此前，公司已成功完成HMS1005在美国的单剂量递增(SAD)临床试验并已公布成功结果，该研究验证了 每日一次口服给药方案用于治疗2型糖尿病合并肥胖患者的可行性。 据悉，本项Ib期临床试验顺利完成后，公司计划寻求合作伙伴，推进HMS1005的全球市场开发工作。二 代GKA的药物研发进展，将进一步巩固华领医药在全球GKA赛道的领先地位。 HMS1005是一款具有改良理化性质的新型分子实体，采用缓释制剂设计，支持每日一次给药以提升患 者用药便利性;同时该设计可延长药物在肠道器官的作用时长，进而增强对患者受损GLP-1分泌功能的修 复效果。HMS1005有望延长药物在人体内的作用时间，提升患者用药依从性，为实现全天候血糖平稳 控制提供可能。 来源：智通财经网 华领医药创始人、CEO陈力博士表示："华领医药在美国启动的Ib期临床试验，是公司在引领糖尿病创 新药物研发和海外市场布局方面的关键一步。依托成熟的试验设计和强大的研发执行力，我们期待充分 验证第二代GKA的安全性与耐受性，为后续临床开发奠定坚实基础。华领医药始终秉持'修复传感、重 塑稳态'的创新理念，在深耕现有产品市场的同时，持续探索更优质的治疗方案，未来将继 ...

据悉，本项Ib期临床试验顺利完成后，公司计划寻求合作伙伴，推进HMS1005的全球市场开发工作。二 代GKA的药物研发进展，将进一步巩固华领医药在全球GKA赛道的领先地位。 12月9日，华领医药(02552)宣布，公司自主研发的第二代葡萄糖激酶激活剂(GKA)HMS1005(曾被称作： HM-002-1005)在美国开展的Ib期多次给药剂量递增(MAD)试验已成功完成首例试验参与者给药。华领医 药在推进海外糖尿病市场拓展方面再获进展，继续引领全球GKA开发新路径。 华领医药创始人、CEO陈力博士表示："华领医药在美国启动的Ib期临床试验，是公司在引领糖尿病创 新药物研发和海外市场布局方面的关键一步。依托成熟的试验设计和强大的研发执行力，我们期待充分 验证第二代GKA的安全性与耐受性，为后续临床开发奠定坚实基础。华领医药始终秉持'修复传感、重 塑稳态'的创新理念，在深耕现有产品市场的同时，持续探索更优质的治疗方案，未来将继续推进更多 创新药物的研发与全球布局，为全球2型糖尿病患者带来新的治疗希望。" 此前，公司已成功完成HMS1005在美国的单剂量递增(SAD)临床试验并已公布成功结果，该研究验证了 每日一次口 ...

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。 ...

Company Background - Hualing Pharmaceutical has been focused on developing glucose kinase activators (GKA) since 2003, with its first product, Daglitin, approved in 2022, marking the first GKA drug to be approved after decades of research failures [1][2] - The company successfully completed Phase II and Phase III clinical trials for Daglitin, leading to its approval by the National Medical Products Administration of China [1] Sales Growth and Commercialization - After taking over the commercialization rights from Bayer in 2025, the company expects rapid sales growth, with H1 2025 revenue projected at 217 million yuan, a year-on-year increase of 110.17% [2] - The company received a one-time deferred income of 1.244 billion yuan from Bayer, resulting in a pre-tax profit of 1.184 billion yuan [2] Second-Generation GKA Development - The company is developing a second-generation GKA using sustained-release technology to extend the drug's action time in the body, with a clinical research application submitted to the FDA by the end of 2023 [3] - Early clinical data indicates that HM-002-1005 can quickly convert to Daglitin in the body, enhancing patient compliance and effectively controlling blood sugar within 24 hours [3] Profit Forecast - The company is considered a rare innovative drug stock in the Hong Kong market, with a strong sales team and a gradually forming pipeline of innovative drug products [4] - Revenue projections for 2025-2027 are 543 million yuan, 862 million yuan, and 1.142 billion yuan, respectively, with net profits of 1.113 billion yuan, 77 million yuan, and 114 million yuan [4] - The initial coverage gives a reasonable valuation of 8.586 billion HKD for Hualing Pharmaceutical in 2025, with a "buy" rating [4]

Investment Rating - The report gives a "Buy" rating for the company, with a target valuation of HKD 85.86 billion for 2025 [3]. Core Insights - The company is a leader in the global glucokinase activator (GKA) market, having successfully developed the first approved GKA drug, Dorzagliatin, after years of research and development [1][12]. - The company has seen rapid sales growth, with a 110.17% year-on-year increase in revenue for the first half of 2025, reaching RMB 217 million [2][15]. - The second-generation GKA is being developed to extend the drug's action time and has received FDA acceptance for clinical research [2][12]. Summary by Sections Company History - The company has focused on glucokinase as a target for diabetes treatment for 14 years and achieved the first drug approval in this category in 2022 [1][12]. Management Team - The management team has extensive experience from multinational corporations, with a strong focus on diabetes drug development [13][14]. Financial Performance - The company has established its own sales team, leading to significant revenue growth, with a projected revenue of RMB 5.43 billion in 2025 [3][15]. - The company reported a tax profit of RMB 1.184 billion in the first half of 2025, marking a turnaround from previous losses [2][15]. Diabetes Market - The global diabetes drug market is substantial, with an expected value of USD 883.2 billion in 2024, growing to USD 2.338 trillion by 2032 [24][25]. - There is a significant need for new therapeutic mechanisms in diabetes treatment due to the limitations of existing drug targets [23][27]. Core Product - Dorzagliatin - Dorzagliatin is the only approved GKA drug globally, showing unique molecular mechanisms that differentiate it from competitors [30][34]. - Clinical trials have demonstrated its efficacy without severe hypoglycemia side effects, making it a promising treatment option [37][42].

Core Viewpoint - The company has successfully transitioned its sales team and is experiencing significant sales growth, particularly with its core product, Huatangning, which has shown impressive revenue and volume increases in the first half of 2025 [1][3]. Sales Performance - Huatangning achieved sales revenue of 217 million yuan, a year-on-year increase of 112%, with sales volume reaching 1.764 million boxes, up 108% compared to the previous year [1][3]. - The company reported a non-operating profit loss of 37 million yuan, which represents a reduction of over 70% year-on-year [1]. Profitability and Margins - The gross profit for the first half of 2025 was approximately 118 million yuan, with a gross margin of about 54.2%, an increase of 7.7 percentage points from the previous year's 46.5% [4]. - The improvement in gross margin is attributed to economies of scale from increased production capacity and reduced promotional costs due to the establishment of an in-house sales team [4]. Market Expansion Strategy - The company plans to expand its market presence by focusing on core hospitals and gradually penetrating grassroots markets, having already covered over 2,000 hospitals in China, including more than 800 core hospitals [4]. - The company aims to enter international markets, starting with Hong Kong and then expanding to Southeast Asia and Portuguese-speaking countries, having submitted new drug registration applications in Hong Kong [4]. Future Product Pipeline - The company is developing new formulations, including a fixed-dose combination of Dorzagliatin and Metformin, as well as a second-generation GKA for metabolic diseases, with plans to initiate further clinical studies by late 2025 or early 2026 [5]. - The company has secured over 330 patents, extending protection until 2039, which will support future indication expansions and global commercialization efforts [4][5]. Financial Position - As of June 30, 2025, the company reported cash reserves of 1.023 billion yuan, positioning itself for strategic investments and growth in the diabetes and metabolic disease treatment sectors [5].