Application for listing of lunvaltinib mesylate capsule, a subsidiary of Xiansheng Dongyuan pharmaceutical, has been accepted by CDE

According to the data of minenet, Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd submitted the listing application of lenvaltinib mesylate capsule according to the four generic drugs, which was accepted by CDE on January 10, with the acceptance number of cyhs2000023 At present, only the products of Weicai, the original research manufacturer, are on sale in the domestic market, and Zhengda Tianqing is the first to submit the application for generic drug listing in June 2019 Lovatinib (also known as lovatinib) is an oral multi-target kinase inhibitor (TKI), which can inhibit vegfr-1,2,3, fgfr-1,2,3,4, PDGFR, RET, kit and other targets This product was developed by Japan Weicai It was first awarded orphan drug in Japan in August 2012 to treat thyroid cancer In 2015, it was officially approved for marketing in the United States and the European Union At present, the approved indications include advanced thyroid cancer, renal cancer, liver cell cancer, etc Figure: global sales of lovatini in 2014-2019 (first half year) (unit: 100 million yen) The global sales volume of lovatini has been bullish since its listing, reaching 62.6 billion yen in 2018 and 50.5 billion yen in the first half of 2019, including 7.1 billion yen in China (about 444 million yuan at the exchange rate on January 14) The industry is generally optimistic about the product, and its annual sales peak is expected to exceed 1 billion US dollars In September 2018, the State Food and Drug Administration approved rivatinib to treat unresectable HCC patients who had not received systemic treatment before, and provided drugs to the patients on November 9, 2018 At present, the price of lovatini in China is 16800 / box, 30 capsules / box, 4mg / capsule According to the data of minenet, in 2018, the sales volume of China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) was 160 million yuan Lovatinib is the main competitive product of sorafenib Clinical research shows that lovatinib is inferior to sorafenib in the main end point (total survival OS), and other secondary end points (including PFS, TTP, Orr, etc.) are superior to sorafenib This is the first phase III clinical study that has achieved positive results in the first-line treatment of advanced liver cancer in the past 10 years since sorafenib went on the market It is expected that lovatinib will become the first-line standard treatment of advanced liver cancer The patent of lovatinib compound expires on October 19, 2021 in China, the patent of preparation method expires on November 8, 2024, and the patent of crystal form expires on December 22, 2024 Although the core patent has not yet expired, there are many domestic pharmaceutical companies to distribute generic drugs Table: Declaration of generic drugs of lovatinib