Tong Youzhi, President of pioneer pharmaceutical industry: China's new drug R & D has a strong sense of urgency, most of which are "filling in gaps"

Dr Tong Youzhi, President of Suzhou development Pharmaceutical Co., Ltd On August 18, 2015, the State Council officially issued the opinions on the reform of the review and approval system for pharmaceutical and medical devices, in which the word "innovative drugs" appeared ten times in total; the main goal is to encourage drug innovation oriented by clinical value, optimize the review and approval procedures for innovative drugs, and accelerate the review of innovative drugs urgently needed in clinical With the increasing globalization of drug research and development, it is very important to take the lead in the global pharmaceutical market The gap between China and European and American pharmaceutical giants in new drug research and development is caused by many factors, such as technology, policy, capital, etc How to solve these problems, so that China's new drug research and development link to a higher level has been the focus of many people in the field of medicine In March 2015, the new drug founders club came into being in such a context As a connecting platform, it is dedicated to promoting exchanges between the founders and relevant principals of new drug R & D companies in China After the success of the new drug national tour · Guangzhou station, the new drug national tour · Suzhou station, sponsored by the new drug founder club and co organized by sippa and BioBAY in Suzhou Industrial Park, was held in BioBAY on May 17 Many entrepreneurs, such as pan wubin, co-founder / President of Suzhou kangnaide biomedical Co., Ltd., Tong Youzhi, President of Suzhou pioneer Pharmaceutical Co., Ltd., were invited to discuss the experience and lessons in the development of small molecule drugs and the thinking in the process of project promotion Founded in 2009, Suzhou Kaifa Pharmaceutical Co., Ltd is a high-tech innovation enterprise dedicated to the research and development of new anti-cancer drugs During the activity, Dr Tong Youzhi, President of the company, delivered a keynote speech entitled "entrepreneurial story of small molecule anti-tumor new drug development", shared his new drug development story and explained specific project cases After the activity, Dr Tong Youzhi accepted an exclusive interview of biological exploration, he said: "in recent years, domestic investment in new drug research and development is relatively active, but it can not be avoided that new drug research and development is still a high-risk industry." 1 The "sense of urgency" of domestic new drug R & D environment is stronger Before returning to China in 2009 to establish Suzhou development Pharmaceutical Co., Ltd., Tong Youzhi served as the vice president of angion company in the United States for six years According to Tong Youzhi, 5% of national research funding in the United States is used to fund companies with fewer than 100 people, often founded by professors from universities After completing his postdoctoral research in Cornell University, Tong Youzhi taught at Einstein Medical College and co founded angion in 2002 Angion initially hoped to carry out research related to gene therapy, but at that time, there were cases of death caused by gene therapy in the United States Finally, the company determined the research direction as a small molecule drug, dedicated to the research and development of new drugs in organ regeneration Talking about the original intention of returning home to start a business, Tong Youzhi said: "our generation has a special complex for the country Previously, due to the long-term relationship between study and work in the United States, I didn't know much about the development of China However, when I returned to China in 2007, I found that China has reached a very good level in terms of "hardware" (experimental equipment, etc.), but there is no complete idea and implementation system for how to carry out new drug research and development I think I should go back home and do something for my country " Now, it has been more than seven years since the establishment of the pioneering pharmaceutical industry Compared with these two entrepreneurial experiences, Tong Youzhi said that angion relies too much on national funds when it operates, so its development will be relatively slow From 2002 to 2008, only one candidate drug of angion entered clinical phase I It is reported that the molecule entered clinical phase III last year "It has something to do with the ideas of the founders themselves," he said In the United States, the sense of urgency in the process of entrepreneurship does not seem to be strong On the contrary, in the fierce domestic competition environment, this sense of urgency is very strong " In the process of entrepreneurship, there will be many "big barriers" and "small barriers", which is inevitable Tong Youzhi said that when the pharmaceutical industry was founded in 2009, although the state had paid attention to and invested in the research and development of new drugs, the social repercussions (market, capital, etc.) at that time were not as enthusiastic as they are now For new drug R & D enterprises, how to raise funds in the initial stage is one of the important problems that need to be faced, and this problem will accompany the whole process of new drug R & D According to Tong Youzhi, the final success of a start-up company depends on the choice of project, the organization of the team, the acquisition and rational use of funds and the protection of patents 2 Prochloraz, a new chemical class I drug for prostate cancer, is known to be the second generation of androgen receptor antagonist, class 1.1 new drug, which is mainly used for the treatment of patients with metastatic castration resistant prostate cancer The research topic of this project was listed in the national "12th Five Year Plan" major new drug creation project in 2011, and it is "one of the enterprises with the smallest scale and the shortest establishment time" among many enterprises undertaking this project Prochloraz has been approved for phase I-III clinical trials in China on March 15, 2015, and for clinical trials in the United States in August of the same year, and has successfully completed double reporting and double approval The better efficacy and safety of Prochloraz is a new compound based on the core structure of enzalutamide, the latest anti prostate cancer drug in the United States, which is designed by computer-aided design based on the crystal structure of target protein and optimized repeatedly Compared with azarulamine, the chemical structure of the drug has many changes, which improves the molecular solubility and kinetic properties, avoids the excessive accumulation of the drug, and may eliminate the central nervous system and other side effects of azarulamine in clinical exposure In addition, compared with azarulamine, prochlorazine has higher targeting activity, more importantly, it increases the unique pharmacological mechanism of inhibiting gene expression of targeted androgen receptor, and is expected to become the second generation of the best clinical drug with dual drug mechanism targeting androgen receptor According to the introduction of Tong you, prochloraz is conducting phase I clinical trials in China and the United States He said that the two countries were chosen mainly because of crowd representation and market factors In addition, he stressed that whether the advantages of Prochloraz in animal models can ultimately achieve the same effect in human trials needs further verification On July 15, 2015, capital favored the development of pharmaceutical industry, which announced that it had obtained 10 million USD investment from Honghui capital focusing on health industry Tong Youzhi recalled that the development of the pharmaceutical industry has experienced several rounds of different investors, the earliest of which is from the government level (Suzhou Industrial Park) The purpose of such investment is to support overseas returnees to return to China for entrepreneurship, with relatively wide coverage, which can support enterprises to start their initial work of innovation and entrepreneurship Then, the company obtained the investment of Lenovo star This round of investment is more "invested" to the entrepreneurs of the company, hoping to cultivate a group of capable and ambitious entrepreneurs for the country Later, when the new drug development funds needed by the company reached a relatively high amount, investors focused on biomedicine began to enter They considered more about the success of the company's leading new drug project and whether there were other drug R & D chains after the failure China's new drug research and development is more "filling the gap" In addition to prochloraz, the research projects in developing the pharmaceutical industry also include kinase inhibitor anti-cancer drugs, kinase inhibitor anti-inflammatory drugs, anti cardiovascular drugs, etc Tong Youzhi said that the development of new drug R & D companies is closely related to their projects If the first project is successful, it will greatly help the company's subsequent development Compared with the United States, it is relatively easier to be a new drug company in China, because the new drugs approved by the United States are more to replace the best existing treatment methods, while the new drug development in China is more to fill the gap During his postdoctoral period, Tong Youzhi engaged in research related to immunotherapy Referring to the current hot trend in this field, he said that in the late 1990s, immunotherapy was not as "hot" as it is now Now, the success of immunotherapy is the result of continuous development and accumulation of science "I believe that the combination of small molecule drugs and immunotherapy is one of the important development directions of cancer treatment in the future," he said In addition to doing some exploratory work on its own, the pharmaceutical industry may also cooperate with other companies " 4 Summary: make a project first, and then lead Tong Youzhi in a certain field to emphasize: "the more solid the work in the early stage of drug research and development, the more helpful it will be for the promotion of later projects Of course, the huge risk of new drug development is inevitable, especially in the future, it will be more and more difficult to develop drugs or technologies to replace existing therapies " At the end of the interview, Tong Youzhi expressed his expectation for the future development of the company "The development of a company cannot be divorced from the reality Every enterprise must have its growth track and life span," he said The development concept of pioneering pharmaceutical industry is to do well in 1-2 projects of the company and make them into medicines, so as to drive the development of other projects; on this basis, the company can create the best treatment method in a disease field No matter how to explore the future of the pharmaceutical industry, what we need to do now is to actively promote the development of the project, worthy of the "comrades in arms" with the company, worthy of the investors, to meet the needs of patients with major diseases for new drugs " About Dr Tong Youzhi, President of Suzhou development Pharmaceutical Co., Ltd., graduated from the Department of chemistry, Peking University with bachelor's degree and master's degree, doctor of pharmacology, Cornell University / Sloan Caitlin cancer center, and completed the postdoctoral research of tumor immunotherapy in Cornell University He has taught in Einstein Medical College, participated in the establishment of American angion pharmaceutical R & D company and served as vice president He has been engaged in the research and development of new drugs for more than 20 years, and has many patents He has presided over several innovative drug R & D projects in the United States and China In 2009, he returned to China to establish Suzhou development Pharmaceutical Co., Ltd and was selected into the eighth "thousand talents plan" of the central organization department in 2012.