HUTCHMED Submits NDA for Fanregratinib, Receives Priority Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
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Source: Globenewswire
- NDA Submission Success: HUTCHMED's New Drug Application for fanregratinib (HMPL-453) targeting advanced unresectable intrahepatic cholangiocarcinoma has been accepted by the NMPA in China and granted priority review, marking a significant advancement in the treatment of liver cancer.
- Clinical Trial Support: The NDA is supported by data from a single-arm, multi-center Phase II registration study in China, which met its primary endpoint of objective response rate (ORR), demonstrating the drug's efficacy and potential market prospects.
- Rising Market Demand: The incidence of intrahepatic cholangiocarcinoma is increasing, with a 5-year survival rate of only 9%, and approximately 10-15% of patients globally harbor FGFR2 gene rearrangements, indicating a pressing need for targeted therapies and significant market potential.
- Global Development Strategy: HUTCHMED retains worldwide rights to fanregratinib, underscoring its commitment to developing targeted therapies for cancer globally, further solidifying its leadership position in the biopharmaceutical industry.
HCM
$13.77+Infinity%1D
Analyst Views on HCM
Wall Street analysts forecast HCM stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for HCM is 19.38 USD with a low forecast of 13.75 USD and a high forecast of 25.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
1 Buy
0 Hold
1 Sell
Hold
Current: 13.520
Low
13.75
Averages
19.38
High
25.00
Current: 13.520
Low
13.75
Averages
19.38
High
25.00
About HCM
HUTCHMED (China) Ltd is an investment holding company principally engaged in the manufacture and sale of pharmaceuticals. The Company operates its business through two segments. Oncology Immunology segment is engaged in the discovery, development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Among it, research and development (R&D) includes research and development activities covering drug discovery, development, manufacturing and regulatory functions, out-licensing of in-house developed drugs, as well as administrative activities to support research and development operations, marketed products comprises the invoiced sales, marketing, manufacture and distribution of drugs developed from research and development activities. Other Ventures segment is engaged in the other commercial businesses which include the sales, marketing, manufacture and distribution of other prescription drugs and healthcare products.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
