此外，MAD Ib期研究成功完成后，公司拟寻求合作伙伴，为全球市场开发HMS1005。 HMS1005为一种物理化学性质有所改善的新型分子实体。其设计为缓释制剂以允许每天服药一次，为 患者带来更多便利并增加药物于肠道中的持续时间，从而增强患者GLP-1分泌不足的修复力。此前，公 司已成功完成并公布HMS1005在美国的单剂量递增研究结果，验证其对T2D及肥胖患者每日一次口服治 疗的可行性。 华领医药-B(02552)发布公告，第二代葡萄糖激酶激活剂(GKA)(HMS1005，前称为HM-002-1005)在美国 开展的多剂量递增(MAD)Ib期试验中，首名患者已成功给药。该研究为随机、双盲、安慰剂对照研究， 旨在评估多剂量递增的HMS1005在美国2型糖尿病(T2D)受试者中的安全性、耐受性、药代动力学特征 及药效学作用。在此研究中，亦将通过评估在空腹和进食状态下的PD标志物(包括血糖、胰岛素、C 肽、GLP-1及胰高血糖素等)，以及通过连续血糖监测仪(CGM)监测血糖波动，进一步探究HMS1005的 作用机制及效果。 ...

智通财经APP讯，华领医药-B(02552)发布公告，第二代葡萄糖激酶激活剂(GKA)(HMS1005，前称为 HM-002-1005)在美国开展的多剂量递增(MAD) Ib期试验中，首名患者已成功给药。该研究为随机、双 盲、安慰剂对照研究，旨在评估多剂量递增的HMS1005在美国2型糖尿病(T2D)受试者中的安全性、耐 受性、药代动力学特征及药效学作用。在此研究中，亦将通过评估在空腹和进食状态下的PD标志物(包 括血糖、胰岛素、C肽、GLP-1及胰高血糖素等)，以及通过连续血糖监测仪(CGM)监测血糖波动，进一 步探究HMS1005的作用机制及效果。 此外，MAD Ib期研究成功完成后，公司拟寻求合作伙伴，为全球市场开发HMS1005。 HMS1005为一种物理化学性质有所改善的新型分子实体。其设计为缓释制剂以允许每天服药一次，为 患者带来更多便利并增加药物于肠道中的持续时间，从而增强患者GLP-1分泌不足的修复力。此前，公 司已成功完成并公布HMS1005在美国的单剂量递增研究结果，验证其对T2D及肥胖患者每日一次口服治 疗的可行性。 ...

MADIb期研究成功完成后，公司拟寻求合作夥伴，为全球市场开发HMS1005。 HMS1005为一种物理化学性质有所改善的新型分子实体。其设计为缓释制剂以允许每天服药一次，为 患者带来更多便利并增加药物于肠道中的持续时间，从而增强患者GLP-1分泌不足的修复力。此前，公 司已成功完成并公布HMS1005在美国的单剂量递增研究结果，验证其对T2D及肥胖患者每日一次口服治 疗的可行性。 格隆汇12月9日丨华领医药-B(02552.HK)宣布，第二代葡萄糖激酶激活剂(「GKA」)(HMS1005，前称为 HM-002-1005)在美国开展的多剂量递增(「MAD」)Ib期试验中，首名患者已成功给药。该研究为随机、 双盲、安慰剂对照研究，旨在评估多剂量递增的HMS1005在美国2型糖尿病(T2D)受试者中的安全性、 耐受性、药代动力学特徵及药效学作用。在此研究中，亦将通过评估在空腹和进食状态下的PD标志物 (包括血糖、胰岛素、C肽、GLP-1及胰高血糖素等)，以及通过连续血糖监测仪(CGM)监测血糖波动，进 一步探究HMS1005的作用机制及效果。 ...

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。 本公告由華領醫藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以告知 股東及潛在投資者有關本公司的最新業務發展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，第二代葡萄糖激酶激活劑 （「GKA」）（HMS1005，前稱為HM-002-1005）在美國開展的多劑量遞增（「MAD」） Ib期試驗中，首名患者已成功給藥。該研究為隨機、雙盲、安慰劑對照研究，旨 在評估多劑量遞增的HMS1005在美國2型糖尿病(T2D)受試者中的安全性、耐受 性、藥代動力學特徵及藥效學作用。在此研究中，亦將通過評估在空腹和進食狀 態下的PD標誌物（包括血糖、胰島素、C肽、GLP-1及胰高血糖素等），以及通過 連續血糖監測儀(CGM)監測血糖波動，進一步探究HMS1005的作用機制及效果。 HUA MEDICINE 華領醫藥 （於開曼群島註冊成立的有限公司） （股份代號：2552） 自願性公告 HMS1005為一種物理化 ...

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11月30日 | | | | 狀態: 新提交 | | --- | --- | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | | | 公司名稱: | 華領醫藥 | | | | | | 呈交日期: | 2025年12月4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) | 02552 | 說明 | 普通股 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 2,000,000,000 | USD | | 0.001 | USD | | 2,000,000 | | 增加 / 減少 (-) ...

Group 1 - The Hong Kong biotechnology sector experienced a widespread decline, with notable drops in several companies' stock prices [1] - Specifically, Gilead Sciences-B fell over 13%, while Sanofi-B dropped more than 10% [1] - Other companies such as Crystal Technology Holdings and Hualing Pharmaceutical-B also saw declines exceeding 6% [1] Group 2 - Gilead Sciences-B's latest price is 11.750, with a market capitalization of 116.56 billion and a year-to-date increase of 290.37% [2] - Sanofi-B's latest price is 7.000, with a market capitalization of 7.44 billion and a year-to-date increase of 102.31% [2] - Crystal Technology Holdings has a latest price of 9.330, a market capitalization of 401.48 billion, and a year-to-date increase of 56.02% [2] - Hualing Pharmaceutical-B's latest price is 3.230, with a market capitalization of 34.13 billion and a year-to-date increase of 121.23% [2] - Other companies like Wangshan Wangshui-B and Sanleaf Biotech-B also reported significant declines, with year-to-date increases of 123.25% and 920.75% respectively [2]

Summary of Hualing Pharmaceutical Conference Call Company Overview - **Company**: Hualing Pharmaceutical - **Product**: Dapagliflozin (多格列艾汀), a GKA (glucokinase activator) for diabetes treatment Key Points Industry and Market Potential - Dapagliflozin sales are projected to grow steadily, with expected revenues of CNY 750 million in 2025, reaching CNY 1.85 billion by 2028, and potentially CNY 2 billion without price reductions. By 2030, sales could approach CNY 3 billion, and by 2032-2033, exceed CNY 4 billion [2][3][22] - The domestic market peak for the first-generation GKA product is estimated at CNY 4-5 billion, while the overseas market could reach USD 7-8 billion, with potential to exceed USD 10 billion [3][16][17] Product Differentiation and Clinical Efficacy - Dapagliflozin is noted for its unique mechanism targeting the root cause of diabetes, protecting pancreatic beta-cell function, and demonstrating superior safety compared to other diabetes medications [2][7][19] - The DRIVE study showed a 52-week drug withdrawal relief rate of 65.2%, indicating its potential for early diabetes patients to manage their condition without long-term medication [2][9][10] Sales and Marketing Strategy - The sales team is expected to double from 100 to over 200 representatives by Q1 2026, with plans to expand to 400-500 by 2028 [2][4][8] - The company aims to submit an IND application for a combination product of Dapagliflozin and Metformin by the end of the year, targeting first-line treatment for severe cases [2][13][14] Research and Development - Ongoing clinical trials are progressing well, with plans for a larger-scale drug withdrawal study expected to yield results in H1 2027 [5][9] - The company is exploring new indications, including diabetes-related cognitive impairment and prevention, with collaborations underway for cystic fibrosis-related diabetes research [5][21] Financial Projections and Cost Management - Sales targets for the next three years are set at CNY 900 million for 2026, CNY 1.35 billion for 2027, and CNY 1.85 billion for 2028, factoring in potential price negotiations [3][22] - The sales expense ratio is projected to decrease from 40% this year to around 35% by 2027, with long-term stabilization between 25-30% [8][19] Competitive Landscape - Dapagliflozin's unique characteristics and strong clinical backing provide a competitive edge in a challenging market environment, supported by favorable national policies [19][20] - The product is positioned to complement GLP-1RA drugs, expanding its applicability beyond just obese patients [18][19] Future Outlook - The company expresses confidence in achieving significant sales growth and enhancing market value through strategic partnerships and product development [6][22] - The second-generation GKA product is anticipated to launch overseas around 2032-2033, with improvements tailored for Western populations [15][16] Conclusion - Hualing Pharmaceutical is strategically positioned in the diabetes treatment market with a robust pipeline, strong sales growth expectations, and a commitment to innovation and collaboration, aiming to enhance its market presence and shareholder value [22]

Core Viewpoint - Hualing Pharmaceutical-B (02552) has seen a significant stock price increase, attributed to the successful commercialization of its core product, the glucose kinase activator (GKA) drug, and its strong revenue growth in the first half of the year [1][2]. Group 1: Company Performance - Hualing Pharmaceutical-B's stock rose over 4% at the close, with a current price of 3.5 HKD and a trading volume of 16.7 million HKD [1]. - The company reported a 110% year-on-year revenue increase in the first half of the year, driven by the commercialization of its GKA product, Mulgrelitin [1]. - The company achieved profitability due to deferred income received from Bayer [1]. Group 2: Product Development - Mulgrelitin, as the first GKA drug globally, was approved for commercialization in 2022, with rapid sales expected after the company regains commercialization rights in 2025 [1]. - Hualing Pharmaceutical-B is developing a second-generation GKA using sustained-release technology and has submitted a clinical application to the FDA [1]. - The GKA field is witnessing a trend of commercialization and internationalization, with Hualing Pharmaceutical-B being a key player, as no other listed companies have clear GKA pipelines [1]. Group 3: Research and Development - A real-world study involving 2,000 type 2 diabetes patients across 80 centers in China confirmed the broad applicability and safety of Mulgrelitin [2]. - New research findings on diabetes remission and cognitive improvement further solidify Hualing Pharmaceutical-B's leading position in GKA research and treatment globally [2].

Core Viewpoint - HuaLing Pharmaceutical-B (02552) has seen a significant stock increase, attributed to its core product, the glucose kinase activator (GKA) drug, which was the first of its kind to be approved in 2022 and is expected to see rapid sales growth after regaining commercialization rights in 2025 [1][2] Group 1: Company Performance - HuaLing Pharmaceutical-B's revenue increased by 110% year-on-year in the first half of the year, driven by the successful commercialization of its core product and deferred income from Bayer [1] - The company reported a stock price increase of over 4% at the close, with a current price of 3.5 HKD and a trading volume of 16.7 million HKD [1] Group 2: Product Development - The company is developing a second-generation GKA using sustained-release technology and has submitted a clinical application to the FDA, indicating a strategic move towards international markets [1] - Recent real-world studies involving 2,000 type 2 diabetes patients across 80 centers in China have confirmed the broad applicability and safety of the GKA drug, further solidifying the company's leading position in GKA research and treatment [2] Group 3: Industry Context - The GKA class of drugs has faced challenges in development due to side effects and efficacy issues, but recent advancements have led to the first drug's commercialization and ongoing research into safety and efficacy [1] - HuaLing Pharmaceutical-B stands out as a benchmark in the GKA field, with no other listed companies currently advancing a core GKA pipeline [1]

Core Insights - Hualing Pharmaceutical-B (02552) saw a significant stock increase, closing up over 4% and reaching a trading volume of 16.7041 million HKD [1] - The company’s core product, Dapagliflozin, is the first glucose kinase activator (GKA) approved globally in 2022, with rapid sales growth expected after regaining commercialization rights in 2025 [1] - The company reported a 110% year-on-year revenue increase in the first half of the year, driven by deferred income from Bayer, leading to profitability [1] - Hualing Pharmaceutical-B is developing a second-generation GKA using sustained-release technology and has submitted a clinical application to the FDA, indicating a focus on international expansion [1] - The GKA market is evolving with the first drug commercialized and second-generation products advancing, positioning Hualing Pharmaceutical-B as a key player in this sector with no other listed companies currently advancing similar core pipelines [1] Research and Development - A real-world study involving 2,000 type 2 diabetes patients across 80 centers in China confirmed the broad applicability and safety of Dapagliflozin [2] - New research findings on diabetes remission and cognitive improvement further solidify Hualing Pharmaceutical-B's global leadership in GKA research and treatment [2]