Progress announcement of the application for clinical registration of kpcxm18, a new drug for the treatment of ischemic stroke, and kpcxm18 for injection by Kunming Pharmaceutical Group Co., Ltd

There are no false records, misleading statements or major omissions in the contents of the announcement, and shall be jointly and severally liable for the authenticity, accuracy and completeness of the contents Recently, after consulting the website of the drug evaluation center of the State Food and Drug Administration (hereinafter referred to as CFDA evaluation center, Org CN), it was learned that the clinical registration application of kpcxm18 and kpcxm18 for injection, a class I new drug for the treatment of ischemic stroke of kunyao Group Co., Ltd (hereinafter referred to as "kunyao group" and "company"), was marked as a special approval procedure The specific information of the new drug application is as follows: I Basic information of the drug 1) drug name: kpcxm18 \ kpcxm18 for injection 2) dosage form: raw material + injection 3) acceptance No.: cxzl150053 Dian, cxzl150055 Dian acceptance time: September 28, 2015 4) application items: domestic drug registration 5) applicant: Kunming Pharmaceutical Group Co., Ltd 6) registration classification: natural medicine category 1 7) approval stage: clinical registration stage 8) review progress: up to now, the review of pharmacy and clinical has been completed, and the pharmacology and toxicology specialty is under review 2 Other information of drug research on September 28, 2015, the company submitted the application for clinical application to the State Food and Drug Administration for the first time on kpcxm18 and kpcxm18 for injection and was accepted The new drug is the product of the company's R & D projects ky1018 and ky11020 Up to now, the company has invested RMB 2003.19 million in the R & D cost of the product Kpcxm18 and kpcxm18 for injection developed by the company are intended to be used for the first-line treatment of neurologic defects in patients with acute cerebral infarction, but the impact on conventional treatment drugs or other treatment methods of cerebral infarction (such as thrombectomy of large artery in the blood vessel) remains to be further studied All over the world, acute ischemic stroke is the leading cause of severe disability or death According to WHO data, the incidence rate of stroke in China is increasing at 8.7% annually, which is twice as high as that in the United States China's Stroke Prevention report (2015) shows that the incidence rate of stroke in China is increasing or even younger Every 12 seconds, one person has been attacked and one person died of stroke every 21 seconds The incidence rate of city smokers is far higher than that of the elderly, and the incidence rate of urban residents is higher than that of rural areas The mortality rate of cerebrovascular disease in China is 4-6 times of that of myocardial infarction, and the economic burden is 10 times of that of myocardial infarction, which is more than 40 billion yuan Stroke has become the primary cause of death in Chinese residents 70% of the survivors not only have hemiplegia and aphasia, but also face high risk of recurrence According to statistics, the recurrence rate of cerebral infarction patients within one year is as high as 20%, which is one of the main causes of death According to the internal network data of CFDA Southern Institute of pharmaceutical economics, the sales amount of Chinese patent medicine in public hospitals in key cities in 2015 was 4.416 billion yuan The product is a new natural drug of class 1 At present, no enterprise has obtained the production approval of the drug 3 Risk Reminder according to the requirements of laws and regulations related to drug registration in China, innovative drugs need to carry out phase I, phase II and phase III clinical trials after obtaining the approval of clinical trials, and can only be produced and marketed after being approved by the drug evaluation center of the State Food and drug administration After submitting the clinical registration, the company has started the clinical research related work of drugs, and can obtain the phase I clinical approval document after being reviewed and approved by the drug evaluation center of the State Food and drug administration Due to the particularity of drug research and development, drug production from clinical trial to approval will be affected by technology, approval, policy and other factors There are many uncertainties in the progress and results of clinical trial and the future product competition situation Please pay attention to the investment risks The company will timely perform the obligation of disclosure according to the actual progress of drug research and development It is hereby announced Board of directors of Kunming Pharmaceutical Group Co., Ltd May 31, 2016