Why can a new deal from CFDA let him leave the company?
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Last Update: 2017-04-22
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Source: Internet
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Author: User
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The new drug application process of international multi clinical centers will be simplified, which will bring significant business opportunities for innovative drugs to enter the Chinese market Under the background of such great opportunities, many innovative drug projects have rapidly prepared multiple competitive factors needed to enter the market, and cooperation and joint ventures emerge in an endless stream On March 17, CFDA published a 480 word consultation draft on the official website of the decision on adjusting the registration and management of imported drugs, which triggered a thousand waves That night, ye Xiaoping, chairman of tiger pharmaceutical, and Mei Jianming discussed on wechat very late, with only one topic to discuss: very excited, very good news! How to seize this opportunity? The core of the draft is also simple: the new drug application process of international multi clinical centers will be simplified, and the speed of innovative drugs entering China will be greatly improved "We predict that the time for us to shorten is about three years." Ye Xiaoping said On March 31, Mei Jianming ended his last working day as executive director of global clinical research and Development Department of Xinji company and devoted himself to the start-up of deqi Pharmaceutical Technology Co., Ltd On April 13, the cooperation agreement on Xinji's stake in Deqi pharmaceutical was officially announced in Shaoxing, Zhejiang Province: first, Xinji's stake in Deqi pharmaceutical; second, Xinji company handed over the clinical development and sales rights of some tumor drugs in Greater China (including Mainland China, Taiwan, Hong Kong, Macao), as well as other East and Southeast Asian countries and regions to Deqi pharmaceutical Ye Xiaoping, as one of the main investors of deqi, participated in the whole process "For me personally, it's not only an internal business, but also a re start of changing the runway." "We hope that through this cooperation, we can reach a long-term, in-depth and extensive strategic partnership," meijianming said in an interview with e pharmaceutical managers As the first project of cooperation between the two sides, Deqi pharmaceutical will quickly launch cc-223 (atg-008) clinical experiment of innovative drugs for liver cancer and application for approval of CFDA, patent layout and clinical development of several imported innovative drugs such as gastric cancer, esophageal cancer, breast cancer, nasopharyngeal cancer, lung cancer, etc will be carried out at the same time, and 7000 square meters of modern dust-free production workshops and laboratories meeting GMP requirements will be built in phase I, and construction investment and decoration work will be started in 2017 It is estimated that the annual output value will exceed 500 million yuan after the project is completed and put into operation and the products are approved Thalidomide and lenalidomide (the Chinese trade name is "reexamine"), two heavyweight products in the field of multiple myeloma, have established the position of new base in the global pharmaceutical field, and are one of the representative companies of the rapidly growing biological upstarts in the United States in the past 30 years "The cooperation between the two sides will be mainly in the form of patent authorization and equity cooperation After the introduction of some innovative drug projects of new base company through Deqi pharmaceutical platform, the two sides will carry out rapid R & D, clinical experiments and industrial production layout, so as to realize the accelerated industrialization of foreign innovative drugs in China." Angus grant, vice president of new base pharmaceutical headquarters, said, "we are opportunists to some extent in China We are looking for many aspects of cooperation in China to develop more effective drugs for patients." There is no doubt that there are a lot of potential varieties on the product line of new and expensive biological clinical research, such as Xinji Considering the disease spectrum and the strategic focus of the company's development, even if the early clinical trials have shown good data, not all potential varieties can be equipped with resources On the other hand, such varieties can provide resources for some potential varieties The market is likely to be in urgent need Cc-223 (atg-008) is such a variety Mei Jianming, who has served in Xinji for nine years, clearly understands the value of this variety and the significance of innovative liver cancer drugs for the Chinese market: few competitors, broad market and high clinical value For new China, this kind of cooperation is an addition The two sides hit it off It is reported that Deqi pharmaceutical will set up innovative drug development headquarters and modern production and manufacturing base in Shaoxing Binhai New Town, and it is expected to introduce multiple clinical phase I, II and III innovative drug projects for development, approval and subsequent industrial production within 5 years "In the future, we will actively expand the financing channels, actively carry out the clinical trial application of the project and start to plan the next round of financing of no less than US $30 million under the condition that the current US $15 million financing is about to be implemented, provide funds for the new project reserve and clinical development, and input blood for the sustainable development of deqi," said Mei
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