消息面上，和誉公布，其附属和誉医药在结缔组织肿瘤学会(CTOS)2025年会上以壁报形式，展示匹米 替尼(pimicotinib/ABSK021)治疗腱鞘巨细胞瘤(TGCT)患者的全球III期MANEUVER研究的长期疗效、安 全性及患者报告结果数据。 和誉-B(02256)尾盘涨超4%，截至发稿，涨3.9%，报14.13港元，成交额4541万港元。 该长期分析显示，持续接受匹米替尼治疗可为TGCT患者在肿瘤缓解方面带来疗效持续提升与患者报告 结果(包括疼痛与功能)的进一步改善，同时维持可接受的安全性，强化匹米替尼在适合患者中的长期应 用潜力。 ...

智通财经APP获悉，和誉-B(02256)尾盘涨超4%，截至发稿，涨3.9%，报14.13港元，成交额4541万港 元。 消息面上，和誉公布，其附属和誉医药在结缔组织肿瘤学会(CTOS)2025年会上以壁报形式，展示匹米 替尼(pimicotinib/ABSK021)治疗腱鞘巨细胞瘤(TGCT)患者的全球III期MANEUVER研究的长期疗效、安 全性及患者报告结果数据。 该长期分析显示，持续接受匹米替尼治疗可为TGCT患者在肿瘤缓解方面带来疗效持续提升与患者报告 结果(包括疼痛与功能)的进一步改善，同时维持可接受的安全性，强化匹米替尼在适合患者中的长期应 用潜力。 ...

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 ...

Major Events - Shandong Xinhua Pharmaceutical Co., Ltd. received the approval notice for the listing application of fumaric acid vonoprazan chemical raw materials [1] - HeYue Pharmaceutical showcased long-term efficacy and safety data from the clinical III MANEUVER study of pitmiprazole at the CTOS 2025 conference [1] - China Software International partnered with Deep Open Hong and Yiswei Computing to build a new ecosystem for "open-source HarmonyOS + RISC-V" digital infrastructure [1] - China General Nuclear Power Corporation's Zhaoyuan Unit 1 is set to begin full construction [1] - Hengrui Medicine's fumaric acid teglutide injection received approval for clinical trials [1] - China National Nuclear Corporation signed an intention procurement agreement for cobalt-60 irradiation sources with the Brazilian National Nuclear Energy Commission [1] Operating Performance - China Railway Construction Corporation recently won several major projects with a total investment of 49.629 billion yuan [1] - Geely Automobile reported a net profit of 3.82 billion yuan for the third quarter, a year-on-year increase of 59% [1] - China Resources Power's subsidiary power plants achieved a cumulative electricity sales volume of 185 million megawatt-hours in the first ten months, a year-on-year increase of 6.5% [1] - Leap Motor reported a net profit of 150 million yuan for the third quarter, maintaining the top sales position among new force brands in China for eight consecutive months [1] - Huazhu Group's net profit attributable to shareholders for the third quarter was 1.5 billion yuan, a year-on-year growth of 15.4% [1] - Air China saw a year-on-year increase of 8.7% in passenger turnover in October [1] - China Eastern Airlines reported a year-on-year increase of 10.58% in passenger turnover in October [1]

Core Viewpoint - The announcement highlights the long-term efficacy and safety of pimicotinib in treating TGCT patients, as presented at the CTOS 2025 conference, reinforcing its potential for long-term application in suitable patients [1] Group 1: Company Information - Shanghai Heyu Biopharmaceutical Technology Co., Ltd., a subsidiary of Heyu-B, showcased data from the global Phase III MANEUVER study on pimicotinib for TGCT patients [1] - The study results indicate that continuous treatment with pimicotinib leads to sustained improvements in tumor response and patient-reported outcomes, including pain and function [1] Group 2: Industry Insights - The findings from the MANEUVER study strengthen the position of pimicotinib in the treatment landscape for TGCT, suggesting a viable long-term treatment option for patients [1] - The acceptable safety profile maintained during the study supports the ongoing development and potential market introduction of pimicotinib for this indication [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。 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CTOS 2025年會展示匹米替尼臨床III期 MANEUVER研究長期療效和安全性數據 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11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 和譽開曼有限責任公司（「本公司」，連同其附屬公司統稱「本集團」）謹此隨附新 聞稿，以告知本公司股東及潛在投資者，本公司之附屬公司上海和譽生物醫藥科 技有限公司（「和譽醫藥」）宣佈，其在結締組織腫瘤學會（「CTOS」）2025年會上以 壁報形式展示了匹米替尼(pimicotinib/ABSK021)治療腱鞘巨細胞瘤（「TGCT」）患 者的全球III期MANEU ...

Core Insights - The company, He Yu Pharmaceutical, is advancing in "source innovation" through strong new drug development, global clinical capabilities, and international collaborations [1][2] - The company has a robust pipeline with 22 drugs in development, over 10 of which are in clinical stages, showcased during the 2025 R&D Day [1][3] R&D Strategy - He Yu emphasizes a dual-driven strategy of "depth + breadth" to enhance its pipeline, focusing on both innovative therapies in oncology and expanding into non-oncology indications [2][8] - The company has maintained a compound annual growth rate of 54% in R&D investment since its inception, ensuring a strong pipeline of differentiated Best-in-Class (BIC) and First-in-Class (FIC) drugs [8][11] Key Products - The core product, Pimicotinib, is the first Chinese-developed CSF-1R inhibitor entering global Phase III clinical trials, with significant potential in multiple indications [5][7] - Pimicotinib has received breakthrough therapy designation from regulatory agencies in multiple countries and is projected to achieve global sales peak of over $2 billion [5][6] Clinical Data and Market Potential - Recent data from the ESMO Congress 2025 demonstrated Pimicotinib's strong and durable efficacy in treating TGCT patients, reinforcing its potential as a best-in-class treatment [6][10] - The company is also developing the FGFR4 inhibitor, Absk-011, which has shown promising clinical results in advanced HCC patients, indicating a strong market opportunity [9][10] Financial Outlook - He Yu holds over 2 billion yuan in cash and is recognized for enhancing investor returns through stock buybacks while being in the early stages of commercialization [11] - Recent analyst reports from various brokerages have given positive ratings for He Yu, with target prices indicating significant upside potential [11]

Core Insights - The company, He Yu Pharmaceutical, is advancing in "source innovation" through strong new drug development, global clinical capabilities, and international collaborations [1][2] - The company has a robust pipeline with 22 drugs in development, over 10 of which are in clinical stages, highlighted during the R&D Day event on October 30 [1][2] R&D Strategy - He Yu emphasizes a dual-driven strategy of "depth + breadth" to enhance its pipeline, focusing on developing differentiated innovative therapies for unmet clinical needs [2][7] - The company has maintained a compound annual growth rate of 54% in R&D investment since its inception, ensuring a strong pipeline of over 10 clinical-stage oncology products [7] Key Products - The core product, Pimicotinib, is the first Chinese-developed CSF-1R inhibitor entering global Phase III clinical trials, with breakthrough therapy designation from multiple regulatory agencies [4][6] - Pimicotinib has shown significant potential in treating TGCT and other indications, with a projected global peak sales exceeding $2 billion [4][5] Clinical Data - Recent data presented at the ESMO Congress 2025 demonstrated Pimicotinib's strong and durable tumor response in TGCT patients, confirming its potential as a best-in-class treatment [5] - The drug is currently under priority review in China and is expected to submit an NDA in the U.S. by the end of the year, with potential approvals in 2026 [6] Pipeline Development - The company is also exploring FGFR and KRAS targets, with the FGFR4 inhibitor, Absk-011, showing promising clinical results in advanced HCC patients [8][9] - Absk-011 has received breakthrough therapy designation and is positioned to become a leading targeted therapy for liver cancer [8][9] Market Potential - Approximately 30% of global HCC patients have FGF19 overexpression, indicating a significant market opportunity for Absk-011 upon approval [9] - The company is advancing multiple promising candidates, including oral small molecule PD-L1 inhibitors and other innovative therapies, enhancing its commercial prospects [9][10] Financial Outlook - He Yu holds over 2 billion yuan in cash and is recognized for enhancing investor returns through stock buybacks while being in the early stages of commercialization [10] - Recent analyst reports have issued "buy" ratings for the company, with target prices indicating substantial upside potential [10]

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]