2026年2月6日，君圣泰医药一场面向投资人的会议引来关注。据悉，会议主要围绕公司在心肾代谢系统疾病（CKM） 的战略布局及该领域的多项临床研究数据进行了解读。值得关注的是，新任首席医学官Filip Surmont博士亦在会上首 次亮相。 这位曾将达格列净推上全球畅销药舞台的行业巨擘，在心血管、代谢与肾脏疾病领域深耕三十余年后，将其职业生涯 的下一站锚定在了君圣泰医药这家中国生物科技公司；结合中国医药产业在国际舞台上快速发展的新业态和君圣泰医 药的业务积淀，Surmont博士的决定在意料之外，又在情理之中。而答案，指向一个庞大疾病领域"心肾代谢系统疾 病"（CKM)的巨大市场潜力，以及一款以"一药多效"能力重新定义其治疗范式的中国原创新药HTD1801。 这场会议，无疑是为解读这一选择、审视这种范式提供了首个公开注脚。而在创新药行业从"故事驱动"加速迈向"价值 兑现实绩"的2026年，君圣泰的这份答卷也将带来市场的新评估。 范式转变：从"单病单治"到"系统共治" 心肾代谢系统疾病（CKM），正从一个临床概念，迅速演变为一个被重新定义的重大健康挑战。 传统医学常将心脏病、慢性肾病、糖尿病等视为独立疾病进行诊治。 ...

Core Insights - The company is leading a new era in comprehensive treatment for cardiovascular, kidney, and metabolic diseases (CKM) through its "one drug, multiple effects" strategy [1][2] Group 1: Clinical Developments - The company presented breakthrough data from its oral drug HTD1801 in a pivotal Phase III clinical trial (HARMONY study) for type 2 diabetes, showing superiority over the mainstream drug Dapagliflozin in reducing glycated hemoglobin and improving various cardiovascular metabolic indicators [1] - The company also shared data and development potential for chronic kidney disease (CKD) and the Phase IIb clinical results for metabolic-associated fatty liver disease (MASH) [1] Group 2: Leadership and Strategy - The new Chief Medical Officer (CMO) Dr. Filip Surmont made his official debut at the meeting, bringing over 30 years of global experience in cardiovascular, metabolic, and kidney diseases, including 18 years in senior medical leadership roles at multinational pharmaceutical companies like Pfizer and AstraZeneca [1] - Dr. Surmont's experience in leading medical affairs and driving successful clinical development in key global markets is expected to accelerate the company's CKM pipeline's research and implementation worldwide [1]

在引入第三方机构进行核查，对研究执行情况进一步审查后发现，在试验期间存在患者合并用药管理 (如，安慰剂组有明显更多患者违背方案新增或强化了 GLP-1RA治疗)、患者依从性管理等研究执行和 质量管理范畴的问题，且这些问题可能对试验结果造成明显影响。 鉴于HTD1801此前在合并T2DM的MASH患者中开展的IIa期临床研究，以及其在 T2DM患者人群中完成 的3项临床III期研究中，均成功达主要终点，呈现多重获益且顺利推进NDA。君圣泰医药将结合本次研 究的整体数据、审查结果及事后分析结论，对HTD1801在MASH适应症中的临床开发策略开展进一步评 估，并与美国食品药品监督管理局(FDA)进行沟通，在监管意见的基础上进行综合评估，以明确后续开 发方案。 初步分析结果显示，本研究中安慰剂组有48%的患者在治疗结束后实现非酒精性脂肪性肝炎活动度评分 (NAS)降低≥2分且无纤维化恶化或MASH缓解且无纤维化恶化。该结果大幅高于既往同类临床研究中的 安慰剂效应。一项发表于2025 年的荟萃分析中涵盖了78种不同研究药物的127项MASH临床试验。该分 析显示，这些临床试验采取和本项研究类似的试验设计，安慰剂效应通 ...

鉴于HTD1801此前在合并T2DM的MASH患者中开展的IIa期临床研究，以及其在 T2DM患者人群中完成 的3项临床III期研究中，均成功达主要终点，呈现多重获益且顺利推进NDA。君圣泰医药将结合本次研 究的整体数据、审查结果及事后分析结论，对HTD1801在MASH适应症中的临床开发策略开展进一步评 估，并与美国食品药品监督管理局(FDA)进行沟通，在监管意见的基础上进行综合评估，以明确后续开 发方案。 初步分析结果显示，本研究中安慰剂组有48%的患者在治疗结束后实现非酒精性脂肪性肝炎活动度评分 (NAS)降低≥2分且无纤维化恶化或MASH缓解且无纤维化恶化。该结果大幅高于既往同类临床研究中的 安慰剂效应。一项发表于2025 年的荟萃分析中涵盖了78种不同研究药物的127项MASH临床试验。该分 析显示，这些临床试验采取和本项研究类似的试验设计，安慰剂效应通常不高于20% (Clinical Gastroenterology and Hepatology. 2025 Nov 4:S1542-3565(25)00860-2)。 在引入第三方机构进行核查，对研究执行情况进一步审查后发现，在试验期间存在患者合 ...

在引入第三方机构进行核查，对研究执行情况进一步审查后发现，在试验期间存在患者合并用药管理 (如，安慰剂组有明显更多患者违背方案新增或强化了GLP-1RA治疗)、患者依从性管理等研究执行和质 量管理范畴的问题，且这些问题可能对试验结果造成明显影响。 基于上述情况，公司对研究数据进行了事后分析，在剔除违规用药等异常干扰因素后，安慰剂效应有明 显下降，HTD1801相较安慰剂在多项肝脏组织学指标上呈现出治疗改善趋势。该事后分析结果进一步 提示，本研究受多个执行及质量管理因素的影响和干扰。HTD1801在该研究中展现出的长期安全性与 耐受性与既往临床研究结果一致。 格隆汇2月5日丨君圣泰医药-B(02511.HK)发布公告，HTD1801在代谢相关脂肪性肝炎(MASH)患者中开 展的全球多中心IIb期临床研究已完成。 CENTRICITY(NCT05623189)是一项随机、双盲、安慰剂对照的全球多中心IIb期临床试验(N=218)，旨 在评估HTD1801与安慰剂相比，在合并2型糖尿病(T2DM)或糖尿病前期的MASH患者中的有效性与安全 性。 初步分析结果显示，本研究中安慰剂组有48%的患者在治疗结束后实现非酒精 ...

HighTide Therapeutics, Inc. （於開曼群島註冊成立的有限公司） （股份代號：2511） 君聖泰醫藥宣佈完成HTD1801治療代謝相關脂肪性肝炎的 IIb期臨床研究 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。 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。 CENTRICITY(NCT05623189)是一項隨機、雙盲、安慰劑對照的全球多中心IIb期 臨床試驗（N=218），旨在評估HTD1801與安慰劑相比，在合併2型糖尿病(T2DM) 或糖尿病前期的MASH患者中的有效性與安全性。 初步分析結果顯示，本研究中安慰劑組有48%的患者在治療結束後實現非酒精 性脂肪性肝炎活動度評分(NAS)降低≥2分且無纖維化惡化或MASH緩解且無纖維 化惡化。該結果大幅高於既往同類臨床研究中的安慰劑效應。一項發表於2025 年的薈萃分析中涵蓋了78種不同研 ...

"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].

Investment Rating - The report assigns a "Buy (Initiate)" investment rating to the company, with a target price of HKD 5.78 per share over the next six months [6]. Core Insights - The company's core product, HTD1801, is expected to accelerate its commercialization process, with significant clinical trial milestones achieved in 2025, including the completion of two Phase III trials for Type 2 Diabetes Mellitus (T2DM) patients [2][3]. - HTD1801 is a first-in-class oral anti-inflammatory and metabolic regulator, showing a unique dual mechanism of action that activates AMPK and inhibits NLRP3, making it a potential cornerstone therapy for cardiovascular and kidney metabolic diseases (CKM) [3][4]. - The market for CKM therapies is vast, with unmet clinical needs and a growing demand for multi-functional treatment options, positioning HTD1801 favorably against existing therapies [3][4]. Summary by Sections Company Overview - The company, Junshengtai Pharmaceutical (02511.HK), was founded in November 2011 and focuses on breakthrough multi-functional therapies for metabolic diseases. It successfully listed on the Hong Kong Stock Exchange in December 2023 [30][34]. Product Pipeline and Clinical Trials - The company has developed a robust pipeline with seven patented drug candidates targeting various conditions, including T2DM, metabolic-associated fatty liver disease, chronic kidney disease, and obesity. HTD1801 is currently in Phase III trials for T2DM and has shown significant efficacy in improving blood glucose levels and other metabolic markers [35][67]. - Clinical data indicate that HTD1801 significantly reduces HbA1c levels by 1.1% to 1.3% and improves insulin resistance, with a higher percentage of patients achieving HbA1c<7% compared to standard treatments [4][62]. Financial Projections - The company forecasts revenues of HKD 0 million in 2025, HKD 0 million in 2026, and HKD 253 million in 2027, with a gross margin projected to reach 43% by 2027 [6][8]. - The report anticipates that HTD1801 will be submitted for new drug application by the end of 2025, with a successful launch expected in 2027, contributing significantly to revenue growth [70]. Market Analysis - The global market for metabolic diseases, including T2DM and chronic kidney disease, is projected to grow significantly, with the T2DM drug market expected to reach USD 70.4 billion by 2032, driven by increasing prevalence and demand for innovative therapies [15][21]. - The competitive landscape for CKM therapies is evolving, with a shift towards multi-targeted and multi-functional treatment solutions, which HTD1801 is well-positioned to capitalize on [24][26].