GenFleet Therapeutics (Shanghai) (2595) Study result presentation summary

GFH375 efficacy in CCA and CRC

• In heavily pretreated CCA (75% in 3L+), ORR was 40% (8/20), confirmed ORR 20%, DCR 95%; median PFS 6.2 months and median OS not reached.

• In heavily pretreated CRC (61% in 4L+), ORR was 11% (4/35 evaluable), confirmed ORR 9%, DCR 77%; median PFS 4.1 months and median OS 10.3 months.

• Efficacy analyses used a 20 Apr 2026 data cutoff; median follow-up was 5.7 months for CCA PFS and 8.3 months for CRC PFS.

• GFH375 is a selective KRAS G12D inhibitor targeting both GTP-bound ON and GDP-bound OFF states; further monotherapy and combination development is planned.

GFH375 safety

• In the 61-patient CCA/CRC safety set, any TRAE occurred in 98.4%; grade 3 or higher TRAEs in 31.1%, treatment-related SAEs in 8.2%, and TRAEs leading to discontinuation in 3.3%.

• One grade 5 TRAE was recorded in CRC (1/41, 2.4%) and coded as an undetermined death; causality could not be concluded from available information.

• Common TRAEs included gastrointestinal, hematologic and liver enzyme events; most were grade 1 or 2 and recovered with supportive treatment, with no new safety signals reported.

GFS202A study and interim findings

• As of 11 Mar 2026, 19 pre-cachexia or cachexia patients had received GFS202A at 5–400 mg Q3W; 94.7% had stage IV disease and 78.9% had received at least two prior lines of therapy.

• GFS202A is being evaluated in a dose-escalation study; primary endpoints include safety, serious AEs and dose-limiting toxicities, with PK, GDF15/CRP, body weight, muscle mass and appetite among secondary endpoints.

• PK exposure increased with dose; half-life was 3.2–7.5 days, no obvious accumulation was observed, and complete, sustained GDF15 inhibition was achieved at 200 mg Q3W and above.

• Most patients had improved mGPS; mean CRP decreases of 39.81 and 49.42 mg/L and mean albumin increases of 3.4 and 2.8 g/L were reported across the displayed assessments.

• Dose-dependent weight gain was observed; skeletal muscle mass and appetite improvements were also reported.