Sovleplenib - (China trial)

Aug. 7, 2025: HUTCHMED (China) Limited (Nasdaq/AIM: HCM; HKEX: 13) reported H1 2025 results and provided multi-program catalyst updates.

ORPATHYS (savolitinib) + TAGRISSO (osimertinib): China NMPA approved a third lung cancer indication on June 30, 2025 for EGFR-mutant NSCLC with MET amplification after progression on EGFR inhibitors, triggering an $11.0M milestone from AstraZeneca. SACHI Phase III (ASCO 2025) showed mPFS 8.2 months vs 4.5 months with chemotherapy in ITT (HR 0.34) and 6.9 vs 3.0 months post–3rd gen EGFR TKI subgroup (HR 0.32; both p<0.0001). SAVANNAH Phase II (ELCC 2025) reported ORR 56%, mPFS 7.4 months, mDoR 7.1 months. SAFFRON global Phase III enrollment expected to complete in H2 2025; readout targeted H1 2026. SANOVO China Phase III enrollment completion targeted H2 2025.

ELUNATE/FRUZAQLA (fruquintinib): Positive FRUSICA-2 Phase III supported a China submission for ELUNATE + TYVYT in previously treated RCC; details planned for ESMO Congress; this 3rd RCC indication was accepted for NMPA review in June 2025.

Sovleplenib (HMPL-523): ESLIM-01 ITP NMPA NDA review requires additional manufacturing validation; target re-submission H1 2026. ESLIM-02 warm AIHA Phase III enrollment completed June 2025; sNDA submission targeted H1 2026.

SULANDA (surufatinib): Phase II/III trial in 1L metastatic pancreatic cancer (with camrelizumab + chemo) targets data readout in H2/late 2025.

TAZVERIK (tazemetostat): Conditionally approved by NMPA in March 2025 for 3L R/R EZH2-mutant follicular lymphoma; launched in mainland China in July 2025; SYMPHONY-1 Phase III China portion enrolling.

ATTC platform: first ATTC candidate clinical initiation planned around end of 2025; multiple global IND filings planned in 2026; preclinical data presentation planned before end-2025.

IMG-007 (licensed to ImageneBio): Positive Phase IIa in atopic dermatitis (April 2025; week-16 EASI change 77%, EASI-75 54%); first patient dosed in Phase IIb in July 2025; positive Phase IIa alopecia areata data reported Jan 2025 (week-36 SALT reduction 30.1%).