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 FGFR4抑制劑依帕戈替尼獲FDA快速通道資格，用於 治療HCC患者 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，本公司之附屬公司上海和譽生物醫 藥科技有限公司（「和譽醫藥」）宣佈，美國食品藥品監督管理局（「FDA」）已授 予和譽醫藥自主研發的高選擇性小分子FGFR4抑制劑依帕戈替尼(Irpagratinib/ ABSK-011)快速通道資格認定（「FTD」），用於治療既往接受過免疫檢查點抑制劑 （「ICIs」）和多靶點激酶抑制劑（「mTKIs」）治療，且存在FGF19過表達的肝細胞癌 （「HCC」）患者。 此為本公司刊發的自願性公告。本集團無法保證依帕戈替尼最終將成功獲批上 市。本公司股東及潛在投 ...

Market Overview - The A-share pharmaceutical and biotechnology index rose by 0.14%, outperforming the CSI 300 index by 1.47 percentage points and the ChiNext index by 2.06 percentage points, ranking 15th among 31 sub-industries [4] - The Hong Kong Hang Seng Healthcare Index fell by 1.41%, outperforming the Hang Seng Index by 1.65 percentage points [4] R&D Progress - Heng Rui Medicine submitted an NDA for HRS-9531; He Yu Bio's ABSK043 clinical application is under new undertaking [5] - Xianwei's Enogrelide is in Phase III clinical trials; Xiansheng Pharmaceutical's SIM0278 is in Phase II clinical trials; Yingxi Intelligent's ISM-4808 is in Phase I clinical trials [5] Investment Outlook - Continuous attention to AI healthcare-related investment opportunities is advised [6] - The Ministry of Industry and Information Technology, along with eight other ministries, issued the "Implementation Plan for High-Quality Development of Traditional Chinese Medicine Industry (2026-2030)", aiming to establish a collaborative development system for the entire industry chain by 2030 [6] - The plan focuses on enhancing the stable supply of key traditional Chinese medicine raw materials, improving digital and green levels, and optimizing the structure of the traditional Chinese medicine industry, which is expected to benefit the sector through policy dividends [6] Investment Strategy for 2026 - Future investments in the pharmaceutical sector should increasingly focus on the intrinsic clinical value of medicines, addressing clinical needs of patients [7] - Both domestic medical insurance policies and global expansion strategies are placing higher premiums on clinical value [7]

Investment Rating - The report maintains a "Buy" rating for key companies in the pharmaceutical sector, including Innovent Biologics, Efang Biologics, Tianshili, WuXi AppTec, and Mindray Medical [4][28]. Core Insights - The policy-driven upgrade of traditional Chinese medicine (TCM) industry is expected to enhance industry concentration in the medium to long term, benefiting companies with strong quality control and innovative capabilities [2][24]. - The implementation plan for high-quality development of the TCM industry aims to establish a collaborative development system by 2030, focusing on raw material supply, innovation, production quality control, and internationalization [2][23]. - The investment strategy emphasizes the importance of clinical value in the pharmaceutical sector, recommending a focus on innovative drugs and high-end medical devices [3][26]. Summary by Sections Market Review - The A-share pharmaceutical index rose by 0.14%, outperforming the CSI 300 index by 1.47 percentage points [1][16]. - The Hong Kong Hang Seng Medical Health Index fell by 1.41%, but still outperformed the Hang Seng Index by 1.65 percentage points [1][16]. Policy Insights - The Ministry of Industry and Information Technology and other departments issued a plan to enhance the TCM industry, which includes fostering leading enterprises and establishing high-standard raw material production bases [2][24]. - The plan emphasizes digitalization and sustainability, aiming to raise compliance standards and accelerate the exit of smaller companies from the market [2][25]. Company Updates - Recent clinical progress includes the NDA submission for HRS-9531 by Heng Rui Medicine and the initiation of clinical trials for various drugs by other companies [1][31][32]. - Key companies such as Yunnan Baiyao, Baiyunshan, and Taiji Group are highlighted for their strong positions in raw material supply [2][25]. Financial Forecasts - The report provides earnings per share (EPS) forecasts for key companies, with Innovent Biologics projected to have an EPS of 0.49 in 2025 and WuXi AppTec expected to reach an EPS of 5.07 in the same year [4][28]. - The pharmaceutical manufacturing industry reported a revenue decline of 1.2% year-on-year for 2025, with total revenue reaching 2,487 billion yuan [51].

Investment Rating - The report provides an "Outperform" rating for multiple companies in the healthcare sector, including BeiGene, JD Health, WuXi Biologics, and others, indicating a positive outlook for these stocks [1]. Core Insights - The macro and industry environment is improving due to the resolution of policy uncertainties, the release of significant clinical data, and a resurgence in global M&A activity, leading to a notable increase in investor sentiment towards innovative drugs for 2026 [4][11]. - In oncology, the PD-1/VEGF dual antibody approach is transitioning from "mechanism validation" to "clinical and industrial resonance," with multiple global Phase III trials underway, expected to catalyze approvals and data releases within the year [5][17]. - The metabolic sector is seeing growth in the cash-pay market for GLP-1 drugs, driven by limited insurance coverage and high out-of-pocket costs, prompting companies to enhance accessibility through direct sales and pricing adjustments [6][25]. - In the autoimmune space, there is a growing concentration risk among major products from multinational corporations (MNCs), with new antibody platforms expected to yield significant data in 2026, potentially leading to new business development opportunities [7]. - The central nervous system (CNS) investment focus remains on advancing Aβ monoclonal antibody treatments, with key data expected to open up early intervention market opportunities [9]. Summary by Sections Oncology - The PD-1/VEGF dual antibody's clinical and industrial certainty is strengthening, with major companies conducting multiple global Phase III trials across high-value indications [17]. - The Pan-RAS precision therapy is entering a realization phase, with key Phase III data expected in 2026 for pancreatic cancer and NSCLC [22]. Metabolic - The cash-pay market for GLP-1 drugs is expanding due to limited insurance coverage, with companies like Eli Lilly and Novo Nordisk adopting different direct-to-consumer strategies to enhance accessibility [25][26]. - Small nucleic acid therapies are expected to upgrade treatment paradigms, showing competitive data in weight loss and safety profiles when combined with GLP-1 [30]. Autoimmune - MNCs are increasingly reliant on a few blockbuster products, with structural opportunities arising from new antibody platforms expected to report data in 2026 [7]. - The trend towards oral formulations in autoimmune diseases is gaining traction, offering advantages in adherence and competitive differentiation [7]. CNS - The focus in CNS remains on Aβ monoclonal antibody treatments, with advancements expected to shift treatment towards earlier intervention populations [9]. - New delivery methods, such as systemic administration of small nucleic acids, are being explored as complementary approaches [9].

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: 2026年2月5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/註冊股本總額： USD 50,000 FF301 第 1 頁 共 10 頁 v 1.2.0 股份發行人及根據《上市規則》第十九B章上市的香港預 ...

中泰证券（600918）发布研报称，此事件标志着和誉医药正式从临床研发阶段进入到商业化阶段，验证 了其从研发到上市的全周期创新能力。长期随访数据显示ABSK021缓解率随时间持续提升，结合与默 克的商业化合作，有望为公司提供稳定现金流。 和誉-B(02256)午后涨超6%，截至发稿，涨6.29%，报13.34港元，成交额2293.49万港元。 消息面上，近日，根据NMPA官网最新公示，和誉核心产品ABSK021的NDA已获得批准，用于治疗手 术切除可能会导致功能受限或出现较严重并发症的症状性成人腱鞘巨细胞瘤(TGCT)患者。随后， ABSK021用于腱鞘巨细胞瘤(TGCT)患者系统性治疗的NDA亦获FDA正式受理。 ...

消息面上，近日，根据NMPA官网最新公示，和誉核心产品ABSK021的NDA已获得批准，用于治疗手 术切除可能会导致功能受限或出现较严重并发症的症状性成人腱鞘巨细胞瘤(TGCT)患者。随后， ABSK021用于腱鞘巨细胞瘤(TGCT)患者系统性治疗的NDA亦获FDA正式受理。 中泰证券发布研报称，此事件标志着和誉医药正式从临床研发阶段进入到商业化阶段，验证了其从研发 到上市的全周期创新能力。长期随访数据显示ABSK021缓解率随时间持续提升，结合与默克的商业化 合作，有望为公司提供稳定现金流。 智通财经APP获悉，和誉-B(02256)午后涨超6%，截至发稿，涨6.29%，报13.34港元，成交额2293.49万 港元。 ...

中泰证券（600918）发布研报称，维持和誉-B(02256)"买入"评级，医药核心产品ABSK021近日获得 NMPA批准上市，成为中国首个自主研发的腱鞘巨细胞瘤治疗药物，其NDA也已获FDA受理。该产品的 成功获批标志着公司正式进入商业化阶段，验证了其从研发到上市的全周期创新能力。长期随访数据显 示ABSK021缓解率随时间持续提升，结合与默克的商业化合作，有望为公司提供稳定现金流。 中泰证券主要观点如下： 近期事件 近日，根据NMPA官网最新公示，公司核心产品ABSK021的NDA已获得批准，用于治疗手术切除可能 会导致功能受限或出现较严重并发症的症状性成人腱鞘巨细胞瘤(TGCT)患者。该药物是和誉医药旗下 首个获批上市的自研创新药产品，也是中国首个自主研发的腱鞘巨细胞瘤(TGCT)系统性治疗药物。随 后，ABSK021用于腱鞘巨细胞瘤(TGCT)患者系统性治疗的NDA亦获FDA正式受理。 此事件标志着和誉医药正式从临床研发阶段进入到商业化阶段，公司具备差异化多管线价值进入兑现阶 段，ABSK021的成功上市，首次完整验证了公司从靶点选择、分子设计、临床开发到获批上市的完整 周期创新能力，极大提升了后续 ...

此事件标志着和誉医药正式从临床研发阶段进入到商业化阶段，公司具备差异化多管线价值进入兑现阶 段，ABSK021的成功上市，首次完整验证了公司从靶点选择、分子设计、临床开发到获批上市的完整 周期创新能力，极大提升了后续管线成功开发的可兑现性。 智通财经APP获悉，中泰证券发布研报称，维持和誉-B(02256)"买入"评级，医药核心产品ABSK021近 日获得NMPA批准上市，成为中国首个自主研发的腱鞘巨细胞瘤治疗药物，其NDA也已获FDA受理。该 产品的成功获批标志着公司正式进入商业化阶段，验证了其从研发到上市的全周期创新能力。长期随访 数据显示ABSK021缓解率随时间持续提升，结合与默克的商业化合作，有望为公司提供稳定现金流。 中泰证券主要观点如下： 近期事件 近日，根据NMPA官网最新公示，公司核心产品ABSK021的NDA已获得批准，用于治疗手术切除可能 会导致功能受限或出现较严重并发症的症状性成人腱鞘巨细胞瘤(TGCT)患者。该药物是和誉医药旗下 首个获批上市的自研创新药产品，也是中国首个自主研发的腱鞘巨细胞瘤(TGCT)系统性治疗药物。随 后，ABSK021用于腱鞘巨细胞瘤(TGCT)患者系统性治疗 ...

Core Viewpoint - Shanghai Heyu Biopharmaceutical Technology Co., Ltd. announced that its new oral, highly selective, and effective small molecule CSF-1R inhibitor, Beijiemai® (Pimitidine Hydrochloride Capsules), has received formal acceptance for New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for the systemic treatment of patients with Tenosynovial Giant Cell Tumor (TGCT) [1][2] Group 1 - Beijiemai® is independently developed by the company and has been authorized to Merck for global commercialization [1][3] - The NDA acceptance is based on positive results from the global multicenter, randomized, double-blind, placebo-controlled Phase III MANEUVER study, which showed a significant improvement in objective response rate (ORR) for TGCT patients treated with Beijiemai® compared to the placebo group [2] - Secondary endpoints related to key clinical outcomes for TGCT patients showed significant and clinically meaningful improvements, including enhanced joint range of motion and physical function, as well as reduced stiffness and pain [2] Group 2 - TGCT is a rare locally aggressive tumor occurring in or around joints, leading to swelling, stiffness, and restricted movement, significantly impacting patients' daily activities and quality of life [2] - Beijiemai® has already been approved by the National Medical Products Administration (NMPA) in China for symptomatic TGCT adult patients who may experience functional limitations or severe complications from surgical resection [3] - The drug has also received Breakthrough Therapy Designation (BTD) from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for its overseas applications [3]