Ivertinib, the original drug of Essen medicine, has initial clinical effect and breaks through the difficult problem of targeted treatment of lung cancer

300mg is the best effective dose, and the effective rate of lung cancer focus reduction is more than 50% This is the latest progress of the first original third generation EGFR (epidermal growth factor) targeted new drug in China and phase I clinical research of ivetinib supported by the national "12th Five Year Plan" major new drug project Ivetinib capsule On September 8, Professor Wu Yilong, President of the Chinese society of Clinical Oncology, introduced that the results of the phase I clinical trial of ivetinib showed that the effectiveness and safety of the drug were very good In the future, ivetinib can not only reduce the serious rash, diarrhea and other side effects caused by the first and second generation EGFR inhibitor treatment, but also overcome the side effects caused by the existing EGFR targeted drug treatment Drug resistance In the next key clinical study of ivetinib, Wu Yilong said that the clinical study will verify the results achieved in phase I, shorten the market time of the drug, and benefit more lung cancer patients with greater welfare The highest incidence rate of lung cancer is increasing The incidence of drug resistance is embarrassed Every 4 people die in the world 1 of them die from cancer 1 of the 4 to 5 people who die of cancer die from lung cancer China's incidence rate of China's lung cancer is increasing at 26.9% annually China's third death causes survey also shows that lung cancer mortality has increased by 465% over the past 30 years, and has become the highest mortality rate in China The high incidence rate is the embarrassed situation of lung cancer treatment As an international lung cancer expert who has long-term research and concerns about lung cancer patients, Wu Yilong said: "according to current words, the treatment effect of lung cancer in China is not very good Only about 10% of lung cancer patients in China can live for 5 years, and most people will die within one year." In many years of research, Wu Yilong found that in lung cancer types, the proportion of adenocarcinoma increased year by year, accounting for about 60% Adenocarcinoma patients are more common in non-smoking patients, or related to air pollution and air pollution It is worth noting that "there are very big characteristics in Chinese adenocarcinoma patients, whose disease is related to gene changes, such as mutations of EGFR in adenocarcinoma." In the current lung cancer treatment, as early as 2004, human beings have found the relationship between the gene mutation and lung cancer, and developed the first generation of EGFR targeted inhibition drugs, such as Kemena, Iressa and troikae "However, after these drugs are put on the market, although the life span of patients with epidermal growth factor mutations in lung cancer has been greatly prolonged, and the effective rate of using the drug has reached more than 70%, with the use of the drug, the patients have gradually developed drug resistance, which also means that there is a new mutation in the gene, known as T790M mutation." Wu Yilong said After the emergence of new problems, it is followed by new countermeasures The first foreign third generation EGFR inhibitor for lung cancer was approved in the United States at the end of last year, ushering in a new dawn for lung cancer patients However, such dawn, in the treatment of lung cancer patients in China, is in an awkward situation Wu Yilong said that the drug has not yet been listed in China, even if it can be successfully listed in China, it must be a year later In addition, the development cost of the drug is very expensive, so after it is listed, people will also face the problem of high price "China urgently needs a third generation EGFR drug for lung cancer produced by itself and will face the society at a preferential price," he called The innovation road of Chinese original drug avidini "challenges" the international new drug "avidini is such a newborn calf to challenge the majestic lion, the third generation EGFR inhibitor of lung cancer in the world." Wu Yilong makes such an interesting comparison with the emergence of avidini It is reported that ivetinib is independently developed by Zhejiang Hangzhou Essen Pharmaceutical Research Co., Ltd and has the earliest global intellectual property rights It is the first original EGFR inhibitor of the third generation to carry out clinical research in China, and selectively targets tumor related EGFR mutations and T790M resistant mutations New drug research and development is a time-consuming and expensive system engineering After the completion of the preliminary basic research (Pharmacology, toxicology, pharmacodynamics and other animal studies), the application begins to enter the human clinical trial stage, the clinical trial cycle is I, II, III and so on After several years of preclinical research, in September 2014, ivetinib obtained the clinical approval and was the first T790M mutant drug approved in China Fortunately, avetinib has explored the safety and effectiveness of treatment in nearly 200 lung cancer patients, and achieved encouraging clinical results It is reported that ivetinib is currently carrying out or about to launch a number of key clinical studies, involving nearly 60 top three hospitals nationwide It is planned to join the group of advanced non-small cell lung cancer patients with T790M drug-resistant mutation who have failed the treatment of existing EGFR targeted inhibitors Professor Wu Yilong is one of the main researchers in the phase I clinical study of ivetinib The "main battlefield" of its clinical study is the people's Hospital of Guangdong Province According to the latest research data of the hospital, the best effective dose of ivetinib is 300mg, and the effective rate of reducing lung cancer focus with target is more than 50% It can not only reduce the serious side effects of skin rash and diarrhea caused by the first and second generation EGFR inhibitor treatment, but also overcome the drug resistance problem after the existing EGFR targeted drug treatment "If the patients with this drug-resistant gene mutation succeed in phase I clinical trials, it means that there is a high probability of success in future confirmatory clinical studies." In Wu Yilong's view, ivetinib is more innovative in the clinical research of "newborn calf" He analyzed that in the early clinical trials, the safety in phase I and the efficacy in phase II, the structural innovation in the current clinical research is directly carried out, and the phase II trial is directly combined in the phase I clinical trials of avetinib, so as to accelerate the promotion of drug research In the next key clinical studies, the effectiveness of the early drug research will be verified At present, ivetinib is providing free treatment and examination opportunities for appropriate patients all over the country to meet the clinical needs before the drug is put on the market "In this way, two to three years of clinical research on ivertinib will be much longer than five to seven years of clinical research on drugs." Avidini, a newborn calf, has undoubtedly brought encouraging good news to drug-resistant lung cancer patients In this regard, Wu Yilong has great expectations "The development of ivetinib has set an example of innovative research in Chinese medicine internationally In the past, the international evaluation of China suggested that the Chinese could only imitate, but now, we can say that China can also innovate in medicine, even not lose the international level," he said At home, we look forward to more scientific research in China, especially for innovative drugs, so as to form a good social effect, and more patients are expected to benefit from the preferential price of drugs "