significant reduction in mortality. Compared with commercially available products, the anticoagulant oral preparation developed by Bostao can reduce the dosage of drugs, reduce side effects, and improve the convenience of medication for patients, which has a high clinical value and market value.
About stroke
Stroke (commonly known as "stroke") IS a kind of acute cerebrovascular disease, which is a group of diseases caused by the sudden rupture or blockage of cerebrovascular blood which can not supply to the brain and cause brain tissue damage. It can usually be divided into two categories: ischemic (cerebral infarction IS) and hemorrhagic (including cerebral hemorrhage ICH and subarachnoid hemorrhage SAH). Stroke can lead to limb paralysis, speech disorders, dysphagia, cognitive disorders, mental and emotional disorders and other symptoms, with high incidence, high recurrence rate, high disability rate, high mortality of the "four high" characteristics. According to the 2017 Global Burden of Diseases, Injuries and Risk Factors Study (GBD), stroke is the second leading cause of death and the third leading cause of disability (measured by disability-adjusted life years [DALYs]) worldwide. The GBD 2019 Stroke Collaboration published global, regional and national stroke statistics for 1990-2019 in Lancet Neurology. Data show that from 1990 to 2019, the absolute number of stroke events increased by 70% globally and the prevalence of stroke increased by 85%. At the same time, stroke related death increased by 43% and stroke DALY s increased by 32%. On the other hand, the incidence of stroke is significantly younger, with a significant increase in age-specific stroke prevalence (22%[21.0-24.0]) and incidence (15%[12.0-18.0]) among people under 70 years of age worldwide. According to the data released by the World Health Organization (WHO), worldwide, the incidence of stroke in people under 35 years old accounts for 9.77% of the total number. In every 4 adults over 25 years old, 1 person will have a stroke in their lifetime, suggesting that the incidence of stroke is gradually getting younger.
About Guangzhou Bositao
Guangzhou Bositao is a high-tech enterprise with new drug release system as the core. It is an important research and development direction of the company to carry out secondary development of products already on the market through new preparation technology and provide products with more clinical value and market value. Currently, the company has more than 10 new drugs or 505 (b) (2), which are in various stages of development.
Guangzhou Bospitao has also established a "one-stop" preparation technical service platform, which is capable of developing a variety of complex injections and oral slow-controlled release preparations, and can provide domestic and foreign pharmaceutical enterprises with a full range of customized drug development services, and has successfully developed and declared nearly 60 various products for domestic and foreign customers.
