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PegBio:Calm down and take your own way

time:05/05/2017 page views: resource:BioBAY

The first close contact with PhD. Xu Min was in the signing ceremony of the GKA project between PegBio and PfizerBio, his speech was brief and slightly understated. Once again into the Suzhou BioBAY , and sit with the lean and capable CEO , his humor and wisdom in conversation has beyond the general imagination of most people who are interested in medical R&D.
 
He talked about his own experience lightly, but let my mood ups and downs. Who would have thought that it was also a very good venture capitalist for four years to complete the PhD medical profession at the Columbia University? From a venture capitalist's perspective to see today's Chinese new drug R&D, Xu Min's views are somewhat different.

Entrepreneurship is a seemingly simple but difficult choice

Frankly speaking, R & D passengers twice approached PegBio and have such doubts: When the domestic (or foreign) most pharmaceutical companies are together in oncology drug development, PegBio has chosen the field of metabolic disease , what is the reason for that consideration?

"Because of my medical background, I've been thinking more about how to make new drugs from a clinical perspective. Of course, cancer drugs are really an urgent concern in the clinic, however, in terms of clinical practice in china, there are many other diseases that are not met, except cancer."

In PhD. Xu Min's view, there are more other gaps need new drug R&D to fill except cancer in clinical needs . The hope of life forces everyone to make a choice that many pharmaceutical companies are concentrated in the field of cancer, such a popular will also make investors more interested. Take a broad view, the demand for other diseases is also very large, but the requirements will be high for drug reviews, the so-called “druggability”are not as high as cancer drugs. The reason why we don't first choose cancer is because the demand of the field like metabolic diseases, immune chronic diseases is very large in China ."

"With this feeling, Xu Min focus on poly glycol technology. In a sense, it is a dosage form transformation, after all, it is not the discovery of new targets. “In Xu Min's view, the course of China's innovative drugs must be from me-too to me-better, and finally to achieve first-in-class. "New drug R&D needs more than ten years, each link is very finely differentiated, and the required knowledge and experience are different.". Therefore, it is impossible for a person to understand all the processes of a drug well, including the understanding of the technology and the cognition of the regulations. Perhaps it is this honesty and humility that sustain him through many entrepreneurial twists and turns.

PegBio Medicine is one of the earliest companies to enter BioBAY. Since officially settled in 2008 , PegBio has stayed in the office for ten years, and never had moved. The exterior walls of the building where the office is located are somewhat old, with passages criss cross the room, there is a fire sprinkler at every intervals in the corridor.

However, for Xu Min personal, he started his business in China 8 years ago, and in 2000, he had stayed in Zhangjiang, Shanghai for a period of time. "At that time, I saw that the first generation of recombinant protein genetic engineering companies wanted to do long-term product development, so they tried to survive with the new drug development model, that is, CRO model." But he soon discovered that it was difficult to support the development of new drugs by using the business model of services. After many reflections, Xu Min decided to do his new drug R&D, and told investors about the decision. Then, PegBio medicine was born with the support of $ 1.2 million.

Xu Min said, as one of the core techniques of PegBio, PEGylation technology is not a panacea that must be applied to suitable project. Only in this way, can we give full play to the technical characteristics, improve some drugs, and finally achieve the effect in the clinic.

 


PegBio CEO PhD Xu Min


"This process is full of sad and depressing things, but there are lots of happy times, too." Every entrepreneur has many unknown ups and downs, Xu Min is no exception: “Don't be conceited when you achieve your results, and don’t be discouraged when you are frustrated, raise your head proudly, and even if it's over tomorrow, you can be proud of yourself."That emotional monologue is the most touching part of the whole interview. "That's what I'm most happy about, not how many items our company has declared, and how much the money is raised.”

Good time makes the innovative phiarmaceutical industry development.

“Financing is one of the ways that the outside world accepts you, but not all. If you really want to do a good job, there are many ways to prove your worth and your sense of existence.” In fact, PhD. Xu Min returned as a venture capital manager in 1997,which is very rare in new drug R&D entrepreneurs. As a result, he has witnessed the development of China's innovative medicine from a venture capitalist perspective. “The first time to witness the development of biotechnology in China was in the late 80s.” Interferon was the first biotechnology product, at that time, China had more than 60 enterprises to study recombinant interferon, and later they could only reduce drug prices to obtain market share." Today, China has entered the upsurge of PD-1 antibody(Ab)R&D. The cost of Ab research is far higher than that of recombinant interferon, and whether the Chinese market can hold so many PD-1 drugs is still unknown. Although China has a lot of cancer patients, price competition will be a trend. “The second witness is in recent years.” Xu Min said. From 1990 to 2000, generic drugs were sold throughout the Chinese market with profit no more than 1%. At the same time, China's economy is not as explosive as it is today, investors are also difficult to support the development of innovative drugs.

"For Ab drugs, the global multinational pharmaceutical companies are in fierce competition, the following factors are critical to the success of Chinese enterprises: First of all, on the development schedule, the Ab drugs developed by Chinese enterprises can enter the market(Chinese)before multinational enterprises; the developed drugs can differentiate other competing products clinically (efficacy and safety); on the process, whether the large-scale production of Chinese Ab products can be superior to multinational products, and reduce the production cost of Ab products. On the other hand, investors do not like the United States as they have experienced several product cycles, fully understanding and grasping the situation of making money and losing money. In the field of biopharmaceutical, investment funds have not yet fully experienced those cycles, everyone is not sure about how much money can the investment project eventually make, or how much it will loss.In addition, China's capital market is far less mature than the USA, the USA has a mature capital industry chain, especially in the field of biopharmaceutical or innovative drugs and technology, China's capital markets are not performing well. For example, how to successfully withdraw capital used to invest in innovative drugs or technologies, and to obtain returns on investment, is still very challenging and uncertain. Such a situation is detrimental to the development of China's biomedicine. "In a sense, ten years of China's economic development has saved countless enterprises. It broke out in the last two or three years, and met the best chance. However, even today, innovative drug companies are mushrooming, they can't afford to be truly original medicine. " The reason why there are so many original medicines in Europe and America is based on their excellent and solid basic research and talents. In terms of investment, it is also because of the twenty or thirty years of economic development that China has invested in innovative drugs."Indeed, from the discovery of the target mechanism of the innovation drug, to the screening of the compounds, and the step-by-step completion of the clinical, it is difficult to achieve the original drug without thirty years' accumulation. "New drug R&D requires data and experiment, the most important thing is whether the products developed can be translated into clinical manifestations, and the advantages and characteristics of this product are demonstrated clinically. It is tempting to speculate that the reason why PegBio didn’t accept the wide range of media exposure is probably that. 


Blockbuster drugs are poised to take off

If the spotlight's reputation can not move the mature R&D team, then, when talking about the products under study, Xu Min finally showed confidence and determination. Here, as the projection didn't work very well, he carried the computer and came across from the opposite of conference table to us,explained to us the current company product R&D progress with each piece of data and form. In 2006, PegBio began to focus on the use of PEGylation in diabetes drugs .The original medicine listed in 2005, is the product of GLP-1 for diabetes, as a peptide drug, it is easy to be excreted by the kidneys,and there are DPP4 enzymes in the human body, which can be inactivated after cutting off, so two injections are needed after listing. In the absence of medical insurance, the patient needs to pay 2000 Yuan per month. Xu Min believes that the drug has some defects, including low compliance , toxic, and expensive. Therefore,BP-119, which is being studied by PegBio, is designed to reduce the side effects of the drug by PEGylation and to improve its compliance.
After PEGylation, it reached steady state quickly after single dose. It can be inferred that it will have a good effect. The t1/2 is 70~80 hours,so it can be administered once a week. Xu Min revealed the progress of the current PB-119 test results to the R & D passengers “ The incidence of some side effects, such as nausea and vomiting, was 50%, ours is less than 30%." As an exogenous polypeptide drug, Ab will appeared when a long-term use. "The data show that the Ab production of the original drug is 67%, our product is only 25%, and this is our products’ advantages and competitiveness in clinical in the future ." The results of the PB-119 in the United States are very consistent with the results in China, without racial differences. Xu Min added that in addition to being used for primary diabetes, PB-119 has a significant hypoglycemic effect with the increase in dosage when it is used in combination with metformin. For the time being now, it can be used alone or in combination. Since PB-119 has good efficacy, less side effects, and high compliance, it is estimated that the cost of using PB-119 is only about 1/3 of the current imported products after the future listing. 


At the same time,PB-119 achieved the CFDA and FDA declaration.CFDA and FDA declaration have two main indicators “The first one is the new drugs developed must solve the clinical unresolved needs. Since many diseases have been treated with drugs, the products developed must be differentiated from existing products, with better efficacy or less toxic and side effects. Another one is the need for global intellectual property rights." At present, PegBio has two compounds with global intellectual property rights. In 2016, GKA project cooperated between Pfizer and Peg is also for the field of diabetes. "The goal of our collaboration is to provide patients with drugs used for chronic metabolic diseases, so as to achieve the so-called precise treatment. Because each person's response to the drug is different, the efficacy and side effects are not the same, can be combined treatment or treatment alone. On that basis, products with other mechanisms of action can also be continuously increased." In fact, Peg is developing a blockbuster original drug used for antihypertensive, hypolipidemic, obese and non-alcoholic fatty liver. Xu Min revealed that the drug belonged to first-in-class. From me-too to me-better, realize first-in-class finally, Paige is according to its own rhythm in the jungle looking for better survival and development. "Many people question those who have done investment before, and now they are doing research, because I like challenges, I said. Perhaps everyone loves challenges, but the key is whether you can face the real challenge brought by the challenge! each period has different problems, funds, projects and talents." At the end of the interview, and lean and capable CEO still calmly"For me, the challenge that I didn’t stepped over is a setback, but it is a experience when I crossed."