Kintor Pharmaceuticals：Being a leader in the field of treatment
February 27th is the Dragon Heads-raising Day falls on the second day of the second lunar month, which is a traditional festival. Kintor Pharmaceuticals is officially listed in Chinaipo . Founder and CEO PhD. Tong Youzhi, co-founder and CSO PhD. Guo Chuangxin and team members wear a long red scarf together to celebrate the historic moment of listing.
PhD. Tong Youzhi
It was questioned that it would do more harm than good to let an innovative drug companies listing earlier, but Tong Youzhi is still firmly out of this step. He believed that "listing is not just for financing. It is good for the company's standard management and employee motivation in the long run.”
Surprise found: pucalutamide
Pucalutamide is the flagship product of Kintor Pharmaceutical ,it is also the company's fastest-growing R&D products.It is used in the treatment of advanced prostate cancer. At present, clinical trials have been carried out in both China and the United States, and China has entered the phase II clinical phase. The drug's breast cancer development indication has just received the China 1 ~ 3 clinical approval.
It is a follow on innovative medicine, in 2009, Kintor Pharmaceutical research was approved when Enzalutamide is in clinical phase II. Enzalutamide is the second generation of androgen receptor inhibitors, mainly used in the treatment of prostate cancer,which was finally accelerated approval listing by FDA in 2012, much faster than the expected.
There's a little story in it. In fact, at that time, the first generation of androgen receptor inhibitor Bicalutamide had achieved good effect in the treatment of prostate cancer, but it had been effective only for early patients, so many people believed that androgen may not be the main cause of the worsening of advanced cancer patients, which resulted in the treatment of advanced patients take many detours at that time.
"At that time, we saw the clinical advantages of the drug, but also holding a small company to stabilize the mentality, so we follow the study of new drugs with this mechanism firstly.”Tong Youzhi said. "Enzalutamide has side effects that lead to epilepsy, so we first modified its structure so that it could not pass through the brain barrier.",however, when the molecule was sent to the United States for a pharmacodynamic review in 2012, there was a more surprising discovery that it could down regulate the expression of the AR gene, which changed our company's strategic objectives that from the original only intended to do China's mitation of innovative drugs, adjusted to do a global development strategy."
Therefore, Tong Youzhi is confident of pucalutamide, he predicted that Enzalutamide will be listed in China in 2019, and that his own drugs by the fastest speed will also be listed in 2019 - 2020. Pucalutamide got the I / II / III linkage large documents, which saved a lot of time. Tong Youzhi said: “although the funds of company's early development was very difficult, we strictly controlled the experiments related to the safety of the drugs.” That's why our clinical trials have been approved at a faster rate, in terms of the advances in breast cancer and other indications, we may be even more faster than our competitors in domestic."
From the speed of extended indications declaration , Puccinamine completed all preclinical studies in September 2013, submitted a clinical trial application for prostate cancer indications to the Jiangsu Drug Administration, and obtained CFDA clinical approval in March 2015 , the whole process took one and a half years. The test application of breast cancer and other tumor indications is benefit from priority review policy. It was submitted to the Jiangsu Drug Administration in July 2016, and to the State Drug Administration in September the same year, and was priority reviewed and approved in November , only 5 months.
R & D progress first
Tong Youzhi had been involved in cancer drug research since he studied in the United States. He had studied gene therapy and immunotherapy, the two most popular cancer treatments at present. During his PhD in pharmacology at MemorialSloan-Kettering Cancer Center, he tried to change the bone marrow cell gene to make them resistant, so as to reduce the damage of chemotherapy drugs on the human body. During his postdoctoral study, he spent two years in the study of immunotherapy, but gene therapy and immunotherapy were lukewarm at the time, and occasionally negative news emerged.
Later, Tong Youzhi went to Albert Einstein School's of Medicine , started his own laboratory, and met the dean, a jew. Because the United States NIH also encouraged professors to open the company to carry out scientific research transformation, applied for a certain amount of R & D funding through special projects each year, so the dean also wanted to form his own company and invited Tong Youzhi to join, thus Tong Youzhi became Vice President of the innovation company, and spent 6 years in this innovative drug companies called ANGION.
Tong Youzhi had gained extensive experience in the development of small molecule drugs at ANGION. He said: "at first, the Dean selected the direction of gene therapy, but gene therapy was an accident in American clinical trials, the government was no longer willing to grant, so we began to look for other targets to do small molecule chemotherapy drug research, but they were some of the first in class targets. "
Tong Youzhi also learned how to start designing his own lab from scratch, what people need to hire to support his own work, but also experienced a relatively complete drug R&D process, and knew how to standardize the experimental operation, which were useful when he opened up the Kintor pharmaceuticals. He said: "I learned a lot from ANGION, the laboratory work was not redundant, sometimes the repeatability was not good, in order to adjust the R & D direction according to the problem, we should operate in person and operate according to the standards, the process also allows my team to continue to get the chance to exercise in practice and improve the R & D strength of the company."
As to here, Tong Youzhi recalled the fastest new drug at ANGION at the time:"It was a new drug for C-Met target, phase III clinical has now been achieved, anti-cancer effects will be achieved if the target is suppressed, but we have been surprised to find that when activated, it can act as a liver fiber growth factor, and is used to treat many organ damage diseases, including stroke, organ fibrosis and so on."
However, Tong Youzhi is not very excited about the progress of ANGION research, but feel a little sorry. "It could have progressed faster," Tong Youzhi said."The original boss was always tightly grasp the stock right in hands, in addition to limited government R & D funding, he never wanted to use the stock in exchange for financing, to speed up the progress of drug R&D. Drug molecules had been identified in 2004, but clinical studies have dragged on today."
With the lesson, after the founding of Kintor pharmaceuticals, Tong Youzhi placed drug development speed at the first place. He doesn't care much about how much he owns, and thinks that the only thing that matters is that the company develops at its own pace.
Keep a cool head
The rapid growth of the Chinese pharmaceutical industry finally made Tong Youzhi decide to return home.
In 2007, he went to China for an activity,when a Guangdong pharmaceutical company invited him to make a report on new drug research and development. He was astonished by the laboratory equipment of the company, he quoted a remark from foreign media reports: "we're like entering the HPLC forest.".Later, a friend in the United States lost his job ,which accelerated the pace of his resignation and return to his hometown.
During the return to find a foothold, Tong Youzhi attended a roadshow in an investment forum in Suzhou, and showed the plan to build a new company. Finally, his road show won first place, Tong Youzhi began to set up a new company logically. However, a financial crisis in 2008 made the hope of financing into a bubble completely ,"drive a duck onto a perch "is the deep impression of Tong Youzhi on the next company's operating state.
He had quit his job in the United States, there's no escape route. So, in March 2009, Tong Youzhi still registered the Kintor pharmaceuticals, together with the partners to complete the laboratory renovation, laboratory reagents to buy and hire staff. He told a detail:" We would deliberately slow down the pace of the experiment, so that employees were not so busy, because the faster the more money would be wasted, the next month might be difficult to maintain."
The turnaround took place in 2010, Kintor pharmaceuticals hormone inhibitor project was shortlisted for the national "Twelfth Five-year " major special plan Period, with the shortest time to set up among all shortlisted companies. At this time, Yuandian venture capital invested 2.5 million to complete the company's angel wheel investment, then major special funds were quickly allocated, the development of the company was finally come around.
"Compared to the current situation, it was really hard to make an innovative medicine, and more importantly, no one understood your idea, so it was very difficult for innovative drug companies to get investment.".Tong Youzhi sighed with emotion.
However, even if the R & D environment that Kintor pharmaceuticals facing is more relaxed than before,in Tong Youzhi's view, "the focus on the risks and clinical needs of innovative drugs will not be changed.”.
"Capital can reduce the threshold of the new drugs, but can not reduce the risk of new drugs, moreover, China's future threshold for new drugs will be higher and higher,in addition to the more stringent regulation, the market will have higher requirements for new drugs. The United States approves about 20 new drugs a year, it seeks not just a new mechanism, a new target, or a new compound, but also requires better treatment than the existing treatment, which will be the same in china in the future." Tong Youzhi said: "the failure will certainly appear, so you should think about is whether you have given yourself a chance to fight back."
R & D is not a person's work, in order to complete, it requires a team to cooperate with each other. Tong Youzhi has been grateful for the addition of PhD. Guo Chuangxin, the Kintor chief scientific officer. They were brothers in the same department of Peking university. Soon after the founding of the Kintor pharmaceuticals ,Guo Chuangxin returned home and became the co-founder of the Kintor pharmaceuticals. Tong Youzhi said: "In many ways, we are complementary, I've been working for a small innovation company, while PhD Guo has been involved in new drug R&D at large companies such as pfizer, our experience can complement each other, so we've been working together very well these years."
Become a leader in the field of treatment
Over the past few years, the financing of Kintor pharmaceuticals has been more and more smoothly. Looking back, even in the most difficult times, Kintor pharmaceuticals has not developed other business to increase revenue, just to not distract the research effort.
After the product has entered the clinic, Kintor pharmaceuticals hopes to focus on the drug R&D in a disease field and provides the best treatment for a disease. Therefore, the product line layout of Kintor pharmaceuticals will focus on an area of indications.On the basis of the company's own R&D, the introduction of other potential products, so that the product line is deep and thick. Tong Youzhi told R & D passengers that the company recently introduced a targeted inhibitor for cancer treatment, which will become the company's new product for clinical declaration this year.
Now, Kintor pharmaceuticals also began to participate in First in Class product R&D, the future is full of challenges with the step is made, after all, in the review and approval, China has not yet many cases of successful approval of the original new drugs. Facing the future, Tong Youzhi stresses : "the R&D of new drugs must be carried out in accordance with scientific standards.".