"None of the more than 5,000 existing pharmaceutical companies in the country have yet entered the world's top 50 pharmaceutical companies. Even from the perspective of generic drugs, Chinese pharmaceutical companies are quite far from generic drug giants such as Israel's Teva and Germany's Sandoz." In a recent corporate interview, Dr. Hongli Liu, General Manager of Shanghai Hepu Biotechnology Co., Ltd., was worried about this. 90% of the drugs currently approved in China are dosage form modification and generic drugs. The main reason is that the investment in innovative drug research and development is long and the research and development cycle is long. The majority of pharmaceutical companies may be discouraged or unwilling to take risks. Among the only 10% innovative drug research and development companies, some companies did not proceed from market demand, and the variety development process did not form a capitalized business development model, resulting in the failure of most innovative varieties to effectively industrialize and eventually die.
Drawing on the commercial development model of capitalization of the international new drug R & D process and aiming at the needs of China's differentiated pharmaceutical market, the new drug R & D, drug market and capital market will be seamlessly connected, becoming Shanghai Hepu Biotechnology Co., Ltd. ) Waiting for a group of Zhangjiang Pharmaceutical Valley companies to strive to explore the development direction.
Chronic hepatitis B virus (HBV) infection is one of the most serious health problems in China. There are 87 million long-term HBV carriers in China, 20 million chronic hepatitis B patients, and more than 1.5 million chronic hepatitis B cases each year. The huge medical demand for liver diseases makes China the world's largest market for liver medicine. Hepatitis B and related liver diseases are relatively rare in Europe and the United States. The major Western pharmaceutical companies have very limited investment in the development of new hepatitis B drugs. Self-reliance research and development of new hepatitis B drugs is the only way to solve the problem of liver disease treatment in China. It is also extremely rare for China's R & D drug companies It has reserved a development space where the market is relatively broad and the competition is not fierce.
Long-term research and development of original drugs, Shanghai Hepu has formulated a development strategy of "focusing on the development of innovative drugs for hepatitis B-related diseases to achieve business growth, gradually intervening in the mainstream market for new drug research and development to complete the company's growth", and for this purpose has deployed Hepratide and Hepu The competitive R & D line of new drugs for hepatitis B-related diseases including Yinfen. Among them, hepalatide belongs to a new mechanism for the treatment of hepatitis B. By combining with HBV infection receptors, it protects healthy liver cells from hepatitis B virus reinfection, and the virus-infected liver cells are gradually destroyed and cleared by the immune system. Provide a new treatment strategy for chronic hepatitis B. The project has been approved by the National Key Science and Technology Project of "Major New Drug Creation". In 2014, it will enter the clinical trial research phase in accordance with the national category 1.1 innovative chemical drugs. Hepuinfen is the third generation of interferon after ordinary interferon and long-acting interferon. It targets interferon to the liver, the main organ of hepatitis B virus replication, through a specific guide structure. While reducing the extrahepatic toxicity of interferon, effectively increasing the drug concentration in the liver is expected to solve the current problem between the efficacy and toxicity of interferon. The project has been approved by the National Science and Technology SME Innovation Fund.
The R & D cycle of innovative drugs often lasts for more than 10 years, and requires huge and long-term continuous investment of R & D funds. The end of technological innovation is the listing of products. The general manager Dr. Liu Hongli said that innovative drug research and development is a double dance of technology and capital, and technological innovation and capital drive are indispensable; and the state's support for innovative drug research and development has achieved a broad stage for innovative drug research and development. As early as Shanghai Hepu's first R & D project, Hepratide technology research and development, Shanghai Hepu maintained a high degree of commercial sensitivity, keeping technology research and development in sync with business plans, while paying close attention to relevant national support policies.
In 2010, Shanghai Hepu declared the National Science and Technology Major Project of "Major New Drug Creation" with the results of the Hepatide pilot test, and obtained 5 million yuan of research and development funds from the Ministry of Science and Technology and Shanghai Zhangjiang Park, which provided the key for the follow-up preclinical research of this project. support.
After the completion of the clinical research application of the Hepratide project in 2012, Shanghai Hepu had extensive contact with investment capital in the pharmaceutical field. Finally, the project was priced at 50 million yuan and received a 25 million yuan investment from the Shanghai Pudong Biomedical Industry Development Fund. The general manager Dr. Liu Hongli emphasized that the development of new drug projects must be consistent with the increase in capital gains and form a mutually beneficial and win-win situation before new drug research and development can reach the end. Taking the Hepratide project as an example, the pre-clinical R & D investment is about 10 million yuan, and the value of the project is 50 million yuan after entering the clinical research stage. The value-added of the initial investment reaches 400%; the project value is expected to reach 300 million after the completion of the phase II clinical trial Yuan, the capital gain of this round of financing is expected to reach 300%; the value of the project after the listing of the new drug is expected to reach 500 million to 1 billion yuan, and the capital gain rate is expected to be higher. The market faced by the new drug is directly related to the value of the project, and Dr. Liu Hongli had a clear understanding of this at the beginning of the company. Through the huge market, the value of new drug R & D projects is mapped, the project development drives capital appreciation, and the capital appreciation effect drives more R & D capital investment, and ultimately achieves the ecology of technological innovation, market and capital win-win. How innovative products are marketed more effectively is testing the wisdom of entrepreneurs.
With the increasing difficulty of drug research and development and the continuous expansion of the field of drug technology, the development of R & D pharmaceutical companies will face severe challenges. "Hepu Bio's Hepratide, Hepfin, and subsequent new drug development will form a strategic market support point for hepatitis B treatment." Liu Hongli said. At present, Shanghai Hepu's main market is mainly China, and the follow-up projects will gradually transition from local innovation to international development. The first batch of patent promotion countries will be countries with large populations such as India and Indonesia and the same high hepatitis B infection rate. In the field of research, it will also try to expand into the field of liver cancer and hepatitis C treatment.