Core Insights - The company has successfully completed the first dosing of its second-generation glucose kinase activator (GKA) HMS1005 in a Phase Ib multiple ascending dose (MAD) trial in the United States, marking a significant step in its expansion into the overseas diabetes market [1][2] - HMS1005 is designed as a novel molecular entity with improved physicochemical properties, featuring a sustained-release formulation that allows for once-daily dosing, enhancing patient convenience and potentially improving adherence to treatment [1] - Following the successful completion of the Phase Ib trial, the company plans to seek partners to advance the global market development of HMS1005, further solidifying its leading position in the global GKA sector [1] Group 1 - The Phase Ib clinical trial is a critical step for the company in leading the development of innovative diabetes drugs and expanding into overseas markets [2] - The company emphasizes its commitment to the innovation concept of "repairing sensing and reshaping homeostasis," while continuing to explore better treatment options for type 2 diabetes patients [2] - The successful results from previous single ascending dose (SAD) trials have validated the feasibility of a once-daily oral dosing regimen for treating type 2 diabetes patients with obesity [1]

Core Viewpoint - The company has initiated a multi-dose escalation Phase Ib trial for its second-generation glucose kinase activator (GKA), HMS1005, in the United States, marking a significant step in its development for treating type 2 diabetes (T2D) [1] Group 1: Trial Details - The Phase Ib trial is a randomized, double-blind, placebo-controlled study aimed at assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of HMS1005 in T2D subjects [1] - The study will evaluate pharmacodynamic markers such as blood glucose, insulin, C-peptide, GLP-1, and glucagon in both fasting and fed states, alongside continuous glucose monitoring (CGM) to explore the mechanism and effects of HMS1005 [1] Group 2: Drug Characteristics - HMS1005 is a novel molecular entity with improved physicochemical properties, designed as a sustained-release formulation to allow once-daily dosing, enhancing patient convenience and prolonging the drug's duration in the intestine [1] - The drug aims to improve the repair of GLP-1 secretion deficiencies in patients [1] Group 3: Future Plans - Upon successful completion of the MAD Phase Ib study, the company plans to seek partnerships for the global development of HMS1005 [1]

Core Viewpoint - The company has initiated a multi-dose escalation (MAD) Phase Ib trial for its second-generation glucose kinase activator (GKA), HMS1005, in the United States, marking a significant step in its development for treating type 2 diabetes (T2D) [1] Group 1: Clinical Trial Details - The trial is a randomized, double-blind, placebo-controlled study aimed at assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of HMS1005 in T2D subjects [1] - The study will evaluate pharmacodynamic markers such as blood glucose, insulin, C-peptide, GLP-1, and glucagon, as well as monitor blood glucose fluctuations using continuous glucose monitoring (CGM) [1] Group 2: Drug Characteristics - HMS1005 is a novel molecular entity with improved physicochemical properties, designed as a sustained-release formulation to allow once-daily dosing, enhancing patient convenience and prolonging the drug's duration in the intestine [1] - The drug aims to improve the secretion of GLP-1, which is often insufficient in patients [1] Group 3: Future Plans - Upon successful completion of the MAD Phase Ib study, the company plans to seek partnerships for the global development of HMS1005 [1]

Core Viewpoint - The company has initiated a multi-dose escalation Phase Ib trial for its second-generation glucose kinase activator (GKA), HMS1005, in the United States, marking a significant step in its development for treating type 2 diabetes (T2D) [1] Group 1: Trial Details - The Phase Ib trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of HMS1005 in T2D subjects [1] - The study will assess pharmacodynamic markers such as blood glucose, insulin, C-peptide, GLP-1, and glucagon in both fasting and fed states, along with continuous glucose monitoring (CGM) to explore the mechanism and effects of HMS1005 [1] Group 2: Product Characteristics - HMS1005 is a new molecular entity with improved physicochemical properties, designed as a sustained-release formulation to allow once-daily dosing, enhancing patient convenience and prolonging the drug's duration in the intestine [1] - The drug aims to improve the repair of GLP-1 secretion deficiencies in patients [1] Group 3: Future Plans - Upon successful completion of the Phase Ib trial, the company plans to seek partnerships for the global development of HMS1005 [1]

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]