Core Insights - The company, He Yu-B (02256.HK), announced preliminary results from its Phase II clinical study (ABSK043-202) of the oral small molecule PD-L1 inhibitor, ABSK043, in combination with the third-generation EGFR-TKI, Furmetinib, for the treatment of non-small cell lung cancer (NSCLC) [1] Group 1: Clinical Study Results - The combination therapy of ABSK043 and Furmetinib demonstrated good safety and tolerability [1] - Regulatory authorities have approved the expansion of the study to include first-line treatment for EGFR mutation-positive and PD-L1 positive NSCLC patients based on the favorable safety profile [1]

Core Viewpoint - The company announced preliminary results from a Phase II clinical study of its oral small molecule PD-L1 inhibitor ABSK043 in combination with the third-generation EGFR-TKI, furmonertinib, for the treatment of non-small cell lung cancer (NSCLC) [1] Group 1: Clinical Study Results - The initial results from the dose escalation phase of the ABSK043-202 study indicate that the "targeted immune combination" regimen shows good safety and tolerability [1] - Regulatory authorities have agreed to expand the study to include first-line treatment research for EGFR mutation-positive and PD-L1 positive NSCLC patients based on the favorable safety profile of the regimen [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ESMO Asia 2025公佈口服PD-L1抑制劑ABSK043聯合 EGFR抑制劑伏美替尼治療NSCLC的II期臨床初步結果 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2025年歐洲腫瘤內科學會亞洲年會（「ESMO Asia 2025」）公佈其在研口服小分子PD-L1抑制劑ABSK043聯合上海艾力斯醫 藥科技股份有限公司（「艾力斯」）第三代EGFR-TKI伏美替尼治療非小細胞肺癌 （「NSCLC」）的II期臨床研究(ABSK043-202)劑量遞增階段的初步結果。數據顯 示，ABSK043與伏美替尼的「靶免聯合」 ...

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11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12月3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 ...

Group 1 - The Hong Kong biotechnology sector experienced a widespread decline, with notable drops in several companies' stock prices [1] - Specifically, Gilead Sciences-B fell over 13%, while Sanofi-B dropped more than 10% [1] - Other companies such as Crystal Technology Holdings and Hualing Pharmaceutical-B also saw declines exceeding 6% [1] Group 2 - Gilead Sciences-B's latest price is 11.750, with a market capitalization of 116.56 billion and a year-to-date increase of 290.37% [2] - Sanofi-B's latest price is 7.000, with a market capitalization of 7.44 billion and a year-to-date increase of 102.31% [2] - Crystal Technology Holdings has a latest price of 9.330, a market capitalization of 401.48 billion, and a year-to-date increase of 56.02% [2] - Hualing Pharmaceutical-B's latest price is 3.230, with a market capitalization of 34.13 billion and a year-to-date increase of 121.23% [2] - Other companies like Wangshan Wangshui-B and Sanleaf Biotech-B also reported significant declines, with year-to-date increases of 123.25% and 920.75% respectively [2]

Group 1 - The core point of the news is that Baihua Pharmaceutical's controlling shareholder and actual controllers have their agreement to act in concert expire, which will not adversely affect the company's management or change its controlling shareholder [1] - The expiration of the agreement is a routine corporate governance action, and the company confirms that it will not impact daily operations [1] - Such agreements not being renewed after expiration is common in the A-share market [1] Group 2 - YKYY018 aerosol inhalation agent from Yuyuan Pharmaceutical has received clinical trial approval from both Chinese and U.S. regulatory authorities for the prevention and treatment of respiratory syncytial virus (RSV) infections [2] - This product addresses a significant clinical need, particularly in high-risk populations, and utilizes an innovative aerosol inhalation delivery method [2] Group 3 - HeYu Pharmaceutical's oral small molecule KRAS G12D inhibitor, ABSK141, has received IND approval from the U.S. FDA for treating patients with advanced solid tumors carrying the KRAS G12D mutation [3] - This drug targets a common oncogenic mutation associated with several cancers, including pancreatic and colorectal cancer, indicating a pressing clinical demand [3] Group 4 - The China Drug Price Registration System has been officially launched, aimed at providing authoritative and accurate drug price information to support the internationalization of pharmaceutical companies [4] - This system is a key step towards establishing a scientific and transparent pricing system for innovative drugs in China, facilitating high-quality development in the pharmaceutical industry [4]

Personnel Changes - Yunnan Baiyao announced the election of Zhang Wenxue as chairman and Dong Ming as vice chairman during the first meeting of the 11th board of directors on November 10, 2025 [2] - China National Pharmaceutical Group (Sinopharm) reported the resignation of Zhao Bingxiang from multiple positions, including non-executive director and chairman, with Jin Bin proposed as the new chairman [3] - Huatai Medical announced a board restructuring, nominating several candidates for its third board of directors, including current executives from Mindray Medical [4] - Hanyu Pharmaceutical reported the retirement of its executive director Pinxiang Yu and appointed two new executive directors, Shen Yaping and Tang Yangming [5] - GSK China appointed Sheng Feng as vice president, responsible for market access and commercial operations, effective December 1, 2025 [12] Executive Appointments - Medtronic appointed Larry Xu as vice president for orthopedic and neurosurgery business in China, effective November 10, 2025 [9] - Pfizer China announced the appointment of Su Tianyu as head of the broad market division, effective immediately [10][11] - Eli Lilly appointed Carole Ho as president of the neuroscience division, while Adrienne Brown was promoted to president of the immunology division [15] - Restore Medical appointed Chris Cleary, former senior vice president at Medtronic, as chairman of the board [18] Resignations - Johnson & Johnson announced the departure of Alex He, vice president and head of the PINS division, effective December 31, 2025 [8] - Several executives across various companies, including Chen Changbing from Sinopharm United and Wang Junbo from Guangyu Yuan, submitted their resignations due to work adjustments [3][5]

Core Viewpoint - The company announced that its subsidiary, Shanghai Heyu Biopharmaceutical Technology Co., Ltd., has received FDA approval for the IND application of a new oral, highly active, and selective small molecule KRAS G12D inhibitor, ABSK141, aimed at treating patients with advanced solid tumors carrying the KRAS G12D mutation [1] Group 1 - The new drug ABSK141 targets advanced solid tumors with KRAS G12D mutations [1] - The FDA approval marks a significant milestone for the company's research and development efforts in oncology [1] - The development of ABSK141 reflects the growing focus on targeted therapies in cancer treatment [1]

智通财经APP讯，和誉-B(02256)发布公告，公司的附属公司上海和誉生物医药科技有限公司宣布，一种 用于治疗携带KRAS G12D突变的晚期实体瘤患者的口服、高活性、高选择性小分子KRAS G12D抑制剂 ABSK141的新药临床试验(IND)申请已获得美国食品药品监督管理局(FDA)批准。 ...

格隆汇12月1日丨和誉-B(02256.HK)宣布，一种用于治疗携带KRAS G12D突变的晚期实体瘤患者的口 服、高活性、高选择性小分子KRAS G12D抑制剂ABSK141的新药临床试验("IND")申请已获得美国食品 药品监督管理局("FDA")批准。 ...