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和誉(02256) - 自愿性公告 - 口服小分子KRAS G12D抑制剂ABSK141的IND申请...
2025-12-01 09:39
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。 1 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 口服小分子KRAS G12D抑制劑 ABSK141的IND申請獲FDA批准 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,一種用於治療攜帶KRAS G12D突變的晚期實體瘤 患者的口服、高活性、高選擇性小分子KRAS G12D抑制劑ABSK141的新藥臨床 試驗(「IND」)申請已獲得美國食品藥品監督管理局(「FDA」)批准。 此為本公司刊發的自願性公告。本集團無法保證ABSK141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12月 ...
和誉-B(02256.HK)获Allianz SE增持116.7万股
Ge Long Hui A P P· 2025-11-26 23:41
Group 1 - Allianz SE increased its stake in 和誉-B (02256.HK) by acquiring 1.167 million shares at an average price of HKD 13.2512 per share, totaling approximately HKD 15.4642 million [1] - Following this acquisition, Allianz SE's total shareholding in 和誉-B rose to 40.692 million shares, increasing its ownership percentage from 5.88% to 6.05% [1]
和誉-B尾盘涨超4% 公司展示匹米替尼临床III期MANEUVER研究长期疗效和安全性数据
Zhi Tong Cai Jing· 2025-11-20 07:01
Core Viewpoint - The stock of He Yu-B (02256) has seen a significant increase, with a rise of over 4% in the late trading session, currently up by 3.9% at HKD 14.13, with a trading volume of HKD 45.41 million [1] Group 1: Company Developments - He Yu announced that its subsidiary, He Yu Pharmaceutical, presented long-term efficacy, safety, and patient-reported outcome data from the global Phase III MANEUVER study of pimicotinib (ABSK021) for patients with tenosynovial giant cell tumor (TGCT) at the CTOS 2025 conference [1] - The long-term analysis indicates that continuous treatment with pimicotinib can lead to sustained improvements in tumor response and further enhancements in patient-reported outcomes, including pain and function, while maintaining an acceptable safety profile [1] - The findings reinforce the long-term application potential of pimicotinib in suitable patients [1]
港股异动 | 和誉-B(02256)尾盘涨超4% 公司展示匹米替尼临床III期MANEUVER研究长期疗效和安全性数据
智通财经网· 2025-11-20 06:58
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
2025-11-20 02:16
Company and Industry Summary Company Overview - The company is focused on the development and commercialization of innovative drugs, particularly in oncology, with key products including Pitimatinib and ABS K043 [2][4][5]. Key Products and Market Potential Pitimatinib - Expected to be commercialized in the second half of 2026 across the US, Europe, and China, potentially generating sustainable cash flow [2][4]. - Peak sales projections: - US: $500-600 million - Europe: €400-500 million - China: ¥1-1.5 billion - Additional contributions expected from Canada and Japan [2][14][17]. FGFR 4 Project - Registration clinical trials for the second-line FGFR 4 drug are set to start patient enrollment in June 2025, with completion expected in 2026 [2][6]. - Anticipated commercialization between Q4 2027 and H1 2028, with a peak sales potential of several hundred million dollars, possibly nearing $1 billion [2][7]. ABS K043 - Positioned as a first-in-class small molecule, with significant advantages over competitors, particularly in terms of oral bioavailability and rapid metabolism [2][9]. - Clinical trials show promising results, with an objective response rate (ORR) of 75% in gastric cancer when combined with FGFR23 [3][11]. - Expected to enter Phase III trials, focusing on head-to-head comparisons with existing therapies [18]. Competitive Landscape - The company is advancing its projects while competitors like Incyte have halted their clinical trials [8][9]. - The market for ABS K043 is expected to be substantial due to its unique properties and the current lack of effective alternatives [9][10]. Strategic Development - The company aims to ensure self-sustaining cash flow exceeding $100 million annually through successful drug commercialization [5][12]. - Plans to leverage product synergies and early-stage research projects to achieve long-term sustainable growth [5][12]. Financial Health and Risk Management - The company maintains a strong cash position to support R&D and operational needs, employing a diversified strategy to mitigate risks [15]. - Collaboration with partners is emphasized to enhance efficiency and share resources [15]. Future Outlook - The company is optimistic about increasing attention from international investors, particularly due to partnerships and the anticipated commercialization of Pitimatinib [13]. - Future core products, including Kimi and 04,011, are expected to enter the market between 2028 and 2030, with strong clinical data supporting their potential [29]. Additional Insights - The company is exploring various combinations of therapies, including PD-L1 and VEGF, to enhance treatment efficacy in liver cancer [19][20]. - The competitive landscape is expected to remain favorable, allowing the company to maintain pricing power and market leadership [29].
决胜港股升浪·牛启东方2026——第十届智通财经资本市场年会邀您共赴资本盛宴
智通财经网· 2025-11-18 00:56
Group 1 - The core theme of the upcoming "10th Zhitong Financial Capital Market Annual Conference" is "Winning the Hong Kong Stock Surge: Bullish Outlook for 2026," focusing on the potential of Chinese assets amid a new technology-driven bull market [1] - The Hang Seng Index surged by 28% in a single quarter, while the Hang Seng Tech Index rebounded over 50% year-to-date, indicating a significant capital influx into undervalued Chinese assets [1] - The conference will feature prominent speakers, including economists and fund managers, who will discuss cross-border capital flows and relative valuation opportunities in the Hong Kong stock market [2] Group 2 - The afternoon session will focus on innovative pharmaceuticals, with companies like Deke Pharma and He Yu sharing insights on their latest clinical developments and commercialization strategies [3] - A diverse lineup of over 80 listed companies will participate in roadshows, providing investors with opportunities for in-depth discussions and identifying quality investment targets [4] Group 3 - The "3rd Overseas Fund Summit" will take place on December 4, featuring discussions on global capital allocation strategies and the impact of geopolitical shifts on investment [5] - The event will include four strategic roundtable discussions, addressing topics such as cognitive warfare and the mission of capital in a post-scarcity era [6] - The conference will conclude with the presentation of the New Intelligence Awards, showcasing the evolution of investment strategies from present to future [6] Group 4 - The event will continue in Hong Kong on December 5, maintaining a dual-city format that emphasizes the synergy between technological breakthroughs and global capital trends [6] - The conference aims to explore new patterns, tracks, and dividends arising from the new technological revolution, inviting participants to engage in high-level discussions [6]
港股公告掘金 | 中国软件国际携手深开鸿与奕斯伟计算达成战略合作 共建“开源鸿蒙+RISC-V”双开源数字基础设施新生态
Zhi Tong Cai Jing· 2025-11-17 15:26
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]
和誉-B:和誉医药于CTOS 2025年会展示匹米替尼临床III期 MANEUVER研究长期疗效和安全性数据
Zhi Tong Cai Jing· 2025-11-17 00:09
Core Viewpoint - The announcement highlights the long-term efficacy and safety of pimicotinib in treating TGCT patients, reinforcing its potential for long-term application in suitable patients [1] Group 1: Company Information - The subsidiary Shanghai Heyu Biopharmaceutical Technology Co., Ltd. presented data at the CTOS 2025 conference regarding the global Phase III MANEUVER study of pimicotinib for TGCT patients [1] - The long-term analysis indicates that continuous treatment with pimicotinib leads to sustained improvements in tumor response and patient-reported outcomes, including pain and function [1] - The study emphasizes that the treatment maintains an acceptable safety profile, supporting the long-term use of pimicotinib in appropriate patients [1]
和誉-B(02256):和誉医药于CTOS 2025年会展示匹米替尼临床III期 MANEUVER研究长期疗效和安全性数据
智通财经网· 2025-11-17 00:05
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]
和誉(02256) - 自愿性公告 - 和誉医药於CTOS 2025年会展示匹米替尼临床III期MA...
2025-11-17 00:00
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 ...