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]

Core Insights - The drug Beijiemai® (pimitidine hydrochloride capsules) developed by HeYu Pharmaceutical has received formal acceptance of its 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) [4] - Beijiemai® has been approved by the National Medical Products Administration (NMPA) in China for adult patients with symptomatic TGCT who may experience functional limitations or serious complications from surgical resection [2][4] - The NDA acceptance is based on positive results from the global multicenter, randomized, double-blind, placebo-controlled Phase III MANEUVER study, which demonstrated a significant improvement in objective response rate (ORR) for patients treated with Beijiemai® compared to the placebo group [1] Group 1 - TGCT is a rare locally aggressive tumor that occurs in or around joints, leading to swelling, stiffness, and limited mobility, significantly impacting patients' daily activities and quality of life [2] - Beijiemai® is a novel, oral, highly selective, and effective small molecule CSF-1R inhibitor, which is expected to provide an innovative treatment option for TGCT patients globally, addressing unmet clinical needs in this disease area [2] - The drug has also received Breakthrough Therapy Designation (BTD) from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) [2]

Core Viewpoint - Shanghai Heyu Biopharmaceutical Technology Co., Ltd. announced that its self-developed oral and highly selective small molecule CSF-1R inhibitor, Beijiemai (pimitinib hydrochloride capsules), has received formal acceptance of its New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for the systemic treatment of patients with tenosynovial giant cell tumors (TGCT) [1][2]. Group 1 - Beijiemai is a novel, oral, highly selective, and efficient small molecule CSF-1R inhibitor developed independently by the company [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]. - All 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 that occurs 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 company has reached an agreement with Merck for the global commercialization rights of Beijiemai, which has also received breakthrough therapy designation (BTD) from the FDA and priority medicine (PRIME) designation from the European Medicines Agency (EMA) [3].

Core Viewpoint - The announcement by He Yu-B (02256) regarding the acceptance of the New Drug Application (NDA) for the oral, highly selective, and effective small molecule CSF-1R inhibitor, Beijiemai (ABSK021), by the FDA marks a significant milestone for the treatment of TGCT patients [1][2]. Group 1: Drug Development and Approval - Beijiemai, developed by He Yu Pharmaceutical, has received FDA acceptance for its NDA, based on positive efficacy and safety results from the global Phase III MANEUVER study [1]. - The drug is expected to be commercially available globally through a partnership with Merck [1]. - Beijiemai was previously approved by the NMPA in China in December 2025 for symptomatic TGCT adult patients who may face functional limitations or severe complications from surgical removal [1]. Group 2: Clinical Efficacy and Safety - The Phase III study demonstrated statistically significant improvement in the objective response rate (ORR) for TGCT patients treated with Beijiemai, assessed at week 25 according to RECIST v1.1 standards [1]. - All 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]. - Long-term data from a median follow-up of 14.3 months indicated a continuous increase in ORR for patients who received Beijiemai treatment from the start of the study [3]. Group 3: Market Potential and Clinical Need - TGCT is a rare locally aggressive tumor that can lead to joint swelling, stiffness, and limited mobility, significantly impacting patients' daily activities and quality of life [3]. - If untreated or recurrent, TGCT can cause irreversible damage to bones, joints, and surrounding tissues [3]. - The ongoing regulatory submissions for Beijiemai in major global markets position the drug as a promising daily oral treatment option that is effective and well-tolerated, addressing unmet clinical needs in the TGCT field [3].