Formed Alliance tasly willing to lead the Chinese Materia Medica internationalization
reporter Xu Yuhai
tasly determination in Chinese traditional medicine internationalization renewed glory. Following the announcement late last week, saying its main drug — compound danshen dropping pill has become the first complete United States food and Drug Administration (FDA) after the phase ⅱ clinical trial of drugs, tasly announced again on Saturday, will start the FDA phase III clinical trial early next year, after 3 years is expected, compound danshen dripping pills in drug status in the United States and the global market. Tasly will also lead to form “ modern Chinese Materia Medica internationalization research Union ”, promoting the advantages of more varieties of traditional Chinese medicine drug status into the mainstream of European pharmaceutical market.
yanxijun, Chairman of tasly said within the next 2 years, tasly will build 50 to 70 in global clinical trials Center, complete the FDA phase III clinical trial. Analysts pointed out that the main authentication products under small sample FDA phase ⅱ clinical effectiveness, safety and effective dose, while the phase ⅲ clinical research expanded samples of efficacy and safety. For a used in China for more than 10 years, more than 10 million consumers of drugs, compound danshen drop pills entered phase III clinical trial, has basically means that its success by testing the possibility of closer to 100%.
yanxijun revealed, tasly for phase III clinical trial to invest 200 million to 300 million Yuan, mainly used to participate in the trial of the case take, overseas test supporting capacity-building, and so on. Although huge, but analysts pointed out that the compound danshen dripping pills by FDA has a fundamental role in promoting certification to its future growth. Currently, despite compound Dan drops pill has entered basic drug directory and basic medical insurance directory, but in Chinese medicine does not was Western medical by accepted of situation Xia, its more of incremental income from Yu rural, and retail pharmacies and grass-roots medical institutions,; once by FDAIII period clinical test, means with compound Dan drops pill has after world most strictly of clinical research proved its security and the effectiveness, will official get into global market of pass. As for the domestic market, it means that the per cent of cardiovascular drugs market, 80% market share hospital, on compound danshen dropping pill full open, which will promote its sales revenue achieved fast growth.
yanxijun, with the increasing investment in research and development of new chemical drugs, research and development cycles are getting longer, innovation and globalization are greeting the rare opportunities for development. Based on this consideration, tasly lead organizations, Tianjin University, Peking University, Beijing University of Chinese medicine, Tianjin University of traditional Chinese medicine and the Yangtze River pharmaceutical drug, stone group, 18 schools and enterprises, such as the pharmaceutical industry, a joint “ modern Chinese Materia Medica internationalization research Union ” and announced the Union was officially launched in Beijing on Saturday. The Alliance under the drug registration and Technology Research Center, Center for international marketing and trade in services, and international medical service center of traditional Chinese medicine, Chinese medicine industry Fund and other institutions, tasly through such a platform, experience gained in the process of internationalization of traditional Chinese medicine passed to the enterprise, and formed a project to link interests are fair and reasonable allocation of cooperative organizations.
<p> which the internationalization of traditional Chinese medicine industry fund the first phase is expected to reach $ 500 million to 800 million agreement to raise funds, invested in internationalization of traditional Chinese medicine products and industrial development of the target company, helped push the pace of growth and internationalization of enterprises. In the case of Union enterprises agree, some mature projects will also inject tasly its wholly-owned subsidiaries of pharmaceutical industry in North America. North American pharmaceutical industry will achieve the overseas listing in the future, become tasly group in overseas capital operation platform, subject to commitments of compound danshen dropping pill tasly operation of their products in overseas markets, such as business, investment benefit also from the Union project.
yanxijun disclosed that “ 35 ” period, the Union will strive to achieve 1 products in the United States and global listing, 1 to 2 products into the United States FDA phase ⅲ clinical study, 3 products into the United States FDA phase ⅱ clinical study, 5 product? Clinical research, and filter reserves 10 products. He also said, tasly is its qishen Yiqi drop pills, Wattle flower further back to drug a study on weikang capsule, explore the possibility of its future FDA certification testing company subunit influenza vaccine, prourokinase bio-pharmaceutical products should be expected to the year listed, thereby enriching the company product line.