Shenwan Hongyuan released a research report stating that on December 22, ABBISKO-B (02256) announced that its CSF-1R inhibitor, pimitesinib, received marketing approval from China's NMPA for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) where surgical resection may lead to functional limitations or severe complications. The approval of this first self-developed new drug marks the beginning of a new commercial journey, while the R&D pipeline continues to advance steadily, creating a virtuous cycle of "self-sustaining" capabilities, prompting the maintenance of a "Buy" rating.
The first self-developed drug, pimitesinib, has been launched, and its subsequent commercialization will be driven by Merck. Pimitesinib (brand name: Bejiemai) is an orally administered, highly selective, and potent small molecule CSF-1R inhibitor independently developed by the company. Results from the global Phase III MANEUVER study previously showed that pimitesinib demonstrated the best-in-class Objective Response Rate (ORR) among its peers, along with a clear safety advantage. Long-term follow-up data presented at the 2025 ESMO (European Society for Medical Oncology) congress showed that in patients receiving pimitesinib from the start of the study, with a median follow-up of 14.3 months, the ORR significantly increased from 54% at 25 weeks to 76.2%, including 4 cases achieving complete response. As the company's first approved new drug, an exclusive commercialization agreement was previously reached with Merck, which will expedite the product's commercial launch post-approval. Given pimitesinib's differentiated product advantages and Merck's strong global commercialization capabilities, the firm is optimistic about the product's market uptake following its launch.
Preliminary later-line data has been announced for the oral small molecule PD-L1 inhibitor in combination with fumetinib. On December 8, Phase II data for ABSK043 combined with fumetinib in the treatment of EGFR-mutant, PD-L1 positive, pre-treated advanced non-small cell lung cancer was presented at the 2025 ESMO Asia Congress, showing good safety and tolerability. Based on these results, China's NMPA has agreed to initiate a first-line treatment study for this regimen. Previous research indicated that in EGFR-mutant patients with concurrent high PD-L1 expression, combination therapies of PD-1/PD-L1 monoclonal antibodies with EGFR-TKIs have been limited due to severe toxicities. The company's small molecule combination regimen has shown preliminary positive results, potentially altering the treatment landscape for this patient population.
Multiple pipeline assets are progressing steadily. The company recently announced progress on several R&D programs: ① The Investigational New Drug (IND) application for its oral small molecule KRAS G12D inhibitor, ABSK141, was approved by China's NMPA; preclinical studies indicated this product has potential best-in-class oral bioavailability. ② The Phase II clinical trial for the FGFR2/3 inhibitor ABSK061 in treating pediatric achondroplasia has dosed its first patient; this product is the first FGFR2/3 selective inhibitor to enter clinical trials globally and is expected to achieve a better therapeutic window and efficacy clinically.
Earnings Forecast: The firm maintains its previous profit forecasts, estimating net profit attributable to shareholders for 2025-2027 to be 63 million, 151 million, and 133 million respectively, corresponding to P/E ratios of 131x, 55x, and 62x.
Risk Warning: Risks include potential R&D failure or delays, earnings volatility, and intensifying competition.