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。 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，中國國家藥品監督管理局(NMPA)已受理 HTD1801用於治療2型糖尿病(T2DM)的新藥上市申請(NDA)。這是君聖泰醫藥提 交的首個新藥上市申請，也是公司邁向產品商業化的重要里程碑。 HTD1801已完成3項針對T2DM適應症的多中心、隨機、雙盲、對照的III期臨床 研究，均達主要終點和多項次要終點，在血糖、血脂、炎症、腎功能等多個心腎 代謝關鍵維度呈現出一致的改善趨勢，充分展現了其一藥多效、綜合獲益的臨床 價值。 香港聯合交易所有限公司證券上市規則第18A.05條規定的警示聲明：本公司無法 保證HTD1801最終會成功上市。本公司股東及潛在投資者於買賣本公司股份時務 請審慎行事。 HighTide Therapeutics, Inc. ...

Core Insights - The meeting held by Junshengtai Pharmaceutical focused on the company's strategic layout in the cardiovascular, kidney, and metabolic (CKM) disease sector and the interpretation of various clinical research data [1] - The appointment of Dr. Filip Surmont as the new Chief Medical Officer is significant, given his extensive experience in the field and the potential of the innovative drug HTD1801 to redefine treatment paradigms in CKM diseases [1][4] Market Potential - CKM diseases are evolving from a clinical concept to a major health challenge, with a significant market opportunity driven by the interconnected nature of these diseases [3] - The global market for major metabolic diseases was approximately $160 billion in 2022 and is projected to reach $458 billion by 2032, with a compound annual growth rate (CAGR) of 11.1% [3] Industry Trends - Traditional pharmaceutical companies often rely on a broad product portfolio targeting individual diseases, while companies like Junshengtai are focusing on developing multi-functional drugs that address multiple issues simultaneously [4] - The industry is shifting from single-target drugs to combination therapies and now to single drugs with multiple targets, aligning with global treatment trends [4] Product Innovation - HTD1801 is a globally innovative oral drug designed to address CKM diseases through a unique dual mechanism that improves metabolic disorders and controls chronic inflammation [6] - The drug combines two natural components, berberine and ursodeoxycholic acid, to form a new molecular entity that targets the root causes of CKM diseases [6] Clinical Efficacy - Clinical trials have demonstrated HTD1801's effectiveness in lowering HbA1c levels by 1.3% in patients with Type 2 Diabetes Mellitus (T2DM) after 24 weeks of treatment, showcasing its long-term blood sugar control capabilities [10] - In patients with mild kidney impairment, HTD1801 showed a significant improvement in estimated glomerular filtration rate (eGFR) by +3.08 mL/min/1.73m², indicating potential disease-modifying effects [11] - HTD1801 also outperformed the traditional drug Dapagliflozin in reducing low-density lipoprotein cholesterol levels, suggesting comprehensive benefits for CKM patients [11] Strategic Positioning - HTD1801 is positioned as a cornerstone therapy in the CKM field, with analysts predicting it will establish a clear differentiation and unique value proposition in a competitive treatment landscape [12] - Junshengtai's approach reflects a broader shift in the pharmaceutical industry towards patient-centered care and holistic treatment strategies [14]

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]

Group 1 - The company announced the completion of a global multicenter Phase IIb clinical study for HTD1801 in patients with Metabolic Associated Steatotic Liver Disease (MASH) [1] - The CENTRICITY trial (NCT05623189) involved 218 patients and aimed to evaluate the efficacy and safety of HTD1801 compared to a placebo in MASH patients with Type 2 Diabetes Mellitus (T2DM) or prediabetes [1] - Preliminary analysis showed that 48% of patients in the placebo group achieved a reduction of ≥2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) without fibrosis worsening, significantly higher than previous studies where placebo effects were typically below 20% [1] Group 2 - Following a review by a third-party organization, issues related to patient medication management and adherence were identified, which may have significantly impacted trial results [2] - After excluding these confounding factors, the placebo effect was found to decrease significantly, and HTD1801 showed a trend of therapeutic improvement in several liver histological indicators [2] - The company plans to reassess the clinical development strategy for HTD1801 in MASH based on the overall data, review findings, and post-hoc analysis conclusions, and will communicate with the FDA for further evaluation of the development plan [2]

Group 1 - The core finding of the global multicenter Phase IIb clinical trial CENTRICITY (NCT05623189) for HTD1801 in patients with Metabolic Associated Steatotic Liver Disease (MASH) indicates that 48% of patients in the placebo group achieved a reduction of ≥2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) without fibrosis worsening, which is significantly higher than the typical placebo effect observed in similar studies [1] - A meta-analysis published in 2025 covering 127 clinical trials for 78 different investigational drugs indicated that the placebo effect in similar trials usually does not exceed 20% [1] Group 2 - Following a review by a third-party organization, issues related to patient medication management and adherence during the trial were identified, which may have significantly impacted the trial results [2] - After excluding abnormal interference factors such as non-compliance with medication protocols, the placebo effect was found to decrease significantly, showing HTD1801 exhibited a trend of therapeutic improvement in several liver histological indicators [2] - The long-term safety and tolerability of HTD1801 in this study were consistent with previous clinical research results, and the company plans to further evaluate the clinical development strategy for HTD1801 in MASH indications based on the overall data and findings from this study [2]

Group 1 - The core viewpoint of the news is that Junsheng Tai Pharmaceutical-B (02511.HK) has completed a global multicenter Phase IIb clinical study of HTD1801 in patients with Metabolic Associated Steatotic Liver Disease (MASH) [1] - The CENTRICITY trial (NCT05623189) involved 218 patients and aimed to evaluate the efficacy and safety of HTD1801 compared to a placebo in MASH patients with type 2 diabetes (T2DM) or prediabetes [1] - Preliminary analysis showed that 48% of patients in the placebo group achieved a reduction of ≥2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) without fibrosis worsening, significantly higher than previous studies where placebo effects were typically below 20% [1] Group 2 - Following a review by a third-party organization, issues were identified in the management of concomitant medications and patient compliance during the trial, which may have significantly impacted the results [2] - After excluding abnormal interference factors such as non-compliant medication use, the placebo effect was found to decrease significantly, indicating a treatment improvement trend for HTD1801 in several liver histological indicators [2] - The post-hoc analysis results suggest that the study was influenced by multiple execution and quality management factors, while HTD1801 demonstrated long-term safety and tolerability consistent with previous clinical research findings [2]

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 ...

Core Viewpoint - Junshengtai Pharmaceutical is leveraging innovative molecules derived from natural products to address metabolic diseases, emphasizing a patient-centered approach to meet unmet clinical needs [2][3]. Group 1: Company Overview - Junshengtai Pharmaceutical was founded by Liu Liping in 2011, focusing on the research and development of drugs for metabolic diseases [3]. - The company aims to explore the potential of natural products in drug development, moving away from traditional methods of producing generic drugs [3]. Group 2: Product Development - The company has developed a novel molecular entity, HTD1801, by combining berberine from traditional Chinese medicine and ursodeoxycholic acid, targeting multiple pathways for treating various metabolic diseases [2][4]. - HTD1801 has shown potential in activating AMPK, improving glucose uptake, and reducing chronic inflammation, which are critical for managing metabolic disorders [4]. Group 3: Clinical Trials and Applications - Junshengtai Pharmaceutical has initiated two Phase 3 clinical trials for HTD1801 in Chinese patients with Type 2 Diabetes Mellitus (T2DM), achieving primary and multiple secondary efficacy endpoints [5]. - The company plans to submit a new drug application for HTD1801 for T2DM treatment and has identified chronic kidney disease (CKD) as an additional indication [5][6]. Group 4: Future Prospects - HTD1801 is expected to expand its indications, with ongoing research into its effects on CKD and potential combination therapies with GLP-1 receptor agonists for obesity management [6]. - The company aims to position HTD1801 as a foundational treatment in the cardiovascular-kidney-metabolic (CKM) field, providing comprehensive health solutions for patients [6]. Group 5: Innovation and Challenges - Liu Liping likens the process of developing innovative drugs to climbing Mount Everest, highlighting the challenges faced in combining natural molecules into a new compound [7]. - The company emphasizes a focus on breakthrough innovations and overcoming obstacles in drug development, reflecting the broader trends in China's pharmaceutical industry [7].

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].