Aspiring to become an academic expert,Dr. Tong accidentally entered the entrepreneurial circle. Under his leadership,Kintor Pharmaceuticals combines independent research and development with external introductions,develops innovative drug Proxalutamide,and works with Pfizer to develop ALK-1 in an attempt to build a leading anti-tumor innovative drug company in China.

"I was invited by the department head in the United States to help him start a novel drugs research and development company,which is equivalent to participating in a complete entrepreneurial process. I have accumulated a lot of experiences in the United States,and I accidentally found many opportunities on the way back to China. I want to develop some novel drugs for my country,so I came back to start a business without hesitation." Dr. Tong,chairman of Suzhou Kintor,said in an interview with the "Medical Community"·E Medicine Manager.

Suzhou Kintor Pharmaceuticals,Inc. (hereinafter referred to as " Suzhou Kintor "),founded by Dr.  Tong in 2009 after returning from the United States is a novel drugs R&D enterprise focusing on major cancers. It has been devoted to research on prostate cancer,breast cancer and liver cancer,the three cancers lacking effective treatment options and accounting for 50% of the population with major malignancies. Its main product,Proxalutamide,has been awarded the special project of "Major Novel Drugs Development" in National 12th/13th five-year plan; Phase III clinical trials for prostate cancer indications in China have been started,and Phase I/II clinical trials have proceeded concurrently in the United States; phase I/Ib clinical trials for breast cancer indications are also underway in China.

Suzhou Kintor takes independent research and development as the main strategy to be supplemented by external introduction. In early 2018,Suzhou Kintor obtained Pfizer-granted global development right for the first new antibody drug ALK-1. So far,this product has received funding for special project of “Major Novel Drugs Development” in 13th Five-Year Plan. An international multi-center Phase II clinical trials for liver cancer indications has been launched. Clinical research on breast cancer,prostate cancer,kidney cancer,macular degeneration indications will start in succession.

Bet on ALK-1

On January 24,2018,Pfizer and Suzhou Kintor reached a global rights authorization agreement for new tumor antibody drugs. Under the agreement,Pfizer will grant Suzhou Kintor the exclusive right to develop,produce and commercialize ALK-1 globally,an innovative antibody drug for cancer,and will provide results of already completed pre-clinical and phase I clinical research as well as support in proprietary technologies. The drug is also expected to become the world's first fully human therapeutic monoclonal antibody against ALK-1 target.

Liver cancer is a cancer species with a higher incidence in Asians,whose incidence is relatively low in Western countries. Suzhou Kintor wants to develop a variety meeting the characteristics of the Chinese market,and ALK-1 as an antibody drug is scientifically challenging. If Suzhou Kintor can really push the drug into clinical use,there will be unlimited market prospect. Based on the results of Pfizer's phase I clinical research,Kintor Pharmaceuticals will carry out global multi-center phase II clinical trials,try combined use with different drugs,and will start relevant work to transfer drug production to China. At the same time,Suzhou Kintor will also actively expand and explore the application of the drug in indications other than liver cancer. The ALK-1 project cooperation is the second project and also the first cancer project authorized by Pfizer to Chinese pharmaceutical enterprise.

Suzhou Kintor has always been engaged in the research and development of micromolecular drugs,relatively lacking research and development capabilities in macromolecule drugs. "It doesn't matter whether the cat is black or white,as long as it catches mice. We should not be limited to small or macromolecular drug company." Dr. Tong said that because many drugs in the future will require combined use,the combination of micromolecular and macromolecule drugs may become a trend. The introduction of ALK-1 can help Suzhou Kintor make overall arrangement in all aspects of macromolecules and personnel,so that expansion is possible regardless of the company's R & D chain or drug development capabilities and fields.

With hardware,but no concept

Dr. Tong was born in Shanghai in the 1960s. Under the influence of his father who graduated from The National Southwest Associated University,he had good academic performance since childhood. As the fourth batch of students after the college entrance examination was restored,he was successfully enrolled in the Department of Chemistry at Peking University where he completed undergraduate and graduate study and stayed to teach after graduation. In pursuit of profound expertise,Dr. Tong attended Cornell University in the United States,during which he was primarily engaged in research on cancer drugs.

During his PhD study,he learned tumor pharmacology from Professor J Bertino at the Memorial Sloan-Kettering Cancer Center,the best research institute in the world,mainly engaged in research on how to circumvent drug resistance and toxicology after chemotherapy. He was exposed to immunotherapy during post-doctoral study and felt that immunotherapy would definitely be a major direction for cancer healing in the future. He had successfully completed the experiment to cure tumors in animals,and always wanted to see whether the same results could be received in human body,which foreshadowed Dr. Tong's future entrepreneurship.

Later,invited by of the department head of Albert Einstein College of Medicine,Dr. Tong joined the company newly founded by the department head as the vice president together with all his laboratory membersDr.. As a veteran employee,Dr. Tong handled matters including corporate management,project management,and drug research and development,which is equivalent to helping the company complete phase I trial of the drug from scratch. This process took more than six years.

With this experience,Dr. Tong gained a wealth of experiences in micromolecular drug development and began to develop his own ideas for entrepreneurship.

In 2007,Dr. Tong was invited to participate in novel drugs R&D experience sharing of a local Chinese pharmaceutical enterprise. When he came to this pharmaceutical enterprise,he found that domestic companies were very complete in hardware,and even dozens of high-performance liquid chromatography were placed in the laboratory,which was in contrast to US laboratories that focus on instrument savings. Despite hardware facilities,domestic pharmaceutical enterprises lack the concept of how to develop innovative drugs. Dr. Tong found that there was a lot of room for improvement in the Chinese market,so he decided to return to China to start a business.

Cross the "hills"

In 2008,after returning to China,Dr. Tong accidentally participated in an investment roadshow held by the Suzhou Biological Park and won the first place. Then,he naturally started to form a company. He originally thought things would go smoothly after winning the jackpot,but then encountered the global financial crisis. On the one hand,the new company has been established,but on the other,no one made investment. In the face of such a dilemma,Dr. Tong gritted his teeth and pulled out all his savings in the United States,embarking his difficult domestic entrepreneurial journey.

"Millions of expense and cost is merely too little for novel drugs companies. At that time,I even hoped that my employees would do less R&D work on a daily basisso that the company could survive for a longer period of time." Dr. Tong said it was not until 2010 that Suzhou Kintor luckily received fund of over RMB3 million through the National 12th Five-Year Plan,which subsidized over 30 novel drugs programs,and over RMB1 million subsidy from Suzhou Biological Park. Thanks to the “timely rain”,Kintor finally overcame the financing hardship and has survived to date.

"It was difficult to recruit quality employees at the beginning,and we finally ‘managed’ to recruit many of the talents.” Dr. Tong said that the recruitment atmosphere was quite different between the United States and China. Job market candidates from the U.S. who held a doctorate or advanced degrees sometimes would like to join small-size companies that offered them with a generous incentive schemefrom the company's potential growth. However,things are little different in China,many highly educated candidates are more willingly to seek opportunities in large companies,where most of them are located in the first tier cities. Therefore,Dr. Tong could only convince candidates with his promise and sincerity. He sometimes succeeded at it,sometimes not.

Kintor Pharmaceuticals’ establishment,Dr. Tong also has a good partner- Dr. Chuangxing Guo,a student of Dr. Tong when he was teaching at Peking University,and six year ahead of Dr. Chuangxing Guo. The two went abroad successively and became good friends. Dr. Chuangxing Guo has nearly 20 years of working experiences in Pfizer,mainly engaged in molecular design and synthesis of chemistry; Dr. Tong has been working in a small innovative drug company,focusing on biological field. "Both of us are engaged in early clinical discoveries. We are a complementary combination. Later,I’m more focused on company management,and he is in charge of science." Dr. Tong said

In the Name of Father

Coincidentally,Dr. Tong's father suffered from prostate cancer in 2007,while Dr. Chuangxing Guo's father also suffered from prostate cancer later.  Suzhou Kintor's core product,Proxalutamide,is exactly a class 1.1 innovative drug for the treatment of advanced prostate cancer and breast cancer.

In developed countries in Europe and the United States,prostate cancer can be detected in over 100 males out of 100,000,nakeing the prostate tumor the first ranking ranking malignant tumors in male. Recent years witness continual growth in the incidence of prostate cancer in China. In 2001,the incidence in China was 2/100,000,and now it is 22/100,000 in large cities,and estimatedly 10/100,000 in small cities,making it one the three major tumors in China with the fastest growth. Therefore,both personally and socially,it has deepened the determination of these two scientists to bring this drug to market.

In 2009,Suzhou Kintor decided to develop a product with strong target and druggability,which shall bring its own intellectual property rights and be domestically marketed not too late compared with the benchmark product. Hence,it began to develop the micromolecule innovative drug Proxalutamide,whose benchmark product is enzalutamide at the stage of phase II clinical trials then.

Enzalutamide is a second-generation androgen receptor inhibitor mainly used in the treatment of prostate cancer. However,this drug has side effects of epilepsy. Suzhou Kintor developed Proxalutamide in the hope that it would bring better safety and more effective performance than enzalutamide. AR overexpression and mutation are the main mechanisms in resistance of prostate cancer cells to enzalutamide therapy,while Proxalutamide is an AR antagonist with "dual action mechanism" that inhibits AR (sex hormone) receptor while inhibiting the expression of AR genes to reduce the possibility of resistance.

Today,enzalutamide was approved in the United States in 2012 and is expected to be approved in China next year. Proxalutamide was approved for the National Phase I~III clinical trials in March 2015,and clinical trials officially began in July. So far,it has entered phase III clinical trials in China. It is expected to submit NDA in China in 2020. Therefore,the two drugs have a relatively small gap in terms of marketing time.

In the start-up stage,Suzhou Kintor only focused on pursuing perfection in one product. As its capital chain continued to expand,it began to undertake more projects. At present,the company has three clinical projects under development at different clinical stages,and there are three projects about to proceed with clinical application. In addition to intensive research on the product's therapeutic fields,Dr. Tong said: "Next,we will display our own characteristics in multiple disease fields by developing drugs in the form of single or combined drugs,so that we can treat and help more patients."

Concerns at Golden Stage

"I think the entrepreneurial environment in the United States is very different from that in China,and the threshold for entrepreneurs in the United States is higher." Dr. Tong said that more pharmaceutical enterprises in the United States would choose to develop innovative drugs. The new targets of innovative drugs demand strong theoretical and scientific basis,so most R&D is undertaken by university professors and research institutes. Many scholars have established some influence and have made achievements in respective research fields,so they will cooperate with professional managers to divide the work and take charge of affairs in the professional field.

However,in China,there are many enterprises engaged in generic drugs and follow-up innovative drugs,and there is a big gap from foreign markets. At this stage,China is still unable to successfully enter the established pharmaceutical fields abroad,and many innovative drugs made by China are actually filling in blanks.

After experiencing the cold winter in biopharmaceutical entrepreneurship,the Chinese market has now entered a golden stage,enjoying particularly rich capital reserve. If Chinese pharmaceutical enterprises are to move forward,they must realize that despite the relatively weak foundation,the national government and the capital market are quite strong. Domestic pharmaceutical enterprises can introduce fine projects through license-in model,and then develop global influential products,thereby further elevating their position in the industry.

Chinese pharmaceutical enterprises are moving forward without a stop,and Dr. Tong's career has never paused. For the 38 years in the pharmaceutical industry,he almost has no private time.

Greater ability comes with greater responsibility,Dr. Tong said,"I will always be busy,never thinking of retirement. It is very proud and meaningful for me to participate in this industry which I love and can create health for the mankind."

Source: E Medicine Manager