FF301 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12月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 君圣泰医药（於開曼群島註冊成立的有限公司） 呈交日期: 2026年1月2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) | 02511 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 1,000,000,000 | USD | | 0.0001 | USD | | 100,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 1,000,000,000 | USD | | 0.0001 | USD | | 100, ...

"创新药企业要有更强的竞争力，必须始终以患者为中心，聚焦未被满足的临床需求。"近日，君圣泰医 药创始人刘利平在接受上海证券报记者专访时，谈及她选择创新药赛道的初心。 深耕代谢性疾病领域多年的她，带领团队从传统天然产物中寻找灵感，将中药黄连中的小檗碱和熊胆中 的成分熊去氧胆酸创新结合，研发出新型分子实体HTD1801。这一原创新药开启了"多靶点、多机制"治 疗多种代谢性疾病的探索之路，展现出创新药研发的无限可能。 从天然产物出发探索代谢病药物蓝海 不同于沿着被验证过的路径直接"照猫画虎"、批量生产仿制药，创新药的研发意味着要走出一条自己的 路。这个过程往往是摸黑前进，未知与困难伴行。 2011年，在海外主要研究免疫治疗与代谢性疾病的刘利平，回国创立君圣泰医药，选择深耕代谢性疾病 领域。 "代谢性疾病治疗是一个充满挑战的赛道，也是一个前景非常广阔的赛道。"在刘利平看来，随着人类生 活方式改变和寿命延长，代谢性疾病正日益成为全球性的长期健康问题。 确定赛道后，代谢性疾病领域的"大药"给了刘利平创新研发灵感。在代谢性疾病领域，已有从天然植物 山羊豆里提取关键成分，研发出二甲双胍的先例；在其他疾病领域，也有从金鸡纳树皮 ...

HighTide Therapeutics, Inc. 君聖泰醫藥 （於開曼群島註冊成立的有限公司） 股份代號：2511 HighTide Therapeutics, Inc. （「本公司」） 提名委員會職權範圍 1 釋義 高級管理層指行政總裁、首席財務官、首席運營官、首席開發官及本公司任 何其他高級職員，其薪酬待遇或建議薪酬待遇較任何由董事會委任的高級職 員優厚；及任何其他由薪酬委員會釐定的本公司僱員。 股東指本公司的股東。 聯交所指香港聯合交易所有限公司。 1. 就本職權範圍（「職權範圍」）而言： 董事會指本公司的董事會。 首席財務官指董事會不時委任負責財務管理的本公司高級人員。 公司秘書指本公司的任何一名聯席公司秘書。 董事指董事會成員。 本集團指本公司及其於有關時期的附屬公司和聯營公司；或按文義所指，於 本公司成為其當前附屬公司和聯營公司的控股公司前的期間，本公司當前的 附屬公司和聯營公司或其當前附屬公司和聯營公司或（視情況而定）其前身所 營運的企業。 上市規則指香港聯合交易所有限公司證券上市規則（經不時修訂）。 提名委員會指根據本職權範圍第2條通過董事會的決議案設立的提名委員會。 成立 2. 提名委 ...

Group 1 - The "Annual Growth Value Award" recognizes companies with significant growth potential in the capital market, emphasizing the importance of continuous growth for sustainable development [1][2] - The award selection process involves quantitative data analysis and expert review to identify companies that are proactive and committed to expansion [1] - The event highlighted ten companies that received the "Annual Growth Value Award," including 比优集团 (Biyou Group), 地平线机器人-W (Horizon Robotics-W), and others, listed in alphabetical order [1] Group 2 - The "Golden Grid Award" aims to create a valuable reference list of listed companies and unicorns, covering all companies listed on major exchanges such as the Hong Kong Stock Exchange, Shanghai Stock Exchange, Shenzhen Stock Exchange, and others [2] - The initiative reflects a global perspective with a focus on investment opportunities in China [2]

Group 1 - The commercialization process of the core product HTD1801 is expected to accelerate within the year, with the NDA stage anticipated by the end of 2025 [1] - The company forecasts revenues of 0 million, 0 million, and 2.53 billion for the years 2025, 2026, and 2027 respectively [1] - A target price of 5.78 HKD per share is set for the next six months, with an initial "recommend" investment rating [1] Group 2 - HTD1801 is a globally innovative oral anti-inflammatory and metabolic regulator, granted two Fast Track designations by the FDA [2] - The product operates through a unique dual mechanism, aiming to treat cardiovascular and metabolic diseases comprehensively, showing significant efficacy in improving blood glucose metabolism and other health markers [2] - Clinical trial data indicates HTD1801 can significantly reduce HbA1c levels by -1.1% to -1.3%, outperforming the leading drug Dapagliflozin in achieving ideal HbA1c control [2] Group 3 - HTD1801 shows potential in chronic kidney disease (CKD) treatment, with clinical studies indicating it can improve eGFR levels in early-stage patients [3] - The drug demonstrated a significant improvement in eGFR compared to placebo in patients with mild kidney function impairment [3] - HTD1801 may also have a trend of reducing eGFR in patients with high renal filtration [3]

Core Viewpoint - The commercialization process of the core product HTD1801 is expected to accelerate within the year, with positive Phase III trial data for treating type 2 diabetes, showcasing significant differentiation and multi-effect advantages [1][2]. Product Development - HTD1801 has successfully completed two Phase III clinical trials for type 2 diabetes patients in China, with data readouts completed and a head-to-head trial against Dapagliflozin expected to be announced by December 2025 [2]. - The product is in the final sprint of development and is anticipated to enter the New Drug Application (NDA) stage by the end of 2025 [2]. Product Features and Market Potential - HTD1801 is a globally innovative oral anti-inflammatory and metabolic modulator, granted two Fast Track designations by the FDA, and operates through a unique dual mechanism that activates AMPK and inhibits NLRP3 [3]. - The product shows broad efficacy in improving blood glucose metabolism, kidney protection, heart protection, liver protection, anti-inflammation, and weight loss, distinguishing it from other diabetes treatments [3]. - There is a significant unmet clinical need in the treatment of cardio-renal metabolic (CKM) diseases, and HTD1801 has the potential to become a cornerstone therapy in this area, indicating a vast market opportunity [3]. Clinical Trial Results - Phase III clinical data indicates that HTD1801 can significantly and clinically meaningfully reduce HbA1c levels by -1.1% to -1.3%, effectively lowering fasting and postprandial blood glucose levels and improving insulin resistance [4]. - HTD1801 demonstrates superior HbA1c reduction compared to Dapagliflozin, with a higher proportion of patients achieving HbA1c < 7% [4]. - The product also shows significant improvements in cardiovascular metabolic indicators such as LDL-C and non-HDL-C compared to Dapagliflozin, highlighting its competitive advantages [4]. Chronic Kidney Disease (CKD) Application - HTD1801 has shown potential in improving eGFR levels in chronic kidney disease (CKD) treatment, with clinical data indicating its ability to improve eGFR changes in early-stage patients [5]. - In patients with mild renal impairment, HTD1801 significantly improved eGFR compared to placebo, suggesting its potential for restoring kidney function [5].

港股研究报告|2025 年 12 月 08 日 "一药多效"核心产品 HTD1801 商业化进程提速在即，心肾代谢系统疾病(CKM)基石 疗法市场空间广阔——君圣泰医药-B(02511.HK)投资价值分析报告 公司核心产品的商业化进程预计将于年内迎来提速 2025 年 10 月，公司核心产品 HTD1801 在中国 2 型糖尿病患者中开展的两项 III 期临床 试验已顺利完成，并完成 52 周数据读出。2025 年 12 月，与达格列净头对头的 III 期试 验数据公布。该产品用于治疗 T2DM 适应症的研发已进入最后冲刺阶段，预计将于 2025 年底进入新药上市申请阶段。 HTD1801 产品一药多效，CKM 基石疗法市场空间广阔 HTD1801 为一款全球首创的口服抗炎及代谢调节剂，该产品已被美国 FDA 授予 2 项快 速通道资格认定。HTD1801 是具有独特双机制的新分子实体，通过激活 AMPK 与抑制 NLRP3 的双机制协同互补，旨在综合治疗心肾代谢系统疾病。HTD1801 在显著改善血 糖代谢的同时，其在护肾、护心、保肝、抗炎、减重等多个方面具有广泛疗效。HTD1801 一药多效、区别于其他糖 ...

呈交日期: 2025年12月2日 I. 法定/註冊股本變動 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: 君圣泰医药（於開曼群島註冊成立的有限公司） FF301 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 | 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) | 02511 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,000,000,000 | USD | | 0.0001 USD | | 100,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 1,000,000,000 | USD | | 0.0001 USD | | 100,000 | 本月底法定/註冊股本總 ...

Core Viewpoint - Junsheng Tai Pharmaceutical-B (02511) experienced a significant increase of over 6%, currently trading at 3.03 HKD with a transaction volume of 1.1919 million HKD, following positive results from its clinical trial for HTD1801 in Type 2 Diabetes Mellitus (T2DM) patients [1] Group 1 - The clinical trial (HARMONY) for HTD1801 against Dapagliflozin achieved its primary endpoint and showed improvements in several key cardiovascular metabolic indicators compared to Dapagliflozin [1] - HARMONY is the third Phase III trial to report positive results for HTD1801, following the SYMPHONY-1 and SYMPHONY-2 trials, reinforcing its potential as a foundational treatment for cardiorenal metabolic diseases (CKM) [1] - The company plans to initiate a New Drug Application (NDA) for the HTD1801 project within this year [1]

Core Insights - Junsheng Tai Pharmaceutical (2511.HK) announced positive results from the Phase III clinical trial (HARMONY) of HTD1801 in patients with Type 2 Diabetes Mellitus (T2DM), achieving its primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] Group 1: Clinical Trial Results - HTD1801 demonstrated superior performance compared to SGLT2 inhibitors by simultaneously regulating metabolic and inflammatory pathways, targeting the core pathological mechanisms of T2DM more precisely [2] - HARMONY is the third Phase III trial to yield positive results for HTD1801, following SYMPHONY-1 and SYMPHONY-2, further validating its strong potential as a foundational treatment for cardiorenal metabolic diseases (CKM) [2] Group 2: Future Plans and Statements - Junsheng Tai Pharmaceutical plans to initiate a New Drug Application (NDA) for the HTD1801 project within the year [2] - Dr. Li Ping Liu, the founder, chairman, and CEO of Junsheng Tai Pharmaceutical, stated that the data readout from the HARMONY study marks a key milestone in the global development process of HTD1801, highlighting its innovative "one drug, multiple effects" characteristics and potential to complement or even surpass the treatment boundaries of SGLT2 inhibitors for T2DM patients [2]