Dr. Tong Youzhi received an exclusive interview of Biodiscover. He said: “It is easier to operate new drug companies in China than in the United States. This is because new drugs approved to launch in the market in the United States are more to replace the best existing treatments. However, new drug development in China is more of filling a gap in the industry.”
Dr. Tong Youzhi, President of Suzhou Kintor Pharmaceutical Co., Ltd (abbreviated as Kintor).
On August 18, 2015, the State Council officially issued Opinions on Reforming the Examination, Evaluation and Approval System for Pharmaceuticals and Medical Devices. The term “innovative drug” appeared ten times in the document. It also points out that it is necessary to encourage clinical value-oriented drug innovation, optimize review and approval procedures for innovative drugs, and accelerate review innovative drugs that are urgently needed in clinic.
Drug R&D is increasingly globalized. If companies want to take a leading position in the global pharmaceutical market, it is critical to take the lead in new drug development. The gap between China’s R&D in new drugs and the European and American pharmaceutical giants is caused by many factors, e.g. technology, policies, and capital. How to solve these problems and increase the R&D capability of new drugs in China has always been the focus of many people in pharmaceutical field.
In March 2015, the New Drug Founders Club was founded. As a connection platform, it is committed to promoting the communication between the founders of the new drug R&D Company and the relevant persons in charge. Following the successful completion of Guangzhou Station of the National Tour, the Suzhou Station of the National Tour, organized by New Drug Founders Club and co-organized by SIPPA and BioBAY, was held in BioBAY on May 17th. A number of entrepreneurs were invited, including Pan Wubin, co-founder/president of Suzhou Connaught Biomedical Co., Ltd. and Tong Youzhi, president of Kintor. They jointly discussed the lessons learned in the development of small-molecule drugs and their ideas achieved from projects.
Founded in 2009, Kintor is a high-tech innovation company focusing on the research and development of new anti-cancer drugs. Dr. Tong Youzhi, president of Kintor, delivered a keynote speech titled The Entrepreneurial Story of Small Molecule Anti-tumor Drug Development. In the speech, he also shared his new drug development story and explained specific project cases. After the event, Dr. Tong Youzhi received an exclusive interview with Biodiscover. He said: “In recent years, domestic investment in R&D of new drugs has been relatively active, but R&D of new drugs remains extremely risky.”
1. An urgent need for developing new drugs in China
Tong Youzhi served as the vice president of Angion in the United States for 6 years before establishing Kintor in 2009. He said that 5% of the national research funds in the United States are used to subsidize companies less than 100 people, and these companies are often founded by university professors.
After completing his postdoctoral research at Cornell University in the United States, Tong Youzhi taught at Einstein College of Medicine. In 2002, he participated in establishing Angion. The company initially carried out research related to gene therapy. However, at that time, there were cases of deaths due to gene therapy in the United States. The company eventually identified the research direction as small molecule drugs and devoted itself to the research and development of new drugs for organ regeneration.
When talking about the original intention of returning to start a business, Tong Youzhi said: “People of our generation have a special feeling for the country. I used to study and work in the United States for a long time and I didn’t have much understanding of domestic development. In 2007, I returned and found that ‘hardware’ (experimental equipment, etc.) has reached a very good level. But there is no complete idea and implementation system for how to conduct new drug research and development. I think I should go back and do something for our country.”
Kintor was established more than seven years ago. Tong Youzhi stated that compared with Kintor, Angion depended too much on state funds when it operated, so development would be relatively slow. From 2002 to 2008, there was only one drug candidate allowed to enter clinical phase I for Angion. It is reported that the molecule entered the clinical phase III last year. He said: “This has a certain relationship with the founders’ ideas. In the United States, we did not have a strong sense of urgency. However, due to the fierce domestic competitive environment, this sense of entrepreneurial urgency is very strong.”
It is inevitable to encounter many difficulties for entrepreneurship. Tong Youzhi introduced that when Kintor was established in 2009, although the country had already paid attention and invested in research and development of new drugs, the social repercussions (market, capital, etc.) were not so enthusiastic at the time. For new drug R&D companies, how to raise funds at the initial stage is one of the important challenges and it lasts through the entire new drug R&D process. Tong Youzhi believes that the ultimate success of a startup company depends on factors such as projects, teams, funds, and patents.
2. Proxalutamide, chemical class I new drugs for treating prostate cancer
The key drug in Kintor’s R&D product is the second generation of the new drug, Proxalutamide, which is an androgen receptor antagonist class 1.1. It is mainly used for treating patients with metastatic castration-resistant prostate cancer. The research subject of this project was listed in the national “Twelfth Five-Year” major new drug creation project in 2011. Kintor is one of the companies that have the smallest scale and the shortest time to establish among the many companies that undertake this special project. On March 15, 2015, it was approved that Proxalutamide could be used in China’s Phase I-III clinical trial. In August of the same year, it received clinical approval from the United States.
Better efficacy and safety
Based on the core structure of the newly launched anti-prostate cancer drug Enzalutamide in the United States, the Proxalutamide is a novel compound that is designed and optimized repeatedly using computer-aided design based on the crystal structure of the target protein. The chemical structure of the drug has changed in many ways compared with Enzalutamide. It improves molecular solubility and kinetic properties, avoiding over-accumulation of drugs. Ultimately, it may eliminate clinically exposed CNS and other side effects of Enzalutamide. In addition, Proxalutamide has a higher targeting activity than Enzalutamide. More importantly, it possesses a unique pharmacological mechanism that inhibits the expression of targeted androgen receptor genes. Therefore, it is expected to be the best clinical drug for prostate cancer with a dual drug mechanism targeting the androgen receptor in the second generation.
China and the United States are in Phase I clinically.
Tong Youzhi introduced that currently Proxalutamide is undergoing phase I clinical trials in China and the United States. He said that choosing these two countries is mainly because of their population and the market. In addition, he also emphasized that it still requires further verification whether the advantages of blucuramide in animal models can ultimately be achieved in human trials.
Favored by investors
On July 15, 2015, Kintor announced that it had received a $10 million investment from Honghui Capital, specializing in the health industry. Tong Youzhi recalled that Kintor has achieved many different investments. The earliest investment was from the government (Suzhou Industrial Park). The purpose of this kind of investment is to support the returnees to start their own business in domestic, and the coverage is relatively wide. It can be used to support the initial work of enterprises to start innovation and entrepreneurship. Then, the company obtained the investment of Legend Star. This is more of an “investment” for the company’s entrepreneurs. It is hoped that they can cultivate a group of competent and socially aspirational entrepreneurs for the country. Later, when the company needed a relatively high amount of funds to develop new drugs, we received investment from investors focusing on biopharmaceuticals. They consider more about the success of the company’s leading new drug project and whether there are other drug development chains after the failure.
3. China’s new drug research and development is more of filling gaps.
In addition to Proxalutamide, Kintor’s research projects in the pharmaceutical industry include kinase inhibitors anticancer drugs, kinase inhibitor anti-inflammatory drugs, and anti-cardiovascular diseases drugs. Tong Youzhi stated that the development of the new drug R&D company highly depends on its project. The success of the first project will greatly help the company’s subsequent development. He said: “It is easier to operate new drug companies in China than in the United States. This is because new drugs approved to launch in the market in the United States are more to replace the best existing treatments. However, new drug development in China is more of filling a gap in the industry.””
Tong Youzhi was engaged in immunotherapy-related research during the postdoctoral period. When talking about the current popularity in this area, he said that in the late 1990s, immunotherapy was not as enthusiastic as it is now. The success of immunotherapy is the result of the continuous development and accumulation of science. He said: “I believe that the combination of small-molecule drugs and immunotherapy is one of the important development directions for cancer treatment in the future. Apart from carrying out some exploratory work on its own, Kintor may also cooperate with other companies.”
4. Summary: Make a project first, then take lead in a field
Tong Youzhi said “The more solid the early stage of drug development, the more helpful it will be for the promotion of later projects. The huge risk of new drug development is unavoidable. It will be increasingly difficult in the future to develop drugs or technologies to replace existing treatments.”
At the end of the interview, Tong Youzhi expressed his expectations for his company’s development. He said: “A company’s development cannot be separated from reality; there is a growth trajectory and longevity for each company. Our company’s development philosophy is to make every effort to make the best of 1-2 project(s) so as to drive the development of other projects. This can make the company create the best treatment in a disease area. Regardless of the future of Kintor, what we need to do now is actively promote the development of the project, because we must be responsible for the company’s employees, investors, and patients with major diseases longing for new drugs.
About Dr. Tong Youzhi
As the president of Kintor, Dr. Tong Youzhi got his bachelor’s and master’s degrees in chemistry from Peking University. He is a Ph.D. in Pharmacology from Cornell University/Sloan Kettering Cancer Center. In addition, he completed his postdoctoral research in tumor immunotherapy at Cornell University. He once taught at Einstein College of Medicine and participated in the creation of the American Angion Pharmaceutical R&D company and served as vice president. He has been engaged in the research and development of new anti-cancer drugs for more than 20 years and holds a number of patents. He has conducted several research projects on innovative drugs in the United States and China. In 2009, he returned to China and established Kintor, and in 2012 he was selected as the eighth batch of “Thousand-person Plan” by the Organization Department of the Central Committee of the CPC.