SciClone Pharmaceuticals Inks Exclusive License Agreement with Eisai for FGFR Inhibitor Tasurgratinib in China
SciClone Pharmaceuticals
Biopharmaceutical Manufacturer
Eisai
Pharmaceutical Product R&D and Manufacturer
On February 28, SciClone Pharmaceuticals announced that it had reached a licensing agreement with Eisai.Will ObtainEisai's anticancer drugTasurgratinib succinate（E7090）Exclusive Development and Commercialization Rights in China。Tasurgratinib is aFibroblast Growth Factor Receptor（FGFR）Selective Tyrosine Kinase Inhibitors,Approved for treatment in JapanPatients with biliary tract cancer。SciClone Pharmaceuticals will pay an advance payment to Eisai,Milestone Payment、Royalties, the specific amount has not been disclosed.
Source:SciClone PharmaceuticalsOfficial Weibo
Tasurgratinib is a novel oral tyrosine kinase inhibitor that exhibits selective inhibitory activity against FGFR1, FGFR2, and FGFR3.
In September 2024, Tasurgratinib was approved for marketing in Japan.For the treatment of patients with unresectable biliary tract cancer harboring FGFR2 gene fusions or rearrangements whose disease has progressed after chemotherapy.In China, Tasurgratinib is currently undergoing a trial for the treatment of unresectableAdvanced or Metastatic Cholangiocarcinoma(FGFR2 Gene Fusion)PatientThe non-blind, Phase II trial.
Source: Insight Database
The approval of Tasurgratinib in Japan is based on data from multiple studies, including a multicenter, open-label, single-arm Phase II clinical trial conducted by Eisai in Japan and China.（NCT04238715）The results. A total of 63 patients with unresectable advanced or metastatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements were enrolled in the study. These patients had previously received gemcitabine-based combination chemotherapy. The study'sThe primary endpoint is the objective response rate (ORR).。
Phase II study data show that the study met its primary endpoint, exceeding the pre-specified tumor response threshold.（15%）, with statistical significance: as assessed by independent imaging evaluation,The ORR of patients in the Tasurgratinib treatment group was 30.2%.。
Genetic variations in FGFR are considered to be closely related to the proliferation, survival, and migration of cancer cells, as well as tumor angiogenesis and drug resistance. Due to the observation of FGFR genetic variations in biliary tract cancer and various other cancers, FGFR is increasingly attracting attention as a potential target for cancer treatment.
