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Seven years accumulation,TOT BIOPHARM international departure | JPM

发布时间:2018-02-02

This year's JPM health conference is the first time for TOT BIOPHARM to attend. For a company that has been little exposed in the past, the trip signals an outward search for opportunities. Since its establishment, TOT has gradually realized its plan of "going out".

Write | shi yingzi

Shi.Yingzi@PharmaDJ.com coordinating editor | yao jia Yao.Jia@PharmaDJ.com

Dr. Liu jun, deputy general manager of TOT BIOPHARM, participated in JPM health conference for the first time this year. As scientists, they have not been seen on such occasions in the past, and the main purpose of the trip is to find financing and development partners.

Dai jialing, executive editor of r&d client and Dr. Liu jun met and talked at JPM.

The last public financing of TOT dates back to March 2016. The r&d client interviewed the company's general manager, Ms. Huang chunying, shortly after the financing was completed. Nearly two years have passed. Although in the last wave of financing of domestic biotechnology companies, TOT did not choose to embrace the frenzy of capital.

TOT  currently has a GMP workshop of 10,000 square meters, and an antibody drug production workshop of 13,000 square meters has been constructed since 2016. It is estimated that the antibody drug production capacity will reach 10,000 liters after completion in 2018. Companies have three biological medicine, three chemical medicine in clinical research, one entered the stage of clinical Ⅲ biological medicine. The company became the first approved MAH pilot production enterprise in jiangsu province. Also set up a branch in all parts of the country sales team, responsible for the company's varieties and agent products sales.

This is the achievement that east yao pharmaceutical industry establishs 7 years in time, exposure is in media very few.

hiring

In the past year, TOT  has recruited two vice general managers: Dr. Liu jun, who is in charge of the quality of biological drugs, and Dr. Liu min, who is in charge of clinical research.

Liu jun has been responsible for the development, process development and quality research of protein drugs in bayer and wise chemistry. He has more than 20 years of experience in the research and development of biological drugs. Liu min is a clinician who has been fighting blood cancer for 30 years and has been responsible for a number of transnational and trans-regional clinical studies. They specialize in different areas of expertise and complement each other in management.

This round of recruitment intention is clear: new products before the launch of the sprint provisions. East over the past two years, we carry out increasing the number of clinical research projects, research and development of the fastest varieties has entered a phase III clinical, this stage need to be more professional talents to develop clinical development strategy, to follow up the test project management, and at the same time also need to continue to improve test drug production process, ensure the quality of products, in order to achieve the standards of the sale.

"Two-chain four-platform"

The second part of the company is to build "two chains and four platforms". "Two-chain" refers to the complete industrial value chain and product chain of anti-tumor drug development. "four-platform" includes drug innovation platform, industrialization platform, cooperative development platform and commercial platform. The two are connected in series and constitute the management and development framework of TOT .

Although the scale of TOT  is small, it can complete various tasks such as drug early development, process development, pre-clinical research, transformation research of new cancer drugs, clinical research, new drug market application, drug manufacturing and marketing. The opening of this industrial value chain enables the company to develop drugs at different stages and balance the risks of new drug development with product revenue.

And the product chain layout is getting better and better, giving TOT the potential to develop different product combinations. In the previous interview, huang chunying mentioned that TOT is optimistic about the joint application of different types of tumor treatment drugs, and the implementation of this strategic layout needs a rich variety in research as the basis.

The existing product chain of TOT  includes monoclonal antibody, ADC, oncolytic virus products and small-molecule chemical drugs. It has a comparative advantage in the development of ADC and oncolytic virus, two cutting-edge products. It is one of the few domestic enterprises with the ability to develop and industrialize antibody-conjugated drugs. There are one antibody-conjugated drugs project in research, two pre-research projects, and it is expected that two products will enter the clinical research stage in the next three years. According to Research & Markets, the ADC market will reach $10 billion by 2024. In addition, TVP211, a new generation of onolytic virus product designed by TOT with double gene insertion, is also expected to enter the clinical research stage in the next two years.

"Siping platform" provides relevant services and technical support for the development of the company's internal industrial chain and product chain as well as external cooperation. The company's innovation platform has mastered the key technologies of oncolytic virus, therapeutic monoclonal antibodies, antibody-conjugated drugs and special dosage forms of liposomes. In the future, more new products can be developed with the advantages of these technologies. "The company will put more energy into the early development of new drugs in the future," he said.

The main task of the industrialization platform in the past was the production and development of experimental drugs and preparations. The total area of 10,000 square meters has been built, including 3 chemical drug workshops meeting GMP standards (2 chemical drug oral workshops, 1 injection workshop) and 1 pilot plant of 500 liters of biological drugs. The biological medicine production base started to be built in 2016 is to prepare for the production after the product is launched on the market. After its completion, the production capacity of biological medicine of TOT  will also rank among the top in China.

The other two platforms reflect the new strategic layout that east yao opened nearly two years ago. After several years of internal training, east yao began to the direction of export-oriented companies to develop, take the initiative to find new strategic partners, business follow the pace of policy adjustment. Become the first approved MAH production enterprise in jiangsu province, is a highlight in the company's development in the past two years.

MAH strategic layout

In 2017, the application for the small molecule new drug MAH cooperation project of TOT  pharmaceutical and pioneer pharmaceutical was officially approved by CFDA, which was the first MAH pilot variety approved by CFDA in jiangsu province. This event marks the official landing of MAH system in jiangsu province, and is also a key step forward for the cooperation development platform of TOT on MAH.

As a matter of fact, huang chunying has had this strategic plan for a long time. She thought that there were so many innovative companies around TOT . If each company built its own production base, the research experience would be scattered and the resources would be wasted. Therefore, at the beginning of the drafting of domestic MAH regulations, huang chunying began to make active plans, and even some of the embryonic forms of cooperation programs were already determined at that time.

"The realization of the MAH system in China was a natural process, and the first flower just fell to the TOT  family, because the partner took a fancy to our quality." "It took five years for TOT  to establish a drug life-cycle quality management system to manage all the factors that affect the quality of drugs throughout their life cycle, including product development, technology transfer, commercial production and product termination," liu said.

East yao will also MAH cooperation perspective into the field of macromolecular drug production. Although there is no corresponding policy support at present, liu jun thinks that since it is still in the pilot stage and the policy formulation is relatively conservative, once the time is ripe in the future, it will definitely usher in full liberalization.

"Domestic MAH just started, although the national support is not small, but the industry in the responsibility of risk bearing, insurance protection and other aspects of the current stage also need to multi-run, after the progress should be relatively smooth, TOT  has been ready to cooperate with more enterprises in a wider range of areas. Who said.

Seek outside cooperation

In addition to production, TOT  is also looking for partners in new product development. On the one hand, in considering the introduction of new investment, the Hong Kong listing plan has been considered by the company; On the other hand, it is also actively looking for external cooperation to promote the mutual utilization of r&d resources.

In terms of the development of anticancer drug combination, TOT  is no longer limited to the internal research and development pipeline. Some products have been developed in cooperation with external companies. The company's clinical medical team is also actively looking for external varieties in different development stages to carry out clinical research.

Dr. Liu jun introduced TOT  to investors on JMP.

"You have to have partners to do biologic research and development," he said. "even multinational pharmaceutical giants go from deal to deal. "TOT's accumulation in the past few years has given the company an advantage in cooperation," liu said.

East yao made future "go out" lofty goal. CFDA accelerates the pace of internationalization and draws closer to the developed countries in Europe and America in terms of policy making, which creates opportunities for the development of Chinese and foreign companies. TOT decides to seize these opportunities. "This time at JPM, my biggest feeling is that we have opportunities in the future, and more than now." Liu jun expressed his optimism about the company's future development.

Shi.Yingzi@PharmaDJ.com r&d guest reporter