君圣泰医药-B(02511)公布，集团的全资附属公司深圳君圣泰生物技术有限公司与中国医学科学院医药 生物技术研究所(药生所)共同开展课题合作，评估集团核心产品HTD1801对糖尿病伴慢性肾病(CKD with T2DM)的治疗潜力。该项目已于近日在中国医学科学院完成课题批准。基于本项目，双方将围绕 糖尿病及伴慢性肾病适应症共同开展创新药物的机制和临床研究，致力于探索具备综合干预价值的创新 治疗方案。 本次合作聚焦糖肾代谢相关疾病的开发，依托药生所在药物研发和医学的资源优势，结合集团在代谢性 疾病领域的核心竞争力和产品开发经验，旨在加快创新治疗方案在临床阶段的推进，提升产品应用价 值。 根据合作协议，双方围绕异喹啉类新药共同开展药效与机制研究，并推进临床评估，以拓展其在糖尿病 相关肾病领域的临床应用。 此次合作将加快集团核心项目的临床进展，拓展研发佈局，进一步丰富产品管线，为公司在代谢疾病治 疗领域的持续创新与长期发展提供有力支撑。 据悉，HTD1801是君圣泰医药核心产品，也是本次合作开发主要产品。它是一种靶向肠-肝系统的口服 抗炎及代谢调节剂，具有全球首创的激活AMPK并抑制NLRP3炎症小体的独特双机制。 ...

智通财经APP讯，君圣泰医药-B(02511)公布，集团的全资附属公司深圳君圣泰生物技术有限公司与中国 医学科学院医药生物技术研究所(药生所)共同开展课题合作，评估集团核心产品HTD1801对糖尿病伴慢 性肾病(CKD with T2DM)的治疗潜力。该项目已于近日在中国医学科学院完成课题批准。基于本项目， 双方将围绕糖尿病及伴慢性肾病适应症共同开展创新药物的机制和临床研究，致力于探索具备综合干预 价值的创新治疗方案。 本次合作聚焦糖肾代谢相关疾病的开发，依托药生所在药物研发和医学的资源优势，结合集团在代谢性 疾病领域的核心竞争力和产品开发经验，旨在加快创新治疗方案在临床阶段的推进，提升产品应用价 值。 根据合作协议，双方围绕异喹啉类新药共同开展药效与机制研究，并推进临床评估，以拓展其在糖尿病 相关肾病领域的临床应用。 此次合作将加快集团核心项目的临床进展，拓展研发佈局，进一步丰富产品管线，为公司在代谢疾病治 疗领域的持续创新与长期发展提供有力支撑。 据悉，HTD1801是君圣泰医药核心产品，也是本次合作开发主要产品。它是一种靶向肠-肝系统的口服 抗炎及代谢调节剂，具有全球首创的激活AMPK并抑制NLRP3 ...

HTD1801是君圣泰医药核心产品，也是本次合作开发主要产品。它是一种靶向肠－肝系统的口服抗炎 及代谢调节剂，具有全球首创的激活AMPK并抑制NLRP3炎症小体的独特双机制。全球开展的十余项临 床试验显示，HTD1801可同步改善血糖、血脂、肾功能、体重、肝功能、心血管、炎症等指标，展现 出对2型糖尿病、慢性肾病、肥胖、血脂异常、脂肪肝等多个适应症的共病治疗潜力。 中国医学科学院成立于1956年，是我国最高医学研究机构和领衔医学教育机构。以引领我国医学科技与 教育发展和维护人民健康为己任，医疗领衔行业，为我国现代科学医学体系的建立和发展做出了重要贡 献。 医药生物技术研究所(药生所)是中国医学科学院的直属研究所，其重点领域是微生物药物、抗感染药 物、与生物技术药物研究，在国内一直保持相关学科和领域的研究优势。药生所具备综合的新药研究体 系，在抗感染、抗代谢综合徵、及抗癌等领域的新药研发方面均取得重要进展，已成为不可替代的国家 战略科技力量。 格隆汇8月12日丨君圣泰医药-B(02511.HK)公告，集团的全资附属公司深圳君圣泰生物技术有限公司与 中国医学科学院医药生物技术研究所("药生所")共同开展课题合作， ...

與中國醫學科學院醫藥生物技術研究所開展科研課題合作， 探索創新藥代謝與腎臟獲益潛力 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。 HighTide Therapeutics, Inc. （於開曼群島註冊成立的有限公司） （股份代號：2511） 業務發展最新情況 關於HTD1801 HTD1801是君聖泰醫藥核心產品，也是本次合作開發主要產品。它是一種靶向 腸－肝系統的口服抗炎及代謝調節劑，具有全球首創的激活AMPK並抑制NLRP3 炎症小體的獨特雙機制。全球開展的十餘項臨床試驗顯示，HTD1801可同步改善 血糖、血脂、腎功能、體重、肝功能、心血管、炎症等指標，展現出對2型糖尿 病、慢性腎病、肥胖、血脂異常、脂肪肝等多個適應症的共病治療潛力。 本公司董事會（「董事會」）宣佈，本集團的全資附屬公司深圳君聖泰生物技術有限 ...

格隆汇8月12日丨君圣泰医药-B(02511.HK)宣布，董事会会议将于2025年8月25日（星期一）举行，藉以 （其中包括）审议及批准本公司及其附属公司截至2025年6月30日止六个月的中期业绩及其发布，以及 处理其他事项。 ...

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的內容概不負責，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. 董事會會議召開日期通告 君聖泰醫藥（「本公司」）董事會（「董事會」）謹此宣佈，董事會會議將於二零二五 年八月二十五日（星期一）舉行，藉以（其中包括）審議及批准本公司及其附屬公司 截至二零二五年六月三十日止六個月之中期業績及其發佈，以及處理其他事項。 （於開曼群島註冊成立的有限公司） （股份代號：2511） 香港，二零二五年八月十二日 於本公告日期，董事會成員由執行董事劉利平博士及于萌女士；非執行董事朱迅 博士、馬立雄先生及江峰先生；以及獨立非執行董事譚擘先生、李靖博士及孔德 偉先生組成。 承董事會命 君聖泰醫藥 執行董事兼行政總裁 劉利平博士 ...

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7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: 2025年8月1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 | | 100,000 | 本月底法定/註冊股本總額： USD 1 ...

Core Viewpoint - Junshengtai Pharmaceutical is innovating in the treatment of chronic metabolic diseases by developing a multi-target drug, HTD1801, derived from natural products, combining berberine and ursodeoxycholic acid to provide comprehensive benefits for patients [2][3][4]. Group 1: Company Background and Development - Liu Liping, the founder and CEO of Junshengtai Pharmaceutical, has over a decade of experience in drug development, including leading new drug applications and clinical trials abroad [3]. - The company was established in 2011, focusing on developing innovative drugs that address chronic metabolic diseases through a multi-target approach rather than single-target drugs [3][4]. - The decision to return to China and start the company was influenced by the government's emphasis on developing the biopharmaceutical industry as a strategic emerging industry [3]. Group 2: Drug Development Process - The active ingredients selected for HTD1801 are berberine, known for its anti-inflammatory and blood sugar regulation properties, and ursodeoxycholic acid, which has a long history of clinical application [4][6]. - Initial attempts to combine these two compounds faced challenges, including a failed collaboration with a Boston laboratory, but perseverance led to the successful development of a new molecular entity [6][7]. - The combination of berberine and ursodeoxycholic acid has shown synergistic effects, enhancing efficacy while reducing toxicity, which is a significant advancement in drug development [7]. Group 3: Clinical and Market Potential - HTD1801 is being developed for multiple indications, including type 2 diabetes, metabolic-associated fatty liver disease, chronic kidney disease, and obesity, aiming to address the clinical need for multi-disease treatment [8]. - The drug has gained recognition in the international academic community, with research results presented at major conferences and published in high-impact journals, affirming its scientific value [8]. - In 2018, HTD1801 received fast track designation from the FDA for non-alcoholic steatohepatitis, marking it as the first Chinese innovative drug to achieve this status in the field [8]. Group 4: Company Growth and Future Plans - Junshengtai Pharmaceutical has established a product pipeline with global intellectual property rights, including seven potential leading drugs covering nine indications [9]. - The company plans to submit a new drug application for HTD1801 to the National Medical Products Administration in China within the year, marking its entry into the commercialization phase [9]. - The company went public on the Hong Kong Stock Exchange in 2023, with significant oversubscription during the public offering, indicating strong market interest and confidence in its growth potential [8][9].

Clinical Development and Product Pipeline - The company is advancing the clinical trials of its innovative oral metabolic drug HTD1801, which has shown multiple functions including glucose lowering, lipid lowering, anti-inflammatory, liver protection, and weight loss [6]. - HTD1801's clinical III phase data for Type 2 Diabetes Mellitus (T2DM) is expected to be announced, with NDA submission anticipated by the end of 2025 [7]. - The company has completed patient enrollment for three clinical III trials targeting T2DM in mainland China, assessing the efficacy and safety of HTD1801 [7]. - HTD1801 has demonstrated significant improvements in glycemic control and cardiovascular metabolic parameters, indicating its potential as an innovative treatment for comprehensive management of T2DM [7]. - The global multi-center clinical IIb trial for HTD1801 targeting Metabolic Associated Steatotic Liver Disease (MASH) is ongoing, with results expected in 2025 [8]. - The combination of HTD1801 with GLP-1RA is projected to provide further benefits in glucose lowering, lipid lowering, and weight reduction [9]. - HTD1801 has received compound patent authorization in major global markets, ensuring a long market exclusivity period [6]. - The core product HTD1801 has shown comprehensive benefits, including improved blood sugar control, weight reduction, and decreased liver fat, supported by clinical data from over 2,000 global trial participants [15]. - HTD1801 is currently being developed for multiple indications, including metabolic-associated fatty liver disease, type 2 diabetes, and severe hypertriglyceridemia, expanding its therapeutic scope [16]. - HTD1801 has received two Fast Track designations and one Orphan Drug designation from the FDA, with global development plans advancing towards commercialization [19]. - Phase IIb study for HTD1801 in metabolic-associated fatty liver disease has completed patient enrollment in the US, mainland China, and Hong Kong, with data readout expected in 2025 [21]. - HTD1801 significantly improved liver fat content compared to placebo in a Phase IIa study, indicating its potential as a long-term treatment for chronic diseases [20]. - Multiple Phase III studies for HTD1801 targeting type 2 diabetes have completed patient enrollment in China, with key data results expected in the first half of 2025 [19]. - HTD1801 demonstrated greater improvements in liver injury and inflammation markers compared to GLP-1 receptor agonists in clinical studies [20]. - HTD1801 treatment resulted in statistically significant reductions in serum alkaline phosphatase levels, a key biomarker for cholestatic liver disease, in Phase II trials [25]. - HTD1801 exhibited comprehensive benefits for both type 2 diabetes and metabolic-associated fatty liver disease, showing significant improvements in metabolic markers [22]. - The results from the 2024 EASD meeting highlighted HTD1801's efficacy in both Chinese and Western type 2 diabetes patients, demonstrating comprehensive benefits regardless of baseline conditions [22]. - HTD1801 has shown potential in reducing triglyceride levels in patients with severe hypertriglyceridemia, with clinical significance noted in subjects with baseline triglycerides above 200 mg/dL [29]. Financial Performance and Investments - Other income increased by 98.8% from RMB 34.2 million in the year ended December 31, 2023, to RMB 68.0 million in the year ending December 31, 2024, primarily due to an increase in government subsidies of approximately RMB 28.5 million [39]. - The fair value loss of convertible redeemable preferred shares decreased from a loss of RMB 522.2 million in the year ended December 31, 2023, to zero in the year ending December 31, 2024, as all preferred shares were converted to common stock upon listing [40]. - Research and development costs increased by 16.7% from RMB 311.6 million in the year ended December 31, 2023, to RMB 363.5 million in the year ending December 31, 2024, mainly due to an increase in third-party contract expenses of approximately RMB 60.7 million [42]. - Administrative expenses decreased by 40.6% from RMB 136.7 million in the year ended December 31, 2023, to RMB 81.2 million in the year ending December 31, 2024, primarily due to a reduction in professional service fees [44]. - The company recorded a loss of RMB 381.8 million for the year ending December 31, 2024, compared to a loss of RMB 939.3 million for the year ended December 31, 2023 [46]. - As of December 31, 2024, the company's current assets were RMB 513.4 million, with cash and cash equivalents amounting to RMB 310.8 million, a decrease of 48.9% from RMB 608.2 million as of December 31, 2023 [48]. - The company had outstanding interest-bearing bank loans of approximately RMB 56.9 million as of December 31, 2024, compared to RMB 3.5 million as of December 31, 2023 [49]. - The asset-liability ratio increased to 13.4% as of December 31, 2024, from 0.5% as of December 31, 2023 [51]. - Capital expenditures for the year ending December 31, 2024, were RMB 4.3 million, up from RMB 0.8 million for the year ended December 31, 2023, primarily due to increased renovations of leased properties [57]. - The company made investments of USD 12.5 million in each of Apollo Multi-Asset Growth Fund and Chaince Capital Fund LP, with related assets generating investment income of approximately RMB 11.2 million [53]. - The company reported a net loss of RMB 381.788 million for the fiscal year 2024, a significant improvement from a net loss of RMB 939.306 million in 2023, representing a reduction of approximately 59% [61]. - The adjusted net loss for 2024 was RMB 284.856 million, compared to RMB 288.443 million in 2023, indicating a slight improvement of about 1.5% [61]. - Employee benefits expenses totaled RMB 108.2 million for the fiscal year 2024, down from RMB 116.3 million in 2023, reflecting a decrease of approximately 7.5% [63]. - The company employed 70 staff members as of December 31, 2024, an increase from 66 employees in the previous year, marking a growth of about 6.1% [63]. Corporate Governance and Compliance - The company has no current foreign currency hedging policy but is monitoring foreign exchange risks, particularly with transactions in USD, RMB, and HKD [58]. - The company has adopted share incentive plans on January 22, 2020, and May 24, 2023, to enhance employee motivation and retention [64]. - The company is focused on maintaining environmental sustainability and compliance with relevant environmental laws and regulations [70][72]. - The company has not reported any significant violations of applicable laws and regulations as of December 31, 2024 [72]. - The company’s management is committed to continuous education and training programs to enhance employee skills and knowledge [64]. - The company’s financial performance analysis and future business development indicators are detailed in the management discussion and analysis section of the annual report [69]. - The group maintained stable employee relations during the reporting period, with no significant strikes or labor disputes affecting business activities [73]. - The group has no forfeited contributions available to reduce current contribution levels for retirement benefit plans [74][75]. - The company has established a long-term strategic partnership with Haiprui, leveraging its strong sales force and market share in Europe for the commercialization of licensed products [86]. - The company has not conducted any transactions under the HTD1801 agreement during the reporting period, thus no confirmations will be provided by auditors or independent non-executive directors [92]. - The company will ensure compliance with the terms of the HTD1801 agreement and applicable listing rules through regular monitoring by the CEO [93]. - Independent non-executive directors and auditors will review transactions related to the HTD1801 agreement annually and confirm compliance with relevant listing rules [94]. - The company has disclosed the background and terms of the HTD1801 agreement in its prospectus, along with the rationale for seeking waivers [94]. - The procurement amount from the group's top five suppliers accounted for approximately 36.7% of the total procurement amount for the year ending December 31, 2024, down from 44.5% in 2023 [96]. - The largest supplier's procurement amount represented about 12.5% of the total procurement amount for the year ending December 31, 2024, compared to 19.2% in 2023 [96]. - The company did not experience any significant disputes with its suppliers during the year ending December 31, 2024 [96]. - The company has not entered into any management or administrative contracts regarding its business operations [165]. - The company has a consistent governance structure with automatic renewals of director contracts, ensuring stability in leadership [120]. Leadership and Management - Dr. Liu has over 21 years of experience in new drug development, having held various leadership roles in multiple pharmaceutical companies [174]. - Dr. Liu has been serving as the Executive Director and CEO of Shenzhen Junshengtai since November 2011, with a focus on business strategy and development [176]. - The company has expanded its leadership team, with Ms. Yu Meng appointed as Executive Director in May 2023, responsible for overseeing R&D activities [178]. - Dr. Zhu Xun joined the company as a non-executive director in November 2020, providing strategic guidance and insights [179]. - The company has a strong emphasis on innovation, with Dr. Liu recognized as one of the top ten drug innovation scientists in 2021 [175]. - The leadership team has extensive experience in the pharmaceutical industry, with members holding positions in various listed companies, ensuring effective governance [182]. - The company is committed to R&D, with Ms. Yu Meng previously overseeing CMC and preclinical activities, indicating a robust pipeline [178]. - The company has received recognition for its contributions to technology innovation and entrepreneurship, enhancing its reputation in the industry [175]. - The board believes that Dr. Zhu can dedicate sufficient time to his duties despite holding positions in other companies, ensuring effective oversight [182].

Core Viewpoint - Junsheng Tai Pharmaceutical-B (02511) has announced that its self-developed intestinal and hepatic anti-inflammatory and metabolic regulator, HTD1801, has achieved primary efficacy endpoints and multiple secondary efficacy endpoints in two Phase 3 clinical trials for Type 2 Diabetes Mellitus (T2DM) patients [1][2]. Group 1: Clinical Trial Results - The SYMPHONY 1 and SYMPHONY 2 trials are multi-center, randomized, double-blind, placebo-controlled Phase 3 studies aimed at evaluating the efficacy and safety of HTD1801 in T2DM patients with poor blood glucose control after dietary and exercise interventions (SYMPHONY 1; N=407) and those with inadequate control on metformin (SYMPHONY 2; N=549) [2]. - The primary efficacy endpoint for both studies was the change in glycated hemoglobin (HbA1c) from baseline after 24 weeks of treatment compared to placebo, with secondary endpoints including the percentage of subjects achieving HbA1c <7.0%, fasting plasma glucose (FPG), low-density lipoprotein cholesterol (LDL-C), gamma-glutamyl transferase (GGT), and high-sensitivity C-reactive protein (hs-CRP) [2]. Group 2: Efficacy and Safety Profile - After 24 weeks of treatment, the proportion of patients achieving HbA1c <7.0% in the HTD1801 group was significantly higher than in the placebo group, with HTD1801 also showing significant reductions in both postprandial and fasting blood glucose levels [3]. - HTD1801 demonstrated the ability to lower both glucose and lipids, significantly reducing LDL-C and non-HDL-C levels, as well as inflammatory markers GGT and hs-CRP, which are closely related to cardiovascular events and clinical outcomes in T2DM patients [3]. - Both studies indicated that HTD1801 exhibited good safety and tolerability, with the most common adverse events being gastrointestinal in nature, consistent with previous clinical findings, and less than 2% of subjects discontinued due to adverse events, with no significant risk of hypoglycemia observed [3].