According to the data of the State Food and Drug Administration, there are more than 200 innovative drug declarations in China this year. Although most of them are experts in returnees, some industry professionals have pointed out that “the development of innovative drugs in China has taken a solid step. At the beginning, they were all toddlers, but the development of innovative drugs in China has a good beginning." Among them, in the field of anti-tumor drugs, China has begun to pick up.
According to industry insiders, due to the high incidence of cancer on a global scale and the high mortality rate of some malignant tumor diseases, the development of anti-tumor drugs on a global scale is very high, “from small molecules to targeted therapy, Antibody drugs, to follow-up cancer vaccines, are involved in these directions. Ten innovative drugs, of which five or six are anti-tumor drugs, are more obvious in China.
From “copy-based†to “innovation is the most importantâ€, the Chinese pharmaceutical industry is undergoing a transition from “quantity†to “qualityâ€. Today, China is also making progress in anti-cancer drug innovation.
For example, on the evening of December 6, Beida Pharmaceutical announced that the application for clinical trials of BPI-17509 and BPI-17509 tablets has been accepted by the State Food and Drug Administration, and a series of clinical trials have been carried out and approved by the State Drug Administration. It can be listed after approval by the bureau.
According to the announcement, BPI-17509 is a new chemical structure of fibroblast growth factor receptor (FGFR1/2/3) small molecule oral inhibitor independently developed by Beida Pharmaceutical. It is intended to be used for FGFR gene fusion mutation or amplification. Various types of cancer treatment. FGFR belongs to the tyrosine receptor kinase family and includes four receptor subtypes (FGFR-1, 2, 3 and 4) as well as some isomeric molecules that play an important role in tumor proliferation, angiogenesis, migration and survival. The role. It is reported that BPI-17509 belongs to “innovative drugs that are not listed at home and abroad†and its registration is classified into chemical drugs.
China is also constantly tackling the difficulties in the field of anti-cancer drugs, and a company has also achieved certain results through its efforts. However, China still has a long way to go in the development of innovative drugs. Some analysts pointed out that the development of innovative drugs is very difficult. For example, the cost of innovative drugs is not only reflected in production costs, but also in R&D investment. A drug failed to verify before clinical practice, with an average loss of 50 million yuan, and even a loss of more than 100 million yuan after clinical practice. "These all need to be undertaken by startups. I really feel that failure is a normal state for innovative drug development, and the failure rate is even as high as 90%, but you must not retreat because of this. Of course, you should not underestimate it."
Since May 1, 2018, China Customs has implemented zero tariffs on imported drugs for 28 tariff codes at a tentative rate. It is estimated that this may mean that the Chinese cancer patients will save about 2 billion yuan annually. But from another perspective, the introduction of this policy also reflects the shortcomings of domestic pharmaceutical companies in the independent research and development of oncology drugs. According to statistics, China's current anti-cancer drug market is about 140 billion yuan, and imported drugs account for about one-third of the total, and many of them are special effects drugs.
Faced with the difficulties in the field of innovative medicine, powerful listed companies will also choose to develop some innovative medicine projects, but basically at the same level as the returnee startup company. “Overall, the current domestic innovative drug research and development is still in the imitation stage. At the source, there are fewer innovations. For example, when European and American companies discover new targets to carry out Phase II and Phase III clinical studies, Chinese companies will introduce the domestic rights of the new drugs to develop. However, China is in the field of anticancer drugs. The innovation has never stopped. Some industry said that it started to imitate more, but we believe that the gap with foreign innovative drug research and development will be narrowed step by step.
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