Guoyuan International released a research report stating that ABBISKO-B (02256) is a leader in small-molecule innovative drugs. The firm forecasts revenues of RMB650 million, RMB680 million, and RMB730 million for 2025-2027, with net profits of RMB97 million, RMB111 million, and RMB142 million, respectively. Based on a DCF model, the target price is set at HK$22.06, implying a 48.5% upside from the current price, warranting a Buy rating. Key highlights include:
**Global BIC Drug Pimitesinib Shows Strong Data at ESMO** Pimitesinib's Phase III MANEUVER study data for tenosynovial giant cell tumor (TGCT) patients demonstrated durable efficacy and safety. At a median follow-up of 14.3 months, the ORR per RECIST v1.1 and tumor volume score reached 76.2% (95% CI: 63.8–86.0), with median duration of response not yet reached (range: 0.03–19.81 months). By week 73, patients showed a 23.9% improvement in joint mobility versus baseline. Placebo-group patients switching to pimitesinib in Part 2 achieved a 64.5% ORR. The drug's NDA has been submitted domestically, with FDA filing expected in Q4 2025. A Phase II trial for chronic graft-versus-host disease (cGVHD) is also progressing.
**Accelerated Pipeline Development: Epagotinib for Liver Cancer** In August 2025, the IND application for ABSK043 (oral PD-L1 inhibitor) combined with Eli Lilly’s KRAS G12C inhibitor was approved by China’s CDE for KRAS G12C-mutated NSCLC. Earlier, in March 2025, the duo initiated a trial for ABSK043 plus furmonertinib in advanced NSCLC, with first-patient dosing completed in December 2024. ABSK061 (Phase II) shows promise in achondroplasia and cancers, while ABSK211 (pan-KRAS inhibitor) is in IND preparation. ABSK141 (KRAS G12D) may secure IND approval in H2 2025.
Epagotinib, a monotherapy for FGF19-overexpressing advanced hepatocellular carcinoma (HCC), began registrational trials in June 2025, targeting ~141 patients. With 30% of HCC patients globally exhibiting FGF19 overexpression—a poor prognostic marker—this pathway represents a novel approach. Phase II data presented at ESMO-GI in July 2025 showed ≥50% ORR and ≥7-month PFS in the 220mg BID cohort when combined with atezolizumab.