SciClone Pharmaceuticals Inc. (HKG: 6600) announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for tasurgratinib succinate (E7090), a fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor licensed from Eisai Co., Ltd. (TYO: 4523). The filing seeks approval for unresectable biliary tract cancer with FGFR2 fusion/rearrangement following prior chemotherapy progression—a biomarker-defined orphan indication with no approved targeted therapies in China.
Regulatory Milestone
Item
Detail
Filing Company
SciClone Pharmaceuticals Inc. (HKG: 6600)
Originator
Eisai Co., Ltd. (Tokyo: 4523, Japan)
Agency
NMPA (China)
Asset
Tasurgratinib succinate (E7090) – FGFR1/2/3 TKI
Trade Name (Japan)
Tasfygo (approved September 2024)
Target Indication
Unresectable biliary tract cancer with FGFR2 fusion/rearrangement; post-chemotherapy progression
Licensing Deal
February 2025 – SciClone secured exclusive China rights
Oncogene addiction in cholangiocarcinoma; constitutive FGFR2 activation
Mechanism
Blocks constitutively activated FGFR2 signaling
Tumor growth inhibition; apoptosis induction
Japan Validation
Approved September 2024 as Tasfygo
Regulatory precedent; established efficacy/safety profile
Market Context & Strategic Positioning
Factor
Market Analysis
Biliary Tract Cancer Burden
>180,000 new cases annually in China; 10-15% harbor FGFR2 fusions/rearrangements – addressable population ~18,000-27,000 patients
Unmet Need
No approved FGFR inhibitors in China for biliary cancer; standard chemotherapy (gemcitabine/cisplatin) offers limited durability
Competitive Landscape
Pemigatinib (Incyte) and futibatinib (Taiho) approved in US/EU; tasurgratinib first Japan-approved, now China-bound
SciClone Strategy
In-licensing proven assets from Japanese innovators (Eisai, Taiho); leverages regulatory expertise and hospital relationships for rapid commercialization
Biomarker-Defined Market
Companion diagnostic requirement creates prescription control and premium pricing vs. chemotherapy
Potential label expansion to other FGFR-driven malignancies (urothelial, gastric)
Post-approval
Forward‑Looking Statements This brief contains forward‑looking statements regarding tasurgratinib NMPA approval timelines, SciClone’s commercial execution in biliary tract cancer, and competitive dynamics with pemigatinib and futibatinib in China. Actual results may differ due to regulatory review delays, FGFR2 biomarker testing adoption rates, and pricing negotiations with national reimbursement programs.-Fineline Info & Tech
By Fineline Cube