HUTCHMED Gains as China Grants Priority Review for Cancer Drug Fanregratinib
The Hong Kong-based biotech's treatment for a rare and aggressive liver cancer will receive an accelerated regulatory review, a key step toward commercialization.
Shares of HUTCHMED (Nasdaq: HCM) rose in Monday trading after the company announced a significant regulatory milestone in China for one of its key oncology drug candidates.
The Hong Kong-based biopharmaceutical firm saw its stock climb approximately 1.7% to $13.76 after confirming that China’s National Medical Products Administration (NMPA) accepted its New Drug Application (NDA) for fanregratinib. The drug, a potential treatment for a specific form of advanced liver cancer, was also granted Priority Review status, signaling its potential importance and accelerating its path to market.
This regulatory validation positions fanregratinib for an expedited review process, a designation reserved for therapies that could provide significant clinical advantages over existing treatments or address urgent public health needs. The acceptance is a crucial step for HUTCHMED, a company with a market capitalization of $2.41 billion, as it seeks to commercialize its internally developed pipeline of cancer therapies.
The NDA targets the use of fanregratinib for adults with advanced or unresectable intrahepatic cholangiocarcinoma (ICC), a cancer of the bile ducts within the liver that has a notably poor prognosis. The filing specifically covers patients whose tumors have a fibroblast growth factor receptor 2 (FGFR2) gene fusion or rearrangement and who have already undergone at least one round of systemic therapy. This genetic alteration is a key driver of tumor growth in about 10-15% of ICC patients.
Intrahepatic cholangiocarcinoma is the second most common primary liver cancer and is often diagnosed in its advanced stages, leading to a grim 5-year survival rate of just 9%. The limited options for second-line treatment represent a high unmet medical need, particularly in China, which has a high incidence of liver cancers. The country's broader liver cancer drug market is projected to expand significantly, with one analysis forecasting growth to nearly $770 million by 2030.
HUTCHMED’s submission is backed by positive results from a Phase II registration trial conducted in China. The company reported that the study met its primary endpoint of objective response rate (ORR), a measure of the proportion of patients whose tumors shrink or disappear after treatment. Secondary endpoints, including progression-free survival and overall survival, also supported the drug's clinical profile.
Fanregratinib is a novel, highly selective oral inhibitor of FGFR 1, 2, and 3. Aberrant FGFR signaling pathways are known to be instrumental in tumor proliferation and angiogenesis, making them a key target for modern cancer therapies. The development of targeted FGFR inhibitors represents a growing field in oncology, with multiple companies developing drugs for various cancers.
While there are currently no approved FGFR inhibitors specifically for this indication in China, the landscape is becoming more competitive. If approved, fanregratinib would be a significant entrant into the market, but other domestic players like Abbisko Therapeutics are also advancing their own FGFR inhibitor candidates. The Priority Review status, which can reduce the NMPA's review timeline to as few as 130 working days, could provide HUTCHMED with a critical first-mover advantage. The decision marks a validation of the company's research and development strategy, which focuses heavily on developing targeted therapies for cancers prevalent in Asia and globally.