Zhitong Finance App News, Hehuang Pharmaceutical (00013) announced that the new drug marketing application for fanregratinib (HMPL-453) was conditionally approved by the China National Drug Administration (China Drug Administration) to treat adult patients with advanced, metastatic, or intrahepatic cholangiocarcinoma who have received systematic treatment and have fibroblast growth factor receptor (FGFR) 2 fusion or rearrangement. Vanreglatinib will be sold in the Chinese market under the trade name Ailinda® (English trademark: ATLED®).
Intrahepatic cholangiocarcinoma is a highly aggressive malignant tumor originating from the epithelium of the bile ducts in the liver. It accounts for about 8.2% to 15.0% of primary liver cancer, and is the second most common type of liver cancer after hepatocellular carcinoma. In recent years, the incidence of intrahepatic cholangiocarcinoma has continued to rise, with an overall 5-year survival rate of about 9%. About 10-15% of patients with intrahepatic cholangiocarcinoma worldwide have FGFR2 fusion or rearrangement.
The approval is based on data support for the Phase II registration queue (NCT04353375) in a single-arm, multi-center, open-label phase II/IIb critical clinical trial conducted by Alinda® in China. The results were recently presented at the 2026 European Society of Medical Oncology (ESMO) Gastrointestinal Oncology Congress. The study reached its primary endpoint, showing strong and clinically significant remission in patients with advanced intrahepatic cholangiocarcinoma treated with FGFR2 fusion/rearrangement. The objective remission rate (ORR) as assessed by the Independent Review Committee (IRC) was 42.5% (95% CI: 30.0% - 53.6%).
The key secondary endpoints also showed consistent clinical activity and rapid efficacy, with a median time of 1.4 months to remission of the disease. The median duration of remission (DoR) was 6.9 months (95% CI: 5.6—8.5) and the disease control rate (DCR) reached 83.9% (95% CI: 74.5% — 90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1—8.2), and the median overall survival (OS) was 16.6 months (95% CI: 12.4—16.6).
Mr. Zheng Zefeng, Acting CEO and Chief Financial Officer of Hutchison Pharmaceuticals, said, “As a high-incidence and highly destructive subtype of primary liver cancer, intrahepatic cholangiocarcinoma is burdensome, and targeted treatment options have been very limited in the past. We are pleased to see Elinda® approved by the State Drug Administration, which directly fills a major treatment gap in this clinical field in China. This approval brings an important new treatment option to a large number of previously treated patients with advanced intrahepatic cholangiocarcinoma. We are fully prepared to bring this precision therapy to patients as quickly as possible, with our mature commercial team and system.”
The phase IIIb portion of this clinical trial will serve as a confirmatory study to further verify the clinical benefits and safety of Alinda® in this indication. Patient enrollment in this confirmatory cohort began in January 2026.
Elinda ® (variglatinib, HMPL-453) is a novel, highly selective, and potent FGFR 1, 2, and 3 inhibitor. Abnormal FGFR signaling has been found to induce tumor growth, promote angiogenesis, and develop resistance to anti-tumor treatment. Abnormal FGFR gene changes are thought to be a driver of cell proliferation in a variety of solid tumors. Chi-Med currently owns all rights to vanigratinib worldwide.