Kangzhe Pharmaceutical Co., Ltd. disclosed the preliminary results of clinical research on casein for injection

Kangzhe Pharmaceutical Co., Ltd disclosed the preliminary results of a randomized, double-blind, placebo-controlled multicenter clinical study on the safety and efficacy period of casein for injection in the treatment of liver cell carcinoma (cms024 clinical trial) Casein for injection (cms024) is a national class 1.1 new drug independently developed by kangzhe Pharmaceutical Co., Ltd., and the statistical data disclosed is provided by an independent statistical agency The results of the cms024 trial generally fail to meet the requirements of kangzhe pharmaceutical The results of the cms024 clinical trial show that the further clinical study aimed at the patients with mild disease, such as the subjects without branch cancer thrombus, and taking the total survival time (OS) as the main efficacy index, is of great value As for the patients with branch cancer thrombus, the condition is serious, fast and the exposure time is short, which may lead to the occurrence of the drug in the subjects who have not yet taken effect After the occurrence, most of the subjects stop taking the drug According to the results of the company's tests on 149 patients with more serious disease and 149 patients with less serious disease, the indexes of RFs and OS of the two groups were lower than the expected standard, indicating that the drug needs to be improved Cms024 is of great significance in improving the overall survival The results showed that the total survival time (OS) in the subgroup without cancer thrombus was close to significant difference The difference of survival rate in 600 days after randomization was more than 20%, and the trend of survival improvement was obvious Total survival time (OS) is a gold standard for tumor efficacy evaluation, and the improvement of OS is of great significance The results of clinical trials showed that the total survival time in the subgroup without cancer thrombus was close to significant difference, and the difference of survival rate in 600 days after randomization was more than 20% The significance of improving the total survival time was huge Kangzhe pharmaceutical thought it was responsible for communicating with the State Food and drug administration in a timely manner The company plans to carry out the next clinical trial of cms024 and will continue to bear the cost of the clinical trial At the same time, the company has held urgent consultations with researchers and statisticians on this trend, and both of them have expressed their willingness to cooperate with the group to carry out the next clinical trial of cms024 again, expecting to start within this year Founded in 1995, Shenzhen kangzhe Pharmaceutical Co., Ltd (also known as "CMS") is the largest provider of prescription drug product sales and promotion services in China The company's main products, the antidepressant drug delixin and the gallstone drug Yusuf, have strong rigid demand, and the cardiovascular drug novobin is also rapidly accepted by many hospitals