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].

Product Development and Clinical Trials - The core product HTD1801 has shown significant clinical benefits, including improved blood sugar control, weight reduction, and decreased liver fat content, supported by strong clinical data from over 2,000 global trial participants[5][6]. - HTD1801 is currently in advanced clinical trials for multiple indications, including metabolic-associated fatty liver disease and type 2 diabetes, with ongoing Phase II and III studies in various regions[10]. - HTD1801 has received fast track designation for several indications, indicating its potential to address significant unmet medical needs[10]. - HTD1801 is a targeted oral anti-inflammatory and metabolic modulator currently in the final stages of clinical research in China and the US, with key data results expected in the first half of 2025 for type 2 diabetes[11]. - The IIa clinical trial of HTD1801 for metabolic associated fatty liver disease (MAFLD) combined with type 2 diabetes achieved its primary endpoint, showing significant improvement in liver fat content compared to placebo[12]. - HTD1801 demonstrated greater improvements in liver injury and inflammation markers, blood glucose control, weight loss, and lipid metabolism compared to GLP-1 receptor agonists in patients with MAFLD and type 2 diabetes[14]. - The ongoing IIb study for MAFLD has completed patient enrollment in the US, mainland China, and Hong Kong, with data readout expected in 2025[14]. - HTD1801 has shown significant therapeutic effects in improving glucose metabolism, with statistically significant reductions in HbA1c and fasting blood glucose levels observed in clinical trials[14]. - HTD1801 demonstrated significant improvements in blood glucose, cardiovascular metabolism, and liver benefits in both Chinese and Western type 2 diabetes patients, regardless of the presence of metabolic-associated fatty liver disease[16]. - Patient enrollment for the phase III clinical trials SYMPHONY-1 and SYMPHONY-2 for HTD1801 in type 2 diabetes was completed in June 2024[16]. - The phase III clinical trial HARMONY, comparing HTD1801 to dapagliflozin in poorly controlled type 2 diabetes patients, completed patient enrollment in January 2025[16]. - Data from the SYMPHONY trials is expected to be released in the first half of 2025, while HARMONY data is anticipated in the second half of 2025[16]. - The company plans to submit a new drug application for HTD1801 for type 2 diabetes by the end of 2025[11]. Market Potential and Strategy - The global market for metabolic diseases is projected to reach $458 billion by 2032, presenting substantial growth opportunities for the company's innovative product pipeline[8]. - The company aims to commercialize HTD1801 by 2025, actively pursuing market opportunities in the U.S., China, Canada, and Australia[9]. - The focus on metabolic diseases and inflammatory comorbidities is central to the company's strategy, leveraging the potential of HTD1801 to expand its therapeutic applications[8]. Intellectual Property and Product Pipeline - The company holds a robust intellectual property portfolio with 134 patents and applications across major markets, providing a strong market entry barrier for its products[9]. - The product pipeline includes seven patented drug candidates targeting nine potential indications, with two candidates in clinical stages for five different indications[10]. Financial Performance - 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 ending December 31, 2023[37]. - The total comprehensive loss for the year was RMB 375.5 million, down from RMB 952.7 million in the previous year, marking a decrease of around 60.6%[69]. - The company reported a loss attributable to equity holders of the parent of RMB 381.8 million for the year ended December 31, 2024, a significant improvement from a loss of RMB 939.3 million in 2023, representing a reduction of approximately 59%[68]. - The adjusted loss for the year ending December 31, 2024, was RMB 284.9 million, compared to RMB 288.4 million for the year ending December 31, 2023[52]. - The company recorded other income of RMB 67.97 million in 2024, compared to RMB 34.21 million in 2023, indicating an increase of approximately 98.5%[68]. - R&D costs rose by 16.7% from RMB 311.6 million to RMB 363.5 million, mainly due to increased third-party contract expenses[33]. - Administrative expenses decreased by 40.6% from RMB 136.7 million to RMB 81.2 million, attributed to reduced professional service fees[35]. Cash Flow and Assets - As of December 31, 2024, the company's current assets amounted to RMB 513.4 million, with cash and cash equivalents at RMB 310.8 million, a decrease of 48.9% from RMB 608.2 million as of December 31, 2023, mainly due to R&D expenditures[39]. - The company's current liabilities as of December 31, 2024, were RMB 109.9 million, which included trade payables of RMB 51.5 million and interest-bearing bank borrowings of RMB 46.9 million[39]. - The company had outstanding interest-bearing bank borrowings of approximately RMB 56.9 million as of December 31, 2024, up from RMB 3.5 million as of December 31, 2023[40]. - The asset-liability ratio as of December 31, 2024, was 13.4%, compared to 0.5% as of December 31, 2023[43]. - The capital expenditure for the year ending December 31, 2024, was RMB 4.3 million, an increase from RMB 0.8 million for the year ending December 31, 2023, primarily due to increased lease property renovations[48]. Employee and Governance - The company has adopted a share incentive plan to enhance employee quality and skills, with competitive salaries and bonuses for key employees[55]. - The total number of employees is 70, an increase from 66 employees as of December 31, 2023[54]. - Employee benefits expenses totaled RMB 108.2 million for the year ending December 31, 2024, down from RMB 116.3 million in 2023, primarily due to a reduction in wages and salaries[54]. - The company has complied with all applicable corporate governance codes during the reporting period, except for the separation of the roles of Chairman and CEO[56]. Government Support and Grants - The company has received government grants primarily from local authorities to support research and clinical trial expenses, with the main granting units being the Shenzhen Development and Reform Commission and the Shenzhen Futian District[78]. - Government grants related to expenses increased significantly to RMB 38,195 thousand in 2024 from RMB 9,769 thousand in 2023, representing a growth of 290%[78]. Future Plans and Developments - The company plans to present preclinical results and therapeutic potential of HTD4010 at major international scientific conferences in 2025[20]. - Approximately 80% of the net proceeds from the IPO, amounting to RMB 155.2 million, will be used for the ongoing clinical development of HTD1801, with an expected completion date in December 2025[62]. - About 5% of the net proceeds, totaling RMB 9.7 million, will be allocated for the ongoing development of HTD1804, also expected to be completed by December 2025[62].

Product Development and Clinical Trials - HighTide Therapeutics has developed a pipeline of 5 candidate products targeting 8 indications related to metabolic and digestive diseases, with 2 candidates currently in clinical stages[7]. - The candidate HTD1801 (Ursodeoxycholic Acid) is in Phase II trials for severe hypertriglyceridemia and primary sclerosing cholangitis, with fast track and orphan drug designations in the US and Canada[8]. - The company has completed Phase IIa and IIb studies for metabolic-associated fatty liver disease in the US, Hong Kong, and mainland China[8]. - HTD4010, a peptide drug, has completed Phase I trials for alcoholic hepatitis in Australia[8]. - HighTide Therapeutics aims to provide effective and safe treatment options for complex metabolic and digestive diseases, addressing unmet clinical needs[7]. - HighTide Therapeutics is focused on developing multi-functional and multi-target therapies to improve overall clinical benefits for patients[7]. - The pipeline includes candidates HTD1804, HTD1805, and HTD2802, which are in various stages of development for obesity, metabolic diseases, and inflammatory bowel disease, respectively[8]. - HTD1801 is a new molecular entity targeting intestinal and hepatic inflammation and metabolic regulation, crucial for treating metabolic and digestive system diseases[9]. - The IIa study of HTD1801 in patients with metabolic-associated fatty liver disease (MAFLD) and type 2 diabetes showed statistically significant improvement in liver fat content compared to placebo[10]. - The ongoing IIb study of HTD1801 for MAFLD with type 2 diabetes has completed patient enrollment as of March 2024, with data readout expected in the first half of 2025[11]. - HTD1801 has demonstrated significant therapeutic effects on glucose metabolism, including statistically significant reductions in HbA1c and fasting blood glucose levels in clinical trials conducted in China[12]. - The company initiated a Phase III registration trial for HTD1801 in treating type 2 diabetes in November 2023, with patient enrollment for two Phase III trials completed by June 2024[13]. - HTD1801 treatment has shown to improve key metabolic markers and liver injury indicators in type 2 diabetes patients, particularly in those with more severe disease[12]. - HTD1801's unique mechanism of action may provide significant metabolic benefits for patients with MAFLD and type 2 diabetes, addressing the complex relationship between these conditions[11]. - The company anticipates completing clinical trials for HTD1801 and data readout by 2025, positioning it as a promising treatment option for metabolic complications[13]. - HTD1801 has shown statistically significant reduction in serum alkaline phosphatase levels, a key biomarker for cholestatic liver disease, compared to the placebo group in the Phase II clinical trial[14]. - The Phase II clinical trial for HTD1801 in primary sclerosing cholangitis was completed in August 2020 in the US and Canada, demonstrating good safety profiles including liver-related safety[14]. - Clinical pre-trial studies indicate that HTD1801 may improve lipid levels in models of metabolic-associated fatty liver disease[15]. - The company plans to initiate Phase II clinical trials for HTD1801 in severe hypertriglyceridemia based on clinical progress and resource allocation[16]. - HTD4010 is in early clinical development for the treatment of alcoholic hepatitis, a severe condition characterized by acute liver inflammation[17]. - HTD1804 is being evaluated for its effects on obesity, which is increasingly linked to various health risks including cardiovascular diseases and type 2 diabetes[18]. - HTD1805 is a multifunctional small molecule drug in preclinical stages aimed at treating metabolic diseases, showing potential similar to HTD1801[19]. Financial Performance - The company recorded a loss of RMB 210.9 million for the six months ended June 30, 2024, compared to a loss of RMB 549.7 million for the same period in 2023[32]. - Other income and gains increased by 68.7% to RMB 38.3 million for the six months ended June 30, 2024, compared to RMB 22.7 million for the same period in 2023, primarily due to an increase in government grants of approximately RMB 15.1 million[27]. - Research and development costs rose by 68.2% to RMB 202.0 million for the six months ended June 30, 2024, from RMB 120.1 million for the same period in 2023, mainly due to an increase in third-party contract expenses of approximately RMB 70.8 million[29]. - The group reported a net loss of RMB 210.945 million for the six months ended June 30, 2024, compared to a net loss of RMB 549.744 million for the same period in 2023[44]. - Adjusted net loss for the six months ended June 30, 2024, was RMB 156.909 million, compared to RMB 105.349 million for the same period in 2023[44]. - The company reported a total comprehensive loss of RMB 208,148,000 for the period, a significant reduction from RMB 586,343,000 in the same period last year[96]. - The company reported a significant increase in equity-settled share-based payment arrangements, totaling RMB 54,036,000 for the six months ended June 30, 2024, compared to RMB 28,445,000 for the same period in 2023[99]. - The company recorded a cash outflow from operating activities of RMB 183,507,000 for the six months ended June 30, 2024, compared to RMB 143,908,000 for the same period in 2023[99]. - The company incurred financing costs of RMB 481,000 for the six months ended June 30, 2024, compared to RMB 201,000 for the same period in 2023[99]. - The company’s total liabilities decreased to RMB 1,907,256,000 as of June 30, 2024, from RMB 1,696,311,000 as of December 31, 2023[98]. - The company’s equity attributable to owners was RMB 548,662,000, down from RMB 702,774,000, reflecting a decrease of 22%[97]. - The company reported a basic loss per share of RMB (0.47) for the six months ended June 30, 2024, compared to RMB (2.16) for the same period in 2023, with a weighted average of 452,074,904 shares outstanding[119]. - The total income tax expense for the six months ended June 30, 2024, was RMB 538,000, compared to RMB 26,000 for the same period in 2023, reflecting an increase due to the company's operations in various jurisdictions[117]. Shareholder Information - As of June 30, 2024, Dr. Liu Liping holds 81,000,000 shares, representing approximately 15.74% of the issued shares[60]. - Dr. Liu also has voting rights over 16,351,927 shares, accounting for 3.18% of the issued shares[60]. - Mr. Ma Lixiong controls 30,194,154 shares, which is 5.87% of the total issued shares[60]. - Major shareholder Li Li holds 77,804,710 shares, which is 15.11% of the total issued shares[64]. - Hepalink Biotechnology II Limited has a beneficial ownership of 64,289,500 shares, accounting for 12.49% of the issued shares[64]. - Founder BVI has a beneficial ownership of 81,000,000 shares, representing 15.74% of the total issued shares[64]. - The company has established a consistent action agreement among major shareholders to align on operational and development matters since September 1, 2019[62]. - The total number of issued shares as of June 30, 2024, is 514,770,668[65]. - The company has a total of 41,225,472 shares held under the 2020 Employee Stock Ownership Plan, representing 8.01% of the issued shares[64]. Corporate Governance and Compliance - The company has complied with the corporate governance code, except for the separation of the roles of Chairman and CEO, which are held by the same individual[49]. - The audit committee, consisting of three independent non-executive directors, reviewed the interim results and found them to comply with relevant accounting standards[55]. - The company did not engage in any significant litigation that could adversely affect its financial position or operational performance during the reporting period[52]. - The board does not recommend the distribution of an interim dividend for the six months ending June 30, 2024[57]. - As of June 30, 2024, the company has no other disclosures regarding the interests or short positions of directors or senior executives[63]. Market and Strategic Outlook - The company is investing 50 million USD in R&D for new technologies aimed at treating metabolic-related diseases[132]. - Market expansion plans include entering two new international markets by Q3 2024, projected to increase market share by 5%[134]. - The company has completed a strategic acquisition of a biotech firm for 300 million USD, enhancing its product pipeline[133]. - The company provided guidance for the next quarter, expecting revenue to be between 1.3 billion USD and 1.5 billion USD, indicating a potential growth of 10% to 25%[133]. - New product launches are anticipated to contribute an additional 200 million USD in revenue over the next year[134]. - The company is focusing on addressing severe hypertriglyceridemia, a condition linked to serious health issues, which aligns with its therapeutic goals[135].