Hutchmed (China) Ltd (AIM:HCM, NASDAQ:HCM, HKG:0013, FRA:H7T2) shares rose 4% to 192p after the biopharmaceutical company reported positive top-line results from a late-stage global trial of its lung cancer drug savolitinib.
The Phase III SAFFRON study tested savolitinib, sold as Orpathys, in combination with AstraZeneca PLC's (LSE:AZN, NASDAQ:AZN) Tagrisso in patients with a form of non-small cell lung cancer whose disease had worsened despite treatment.
The trial met its main goal, showing statistically significant improvements in both progression-free survival and overall survival compared with chemotherapy.
The patients involved carried EGFR mutations alongside overexpression or amplification of a protein called MET, a group with few remaining treatment options.
Cavendish, the broker to HUTCHMED, described the result as the first global Phase III study to demonstrate a significant survival benefit for this group.
The broker called the outcome a major de-risking event that validates earlier data from a separate China-based trial known as SACHI.
HUTCHMED and AstraZeneca have confirmed the data will be submitted to regulators worldwide.
Cavendish, which rates the stock a buy with a 370p target price, said a regulatory submission could come before the end of 2026, with a potential US approval during the second half of 2027.
Such an approval would make savolitinib HUTCHMED's second major global oncology drug after Fruzaqla.
Management has indicated that peak sales outside China could reach roughly $800 million, with HUTCHMED entitled to tiered royalties of 9% to 13% on those sales.
Cavendish estimated that ex-China royalties could ultimately generate around $70 million to $100 million a year, before accounting for the separate and more lucrative China opportunity.
The broker said attention now turns to a further China-based trial, SANOVO, which is testing savolitinib as a first-line treatment in a substantially larger patient group.
HUTCHMED shares have fallen 21% over the past year.
