Tzuhiri Fuli Dan Dan Di Pills completed the phase II clinical trial of 1 billion yuan to knock on the US FDA door
Release time: 2010-01-21 & nbsp & nbsp & nbsp Source:
Compound Danshen Di Pills My stake betting appopened stake online sports bettingthe door of the US market one step closer。Yesterday,Tianjin Tasses (600535) Pharmaceutical Co., Ltd. (hereinafter referred to as "Task") disclosure,Its main product compound Danshen Di Pill FDA (US Food and Drug Administration) phase II clinical trial has been completed,The final result will be announced within one or two months。
Fulfang Dan Di Pill is commonly used for the treatment of coronary heart disease,It has been on the market for more than 10 years,is one of Tassem's fist products,annual sales exceeded 1.2 billion yuan。The purpose of this phase II clinical trial is to determine the efficacy and dose response of compound Dan Dan Dan Di Pills for patients with chronic stability angina pectoris in the United States。
It is understood,This phase II clinical trial research has been preparing since February 2007。The final result still needs to wait for the clinical research report formed after the specific data stake online sports bettingMy stake betting appanalysis work is completed。
Almost all people in the industry remember,2007 Tiansi high -profile announcement,Planning to make a huge sum of money to knock on the door of the US FDA registration,Want to make the compound Danshen Di Pills into China's first Chinese patent medicine to enter the US market。But,This road is obviously much more difficult than Tsatsui imagination。
Originally in accordance with the FDA regulations,New drugs need to conduct a total of three phases of clinical trials,Time is about 4 to 5 years,It can be approved after clinical trials。But the compound Danshen Di Pills took 13 years after completing the phase II clinical trial。For this,Chairman Yan Xijun, chairman of Tiansi Group, said in an interview with reporters: "In the past, we felt that as long as Chinese medicine was sold to the West, it was international.,I discovered it now,The internationalization of stake online sports bettingChinese Stake Sports Bettingmedicine is fundamentally standardized。Current,Our problem is,Domestic traditional Chinese medicine production standards are too extensive,It is difficult to meet the requirements of Europe and the United States。”
But there are also industry analysts who think,Although the time to complete the phase II clinical trial is much later than expected,However,So every step of compound Danshen Di Pill has a reference to other Chinese pharmaceutical companies。
Fulfang Dan Di Pill is commonly used for the treatment of coronary heart disease,It has been on the market for more than 10 years,is one of Tassem's fist products,annual sales exceeded 1.2 billion yuan。The purpose of this phase II clinical trial is to determine the efficacy and dose response of compound Dan Dan Dan Di Pills for patients with chronic stability angina pectoris in the United States。
It is understood,This phase II clinical trial research has been preparing since February 2007。The final result still needs to wait for the clinical research report formed after the specific data stake online sports bettingMy stake betting appanalysis work is completed。
Almost all people in the industry remember,2007 Tiansi high -profile announcement,Planning to make a huge sum of money to knock on the door of the US FDA registration,Want to make the compound Danshen Di Pills into China's first Chinese patent medicine to enter the US market。But,This road is obviously much more difficult than Tsatsui imagination。
Originally in accordance with the FDA regulations,New drugs need to conduct a total of three phases of clinical trials,Time is about 4 to 5 years,It can be approved after clinical trials。But the compound Danshen Di Pills took 13 years after completing the phase II clinical trial。For this,Chairman Yan Xijun, chairman of Tiansi Group, said in an interview with reporters: "In the past, we felt that as long as Chinese medicine was sold to the West, it was international.,I discovered it now,The internationalization of stake online sports bettingChinese Stake Sports Bettingmedicine is fundamentally standardized。Current,Our problem is,Domestic traditional Chinese medicine production standards are too extensive,It is difficult to meet the requirements of Europe and the United States。”
But there are also industry analysts who think,Although the time to complete the phase II clinical trial is much later than expected,However,So every step of compound Danshen Di Pill has a reference to other Chinese pharmaceutical companies。
