The R & D power of domestic drugs is increasing

Compared with developed countries, there is still a large gap in the level of drug R & D in China, with more follow-up R & D and relatively lack of breakthrough innovation In response, China has issued a series of policies to deepen the reform of the review and approval system, purify the ecological environment of clinical trials, strengthen the protection of innovative drug patents, and promote the overall development from a big country of generic drugs to a big country of innovative drugs In the past few November, the field of domestic innovative drugs has been reported frequently   On November 2, the National Drug Administration conditionally approved the launch of ganlute sodium capsule (gv-971) for the treatment of mild to moderate Alzheimer's disease; on November 14, zebutinib, a Btk inhibitor developed by Baiji Shenzhou company, was approved by the U.S Food and Drug Administration (FDA) for the treatment of adult mantle cell lymphoma patients; on November 26, hausen pharmaceutical methanesulfonic acid Flumatinib has been approved for marketing, providing a new drug choice for patients with chronic myeloid leukemia All of these three drugs are innovative drugs independently developed and with independent intellectual property rights in China Among them, zebutini is the first Chinese "native" anticancer drug with FDA "breakthrough therapy" identification and "priority review" qualification, which has achieved a new breakthrough in the export of domestic innovative drugs There are many R & D constraints, from the initial project approval to the official approval of FDA listing, and the R & D time of zebutini is more than 7 years In terms of new drug creation, this time is not long There is often a "double ten law" in the field of drug innovation: 10 years, 1 billion dollars, is the average cycle and cost of a new drug from early research and development to commercialization As far as the drug itself is concerned, new drug research and development is a long march, which needs to go through many links such as target confirmation, compound screening, pre clinical research, clinical trials, new drug marketing, post marketing monitoring, etc.; as far as pharmaceutical enterprises are concerned, new drug research and development is a gamble, with long cycle, high cost and high risk, which may become famous in the first world war or lose all over the market Take Baiji Shenzhou company as an example Its financial performance in the third quarter announced on November 12 shows that the company's revenue in the third quarter is 50.14 million US dollars, and its expenditure is 362 million US dollars, including R & D expenses of 237 million US dollars, with a net loss of more than 300 million US dollars In this case, zebutini, which has been approved for listing in the United States, is of great significance or will reverse the situation However, not all pharmaceutical companies have the courage of Baiji Restricted by many factors such as limited economic strength, weak basic research, insufficient talent reserve and imperfect related system and mechanism, domestic pharmaceutical enterprises are mainly producing generic drugs, with weak R & D awareness and ability The original products of foreign pharmaceutical enterprises have long been the leader in China's pharmaceutical market The turning point of policy dividend being released came in 2015 when the state started the reform of drug review and approval system In 2015, the State Council issued the opinions on the reform of drug and medical device review and approval system, marking the beginning of China's drug review reform "Before the reform, the speed of drug examination was too slow Taking the application for clinical trials as an example, the first stage clinical needs to be queued up for one year, the second stage clinical needs to be queued up for another year or even one and a half, and the second stage clinical needs to be queued up for three periods after completion After the reform, phase I to phase III can be approved continuously, and the clinical trial is also changed from the approval system to the implied licensing system, that is, within 60 days after the clinical trial application is accepted, if the approval department does not put forward a negative or query opinion, it will be regarded as a license " According to song Ruilin, President of China pharmaceutical innovation promotion association, policies such as solving the backlog of registration applications, improving the quality and transparency of review and approval, and implementing the system of drug listing license holders hit the "target" of pharmaceutical innovation, which is a milestone in the history of Chinese pharmaceutical innovation   With the opening of the curtain, the reform of drug examination has come to the stage one by one From the opinions on deepening the reform of examination and approval system and encouraging the innovation of medical devices, the technical guidelines for accepting the data of overseas clinical trials of drugs and other documents, to the purification of the ecological environment of clinical trials, to the strengthening of patent protection of innovative drugs, the policy dividend has been released continuously, and drug innovation has ushered in Unprecedented opportunities From a set of data released by the drug evaluation center of the State Food and drug administration, we can see that the relevant measures have achieved remarkable results   In 2016, the center completed 12068 registration applications for review, an increase of 26% compared with 2015 The number of registration applications waiting for review decreased from nearly 22000 in the peak period in September 2015 to nearly 8200 In 2017, the number of registration applications waiting for review decreased to 4000, basically solving the pressure problem of drug registration applications By the end of 2018, the number of registration applications waiting for review decreased to 3440, and all kinds of registration applications were reviewed on time The approval rate is over 90% Innovation enthusiasm and improvement of review and approval speed have brought many benefits to the industry "In the past, innovative drugs have a patent protection period of 20 years, but it sometimes takes more than ten years for new drugs to go on the market from clinical approval, leaving only a few years for enterprises to return We've invested a lot of time and money to make a new drug, but the return is not even as good as making generic drugs The acceleration of approval means that the payback period for us is longer " Sun piaoyang, chairman of Hengrui pharmaceutical, said that the time for review and approval will be shortened, and new drugs will be put on the market more quickly, so that enterprises can see the benefits and invest in the next round of R & D as soon as possible, which can not only improve the R & D power and strength of enterprises, but also meet the drug demand of patients, forming a virtuous circle of drug market From the market point of view, with the implementation of the consistency evaluation, the update of the medical insurance catalog and the nationwide expansion of the volume procurement, the profit space of generic drugs has been greatly compressed, and innovative drugs will become the strategic direction and growth driving force of pharmaceutical enterprises A number of small and medium-sized R & D pharmaceutical enterprises led by experts are developing rapidly, and Hengrui pharmaceutical is expanding rapidly Traditional leading pharmaceutical enterprises, such as Zhengda Tianqing, Fosun Pharmaceutical and Shiyao group, have also arranged innovative drug R & D ahead of time For example, Hengrui pharmaceutical has invested 2.67 billion yuan in R & D in 2018, accounting for more than 15% of sales revenue According to the drug review report issued by the drug review center every year, in 2016, the drug review center accepted 77 domestic innovative drug registration applications, increased to 112 varieties in 2017, and increased 3 varieties in 2018, with the number reaching 115 In addition to 115 varieties of domestic innovative drugs, the center also accepted one variety of domestic innovative drugs and 106 varieties of biological products in the same year Compared with 2017, in 2018, the number of applications for clinical trials (ind) of class 1 innovative drugs increased by 15%, and the number of applications for new drug listing (NDA) increased by 150% The change of the number of applications fully reflects that the innovation enthusiasm of all kinds of subjects in China is increasing year by year Under the joint action of policy encouragement and market promotion, China has stepped into a solid step from a big country of generic drugs to a big country of innovative drugs However, compared with developed countries, there is still a large gap in the level and quality of drug R & D in China, with more follow-up R & D and relatively lack of breakthrough innovation Jiao Hong, director of the State Food and drug administration, said that the drug regulatory authorities will continue to deepen the reform of the review and approval system guided by clinical value, so that innovators will be encouraged and rewarded, and China will move forward from a big pharmaceutical country to a powerful pharmaceutical country.