Tasly Compound Danshen Dropping Pills Completes US FDA Phase III Clinical Trial
December 26, 2016 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, Tasly released the "Announcement of the results of the Phase III clinical trial of the United States FDA International Multi-Center for Compound Danshen Dropping Pills" by Tianshili Pharmaceutical Group Co., Ltd. According to the announcement, Tianshili Compound Danshen Dripping Pills has completed the Phase III clinical trial of the US FDA. Achieving good clinical trial results, or becoming the world's first compound Chinese medicine preparation to complete the US FDA Phase III trial.
According to the announcement, during the trial period, after a series of data management and statistical analysis work, the “Topline Analysis Report†(hereinafter referred to as “Reportâ€) was formed. According to the relevant provisions of the Shanghai Stock Exchange "Guidelines for the Disclosure of Industry Information of Listed Companies No. 7 - Pharmaceutical Manufacturing", Tasly issued the report through an announcement. The following is the content of the report and related announcements in the announcement:
I. Summary conclusions of clinical trials
Top-line Analysis of the main clinical endpoint of the compound Danshen Dripping Pills (T89) for the International Multicenter Phase III Clinical Study of Chronic Stable Angina (T89-07-CAESA) was recently completed. The TEDTotal Exercise Duration under standard Bruce treadmill exercise conditions will be used to change the large-sample, randomized, double-blind, phase III clinical study of 127 centers in nine countries around the world as the primary clinical endpoint. The results are announced as follows:
1. Compound Danshen Dropping Pill has a significant dose-effect relationship at the main clinical endpoint, and the effect of increasing TED is significantly better than the placebo control group and the Sanqi borneol splitting group. Exclude individual cases in which the research data cannot be used due to force majeure (such as national warfare, center collapse), and patients with more severe stable angina pectoris with multiple types of ECG abnormalities. Compound Danshen Dripping Pills are high and low during the first four weeks of clinical research. The effect of increasing dose of TED was similar; followed by the sixth week, the rate of TED continued to increase with the time of administration in the high-dose group remained unchanged, and the growth rate of the low-dose group was relatively slow, but both were statistically significant ( p<0.001) and significantly better than the placebo control group and the Sanqi borneol splitting group (p<0.05); the sixth week of the trial of the company's board of directors and all directors to ensure that there are no false records, misleading statements or Significant omissions, and bear individual and joint responsibility for the authenticity, accuracy and completeness of its content. A point-to-point comparison at the end of the treatment showed that the high-dose group was more effective than the low-dose group, and both groups were significantly better than the placebo control group and the Sanqi borneol splitting group (p<0.05). <>
2. Secondary efficacy observation endpoints support the main clinical endpoints, and the efficacy evidence is chained. After the 4-week treatment period, the high and low dose groups of the compound Danshen dripping pills reduced the use of nitroglycerin by 25% per week compared to the placebo group, and the placebo group increased the nitroglycerin use by about 9% during this period. Compound Danshen dripping pills in the high and low dose groups also significantly reduced the number of episodes per angina pectoris by 27% compared with the placebo group, and the placebo group only reduced the number of angina attacks by 0.001%.
3. For the first time, this trial used a large-scale randomized double-blind international multi-center phase III clinical trial. The efficacy of the compound Danshen dripping pill high-dose group was significantly better than that of the comparable dose of the Sanqi borneol splitting group. The clinical research interprets the prescription basis of the compound Danshen Dripping Pills, and satisfies the requirements of the drug administration for the research and development of the compound Chinese medicine.
4. In view of the fact that there is no visible difference in the efficacy of the compound Danshen Dripping Pills in different production batches, the effective substance control range in the three batches of production samples for Phase III clinical use can be used as the quality standard for listed products. in accordance with.
5. This trial once again proved the clinical safety of Fufang Danshen Dripping Pills. No serious adverse events associated with the test protocol or compound Danshen dropping pills occurred during the entire trial. All other general adverse events were low-frequency, mild, and self-healing, and there was no difference in the incidence of adverse events between study groups. Based on the safety evidences of acute predatory animals, such as acute toxicity and long-term toxicity, and the clinical safety pharmacology evidence of the dose escalation of healthy volunteers, it was verified that the compound Danshen Dripping Pills were safe for clinical use under the high dose conditions used in this experiment.
The safety and efficacy of Compound Danshen Dripping Pills in the treatment of chronic stable angina pectoris in the United States have been further validated.
Second, the compound Danshen dripping pills drug research and development and related information
Compound Danshen Dripping Pills is a kind of medicine for the treatment of cardiovascular diseases developed exclusively by the company. It was awarded the National New Drug Certificate and Production Approval in 1993. It was put on the market in 1995. It is a national medical insurance variety, a national essential medicine catalogue variety, and a national medicine. Low-priced drug catalogues. As a well-known brand of modern Chinese medicine, a large number of consumers use and benefit every year.
On September 29, 1998, Fufang Danshen Dripping Pill was formally approved by the US Food and Drug Administration (FDA) for clinical use (IND).
In 2006, the company re-applied to the FDA for a new IND to determine the clinical indications for the prevention and treatment of chronic stable angina. The clinical trial used the compound Danshen Dripping Pills code as T89. The Phase II clinical trial study began in February 2007. Since the first group of patients in November 2008, multiple doses, random double-blind, and clinical trials were conducted in clinical centers in 11 states including Florida and Texas. Multi-center parallel controls and other clinical trials involving multiple aspects.
At the beginning of 2010, the phase II clinical trial was completed. On August 7, 2010, according to the compound Danshen Dripping Pills (T89), the US Phase II Clinical Trial Report, the company released the results of the US Phase II clinical trial of the compound Danshen Dripping Pills. Prompt announcement.
After a two-year preparation period, the Compound Danshen Dropping Pill (T89) FDA Phase III clinical trial study officially began in August 2012. The phase III clinical study of T89 was designed as a large-sample clinical study of double-blind, randomized, multinational, multicenter, placebo, and split-group dual-controlled trials to evaluate compound Danshen Dripping Pills (T89) in patients with chronic stable angina pectoris Safety and effectiveness. (Excerpt from the Clinical Trial Registration Database https://) and support the establishment of reference standards for quality control of large-volume production products based on evidence of batch differences and dose-effect relationships in clinical studies. The Phase III clinical trial program was launched in 127 clinical centers in 9 countries in the United States, Canada, Russia, Ukraine, Georgia, Belarus, Mexico, Brazil and Taiwan. The clinical work was completed in March 2016 and then entered COV (clinical). The center closed the visit, the database lock-up phase, and then carried out the top-level analysis of the research data, and completed the "Report" recently.
In view of the fact that Fufang Danshen Dripping Pills (T89) is the world's first compound Chinese medicine to be developed overseas and completed Phase III clinical research, it has many cutting-edge and innovative features, especially the originality of the dropping pills in the international new drug declaration, which will still need to be Completed under the guidance of the FDA. According to the FDA's recent face-to-face meeting, before submitting the application to the US FDA, detailed statistical analysis of factors such as treatment time, dosage, background medication, and medication status of the Phase III clinical study is required. Follow-up written and face-to-face discussions with the FDA.
Compound Danshen Dripping Pills (T89) The cumulative R&D investment of the FDA-NDA (New Drug application) project is subject to timely disclosure.
Third, the United States similar drug market situation
Angina pectoris is a clinical syndrome caused by a sharp, temporary oxygen supply and aerobic imbalance in the myocardium. Its clinical features are paroxysmal anterior chest pressure-like pain, mainly in the posterior part of the sternum, which can be radiated to the anterior region, left upper limb, neck, left shoulder and back, often occurring during exertion or emotional excitement. The symptoms quickly disappeared after a few minutes of rest or with a nitrate preparation. Clinically, angina pectoris is divided into three clinical types: stable angina, unstable angina and variant angina.
Its stability includes two aspects: one is that the condition is stable; the other is that the coronary atherosclerotic plaque is stable, no ulcer rupture dissection and thrombosis and other unstable factors. The pathological basis of stable angina is a fixed stenosis caused by coronary atherosclerotic plaque. Chronic stable angina is a patient whose degree, frequency, nature, and predisposing factors of angina pectoris have not changed significantly within a few weeks.
In 2012, there were approximately 8.2 million patients with chronic angina in the United States, accounting for 2.6% of the country's total population, and approximately 565,000 new patients were diagnosed each year.
Fourth, the comparison with the clinical trial conclusions of similar products
Compound Danshen Dripping Pills (T89) has undergone nearly 20 years of research work for the US FDA's new drug declaration, and has withstood the test of rigorous clinical trials in the world. It is the world's first complete FDA Phase III random, double-blind, international multi-centered Compound Chinese medicine preparation for scale clinical trials. At present, the market for chronic angina in the United States is a chemical product, and no similar products are comparable.
<0.001) and significantly better than the placebo control group and the Sanqi borneol splitting group (p<0.05); the sixth week of the trial of the board of directors and all directors of the company to ensure that there is no false record, misleading statement or significant Omissions, and bear individual and joint responsibility for the authenticity, accuracy and completeness of its content. A point-to-point comparison at the end of the treatment showed that the high-dose group was more effective than the low-dose group, and both groups were significantly better than the placebo control group and the Sanqi borneol splitting group (p<0.05).
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