Sold 200 million in 2 months! This medicine is a first-line targeted therapy for liver cancer, Hengrui, Shiyao Made the effort.

Lovatinib is the first drug approved for first-line treatment of advanced liver cancer in China in recent 10 years Since then, it has broken the monopoly of sorafenib on first-line treatment of advanced liver cancer It is reported that within two months after the official domestic supply, the sales volume of lvrtini reached 3.1 billion yen (nearly 200 million yuan) From the perspective of therapeutic effect, lovatinib is better than solafeni, and is expected to become the first-line standard treatment for advanced liver cancer At present, eight pharmaceutical companies, including Hengrui pharmaceutical, Shiyao group, Zhengda Tianqing, and Hunan Kelun pharmaceutical, have developed or copied this product in the domestic market With less than 2 months of drug supply and sales of 3.1 billion yen, 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 The 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 and liver cell cancer In addition, the clinical trials of glioma, non-small cell lung cancer and other indications are in progress Figure 1: global sales of lovatini mesylate capsules (in millions of yen) (source: sales database of Mnet multinational listed companies) from 2014 to 2017 According to sales database data of Mnet multinational listed companies, sales of lovatini rose all the way after listing, reaching 32.2 billion yen in 2017, up 50.14% year on year The industry is generally optimistic about the product, and its annual sales peak is expected to exceed 1 billion US dollars Weicai submitted to CDE the listing application of lovatinib (indications for liver cancer) which was accepted on November 3, 2017, and was included in the priority review on December 18, 2017 on the basis of "innovative drugs with obvious treatment advantages"; In September 2018, the product was approved to be imported by the State Food and Drug Administration for the treatment of unresectable HCC patients who have not received systemic treatment before, and was supplied to patients on November 9, 2018 In 2018, the sales volume in China was 3.1 billion yen The price of lovatinib in China is 16800 yuan / box, 30 capsules / box, 4mg / capsule For patients with liver cancer weighing less than 60kg, 8mg / day (2 capsules) was used; for patients weighing more than 60kg, 12mg / day (3 capsules) was used In addition, lovatinib's charity assistance policy has also been determined Patients with low income can receive assistance free of charge Patients with low income can take (2 + 2) + (2 + x) X is the number of months less than or equal to 10 The specific number of assistance drugs depends on the progress of individual disease, which means that once patients with liver cancer weighing less than 60kg enter the assistance project, they only need to purchase drugs for four months in the whole year, converted into a monthly amount The average cost is 11200 yuan Compared with the world's first multi-target TKI, lovatinib has excellent efficacy Sola Fini is the first approved oral multi target kinase inhibitor in the world It was developed by Bayer and approved by the FDA in December 2005 for the treatment of advanced renal cancer In 2007, it was approved in Europe and the United States for the treatment of liver cancer In July 2008, it was approved by the State Food and drug administration to enter the Chinese market for the treatment of inoperable patients with advanced liver cancer Sorafenib is the first systemic drug with clear evidence to improve the survival of patients with advanced liver cancer, and it is also the first-line clinical standard drug for patients with HCC in China Figure 2: global and domestic sales of toluenesulfonic acid sorafenib in 2014-2017 note: domestic sales refer to terminal sales of public medical institutions in China (source: minenet database) According to the data of mienei.com, as a result of the impact of competitive products, global sales of solafeni began to decline in 2016, and the decline continued to increase In 2018, the global sales revenue reached 712 million euros, down 14.63% year on year In contrast to the domestic market, the sales volume of solafeni in the terminals of public medical institutions in China has maintained a stable growth, and it is expected to further increase after being included in the 2017 national medical insurance catalog In 2017, the sales volume reached 780 million yuan, an increase of 15.18% over the previous year Renvatinib is the main competitive product of solafeni In the phase III clinical trial (reflect study) of first-line treatment of unresectable liver cancer, 954 patients with advanced liver cancer in the world were treated with renvatinib and solafeni head-to-head control trial The objective remission rate of renvatinib was 3 times that of solafeni (40.6% vs 12.4%), and the progression free survival time was 1 times higher than that of solafeni (7.3 months vs 3.6 months), with a median total survival time of 7.3 months The survival time was better than sorafenib (13.6 months vs 12.3 months) Among 954 patients with advanced liver cancer in the world, 288 were in the Greater China region Based on the results of population analysis in this subgroup, the objective remission rate of lovatinib was significantly better than that of sorafenib (43.8% vs 13.2%), the progression free survival time was higher than that of sorafenib (8.4 months vs 3.6 months), and the median total survival time was significantly better than that of sorafenib (15 months vs 10.2 months) From the results of the study, in the main end point (total survival OS), lovatinib was inferior to sorafenib, and in other secondary end points (including PFS, TTP, Orr, etc.), lovatinib was 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 In the instructions, the five most common adverse reactions in patients treated with rivatinib are hypertension (45%), fatigue (44%), diarrhea (39%), loss of appetite (34%) and weight loss (31%), which are consistent with the known side effects of sorafenib Layout of 8 pharmaceutical companies, Hengrui was approved as the first clinical company, and Zhengda Tianqing was the first one to submit application form 1: domestic research and development of lovatinib mesylate capsule (source: minenet database) According to midnet Med China drug review database 2.0, at present, 6 domestic pharmaceutical companies have submitted clinical applications for lovatinib mesylate capsule according to new drug category 3.1 or new drug category 1.6, among which 4 pharmaceutical companies have been approved for clinical application, including Beijing kanglisheng pharmaceutical, New Drug Research Institute of East China Pharmaceutical Group, Jiangsu Xiansheng pharmaceutical and Jiangsu Hengrui pharmaceutical, among which Hengrui pharmaceutical has the earliest products Approved clinical According to the data of Chinese drug clinical trial publicity database of minenet, at present, there are two drug companies in China to register human bioequivalence test (be test) for lovatinib / lovatinib The indications of lovatinib in Zhengda Tianqing pharmaceutical industry are local recurrence or metastasis, progressive, radioiodine refractory differentiated (papillary / follicular / h ü rthle cell) thyroid cancer The be test of this product was incorporated in China on May 8, 2018, and completed in China on June 19, 2018 At present, it has submitted the listing application according to the four types of imitation; Lunvaltinib of Hunan Kelun pharmaceutical was registered on January 11, 2019, aiming at unresectable HCC, which is still in the "on-going (Recruitment)" state At present, the indications of lovatinib of Weicai, the original research manufacturer, approved for marketing in China are liver cancer, while the indications of thyroid cancer have not yet been approved for marketing Zhengda Tianqing's product is expected to become the first lovatinib generic drug and the first lovatinib approved for the treatment of thyroid cancer Source: minenet database, Drug Newsletter