Core Viewpoint - The company announced the long-term efficacy and safety data of pimicotinib in treating TGCT patients, showcasing strong and durable tumor response rates from the global Phase III MANEUVER study presented at the 2025 ESMO meeting [1][3]. Group 1: Study Results - The MANEUVER study demonstrated a significant objective response rate (ORR) of 76.2% based on RECIST v1.1 criteria after a median follow-up of 14.3 months [3]. - The ORR for the pimicotinib treatment group reached 54% at week 25, compared to only 3.2% in the placebo group [2]. - Patients who switched from placebo to pimicotinib in the second part of the study achieved an ORR of 64.5% [3]. Group 2: Drug Profile - Pimicotinib is a novel, oral, highly selective, and effective small molecule CSF-1R inhibitor independently developed by the company [2][4]. - The drug has received breakthrough therapy designation (BTD) from both the NMPA in China and the FDA in the United States, as well as priority medicine designation (PRIME) from the EMA [4]. Group 3: Commercialization and Regulatory Status - The drug has been included in priority review by the NMPA for adult TGCT patients requiring systemic treatment [4]. - A commercialization agreement has been reached between the company and Merck, with Merck responsible for global commercialization of pimicotinib [4].

Core Viewpoint - The company announced the long-term efficacy and safety data of pimicotinib in treating patients with tenosynovial giant cell tumor (TGCT) at the 2025 ESMO conference, demonstrating strong and durable tumor response rates and clinical improvements [1][3]. Group 1: Study Results - The global Phase III MANEUVER study showed that the objective response rate (ORR) for pimicotinib reached 76.2% based on RECIST v1.1 criteria after a median follow-up of 14.3 months [3]. - The first part of the MANEUVER study reported an ORR of 54% for the pimicotinib group at week 25, compared to 3.2% for the placebo group [2]. - After switching from placebo to pimicotinib, patients showed an ORR of 64.5% based on RECIST v1.1 and tumor volume score (TVS) assessments [3]. Group 2: Drug Profile and Regulatory Status - Pimicotinib is a novel, oral, highly selective, and effective small molecule CSF-1R inhibitor developed independently by the company [2][4]. - The drug has received priority review status from the NMPA for adult patients with TGCT requiring systemic treatment and has been granted breakthrough therapy designation (BTD) [4]. - In December 2023, the company entered into a commercialization agreement with Merck for pimicotinib, which will be responsible for its global commercialization [4].

Core Viewpoint - The company has received approval from CDE for clinical research on its PD-L1 small molecule inhibitor ABSK043 in combination with KRAS G12C inhibitor for treating KRAS G12C mutated NSCLC, indicating significant potential in the market for this combination therapy [1] Group 1: ABSK043 Development - ABSK043 is an oral PD-L1 inhibitor designed for combination therapy, showing a balance of efficacy and safety in preliminary clinical data [1][3] - The drug targets nearly half of the NSCLC market and has first-in-class (FIC) potential, with no other PD-(L)1 small molecule drugs currently available globally [1][3] - In a Phase I clinical trial involving 77 patients, 87.0% experienced treatment-emergent adverse events (TEAEs), with 29.9% being grade 3 or higher, and no peripheral neuropathy reported [1] Group 2: Clinical Efficacy - In a study of 10 lung cancer patients who had not received prior immune checkpoint inhibitor (ICI) treatment, the overall response rate (ORR) was 40%, with 50% of both EGFR and KRAS mutation patients achieving partial response (PR) [2] - Among EGFR mutation patients, those with PD-L1 TPS ≥50% showed progression after at least one line of EGFR TKI treatment [2] Group 3: Market Potential and Future Trials - ABSK043 has significant market potential in KRAS and EGFR NSCLC, which account for approximately 45%-60% of NSCLC cases, covering various treatment scenarios [3] - The company is also conducting a Phase II clinical trial combining ABSK043 with the third-generation EGFR TKI, furmonertinib, with preliminary safety data expected by Q4 2025 [3] - Beyond NSCLC, ABSK043 is involved in Phase I trials for monotherapy in solid tumors and in combination with FGFR2/3 inhibitors in China [3] Group 4: Other Key Assets and Financial Projections - The company is advancing multiple core assets, including the KRAS-G12D inhibitor ABSK141, which is expected to receive IND approval in H2 2025 [4] - The Pan-KRAS inhibitor ABSK211 is anticipated to enter clinical stages by 2026, while the CSF-1R inhibitor ABSK021 is expected to submit an NDA to the FDA in H2 2025 [4] - Financial projections estimate revenues of 630 million, 685 million, and 637 million yuan for 2025-2027, with net profits of 45 million, 70 million, and 102 million yuan respectively [4]