该联用方案还展现出积极的抗肿瘤活性。依据RECIST v1.1标准评估的疾病控制率(DCR)达到71%，共有 14例患者实现靶病灶缩小。在达到部分缓解(PR)的5例患者中，有4例曾接受过第三代EGFR-TKI的治 疗。截至数据分析时，中位缓解持续时间(DOR)尚未达到。 表皮生长因子受体(EGFR)突变是NSCLC中最常见的致癌驱动基因突变。尽管第三代EGFR-TKIs已成为 EGFR突变晚期NSCLC的一线标准治疗方案，但研究表明，与PD-L1低表达或阴性患者相比，EGFR突 变合并PD-L1高表达的患者从 EGFR-TKIs的治疗中获益较少。此外，虽然免疫治疗已在多个癌种中表现 出卓越疗效，但PD-1/PD-L1抗体与EGFR-TKI的联合方案因严重毒副反应而受到限制，使得该类患者人 群的临床需求仍未得到满足。 在本届ESMO Asia 2025上，上海交通大学医学院附属上海胸科医院陆舜教授以壁报形式展示了正在开 展的II期研究(ABSK043-202)剂量递增阶段的积极结果。在剂量递增阶段，共纳入21例EGFR突变且PD- L1阳性的经治晚期NSCLC患者，其中17例患者曾接受过第三代EGFR-TKIs ...

和誉-B(02256)发布公告，2025年12月8日，上海和誉生物医药科技有限公司(和誉医药)宣布，其在2025 年欧洲肿瘤内科学会亚洲年会(ESMO Asia2025)公布其在研口服小分子PD-L1抑制剂ABSK043联合上海 艾力斯医药科技股份有限公司(艾力斯)第三代EGFR-TKI伏美替尼治疗非小细胞肺癌(NSCLC)的II期临床 研究(ABSK043-202)剂量递增阶段的积极结果。数据显示，ABSK043与伏美替尼的"靶免联合"方案展现 出良好的安全性和耐受性。监管部门基于该方案良好的安全性，同意将其拓展至用于EGFR突变且PD- L1阳性NSCLC患者的一线治疗研究。 表皮生长因子受体(EGFR)突变是NSCLC中最常见的致癌驱动基因突变。尽管第三代EGFR-TKIs已成为 EGFR突变晚期NSCLC的一线标准治疗方案，但研究表明，与PD-L1低表达或阴性患者相比，EGFR突 变合并PD-L1高表达的患者从EGFR-TKIs的治疗中获益较少。此外，虽然免疫治疗已在多个癌种中表现 出卓越疗效，但PD-1/PD-L1抗体与EGFR-TKI的联合方案因严重毒副反应而受到限制，使得该类患者人 群的临床需求 ...

格隆汇12月8日丨和誉-B(02256.HK)宣布，其在2025年欧洲肿瘤内科学会亚洲年会("ESMOAsia 2025")公 布其在研口服小分子PD-L1抑制剂ABSK043联合上海艾力斯医药科技股份有限公司("艾力斯")第三代 EGFR-TKI伏美替尼治疗非小细胞肺癌("NSCLC")的II期临床研究(ABSK043-202)剂量递增阶段的初步结 果。数据显示，ABSK043与伏美替尼的"靶免联合"方案展现出良好的安全性和耐受性。监管部门基于 该方案良好的安全性，同意将其拓展至用于EGFR突变且PD-L1阳性NSCLC患者的一线治疗研究。 ...

和誉-B公告，公司附属公司和誉医药在2025年欧洲肿瘤内科学会亚洲年会公布其在研口服小分子PD-L1 抑制剂ABSK043联合上海艾力斯医药科技股份有限公司第三代EGFR-TKI伏美替尼治疗非小细胞肺癌的 II期临床研究（ABSK043-202）剂量递增阶段的初步结果。数据显示，ABSK043与伏美替尼的"靶免联 合"方案展现出良好的安全性和耐受性。监管部门基于该方案良好的安全性，同意将其拓展至用于EGFR 突变且PD-L1阳性NSCLC患者的一线治疗研究。 ...

和誉 20251119 摘要 FGFR 4 项目目前进展如何？ FGFR 4 项目在研发日提供的数据和进展超出预期。目前二线加丹药的注册性 临床试验已于今年（2025 年）6 月开始患者入组，进展比原计划更快。预计明 年（2026 年）此时将完成试验并获得 ORR 数据，以便向 CDE 递交 NDA 申请。 这意味着 FGFR 4 可能在 2027 年四季度至 2028 年上半年进入商业化状态。 此外，一线加 Combo FURTHER 研究方案已与 FDA 初步沟通完毕，计划明年 上半年确定方案并开展全球多中心 MRCT 试验。 匹米替尼预计 2026 年下半年在中美欧实现商业化，有望带来可持续现 金流。美国市场销售峰值预计 5-6 亿美元，欧洲 4-5 亿欧元，中国 10- 15 亿人民币，加拿大和日本市场也将贡献增量。 FGFR 4 项目二线加丹药注册性临床试验提前至 2025 年 6 月启动患者 入组，预计 2026 年完成试验并获得 ORR 数据，有望 2027 年四季度至 2028 年上半年商业化。一线加 Combo FURTHER 研究方案已与 FDA 初步沟通，计划明年上半年开展全球多中心 M ...

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]

Summary of Key Points from the Conference Call Industry Overview - **Industry**: Small-cap biotechnology in China - **Context**: The sector is at an inflection point after a four-year down cycle since 2021, with a structural upside for China's innovative drug pipeline in a global context [1][11][34] Core Insights and Arguments - **Survive-to-Thrive Roadmap**: Emphasis on efficient R&D, differentiated pipeline, and committed global partnerships as key growth drivers for small-cap biotech companies [1][11][12] - **US Small-Cap Biotech Learnings**: Historical performance shows a significant divergence between Thrivers (33X growth in market cap from 2005-2025) and Non-thrivers (66% shrinkage) [2][12][19] - **Differentiated Pipeline**: Companies focusing on rare diseases have shown better performance due to less costly and quicker drug development processes [2][12][30] - **Abbisko Therapeutics**: Initiated coverage with a Buy rating, targeting a 12-month DCF-based price of HK$27.10, indicating a 91% upside potential [4][60] Abbisko Therapeutics Highlights - **Pipeline**: Abbisko has a robust pipeline of 22 drug candidates, including 12 in clinical stages, with pimicotinib (CSF-1R inhibitor) expected to achieve US$1.6 billion in risk-adjusted peak sales [4][15][60] - **Global Partnership**: Strong endorsement from Merck KGaA enhances Abbisko's global visibility and market potential [4][15][60] - **R&D Expertise**: Abbisko's deep know-how in small-molecule R&D supports its strategic expansion roadmap into various therapeutic areas [4][15][60] Important but Overlooked Aspects - **Cash Runway Extension**: Companies are focusing on extending their cash runway, with more than half expected to have over five years of cash runway by 2025 [43][44] - **Strategic Pivots**: Companies are making aggressive strategic pivots, such as focusing on early-stage pipelines and leveraging partnerships to maximize asset value [47][48][51] - **Market Dynamics**: The funding environment for China healthcare is bottoming out, with a notable turnaround in private biotech funding expected [35][38] Conclusion - The small-cap biotech sector in China is transitioning from survival to growth, with companies like Abbisko positioned well for future success through strategic partnerships, efficient R&D, and a differentiated pipeline. The insights drawn from the US small-cap biotech experience provide valuable lessons for navigating this evolving landscape [1][11][12][60]

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]

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Insights - The company’s PD-L1 small molecule inhibitor ABSK043 has received approval for clinical research to treat KRAS G12C mutated NSCLC in combination with the KRAS G12C inhibitor, adagrasib [1] - ABSK043 shows potential as a first-in-class (FIC) oral PD-L1 inhibitor, with no other oral PD-(L)1 drugs currently available globally [2] - The initial clinical data indicates a balance of efficacy and safety, with 87% of patients experiencing treatment-emergent adverse events (TEAEs) and no peripheral neuropathy observed [2] - ABSK043 is designed specifically for combination therapy, offering advantages such as a short half-life, reduced immunogenicity, and oral administration flexibility [3] - The market potential for ABSK043 is significant, targeting approximately 45%-60% of NSCLC cases, with ongoing clinical trials in various treatment settings [3] Financial Projections - The company is projected to achieve revenues of 630 million, 685 million, and 637 million yuan for the years 2025, 2026, and 2027 respectively [5] - Expected net profits for the same period are 45 million, 70 million, and 102 million yuan [5] - The target price for the stock is set at 22.88 HKD, with the current price at 19.62 HKD [5] Pipeline Developments - The company has several key assets nearing milestones, including: 1. KRAS-G12D inhibitor ABSK141, expected to receive IND approval in the second half of 2025 [4] 2. Pan-KRAS inhibitor ABSK211, anticipated to enter clinical stages in 2026 [4] 3. CSF-1R inhibitor ABSK021, with an NDA submission planned for the second half of 2025 [4] 4. A bispecific antibody-drug conjugate (BsADC) targeting two pan-cancer targets, expected to achieve preclinical candidate status in early 2026 [4]