Sovleplenib - (ESLIM-02)

March 5, 2026: HUTCHMED (China) Limited (Nasdaq/AIM: HCM; HKEX: 13) reported FY2025 results and highlighted multiple upcoming and recent biopharma catalysts across its portfolio and ATTC platform.

ATTC platform: First-in-human global Phase I/IIa trial of HMPL-A251 (HER2-expressing solid tumors) initiated in December 2025 after preclinical data at AACR-NCI-EORTC (Oct 2025) and IND approvals in China and the US (Nov 2025). Second ATTC HMPL-A580 (EGFR solid tumors) trial initiated March 2026; third candidate HMPL-A830 targeted for Phase I start by year-end 2026, with global IND filings/clinical initiations planned in 2026.

Savolitinib (ORPATHYS): Swissmedic granted temporary authorization (Feb 2026) for savolitinib + TAGRISSO in 2L EGFRm NSCLC with MET amplification/overexpression. NMPA updates include: 2L EGFRm NSCLC with MET amplification approval in June (milestone payment of $11.0m from AstraZeneca); METex14 NSCLC 1L/2L full approval in January and Hong Kong approval in February; priority-review sNDA accepted (Dec) for 3L MET-amplified gastric cancer. Phase III SAFFRON and SANOVO enrollments completed; SAFFRON topline expected H2 2026 and SANOVO late 2026/early 2027.

Fruquintinib (ELUNATE/FRUZAQLA): NMPA accepted sNDA (June) for fruquintinib + sintilimab in 2L RCC after FRUSICA-2 Phase III results (ESMO 2025) showing mPFS 22.2 vs 6.9 months and ORR 60.5% vs 24.3%.

Sovleplenib (HMPL-523): Phase III ESLIM-02 in warm AIHA met the primary endpoint (Jan 2026); NMPA filing planned H1 2026. ITP NDA accepted by NMPA in Feb 2026 (resubmission with added stability studies); rolling data submission planned H2 2026.

Surufatinib (SULANDA): Phase II/III PDAC combo showed mPFS 7.2 vs 5.5 months; Phase III part initiated Dec 2025.

Fanregratinib (HMPL-453): NDA accepted by NMPA with priority review (Dec 2025) for 2L IHCC with FGFR2 fusion/rearrangement based on Phase II registration data.

Tazemetostat (TAZVERIK): NMPA conditional approval (March) for 3L R/R EZH2-mutant follicular lymphoma; SYMPHONY-1 Phase III (China portion) ongoing.

Collaboration (ImageneBio IMG-007): ADAPTIVE Phase IIb in moderate-to-severe atopic dermatitis initiated; Phase IIa at ISDS reported positive AD and alopecia areata signals.