在海外地区，匹米替尼也获得了美国食品药品监督管理局(FDA)授予BTD，和获得欧洲药品管理局 (EMA)授予优先药品(PRIME)认定。 匹米替尼是由和誉医药独立研发的一款新型、口服、高选择性且高效的小分子CSF-1R抑制剂，其全球 III期MANEUVER研究由三部分构成，旨在评估匹米替尼在TGCT患者中的疗效和安全性。在2025年美 国临床肿瘤学会(ASCO)年会上公布的第一部分MANEUVER研究结果显示，匹米替尼为患者带来了显著 的疗效获益：在第25周时，匹米替尼治疗组依据RECIST v1.1标准经BIRC评估的ORR达到了54%，而安 慰剂对照组仅为3.2%。 2025年ESMO会议上，MANUEVER研究的主要研究者(PI)，北京积水潭医院牛晓辉教授汇报了长期疗效 和安全性数据：中位随访14.3个月时，第一部分随机接受匹米替尼治疗的患者依据RECIST v1.1标准经 BIRC评估的ORR提升至76.2%(95%CI:63.8,86.0)，中位缓解持续时间(mDOR)尚未达到(范围：0.03-19.81 个月);第二部分结束时(第49周)，患者临床结果评估持续改善且安全性良好，截至73周，匹米替 ...

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 announced the presentation of long-term efficacy and safety data for pimicotinib in treating patients with tenosynovial giant cell tumor (TGCT) at the 2025 ESMO conference, highlighting strong and durable tumor response rates and clinical improvements [1] Group 1: Study Results - The global Phase III MANEUVER study demonstrated strong and durable tumor response rates for pimicotinib, as assessed by the blinded independent review committee (BIRC) using RECIST v1.1 criteria and tumor volume scoring (TVS) [1] - Objective response rate (ORR) confirmed by the study indicates significant efficacy of pimicotinib in TGCT patients [1] Group 2: Clinical Outcomes - Clinical assessments showed meaningful and sustained improvements in joint mobility, stiffness, pain, and physical function among patients treated with pimicotinib [1] - The long-term feasibility of treatment with pimicotinib has been validated through consistent safety profiles compared to previous analyses [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 此為本公司刊發的自願性公告。本集團無法保證ABSK021最終將成功獲批上市。 本公司股東及潛在投資者於買賣本公司股份時務請審慎行事。 承董事會命 和譽開曼有限責任公司 徐耀昌博士 主席 上海，2025年10月17日 於本公告日期，本公司董事會包括執行董事徐耀昌博士、喻紅平博士及嵇靖博 士；以及獨立非執行董事孫飄揚博士、孫洪斌先生及徐海音女士。 1 和譽醫藥於2025年ESMO會議展示匹米替尼臨床III期MANEUVER研究長 期療效和安全性數據 Abbisko Cayman Limited 和譽開曼有限責任公司 （於開曼群島註冊成立的有限公司） （股份代號：2256） 自願性公告 和譽醫藥於2025年ESMO會議展示匹米替尼 臨床III期MANEUVER研究長期療效和安全性數據 和譽開曼有限責任公司（「本公司」，連同其附屬公司統稱「本集團」）謹在此隨附新 聞稿，以告知本公司股東及潛在投資者，本公司之附屬 ...

Summary of the Conference Call for He Yu Pharmaceutical Company Overview - He Yu Pharmaceutical focuses on the development of small molecule innovative drugs in the oncology field since its establishment in 2016 [3][5] - The company has two significant business development (BD) collaborations: one with Merck for the CSF-1R inhibitor Pimiatinib and another with Elysium Pharmaceuticals for the development of the EGFR C797S mutation inhibitor [3][4] Financial Performance - Total revenue for the first half of the year reached 657 million RMB, primarily driven by an 85 million USD upfront payment from Merck [2][7] - Net profit attributable to shareholders was 329 million RMB, with R&D expenses amounting to 228 million RMB [2][7] - As of the end of the first half, the company had approximately 2.3 billion RMB in cash and liquid financial assets [2][7] Key Products and Clinical Developments Pimiatinib (CSF-1R Inhibitor) - Pimiatinib has received acceptance for NDA submission for the treatment of Tenosynovial Giant Cell Tumor (TGCT) and plans to submit applications to the FDA and EMA [2][8] - Global Phase III clinical data shows an objective response rate (ORR) of 54% at 25 weeks, outperforming existing therapies, with no cholestatic liver injury reported [2][8] - Expected peak sales for Pimiatinib are estimated at 900 million RMB, with a valuation of approximately 9 billion RMB based on a 10x PE ratio [3][15] Ipatasertib (FGFR4 Inhibitor) - Ipatasertib shows an ORR of 36.8% in patients with FGFR19 overexpression in hepatocellular carcinoma (HCC), significantly higher than existing second-line treatments [2][10] - Initial data from a combination therapy with Atezolizumab shows an ORR of 50% for first-line treatment of liver cancer [2][10] - The company plans to complete patient enrollment by 2025 and submit for market approval by 2027, with peak sales expected at 1.5 billion RMB and a valuation of around 4 billion RMB [3][15] Other Products - The company is developing multiple products, including oral PD-L1 inhibitors and PRMT5 inhibitors, with various stages of clinical trials [6][12][14] - The pipeline includes potential products targeting cardiovascular metabolic diseases and autoimmune diseases [13][14] Strategic Partnerships - Collaboration with Merck has resulted in a total of 155 million USD in upfront payments and potential milestone payments of up to 610 million USD for Pimiatinib [2][3] - Partnership with Elysium Pharmaceuticals for the development of the EGFR C797S mutation inhibitor has a total contract value of 188 million USD [2][4] Management Team - The company is led by experienced professionals, including Dr. Xu Yaochang and Dr. Yue Hongping, who have held leadership positions in major pharmaceutical companies [5] Future Outlook - The company aims to expand its product pipeline and explore non-oncology areas, leveraging its expertise in small molecules and linker technology [13][14] - Key milestones for investors include upcoming approvals and clinical trial results for Pimiatinib, Ipatasertib, and oral PD-1 inhibitors [16]

机构：天风证券 研究员：杨松/曹文清 事件 公司的PD-L1 小分子抑制剂ABSK043 联合KRAS G12C 抑制剂戈来雷塞片开展联合用药治疗KRAS G12C 突变的NSCLC 的临床研究申请获CDE 批准。此前，公司已经与艾力斯就联合用药达成了合作协 议。 ABSK043 初步临床数据疗效和安全性平衡，联合疗法瞄准近半NSCLC 市场ABSK043 具有FIC 潜力， 全球暂无PD-（L）1 小分子药物上市。ABSK043 是一款口服PD-L1 抑制剂，可与PD-L1 受体特异性结 合并诱导其从细胞表面内吞，有效地抑制PD-1/PD-L1 的相互作用，解除PD-L1 介导的T 细胞活化抑制 作用。ABSK043 在多个临床前模型中展现出与已获批PD-L1 抗体相当的抗肿瘤功效。PD-（L）1 口服 抑制剂研发的一大障碍就是出现周围神经病变的风险更高（如Incyte 的INCB086550），而ABSK043 在 临床试验中展现出良好的安全性和显著的抗肿瘤活性。在共入组77 例患者的实体瘤I 期临床中，87.0% 的患者出现TEAE，其中29.9%为≥3 级，无周围神经病变。 除NSCLC 以外，ABS ...

天风证券（601162）发布研报称，维持和誉-B(02256)"买入"评级，预计公司2025-2027年的营业收入分 别为6.30亿元、6.85亿元和6.37亿元，归母净利润为0.45亿元、0.70亿元和1.02亿元。公司的PD-L1小分 子抑制剂ABSK043联合KRASG12C抑制剂戈来雷塞片开展联合用药治疗KRASG12C突变的NSCLC的临 床研究申请获CDE批准。此前，公司已经与艾力斯就联合用药达成了合作协议。 报告中称，公司多项核心资产迎来里程碑，发展进入密集催化新阶段。1)KRAS-G12D抑制剂 ABSK141，在小鼠等动物模型中展现了同类最佳口服生物利用度，GLP毒理学研究中展现出良好的安 全性特征，有望于2025年下半年获得IND批准;2)Pan-KRAS inhibitor ABSK211具有泛KRAS抑制剂具有 潜在同类最佳的效力，对多种KRAS突变具有广泛抑制作用，且效力卓越，同时不损伤KRAS非依赖性 细胞系，预计2026年进入临床阶段;3)CSF-1R抑制剂ABSK021(Pimicotinib)的TGCT适应症预计于2025H2 向美国FDA递交NDA。4)靶向两个泛癌靶点的双 ...

报告中称，公司多项核心资产迎来里程碑，发展进入密集催化新阶段。1)KRAS-G12D抑制剂 ABSK141，在小鼠等动物模型中展现了同类最佳口服生物利用度，GLP毒理学研究中展现出良好的安 全性特征，有望于2025年下半年获得IND批准;2)Pan-KRAS inhibitor ABSK211具有泛KRAS抑制剂具有 潜在同类最佳的效力，对多种KRAS突变具有广泛抑制作用，且效力卓越，同时不损伤KRAS非依赖性 细胞系，预计2026年进入临床阶段;3)CSF-1R抑制剂ABSK021(Pimicotinib)的TGCT适应症预计于2025H2 向美国FDA递交NDA。4)靶向两个泛癌靶点的双特异性抗体偶联药物(BsADC)预计于2026年初获得临床 前候选药物，该设计可协同发挥双靶点的治疗优势，通过共表达调控，降低各靶点在正常组织中的副作 用。 智通财经APP获悉，天风证券发布研报称，维持和誉-B(02256)"买入"评级，预计公司2025-2027年的营 业收入分别为6.30亿元、6.85亿元和6.37亿元，归母净利润为0.45亿元、0.70亿元和1.02亿元。公司的 PD-L1小分子抑制剂ABSK043联 ...

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]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 和譽開曼有限责任公司 呈交日期: 2025年10月8日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02256 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | 本月底法定/註冊股本總 ...