On September 3, 2026, according to the official website of the National Medical Products Administration (NMPA) of China, Tasultinib Succinate Tablets, submitted by SciSheng Pharmaceuticals (China) Co., Ltd., were approved for marketing. Public information shows that it was included in the priority review process on November 27, 2025, with the indication of treating unresectable biliary tract cancer patients who have failed prior chemotherapy and have been confirmed to have the FGFR2 fusion/rearrangement gene. China has one of the highest age-standardized incidence rates of biliary tract tumors (BTC). Intrahepatic cholangiocarcinoma (ICC) is a subtype of BTC that originates in the intrahepatic bile ducts and may affect approximately 60,000 people in China each year. Cholangiocarcinoma accounts for about 10%-15% of all primary liver malignancies, making it the second most common primary liver cancer after hepatocellular carcinoma.
Tasurgratinib, developed by Eisai, is an oral selective tyrosine kinase inhibitor of fibroblast growth factor receptor (FGFR). It selectively inhibits the activity of FGFR1, FGFR2, and FGFR3 kinases, blocking downstream tumor proliferation signals and inhibiting the growth of tumors carrying FGFR2 fusion variants.
In September 2024, tasutinib was first approved in Japan for the treatment of patients with unresectable biliary tract cancer that has progressed after chemotherapy and carries FGFR2 gene fusions or rearrangements.
In February 2025, SciScience entered into a licensing agreement with Eisai, acquiring exclusive rights to develop and commercialize tasutinib succinate tablets in China. SciScience will pay Eisai an upfront payment, milestone payments based on development progress and regulatory approvals, and sales milestone payments and a percentage of royalties based on sales after product launch.
This approval is based on a multicenter, open-label, single-arm phase II pivotal clinical trial (E7090-J000-201 study) conducted in China and Japan, which enrolled 63 patients with unresectable advanced or metastatic cholangiocarcinoma who had previously received gemcitabine in combination with chemotherapy and carried FGFR2 gene fusions or rearrangements. The primary endpoint of the study was objective response rate (ORR), with safety and other factors as secondary endpoints.
Updated results showed that, as of May 27, 2025, with a median follow-up of 38 months, the study met its primary endpoint, with the ORR exceeding the pre-specified statistically significant tumor response threshold (15%): based on independent imaging assessment, the ORR in the evaluable population for tasutinib efficacy was 31.7% (95% confidence interval [CI]: 20.6–44.7), of which the ORR in the Chinese population was 37.1% (95% confidence interval [CI]: 21.5–55.1), and the overall survival (OS) was 20.1 months (95% confidence interval [CI]: 11.3–22.4).
Biliary tract cancer is a difficult-to-treat cancer with a poor prognosis. Compared with other cancers, drug treatment options are very limited, resulting in a large unmet medical need. 15%-30% of biliary tract cancers are intrahepatic cholangiocarcinomas, of which approximately 14% involve FGFR2 gene fusion or rearrangement.
Currently, three FGFR-related drugs have been approved for the treatment of biliary tract cancer in China: pemitinib (imported from Incyte by Innovent Biologics ), tenagotinib (imported from Pharmaron), and fanregularinib (imported from Hutchison MediPharma). The recent approval of tasutinib succinate tablets makes it the fourth FGFR-related drug for the treatment of biliary tract cancer in China.
There is a significant unmet clinical need for cholangiocarcinoma in China, especially for patients with FGFR2 fusions/rearrangements who have failed previous chemotherapy and have extremely limited treatment options. The approval of tasutinib succinate tablets in China represents another important advancement for SciSheng Pharmaceuticals in the field of precision oncology. It will also further enrich treatment options for patients with FGFR2 fusions or rearrangements in cholangiocarcinoma in China .

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