Group 1 - The core point of the article is the approval of the CSF-1R inhibitor, Pimitinib, by the Chinese drug regulatory authority for the treatment of symptomatic tenosynovial giant cell tumors (TGCT) in adult patients, marking the company's first self-developed drug to be approved for commercialization [1] - Pimitinib, marketed as Beijiemai, is an oral, highly selective, and effective small molecule CSF-1R inhibitor, which demonstrated the best overall response rate (ORR) in the global Phase III MANEUVER study, with significant safety advantages [1] - Long-term follow-up data presented at the 2025 ESMO showed that the ORR for patients treated with Pimitinib increased from 54% at 25 weeks to 76.2% at a median follow-up of 14.3 months, with four cases achieving complete remission [1] Group 2 - The company has established a commercial partnership with Merck, which will drive the commercialization process of Pimitinib following its approval [1] - The company is also advancing multiple pipeline projects, including the approval of the IND application for the oral small molecule KRAS G12D inhibitor, ABSK141, and the completion of the first patient dosing in the Phase II trial of the FGFR2/3 inhibitor, ABSK061, which is the first selective FGFR2/3 inhibitor to enter clinical trials globally [2] - The company maintains a "buy" rating and forecasts net profits of 63 million, 151 million, and 133 million for the years 2025-2027, corresponding to PE ratios of 131X, 55X, and 62X, respectively, indicating a positive outlook on the commercial journey and pipeline progress [3]

Core Viewpoint - The approval of the CSF-1R inhibitor, Pimitinib, marks a significant milestone for the company as its first self-developed drug, initiating a new phase of commercialization and maintaining a "buy" rating [1] Group 1: Pimitinib Approval and Commercialization - Pimitinib, an oral, highly selective, and effective small molecule CSF-1R inhibitor, has been approved by the China National Medical Products Administration for the treatment of symptomatic tenosynovial giant cell tumors (TGCT) in adult patients [1] - The drug demonstrated a best-in-class overall response rate (ORR) of 76.2% at a median follow-up of 14.3 months, with four patients achieving complete remission [1] - Merck will drive the commercialization process for Pimitinib following its approval, leveraging its strong global commercialization capabilities [1] Group 2: Ongoing Pipeline Developments - The company has announced positive preliminary data for the oral small molecule PD-L1 inhibitor combined with Vomeletinib for treating EGFR-mutant, PD-L1 positive advanced non-small cell lung cancer, showing good safety and tolerability [2] - The IND application for the oral small molecule KRAS G12D inhibitor, ABSK141, has been approved by the China National Medical Products Administration, indicating potential best-in-class oral bioavailability [2] - The FGFR2/3 inhibitor, ABSK061, has completed the first patient dosing in a Phase II clinical trial for treating children with achondroplasia, being the first selective FGFR2/3 inhibitor to enter clinical trials globally [2] Group 3: Profit Forecast - The company maintains its previous profit forecast, expecting net profits attributable to the parent company to be 63 million, 151 million, and 133 million for the years 2025-2027, corresponding to price-to-earnings ratios of 131X, 55X, and 62X respectively [3]

Core Viewpoint - The approval of the CSF-1R inhibitor, Pimitinib, marks the company's first self-developed drug to be commercialized, initiating a new phase in its business journey while maintaining a steady advancement in its pipeline, leading to a positive self-sustaining cycle [1][2]. Group 1: Product Development and Commercialization - Pimitinib (brand name: Beijiemai) is an orally administered, highly selective, and effective small molecule CSF-1R inhibitor, which has shown the best overall response rate (ORR) in its class during the global Phase III MANEUVER study [2]. - The long-term follow-up data presented at the 2025 ESMO showed that the ORR for patients treated with Pimitinib increased significantly from 54% at 25 weeks to 76.2% at a median follow-up of 14.3 months, with four cases achieving complete remission [2]. - The company has established an exclusive commercialization partnership with Merck, which will expedite the commercialization process of Pimitinib [2]. Group 2: Ongoing Research and Development - Preliminary data from the Phase II study of the oral small molecule PD-L1 inhibitor combined with Vomeletinib for EGFR-mutant and PD-L1 positive advanced non-small cell lung cancer showed good safety and tolerability, leading to approval for first-line treatment research by the Chinese regulatory authority [3]. - The company announced several advancements in its pipeline, including the IND approval for the oral small molecule KRAS G12D inhibitor, ABSK141, which demonstrated potential best-in-class oral bioavailability in preclinical studies [3]. - The FGFR2/3 inhibitor, ABSK061, has completed the first patient dosing in a Phase II clinical trial for treating children with achondroplasia, being the first selective FGFR2/3 inhibitor to enter clinical trials globally [3]. Group 3: Financial Forecast - The company maintains its previous profit forecast, expecting net profits attributable to the parent company to be 63 million, 151 million, and 133 million for the years 2025 to 2027, corresponding to price-to-earnings ratios of 131X, 55X, and 62X respectively [4].

Investment Rating - The report maintains a "Buy" rating for the company [2][6]. Core Insights - The approval of the CSF-1R inhibitor, Pimitinib, by the Chinese regulatory authority marks the beginning of a new commercialization journey for the company. This drug is the first self-developed new drug and will be commercialized by Merck [6]. - Pimitinib has shown best-in-class overall response rates (ORR) in clinical trials, with a significant increase from 54% to 76.2% in ORR during a median follow-up of 14.3 months [6]. - The company has multiple ongoing pipeline projects, including the approval of IND for the oral KRAS G12D inhibitor and the completion of the first patient dosing in a clinical trial for the FGFR2/3 inhibitor [6]. Financial Data and Profit Forecast - Revenue projections for the company are as follows: - 2023: 19 million - 2024: 504 million - 2025E: 612 million - 2026E: 756 million - 2027E: 627 million - The net profit attributable to ordinary shareholders is expected to be: - 2023: -432 million - 2024: 28 million - 2025E: 63 million - 2026E: 151 million - 2027E: 133 million - The projected earnings per share (EPS) are: - 2023: -0.67 - 2024: 0.04 - 2025E: 0.09 - 2026E: 0.22 - 2027E: 0.20 [3][7].

Core Viewpoint - The report from CICC indicates that HeYu-B's CSF-1R inhibitor, Pimitinib (Beijiemai), has been approved for marketing in China for the treatment of inoperable giant cell tumors of the tendon sheath, marking the company's first self-developed innovative drug approval [1] Group 1: Approval Details - Pimitinib's approval speed exceeded expectations, taking just over six months from the acceptance of its application in June 2025 to approval [1] - The approval is based on the results of the global Phase III MANEUVER clinical trial, which showed a 25-week overall response rate (ORR) of 54% compared to 3.2% for the placebo, with significant improvements in joint mobility and pain indicators [1] Group 2: Future Outlook - The report suggests monitoring the progress of Pimitinib's U.S. market entry, the registration clinical progress of Ipagofitinib in the second-line setting, and the first-line clinical plans [1] - Potential data readout opportunities for ABSK061 and ABSK043, as well as the development progress of early molecules including ABSK131 and ABSK141, are also highlighted [1] - The firm maintains an "outperform" rating for the stock with a target price of HKD 20 [1]

Group 1 - The core viewpoint of the report is that the company maintains its net profit forecasts for 2025 and 2026 at 48 million and 320 million respectively, with a target price of 20 HKD, indicating a potential upside of 48.8% from the current stock price [1] - The company recently announced the approval of its first self-developed innovative drug, Pimiatinib, for the treatment of unresectable tenosynovial giant cell tumors (TGCT) in China [2] - The approval of Pimiatinib was faster than expected, taking just over six months from the acceptance of its application, based on strong clinical evidence from the global Phase III MANEUVER study, which showed an overall response rate (ORR) of 54% compared to 3.2% for placebo [3] Group 2 - The company has made progress in its pipeline, with the completion of the first patient dosing in a Phase II trial of FGFR2/3 inhibitor ABSK061 for achondroplasia [4] - Additionally, results from a Phase II trial of oral PD-L1 inhibitor ABSK043 combined with Furmetinib for non-small cell lung cancer (NSCLC) were presented at the ESMO Asia 2025 conference, showing a disease control rate (DCR) of 71% without observed dose-limiting toxicities [4]

Group 1 - The core viewpoint of the report is that the company maintains its net profit forecasts for 2025 and 2026 at 48 million and 320 million yuan respectively, with a target price of 20 HKD, indicating a potential upside of 48.8% from the current stock price [1] - The company recently announced the approval of its self-developed innovative drug, Pimiatinib, in China for the treatment of unresectable tenosynovial giant cell tumors (TGCT), marking its first approved product [2] - The approval of Pimiatinib was faster than expected, taking just over six months since the application was accepted, based on strong clinical evidence from the global Phase III MANEUVER study, which showed an overall response rate (ORR) of 54% compared to 3.2% for placebo [3] Group 2 - The company has reported progress in its pipeline, including the completion of the first patient dosing in a Phase II trial for FGFR2/3 inhibitor ABSK061 for achondroplasia [4] - Additionally, results from a Phase II trial of oral PD-L1 inhibitor ABSK043 combined with Furmetinib for non-small cell lung cancer (NSCLC) were presented at the ESMO Asia 2025 conference, showing a disease control rate (DCR) of 71% without observed dose-limiting toxicities [4]

ABSK061是和誉医药自主研发的一种高活性、高选择性小分子FGFR2/3抑制剂。在临床前研究中，其已 显示出显著的靶点抑制活性、良好的药代动力学特征以及安全性优势。其口服给药方式在便捷性和治疗 依从性方面，尤其对儿童患者具有显著优势，这使ABSK061成为治疗儿童及青少年ACH患者的具有潜 在价值的候选药物。 作为一项旨在全面评估ABSK061在3至12岁ACH患儿中的安全性、耐受性、药代动力学及初步疗效的开 放标签II期临床研究的一部分，首例患者给药已完成。该研究于2025年3月获得中国国家药品监督管理 局("NMPA")药品审评中心(" CDE")的临床试验药品("IND")许可。 （原标题：和誉-B(02256)：FGFR2/3抑制剂ABSK061治疗软骨发育不全临床试验完成首例患者给药） 智通财经APP讯，和誉-B(02256)发布公告，2025年12月16日，上海和誉生物医药科技有限公司("和誉医 药")宣布，其高选择性小分子FGFR2/3抑制剂ABSK061在针对3-12岁软骨发育不全("ACH")儿 童患者的 II期临床试验中已成功完成首例患者给药。 ACH是一种会导致儿童严重生长发育障碍的常 ...

Group 1 - The core viewpoint is that He Yu-B (02256) is a leader in small molecule innovative drugs, with projected revenues of RMB 650 million, 680 million, and 730 million for 2025-2027, and net profits of RMB 97 million, 111 million, and 142 million respectively, leading to a target price of HKD 22.06, indicating a potential upside of 48.5% from the current price [1] Group 2 - Global BIC product Pimiatin has shown excellent data at ESMO, with an overall response rate (ORR) of 76.2% in the III phase MANEUVER study for patients with giant cell tumor of the tendon sheath, and a significant improvement in joint activity by 23.9% compared to baseline [2] - The NDA for Pimiatin has been submitted domestically, and the FDA NDA submission is progressing, expected to be submitted in Q4 2025 [2] - Pimiatin is also advancing in a II phase study for treating chronic graft-versus-host disease [2] Group 3 - The development of innovative drugs is accelerating, with the oral PD-L1 inhibitor ABSK043 and the KRASG12C inhibitor from Ailis receiving IND approval for treating KRASG12C mutated non-small cell lung cancer (NSCLC) patients [3] - The single-agent treatment of Ipagotin for advanced hepatocellular carcinoma (HCC) has commenced, with the first patient dosed in June 2025, targeting a population with poor prognosis due to FGF19 overexpression [3] - A novel targeted therapy approach for HCC is being developed, with a II phase study showing an ORR of ≥50% and a progression-free survival (PFS) of ≥7 months when combined with Atezolizumab [3]

Group 1 - The core viewpoint is that He Yu-B (02256) is a leading player in small molecule innovative drugs, with projected revenues of RMB 650 million, 680 million, and 730 million for 2025-2027, and net profits of RMB 97 million, 111 million, and 142 million respectively, leading to a target price of HKD 22.06, indicating a potential upside of 48.5% from the current price [1] Group 2 - Global BIC product Pimiatin has shown excellent data at ESMO, with an overall response rate (ORR) of 76.2% in the III phase MANEUVER study for patients with giant cell tumor of the tendon sheath, and a significant improvement in joint activity by 23.9% compared to baseline [2] - The NDA for Pimiatin has been submitted domestically, and the FDA NDA submission is progressing, expected to be submitted in Q4 2025 [2] - Pimiatin is also advancing in a Phase II study for treating chronic graft-versus-host disease [2] Group 3 - The development of innovative drugs is accelerating, with the oral PD-L1 inhibitor ABSK043 and the KRASG12C inhibitor from Ailis receiving IND approval for treating KRASG12C mutated non-small cell lung cancer (NSCLC) patients [3] - The single-agent treatment of Ipagotini for advanced hepatocellular carcinoma (HCC) is underway, with the first patient dosed in June 2025, targeting a population with poor prognosis due to FGF19 overexpression [3] - A novel targeted therapy approach for HCC is being developed, with a Phase II study showing an ORR of ≥50% and a progression-free survival (PFS) of ≥7 months when combined with Atezolizumab [3]