With repeated failures and battles, tisley's innovative traditional Chinese medicine ushered in new progress in FDA

On December 21, Tianshili Pharmaceutical Group Co., Ltd (hereinafter referred to as "Tianshili") announced that it had received the approval letter from the U.S Food and Drug Administration (FDA) on Tianshili's special protocol assessment (hereinafter referred to as "spa") for carrying out the clinical trial of Compound Danshen Dropping Pills (application code of FDA clinical research is T89) FDA agreed and approved the clinical trial scheme of oresa (test code: t89-08-oresa, hereinafter referred to as "oresa") At present, Tianshili will launch a multicenter, double-blind, randomized controlled clinical trial in the U.S region according to the requirements of the approval letter to verify the efficacy and safety of T89 in the treatment of chronic stable angina pectoris, so as to meet the FDA's requirements for the application of new drugs for the treatment of T89 In 1998, the drug officially passed the first clinical research (ind) application of FDA as a drug In 2006, it was approved by FDA again It determined the clinical indications for the treatment of chronic stable angina pectoris, and became the first compound Chinese medicine preparation in the world to complete the phase III clinical research of FDA Compound Danshen dropping pill is a kind of modern innovative compound Chinese medicine which is mainly used to prevent and treat cardiovascular diseases At present, only Tianshili holds the production approval document exclusively in China And it has won the bid in 31 regions in China Data source of thermodynamic diagram in the bid winning area of 27mg Compound Danshen Dropping Pill: information query database of intelligent drugs bid winning related to this progress: the main content of oresa clinical trial scheme all subjects participating in the trial will be randomly assigned to the high dose group, low dose group and placebo control group in the proportion of 1:1:1, with 255 subjects in each group, a total of 765 subjects The high dose group was 300mg, and the low dose group was 225mg The test will verify the change of total exercise duration (hereinafter referred to as "Ted") relative to the baseline value under the condition of completing the modified Bruce treadmill exercise test at the sixth and eighth weekend after taking the medicine The primary endpoint was the change of Ted relative to baseline at the end of the eighth week, and the secondary endpoint was the change of Ted relative to baseline at the end of the sixth week Spa spa is a procedure specially established by FDA of the United States to discuss and determine the clinical research program of drugs under research in advance, which provides a formal communication way for drug research and development units and FDA review expert groups Spa agreement has legal effect, which indicates that FDA fully recognizes the research program of drug research and development unit Part of the content information source: Tianshili announcement data source: Yaozhi database statement: This article is the integration content, the viewpoint only represents the author, does not represent the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.