HUTCHMED (China) Limited reported Phase III results for ORPATHYS® plus TAGRISSO® in SAFFRON and SANOVO, trials of EGFR-mutated non-small cell lung cancer in different MET-related settings. In SAFFRON, after progression on TAGRISSO®, the combination versus platinum-based chemotherapy reduced the risk of progression or death by 45% (median PFS 7.6 vs. 5.4 months) and the risk of death by 32% (median OS 17.8 vs. 12.9 months).
In first-line SANOVO, versus TAGRISSO® alone, the combination reduced progression-or-death risk by 44% in the intention-to-treat population; median PFS was 24.9 vs. 13.8 months and median OS was 44.5 vs. 34.9 months. In the high-MET population, median PFS was 24.8 vs. 11.1 months. HUTCHMED said the U.S. NDA for the SAFFRON setting was submitted and a China supplemental NDA for SANOVO is planned. In SAFFRON, grade 3 or higher treatment-emergent adverse events occurred in 64% versus 63% of patients, with no new safety concerns reported.
HUTCHMED (China) Ltd, through its subsidiary HUTCHMED Limited, closed an exclusive development and license agreement with a GSK subsidiary for HMPL-A830. The agreement grants worldwide rights to develop and commercialize the candidate, excluding Mainland China, Hong Kong, Macau and Taiwan. It closed after customary conditions, including antitrust regulatory reviews, were completed. HUTCHMED Limited expects to receive a US$110 million upfront payment shortly and may receive additional development, regulatory and commercial milestone payments of up to a total of US$1.185 billion, plus tiered royalties on annual net sales.
HUTCHMED Limited is responsible for the global Phase I development program; the GSK subsidiary will handle all subsequent clinical development and commercialization in its territory. The Phase Ia part of the global trial in patients with unresectable, advanced or metastatic solid tumors in China and the US was initiated in September 2026. HMPL-A830 is designed to deliver a KRAS inhibitor to EGFR-expressing tumors while blocking EGFR and KRAS signaling.
HUTCHMED (HCM) announced that AstraZeneca submitted a U.S. New Drug Application for ORPATHYS (savolitinib) plus TAGRISSO (osimertinib), seeking approval to treat patients with locally advanced or metastatic non-small cell lung cancer whose tumors have MET overexpression or amplification and whose disease progressed on or after EGFR-TKI therapy.
The application is supported by the global Phase III SAFFRON trial, which enrolled 338 patients. HUTCHMED reported statistically significant and clinically meaningful improvements in both progression-free and overall survival versus doublet platinum-based chemotherapy. The safety profile was consistent with the known profiles of the medicines, with no new safety concerns. SAFFRON results will be presented at the upcoming ESMO Congress 2026.
HUTCHMED (China) Limited (HCM) initiated the Phase Ia part of a global clinical trial of HMPL-A830 in patients with unresectable, advanced or metastatic solid tumors. The first patient received a dose in China on September 24, 2026. HMPL-A830 combines a KRAS inhibitor payload with an anti-EGFR antibody. The first-in-human, multicenter, open-label Phase I study evaluates safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy.
On September 3, 2026, HUTCHMED Limited, a subsidiary, entered an exclusive development and license agreement with a subsidiary of GSK plc for worldwide rights to develop and commercialize HMPL-A830, excluding Mainland China, Hong Kong, Macau and Taiwan. HUTCHMED is responsible for the global Phase I development program; the GSK subsidiary is responsible for subsequent clinical development and commercialization outside those territories. The agreement is subject to customary closing conditions, including completion of any antitrust regulatory reviews.
HUTCHMED (China) Ltd announced that new and updated data from studies of its compounds are scheduled for presentation at the ESMO Congress in Madrid, Spain, October 23–27, 2026. Two Phase III studies of savolitinib plus osimertinib were selected for oral presentations: global SAFFRON in the Presidential Symposium on October 25, 2026, and China SANOVO in a Proffered Paper session on October 26, 2026.
HUTCHMED said SAFFRON reported statistically significant and clinically meaningful improvement in progression-free and overall survival versus doublet platinum-based chemotherapy; results were reported August 17, 2026. SANOVO reported statistically significant and clinically meaningful improvement in progression-free survival and a clinically meaningful overall-survival benefit versus osimertinib monotherapy; results were reported August 31, 2026. The presentation list also includes studies of fruquintinib and surufatinib across several cancer types.
HUTCHMED (China) Ltd (HCM) announced a global licensing deal with a GSK plc subsidiary for HMPL-A830, a first-in-class KRAS-EGFR Antibody-Targeted Therapy Conjugate (ATTC), excluding Mainland China, Hong Kong, Macau and Taiwan. HUTCHMED will receive a US$110 million upfront payment, plus potential development, regulatory and commercial milestone payments of up to US$1.185 billion, for a total of up to US$1.295 billion, as well as tiered royalties on the GSK subsidiary’s annual net sales. HUTCHMED retains full development and commercialization rights in Mainland China, Hong Kong, Macau and Taiwan.
HUTCHMED will run the global phase I program for HMPL-A830, which is expected to start in the second half of 2026, initially in colorectal, pancreatic and lung cancers; subsequent development and commercialization outside Greater China will be led by GSK’s subsidiary. The GSK subsidiary also receives a right of first negotiation on one earlier-stage ATTC candidate, while the upfront payment is payable at closing, subject to customary conditions including antitrust reviews.
HUTCHMED (China) Ltd (HCM) reports positive top-line results from the China Phase III SANOVO trial in treatment-naïve patients with locally advanced or metastatic EGFR-mutated, MET-overexpressing NSCLC. ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) showed a statistically significant and highly clinically meaningful improvement in progression-free survival versus TAGRISSO® alone in both high-MET and intention-to-treat populations.
The combination also showed a very encouraging overall survival benefit as a secondary endpoint, with safety consistent with known profiles and no new safety findings. SANOVO randomized 326 patients 1:1 to TAGRISSO® plus ORPATHYS® or placebo, and HUTCHMED plans to share the data with regulatory authorities in China to support first-line use.
HUTCHMED (China) Ltd (HCM) reports that China’s National Medical Products Administration has granted conditional approval for ATLED® (fanregratinib, HMPL-453), a novel oral FGFR 1/2/3 inhibitor, to treat adult patients in China with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement after prior systemic therapy.
The approval is based on a pivotal Phase II/IIIb China study (NCT04353375) whose Phase II registration cohort achieved an IRC-assessed objective response rate of 42.5%, median duration of response 6.9 months, disease control rate 83.9%, median progression-free survival 6.9 months and median overall survival 16.6 months. HUTCHMED retains worldwide rights to fanregratinib, and a Phase IIIb confirmatory cohort began enrollment in January 2026.
HUTCHMED (China) Limited reports an update concerning its Chairman and Non-executive Director, Dr Dan Eldar, under AIM Rule 17 Schedule 2(g). A former directorship held by Dr Eldar at S.D. Sight Diagnostics Ltd., an Israeli private medical device company, became relevant after that company entered insolvency proceedings in Israel.
Applications for insolvency proceedings for S.D. Sight were filed on 12 April 2026, with an order commencing proceedings issued on 24 May 2026 and a trustee appointed on 28 May 2026. Public information indicates proceedings involve about NIS3,057,876 (approximately US$1,019,292). Dr Eldar served as a director of S.D. Sight from 20 December 2018 to 18 March 2026, nominated by Hutchison Water Israel E.P.C Ltd, which invested about 9.98% in S.D. Sight.
HUTCHMED states that neither Hutchison Water Israel E.P.C Ltd nor S.D. Sight is part of the HUTCHMED Group, and the insolvency proceedings do not involve the Group or its businesses. The board expresses the view that this has no impact on the Group’s businesses and operations, and discloses the matter solely as a change of information regarding Dr Eldar.
HUTCHMED (China) Limited announced positive high-level results from the global Phase III SAFFRON trial in patients with EGFR-mutated non-small cell lung cancer whose disease progressed on TAGRISSO®. The study showed that combining ORPATHYS® (savolitinib) with TAGRISSO® (osimertinib) delivered statistically significant and clinically meaningful improvements in both progression-free survival and overall survival versus doublet platinum-based chemotherapy in MET-driven disease.
The trial enrolled 338 patients with high MET overexpression or amplification across 230 centers in 29 countries. The combination’s safety profile was consistent with the known profiles of each medicine, with no new safety findings. HUTCHMED and AstraZeneca plan to present the data at a medical meeting and share them with global regulators, supporting potential broader registrations of the ORPATHYS® plus TAGRISSO® regimen.