华通证券国际发布研报称，君圣泰医药-B(02511)核心产品HTD1801年内商业化进程预计提速。其治疗2 型糖尿病的III期试验数据积极，展现一药多效优势，差异化显著。研发已进入最后冲刺，预计年底进入 NDA阶段。预计公司2025-2027年营业收入分别为0/0/2.53亿元。根据合理估值测算，结合考虑股价催化 剂等因素，给予公司未来六个月内目标价为5.78港元/股，给予公司"推荐(首次)"投资评级。 华通证券国际主要观点如下： 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 ...

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、区别于其他糖尿病治疗药物的差异化竞争优势较为明 显，也与行业正向多功能药物创新治疗方式发展的趋势高度契合。现有应对心肾代谢系统疾病 （CKM）的综合治疗方案相对较少、该领域仍存在大量未满足的临床需求，公司正在开发的品种具有 成为CKM基石疗法的潜力，未来用于综合临床治疗的市场空间广阔。 智通财经APP获悉，华通证券国际发布研报称，君圣泰医药-B(02511)核心产品HTD1801年内商业化进 程预计提速。其治疗2型糖尿病的III期试验数据积极，展现一药多效优势，差异化显著。研发已进入最 后冲刺，预计年底进入NDA阶段。预计公司2025-2027年营业收入分别为0/0/2.53亿元。根据合理估值测 算，结合考虑股价催化剂等因素，给予公司未来六个月内目标价为5.78港元/ ...

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 ...

Core Insights - Company Junsheng Tai Pharmaceutical-B (02511) presented data on HTD1801 at the 58th American Society of Nephrology (ASN) annual meeting, highlighting its potential benefits for patients with mild renal impairment [1] - HTD1801 is a first-in-class anti-inflammatory metabolic modulator (AIMM) designed to address cardiorenal metabolic system diseases (CKM) through a dual mechanism of activating AMPK and inhibiting NLRP3 [1] Clinical Results - The clinical results indicate that HTD1801 significantly improves eGFR in patients with mild renal impairment compared to placebo, with a positive slope in eGFR during treatment [2] - In patients with hyperfiltration, HTD1801 was associated with a reduction in eGFR compared to placebo, suggesting its potential to promote the restoration of normal kidney function [2] - HTD1801 did not show adverse effects on blood pressure, blood sodium, or blood potassium levels [2] Study Design - The data presented is based on a pooled analysis from two Phase III randomized, double-blind, placebo-controlled clinical studies (SYMPHONY1 & 2; N=956) conducted in patients with type 2 diabetes (T2DM) [1] - The analysis included post-hoc evaluations of subgroups with mild renal impairment (baseline eGFR: 60-90 ml/min/1.73m²) and hyperfiltration (baseline eGFR ≥120 ml/min/1.73m²), focusing on eGFR changes as the primary endpoint [1]