New milestone of new drug research and development

Source: on August 12, 2011, cetinib hydrochloride (common name) is a national class 1.1 new drug independently developed by Zhejiang Beida Pharmaceutical Co., Ltd led by Dr Ding liming, a returned scholar of the "thousand talents plan" of the central organization department In the process of research and development, it has obtained the innovation fund of the Ministry of science and technology, the "863" high-tech plan and the national major new drug creation special funding The success of the research and development project of ektinib hydrochloride also strongly shows that China Council for the promotion of drugs, as a social group, has made a significant breakthrough in promoting the combination of industry, University and research and pharmaceutical innovation Both chairman sang Guowei and Minister Chen Zhu gave full affirmation to the efforts of China Council for the promotion of drugs to promote the innovation and development of China's pharmaceutical industry and raised high expectations China's first small molecule targeted anti-tumor drug, exetane hydrochloride, has been successfully listed in China's pharmaceutical innovation with a qualitative breakthrough Since then, China's pharmaceutical market, especially the western pharmaceutical market, has not seen the independently researched and developed new drugs with independent intellectual property rights in China, which mainly focus on the production and sales of generic drugs, while the brand patent drugs are basically monopolized by European and American multinational pharmaceutical enterprises In recent years, with the national economic development strategy proposed to change to the economic growth mode dominated by scientific and technological innovation, especially the implementation of "major new drug creation project" launched in the 11th five year plan, this pattern has quietly changed The drug has obtained the new drug certificate and production approval issued by the State Food and drug administration, and was officially launched on the market recently Exetane hydrochloride (trade name: Kemena) is the first small molecule targeted anticancer drug independently developed in China, breaking through the monopoly of large foreign pharmaceutical enterprises in the field of small molecule targeted drugs, marking a qualitative breakthrough in drug innovation in China Independent innovation: the only way for the innovation of national medicine in China, the development and research of Kemena has gone through 10 years, from preclinical research to clinical research, all of which have been completed in China In the phase III clinical trial icogen study, for the first time in China, the international brand patent drug yiruisha (AstraZeneca) was selected as a positive control to conduct a head-to-head randomized double-blind trial The phase III clinical trial was led by academician Sun Yan of Cancer Hospital of Chinese Academy of Medical Sciences and participated in by 27 hospitals across the country The results showed that Kemena had the same efficacy as Iressa, better safety and more suitable dosage and scheme for Chinese people The results of the study were reported on the ASCO and wclc, which are the highest academic level and the largest scale in the field of International Oncology, on June 7 and July 4, 2011, respectively, and attracted the high praise and attention of international clinical oncologists, which is the first time in the history of innovative drug research and development in China Kemena is successfully developed by Zhejiang Beida Pharmaceutical Co., Ltd and has international patents in China, including the United States, EU countries, etc Founded in 2003, the company is a new high-tech pharmaceutical enterprise mainly engaged in the development of innovative drugs with intellectual property rights, integrating R & D, production and sales "Ektinib hydrochloride has broken the monopoly of foreign anti lung cancer drugs on China's market, so we must take measures to protect the intellectual property rights of ektinib hydrochloride." Chairman sang pointed out In recent years, Kemena has been successively supported by the innovation fund of the Ministry of science and technology of the people's Republic of China, "863 Plan", major new drug creation project, Zhejiang "11th Five Year Plan" major project, Hangzhou major project and Yuhang District Government where the company is located Pharmaceutical innovation needs the scientific and Technological Department, the financial department, the health department, the social security department and other relevant departments to give such independent innovation model enterprises and varieties reasonable supporting policies in many aspects such as finance, tax preference and medical insurance reimbursement In his speech, chairman sang Guowei pointed out that "we must realize that the drug problem of 1.3 billion Chinese people must be solved by Chinese pharmaceutical enterprises themselves The listing of exetane hydrochloride will fill the gap in this field in China and change the situation of China's dependence on imported anti-cancer drugs, which strongly shows that the drug taking problem of 1.3 billion Chinese people can be completely solved by China's own pharmaceutical enterprises " Before the launch of Kemena, most of the targeted anticancer drugs for lung cancer patients in China depended on imported products, including gefitinib (Iressa, AstraZeneca) and erlotinib (trocaine, Roche pharmaceutical) The price of imported products is very expensive, about 550-660 yuan per tablet, one tablet per day The cost of these drugs for patients needs 16500-19800 yuan per month, which is hard for ordinary patients to bear Therefore, although there are more than 500000 new cases and 300000 deaths every year in China, less than 30000 patients can use such drugs The successful research and development of the drug will change the current situation of dependence of lung cancer patients in China on foreign imports Because its price is only 2 / 3 of the price of the same kind of imported drugs, it will greatly reduce the cost of drugs for lung cancer patients in China With the increase of dosage, it is possible to reduce the cost of drugs for lung cancer treatment in China, and effectively reduce the burden of the country, society and patients themselves Minister Chen Zhu said, "new drug research and development is closely related to China's medical and health undertakings", "large pharmaceutical enterprises and drug research and development institutions should take the research and development achievements of exetinib hydrochloride as an opportunity to closely link the research and development of drugs with the health of the Chinese people and serve the overall goal of China's health undertakings More support should be given to R & D projects of great significance to people's health protection, especially for the prevention and treatment of major diseases of the people " Data link: 1 Camry's first indication is the incidence rate and mortality rate of the first lung cancer The first imported control drug was used in China The large-scale double-blind trial was conducted The efficacy and safety were better than those of the control group In terms of safety, exetane hydrochloride has no side effects such as hair loss and leukocyte inhibition caused by traditional chemotherapy It is a new generation of targeted anticancer drug targeting epidermal growth factor receptor (EGFR) tyrosine kinase, and also the first small molecule targeted anticancer drug with independent intellectual property rights in China The success of targeted antitumor drugs is a milestone in the history of human anti-cancer It overcomes the inhibitive effects of traditional chemotherapy drugs, such as poor specificity, toxic side effects, especially bone marrow hematopoiesis 2 Dr Ding liming, the host of the research and development project of cetinib hydrochloride, reported the research results to the central organization department in June this year On July 18, Li Yuanchao, member of the Political Bureau of the CPC Central Committee, Secretary of the Secretariat of the CPC Central Committee and head of the Organization Department of the CPC Central Committee, made a special comment: "the materials are very good, which is the best interpretation of the" thousand talents plan " In particular, the central organization department proposed to increase publicity on this matter.