"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 ...

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 ...

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]

Core Insights - The clinical trial HARMONY for HTD1801 in Type 2 Diabetes Mellitus (T2DM) patients has shown positive results, achieving its primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] - HTD1801 targets the root causes of T2DM, providing comprehensive cardiovascular and metabolic benefits [1] Group 1: Clinical Trial Details - HARMONY is a randomized, double-blind, positive drug-controlled Phase III clinical study involving 369 participants, assessing the efficacy and safety of HTD1801 compared to Dapagliflozin in adults with T2DM who have inadequate blood sugar control after Metformin treatment [1] - The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment, with a non-inferiority margin of 0.4% [1] - HTD1801 achieved a least squares (LS) mean change in HbA1c of -1.12%, while the Dapagliflozin group had a change of -0.93%, showing a significant difference of -0.20% (95% CI: -0.37 to -0.03; P < 0.001) [1] Group 2: Secondary Endpoints and Safety - HTD1801 demonstrated superior results compared to Dapagliflozin in lowering LDL-C and non-HDL-C, with a significantly lower proportion of patients requiring additional or intensified statin therapy [2] - HTD1801 also showed a higher percentage of patients achieving the HbA1c < 7.0% control target and a greater reduction in Lp(a) levels [2] - The safety profile of HTD1801 is favorable, with a serious adverse event rate of 3.8% compared to 4.4% in the Dapagliflozin group, and the most common adverse events were mild to moderate gastrointestinal issues, with no severe hypoglycemic events reported [2] Group 3: Future Prospects - HTD1801's ability to simultaneously regulate metabolic and inflammatory pathways allows for a more precise targeting of the core pathological mechanisms of T2DM, potentially offering comprehensive clinical benefits for patients [2] - Following the positive results from the SYMPHONY-1 and SYMPHONY-2 trials, HARMONY marks the third successful Phase III trial for HTD1801, reinforcing its strong potential as a foundational treatment for cardiorenal metabolic diseases [2] - The company plans to initiate a New Drug Application (NDA) for HTD1801 within this year [2]

Core Insights - The clinical trial HARMONY for HTD1801 in Type 2 Diabetes Mellitus (T2DM) patients has shown positive results, achieving its primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] - HTD1801 targets the root causes of T2DM, providing comprehensive cardiovascular metabolic benefits [1] Summary by Sections Clinical Trial Results - HARMONY is a randomized, double-blind, positive drug-controlled Phase III clinical study involving 369 participants, assessing the efficacy and safety of HTD1801 compared to Dapagliflozin in adults with T2DM who have inadequate blood sugar control after Metformin treatment [1] - The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment, with HTD1801 showing a least squares (LS) mean change of -1.12% compared to -0.93% for Dapagliflozin (LS mean difference: -0.20%; 95% CI: -0.37 to -0.03; P < 0.001) [1] - HTD1801 also achieved multiple secondary endpoints, demonstrating superior reductions in LDL-C and non-HDL-C compared to Dapagliflozin, with a significantly lower proportion of patients requiring additional or intensified statin therapy [1] Safety and Tolerability - HTD1801 exhibited good safety and tolerability, with a serious adverse event rate of 3.8% (compared to 4.4% in the Dapagliflozin group) [2] - The most common adverse events in the HTD1801 group were mild to moderate gastrointestinal issues, with no severe hypoglycemic events reported [2] Future Prospects - HTD1801's ability to simultaneously regulate metabolic and inflammatory pathways positions it as a promising foundational treatment for chronic kidney and metabolic diseases (CKM) [2] - Following the positive outcomes of the SYMPHONY-1 and SYMPHONY-2 trials, HARMONY marks the third successful Phase III trial for HTD1801, reinforcing its potential [2] - The company plans to initiate a New Drug Application (NDA) for HTD1801 within the year [2]

Core Insights - Junsheng Tai Pharmaceutical-B (02511.HK) announced positive results from the Phase III clinical trial (HARMONY) of HTD1801 in patients with Type 2 Diabetes Mellitus (T2DM), achieving the primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] Group 1: Clinical Trial Results - HARMONY (NCT06415773) is a randomized, double-blind, positive drug-controlled Phase III clinical study involving 369 participants, aimed at evaluating the efficacy and safety of HTD1801 compared to Dapagliflozin in adult T2DM patients with inadequate blood sugar control after Metformin treatment [1] - The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment, with HTD1801 showing a least squares (LS) mean change of -1.12% compared to -0.93% for Dapagliflozin, resulting in a LS mean difference of -0.20% (95% CI: -0.37 to -0.03; P < 0.001) [1][2] Group 2: Secondary Endpoints and Safety - HTD1801 significantly outperformed Dapagliflozin in reducing LDL-C and non-HDL-C, with a lower proportion of patients requiring additional or intensified statin therapy compared to the Dapagliflozin group [2] - HTD1801 also showed superior improvement in multiple cardiovascular metabolic indicators, including a higher percentage of patients achieving the HbA1c < 7.0% control target and a greater reduction in Lp(a) levels [2] - The safety profile of HTD1801 was favorable, with a serious adverse event rate of 3.8% (compared to 4.4% for Dapagliflozin), and the most common adverse events were mild to moderate gastrointestinal issues, with no severe hypoglycemic events reported [2] Group 3: Future Prospects - Overall, HTD1801 targets the core pathological mechanisms of T2DM more precisely by simultaneously regulating metabolic and inflammatory pathways, potentially offering comprehensive clinical benefits for T2DM patients [2] - Following the positive results from the SYMPHONY-1 and SYMPHONY-2 trials, HARMONY marks the third successful Phase III trial for HTD1801, reinforcing its strong potential as a foundational treatment for cardiorenal metabolic diseases (CKM) [2] - Junsheng Tai Pharmaceutical plans to initiate a New Drug Application (NDA) for the HTD1801 project within this year [2]

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之內容概不負責，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而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 HighTide Therapeutics, Inc. （ 於開曼群島註冊成立的有限公司 ） （股份代號：2511） 君聖泰醫藥公佈HTD1801與達格列淨的頭對頭III期臨床研究結果 展現控糖優勢及心血管代謝優效獲益 本公告由君聖泰醫藥（「本公司」，連同其附屬公司統稱為「本集團」）自願發佈，以 告知本公司股東及潛在投資者有關本集團的最新業務發展。 本公司董事會（「董事會」）宣佈，HTD1801在2型糖尿病(T2DM)患者中開展的與達 格列淨頭對頭的臨床III期試驗(HARMONY)取得了積極的結果，試驗達到主要終 點，並在多項關鍵心血管代謝指標的改善上優於達格列淨。 試驗數據再次驗證，HTD1801靶向2型糖尿病發生及發展的根源性問題，實現更 全面的心血管代謝綜合獲益。 1 君聖泰醫藥（股票代碼：2511.HK）是一家專注於代謝性慢病的創新生物醫藥公 司，旨在開發多功能、多靶點的創新療法，重點聚焦於解 ...