As a novel, highly potent and highly selective next-generation ALK inhibitor, ensartinib hydrochloride first obtained marketing approval in China in November 2020. It became China's first domestic Class 1 innovative drug indicated for the treatment of advanced non-small cell lung cancer (NSCLC) with ALK mutations, filling the gap in domestic drugs of the same category.
This approval was based on the eXalt3 international multicenter Phase Ⅲ clinical trial, which aimed to evaluate the efficacy and safety of ensartinib versus crizotinib in previously untreated (first-line) ALK-positive NSCLC patients. The global leading principal investigator (PI) of the study is Professor Leora Horn from Vanderbilt University in the United States, and the Chinese leading PI is Professor Wu Yilong from Guangdong Provincial People's Hospital. A total of 123 research centers across 21 countries and regions participated in the trial. Results demonstrated that the median progression-free survival (mPFS) of ALK-positive NSCLC patients treated with ensartinib was significantly longer than that of those treated with crizotinib. The research findings have been published in JAMA Oncology, a top international medical journal with an impact factor of 31.777.
Professor Wu Yilong, global leading PI of the eXalt3 trial and from Guangdong Provincial People's Hospital, stated
"I congratulate ensartinib, a China-developed innovative ALK TKI, on its marketing approval in the United States. This marks the recognition of ensartinib by the world's highest standards and is a highly significant milestone event. Ensartinib was designed with a global layout from the very beginning: international multicenter clinical trials were initiated in 2016, with international and domestic studies carried out simultaneously, which is highly forward-looking and representative. Second, an advisory board composed of the world's most renowned lung cancer experts was involved, making the overall study protocol more scientific and rational. Third, the entire clinical trial process was conducted in accordance with FDA standards, with study monitoring and data quality control meeting extremely high criteria. Therefore, the success of ensartinib provides us with very valuable experience."
Kevin Sang, Chief Executive Officer of Xcovery, commented
"We are delighted that ensartinib has successfully obtained FDA approval for market launch. We look forward to accumulating more real-world clinical data from its further application, so as to provide more treatment options for patients worldwide. The successful approval of ensartinib has accumulated experience for the company's overseas clinical development and regulatory filings of new drugs, laying a solid foundation for more domestic innovative drugs to enter the global market."
Dr. Ding Lieming, Chairman of Betta Pharmaceuticals, said
"Thanks to the joint efforts of numerous experts and colleagues, ensartinib has been approved by the FDA for market launch. As Betta's first product successfully launched overseas and the first small-molecule lung cancer targeted innovative drug globally marketed under the leadership of a Chinese pharmaceutical company, ensartinib fully demonstrates Betta's international innovative capabilities, enabling us to take a substantive step towards our vision of becoming 'a multinational pharmaceutical enterprise headquartered in China'. We expect ensartinib to benefit more patients around the world. Going forward, Betta will adhere to independent innovation to develop more new and high-quality drugs. Meanwhile, we will continuously deepen high-level international cooperation in the field of pharmaceutical innovation, promote the widespread global application of more high-quality innovative achievements, enhance new-quality productive forces in the pharmaceutical sector, and contribute to the development of global human health."
