On September 24, 2024 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho") and Haihe Biopharma Co., Ltd. (hereinafter "Haihe") reported that the MET inhibitor, HAIYITAN tablets 50mg (generic name: gumarontinib hydrate), is schedule for launch on October 11, 2024, in Japan (Press release, Taiho, SEP 24, 2024, View Source [SID1234646843]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In June 2024, Haihe Biopharma K. K., a fully owned affiliate of Haihe, obtained approval to manufacture and market HAIYITAN in Japan for the treatment of unresectable, advanced or recurrent non-small cell lung cancer with MET exon 14 skipping mutations.
HAIYITAN is an oral, small-molecule, receptor-type tyrosine kinase MET inhibitor developed by Haihe. HAIYITAN is expected to inhibit tumor growth by blocking MET phosphorylation and downstream signaling. 1 In China, HAIYITAN has been approved by the National Medical Products Administration (NMPA) for manufacturing and marketing in March 2023.
Taiho and Haihe, together with Haihe Biopharma K. K., will contribute to patients with non-small cell lung cancer and healthcare professionals by providing HAIYITAN as a new treatment option for non-small cell lung cancer.
About Non-Small Cell Lung Cancer with MET exon 14 Skipping Mutations
Primary lung cancer is the second most common malignancy in the world and has the highest mortality rate. 2 In Japan, the number of new patients with lung cancer is reported to be more than 120,000/year (2019), and the number of deaths is over 70,000/year (2020). 3 The percentage of non-small cell lung cancer among patients with lung cancer in Japan is 88%, and the frequency of MET exon 14 skipping mutations is about 3%. 4 Thus, in Japan, the number of patients with MET exon 14 skipping gene mutations positive, unresectable, advanced or recurrent non-small cell lung cancer who are eligible for treatment with HAIYITAN is estimated to be around 1,200/year.
About MET Tyrosine Kinase
MET gene encodes a receptor-type tyrosine kinase. Binding hepatocyte growth factor (HGF), a MET ligand, induces receptor dimerization and autophosphorylation of tyrosine residues in the kinase domain of MET, forming binding sites for various signaling factors. Subsequently, intracellular signaling cascades such as the RAS pathway are activated to stimulate tumor cell growth, migration, invasion, and angiogenesis in cancer.