State Drug Administration priority review and approval, a new generation of domestic lung cancer innovative drugs listed

A new generation of domestic lung cancer innovative drug "Ametini" officially listedMay 10, a reporter learned the news from the Haussen Pharmaceutical Research and Development Center in Zhangjiang, Pudong, ShanghaiThe drug is chemically known as amethesinib, and the product is called Amelthe same day, "Amele" listing will be held in Shanghai, meaning that the drug after the Approval of the State Drug Administration listed, formally to the marketThe birth of this domestic innovative drug is also a representative and significant innovation produced with the special support of national new drug creationAmatinib is the world's second and the first three-generation EGFR-TKI innovative drug developed by Haussen Pharmaceuticals, and is used to treat topical advanced or metastatic non-small cell lung cancer with positive EGFR T790M mutationAmetinib not only brings strong, safe, accessible new choices and direct clinical benefits to patients, but also fills the gap in China's drug use in the field of disease, reduces the dependence of domestic patients on imported drugs, and can bring long-term, high-quality survival hope to more patients with advanced non-small cell lung cancer (NSCLC)from project to approval, Ametini took six yearsin October 2014, the drug was developed, approved by the U.SFDA in April 2016, approved by the National Drug Administration and the Taiwan Food and Drug Administration in February 2017, officially launched Phase I clinical study in May 2017, and in May 2018 to conduct Phase II clinical trialsSubsequently, an application for a new drug listing license will be made in April 2019, and a month later it will be included in the priority review and approval by the State Drug Administrationat the same time, in 2019, Ametinib clinical research also received the national "major new drug creation" science and technology major project support" lung cancer is one of the fastest growing malignant tumors in morbidity and mortality, ranking first in China's cancer morbidity and mortalityChina has 700,000 new lung cancer sons each year, of which 400,000 are patients with advanced lung cancer"The head of this drug clinical trial, Shanghai Chest Hospital Oncology Department Director Lu Wei, said that in China, more than 40% of patients are eGFR gene mutation smaller lung cancer patients, this type of patients are currently mainly using the first and second generation EGFR inhibitors (EGFR-TKI) targeted drug therapy, than traditional chemotherapy advantages, but 1-2 years later there will be drug resistance and disease progression, more than half of which by the T790M mutationClinically, according to the drug resistance after gene changes, to choose new treatment, but the new drugs are less, the treatment is difficult, become an international problem after two years, under the leadership of Lu Wei, this clinical study has made significant progress, and in late 2019 to meet the National Drug Administration's new drug market evaluation the drug study showed that patients with advanced lung cancer who are resistant to EGFR or second-generation drugs can have very good results if their genetic tests show a positive mutation in EGFR T790M Its objective mitigation rate (ORR) reached 68.9%, disease control rate (DCR) reached 93.4%, median progression-less survival (mPFS) reached 12.3 months, and is the world's first medium non-progression lifetime (mPFS) for more than 1 year (second-line use) of the three generations of EGFR-TKI Lu said ametinib has fewer toxic side effects, fewer adverse events and excellent performance in drug resistance and safety than the three generations of imported drugs currently used clinically in addition, Ametinib's response to a generation of targeted drugs for poor brain transfer was welcome The study confirmed that Amatinib can break through the blood-brain barrier, effectively inhibit brain lesions, and effectively alleviate 61.5% of patients with non-small cell lung cancer with brain metastasis Lu Wei believes that the domestic ametinib's clinical research is a milestone in the development of new drugs in China The drug's launch has been driven by the urgent needs of Chinese patients, thanks to government support for accelerated approval of innovative drugs " Ametini's research process, breaking the situation of transnational technology, China's local drug clinical research and development team also embarked on the road of internationalization Lu further said, "In the future, patients with advanced lung cancer with the common EGFR mutation in China will no longer face extinction and hope for a longer survival and a better quality of life." with the launch of the drug, 15-20 000 patients with advanced lung cancer in China will benefit from the innovative drug, said Lu, author: Chen Siens Source: news