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） 內幕消息 和譽醫藥CSF-1R抑制劑貝捷邁®獲中國NMPA批准 本公告由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」）根據 《香港聯合交易所有限公司證券上市規則》（「上市規則」）第13.09(2)(a)條和香港法 例第571章《證券及期貨條例》第XIVA部項下的內幕消息條文（定義見上市規則） 作出。 本公司謹此告知本公司股東及潛在投資者，如隨附之新聞稿所述，2025年12月22 日，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，中國 國家藥品監督管理局（「NMPA」）批准貝捷邁® （鹽酸匹米替尼膠囊），適用於手術 切除可能會導致功能受限或出現較嚴重併發症的症狀性腱鞘巨細胞瘤（「TGCT」） 成年患者。獲批後，默克將盡快推動該產品惠及中國TGC ...

ABSK061是和誉医药自主研发的一种高活性、高选择性小分子FGFR2/3抑制剂。在临床前研究中，其已 显示出显著的靶点抑制活性、良好的药代动力学特征以及安全性优势。其口服给药方式在便捷性和治疗 依从性方面，尤其对儿童患者具有显著优势，这使ABSK061成为治疗儿童及青少年ACH患者的具有潜 在价值的候选药物。 作为一项旨在全面评估ABSK061在3至12岁ACH患儿中的安全性、耐受性、药代动力学及初步疗效的开 放标签II期临床研究的一部分，首例患者给药已完成。该研究于2025年3月获得中国国家药品监督管理 局("NMPA")药品审评中心(" CDE")的临床试验药品("IND")许可。 （原标题：和誉-B(02256)：FGFR2/3抑制剂ABSK061治疗软骨发育不全临床试验完成首例患者给药） 智通财经APP讯，和誉-B(02256)发布公告，2025年12月16日，上海和誉生物医药科技有限公司("和誉医 药")宣布，其高选择性小分子FGFR2/3抑制剂ABSK061在针对3-12岁软骨发育不全("ACH")儿 童患者的 II期临床试验中已成功完成首例患者给药。 ACH是一种会导致儿童严重生长发育障碍的常 ...

作为一项旨在全面评估ABSK061在3至12岁ACH患儿中的安全性、耐受性、药代动力学及初步疗效的开 放标签II期临床研究的一部分，首例患者给药已完成。该研究于2025年3月获得中国国家药品监督管理 局("NMPA")药品审评中心("CDE")的临床试验药品("IND")许可。 ABSK061是和誉医药自主研发的一种高活性、高选择性小分子FGFR2/3抑制剂。在临床前研究中，其已 显示出显著的靶点抑制活性、良好的药代动力学特征以及安全性优势。其口服给药方式在便捷性和治疗 依从性方面，尤其对儿童患者具有显著优势，这使ABSK061成为治疗儿童及青少年ACH患者的具有潜 在价值的候选药物。 和誉-B(02256)发布公告，2025年12月16日，上海和誉生物医药科技有限公司("和誉医药")宣布，其高选 择性小分子FGFR2/3抑制剂ABSK061在针对3-12岁软骨发育不全("ACH")儿童患者的II期临床试验中已 成功完成首例患者给药。 ACH是一种会导致儿童严重生长发育障碍的常染色体遗传性罕见病。研究表明，ACH的发病机制源于 成纤维细胞生长因子受体3("FGFR3")基因突变引起的FGFR3异常激活，从而抑 ...

格隆汇12月16日丨和誉-B(02256.HK)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("和誉 医药")宣布其高选择性小分子FGFR2/3抑制剂ABSK061在针对3-12岁软骨发育不全("ACH")儿童患者的II 期临床试验中已成功完成首例患者给药。 ...

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FGFR2/3抑制劑ABSK061治療軟骨發育不全 臨床試驗完成首例患者給藥 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，其高選擇性小分子FGFR2/3抑制劑ABSK061在針對 3-12歲軟骨發育不全（「ACH」）兒童患者的II期臨床試驗中已成功完成首例患者給 藥。 此為本公司刊發的自願性公告。本集團無法保證ABSK061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16日 於本公告日期，本公司董事會包括執行董事徐耀昌博 ...

Investment Rating - The report maintains a positive outlook on the pharmaceutical industry, recommending a focus on innovative drugs and sectors with improving performance, such as medical devices and upstream segments [3][4]. Core Insights - The pharmaceutical sector experienced a decline of 1.0% this week, ranking 17th among 31 sub-industries. The overall valuation of the pharmaceutical sector stands at 29.2 times earnings, placing it 10th among the primary industries [2][4][7]. - Key events include Fosun Pharma granting exclusive global rights for its oral GLP-1 drug to Pfizer, with potential total payments reaching $2.085 billion. Additionally, Eli Lilly's GLP-1/GIP/GCGR agonist Retatrutide showed promising Phase III clinical data, achieving a weight loss of 28.7% over 68 weeks [3][14][17]. - The report highlights significant mergers and acquisitions, such as Sobi's acquisition of Arthrosi for $950 million upfront and $550 million in milestone payments, and Zhaoli Pharmaceutical's planned acquisition of a multi-trace element injection asset group for approximately RMB 356 million [3][15][22]. Market Performance - The pharmaceutical index decreased by 1.0% this week, while the Shanghai Composite Index fell by 0.3%. The overall performance of the pharmaceutical sector was ranked 17th among 31 sub-industries [2][4][6]. - The report details the performance of various sub-sectors, with notable declines in medical circulation (-4.2%), offline pharmacies (-4.3%), and blood products (-4.1%), while medical R&D outsourcing saw an increase of 3.7% [7][11]. Recent Key Events - The report discusses recent business developments, including the approval of Shanghai Pharma's new drug, and the change of control at Tailong Pharmaceutical, which will now be under Jiang Pharmaceutical Holdings [20][22]. - It also notes the IPO application of Shiyao Innovation, which was accepted with a market value of RMB 47.9 billion, focusing on health-related sectors and innovative drugs [23]. Company Valuation - The report provides a valuation table for key companies in the pharmaceutical sector, indicating projected earnings per share (EPS) and price-to-earnings (PE) ratios for 2025 to 2027. For instance, Mindray Medical is projected to have a PE of 23 in 2025, while Hengrui Medicine is expected to have a PE of 48 [29].

Group 1 - The core viewpoint is that the US economy is expected to maintain moderate growth next year, supported by factors such as Federal Reserve interest rate cuts and AI investments, while remaining strategically bullish on US stocks but cautious of structural differentiation and short-term risks in Q1 [1] - For the Hong Kong stock market outlook, it is anticipated that the market will shift from valuation-driven to profit growth-driven, with valuation expansion likely to weaken but liquidity remaining supportive [1] - The combination of profit-driven growth and liquidity support is expected to emerge by 2026, with new supply creating new demand as a new driving force for the Hong Kong stock market [1] Group 2 - The technology sector in the US stock market is expected to become more rational, with AI remaining a key driver, and the regulatory environment being favorable for mergers and acquisitions [1] - The AI advancements are projected to continue driving revenue and valuation recovery in the Chinese internet sector's cloud business [1] - The domestic pharmaceutical and innovative drug sectors are likely to benefit from a resurgence in mergers and acquisitions by large multinational pharmaceutical companies, as well as an increase in BD transactions [1] Group 3 - The automotive industry is expected to see flat or slightly declining sales next year, with current market sentiment being sufficiently pessimistic, presenting an opportunity to gradually accumulate stocks of companies with high earnings growth certainty [2] - The consumption sector's recovery remains uneven, suggesting a strategy of "anchoring on earnings while leveraging growth" for investment [2] - The education sector is viewed positively for its resilient growth and expansion opportunities [2] Group 4 - Recommended stocks for Q1 next year include: Alphabet (GOOGL.US), Meta (META.US), Netflix (NFLX.US), Tencent Holdings (00700), Alibaba (BABA.US), Bilibili (BILI.US), Hansoh Pharmaceutical (03692), CanSino Biologics-B (02162), Innovent Biologics (01801), and others [2]

Group 1: Economic Outlook - The U.S. economy is expected to maintain moderate growth in the coming year, supported by factors such as Federal Reserve interest rate cuts and AI investments [1] - The Hong Kong stock market is anticipated to shift from valuation-driven to profit growth-driven, with a projected earnings growth rate of 6% to 10% for the Hang Seng Index [1] Group 2: Market Dynamics - The valuation expansion in the Hong Kong market may weaken, but liquidity will remain supportive, leading to a new supply creating new demand [1] - The dual liquidity easing in both China and the U.S. is expected to increase foreign and southbound capital supply, translating into new demand for Hong Kong stocks [1] Group 3: Sector Analysis - The U.S. tech sector is expected to become more rational, with AI continuing to be a key driver, while the regulatory environment will favor mergers and acquisitions [2] - The domestic pharmaceutical and innovative drug sectors are likely to benefit from a resurgence in M&A activity from large multinational companies [2] - The automotive sector is projected to see flat or slightly declining sales, presenting opportunities to gradually accumulate stocks of companies with high earnings growth certainty [2] Group 4: Recommended Stocks - Top stock picks for the first quarter of next year include Alphabet (GOOGL.US), Meta (META.US), Netflix (NFLX.US), Tencent Holdings (00700), Alibaba (BABA.US), and others [3]

Core Viewpoint - The announcement by He Yu-B (02256) highlights positive results from the Phase II clinical study of the oral small molecule PD-L1 inhibitor ABSK043 in combination with the third-generation EGFR-TKI, Furmonertinib, for treating non-small cell lung cancer (NSCLC) [1][2]. Group 1: Clinical Study Results - The Phase II study (ABSK043-202) included 21 patients with EGFR mutations and PD-L1 positivity, of which 17 had previously received third-generation EGFR-TKIs [2]. - The combination of ABSK043 and Furmonertinib demonstrated controllable safety and good tolerability, with no dose-limiting toxicities (DLTs) or interstitial lung disease (ILD) observed [2]. - The most common treatment-related adverse events (TEAEs) were grade 1-2, with no grade 4 or 5 TEAEs reported [2]. Group 2: Antitumor Activity - The combination therapy showed promising antitumor activity, achieving a disease control rate (DCR) of 71%, with 14 patients experiencing tumor shrinkage [3]. - Among the 5 patients who achieved partial response (PR), 4 had previously been treated with third-generation EGFR-TKIs [3]. - The results indicate that the ABSK043 and Furmonertinib combination not only has controllable safety and good tolerability but also exhibits encouraging initial antitumor activity, paving the way for further evaluation in the ongoing dose expansion phase [3].

Core Viewpoint - Shanghai Heyu Biopharmaceutical Technology Co., Ltd. announced positive results from the Phase II clinical study (ABSK043-202) of its oral small molecule PD-L1 inhibitor ABSK043 combined with the third-generation EGFR-TKI, Furmonertinib, for the treatment of non-small cell lung cancer (NSCLC) at the ESMO Asia 2025 conference [1][2]. Group 1: Clinical Study Results - The study included 21 patients with EGFR mutations and positive PD-L1 expression, of which 17 had previously received third-generation EGFR-TKIs [2]. - The combination of ABSK043 and Furmonertinib demonstrated controllable safety and good tolerability, with no dose-limiting toxicities (DLTs) or interstitial lung disease (ILD) observed [2]. - The most common treatment-related adverse events (TEAEs) were grade 1-2, with no grade 4 or 5 TEAEs reported [2]. Group 2: Antitumor Activity - The combination therapy showed promising antitumor activity, achieving a disease control rate (DCR) of 71%, with 14 patients experiencing tumor shrinkage [3]. - Among the 5 patients who achieved partial response (PR), 4 had previously been treated with third-generation EGFR-TKIs [3]. - The results indicate that the ABSK043 and Furmonertinib combination therapy could potentially overcome the toxicity challenges faced by previous EGFR-TKIs and immune therapy antibody combinations, laying the groundwork for the ongoing dose expansion phase [3].