销售快速放量，成药机制领先 公司在2025年后，结束与拜耳的独家推广服务协议，全面接管华堂宁的商业化，随后销售开始快速放 量。2025年H1营业收入达到2.17亿元，同比增长110.17%。并且获得拜耳的一次性递延收入12.44亿元， 实现税前利润11.84亿元。从目前的临床研究文章来看，华堂宁和MK-0941在分子机制研究中发现华堂 宁和葡萄糖激酶的结合位点与MK-0941不同，从临床结果来看，华堂宁成药机制有独特优势。 第二代GKA布局出海赛道 智通财经APP获悉，国盛证券发布研报称，首次覆盖给予华领医药-B(02552)"买入"评级，其核心产品多 格列艾汀作为全球首个葡萄糖激酶激活剂(GKA)类药物于2022年获批上市。2025年公司收回商业化主导 权后销售快速放量，上半年营收同比增110%，并因获得拜耳递延收入实现盈利上涨。公司基于独特的 成药机制，正通过缓释技术开发第二代GKA并已向FDA提交临床申请，布局国际化赛道。 国盛证券主要观点如下： 公司背景 华领医药14年耕耘为攻克GKA难成药靶点，自2003年开始，葡萄糖激酶激活剂(GKA)作为新型口服抗糖 尿病药进入研究视野之后十数年间，相关研发管线 ...

2012 年华领医药正式启动多格列艾汀研究项目。2018 年，多格列艾汀的 2 期研究取得成功。2020 年，多格列艾汀的两项 3 期注册临床研究均成功 完成，并达到主要疗效和安全性终点。2022 年，多格列艾汀片获中国国家 药监局批准上市，是 GKA 被发现半个世纪后的首款获批药物。 销售快速放量，成药机制领先。公司在 2025 年后，结束与拜耳的独家推 广服务协议，全面接管华堂宁的商业化，随后销售开始快速放量。2025 年 H1 营业收入达到 2.17 亿元，同比增长 110.17%。并且获得拜耳的一次性 递延收入 12.44 亿元，实现税前利润 11.84 亿元，实现扭亏为盈。从目前 的临床研究文章来看，华堂宁和 MK-0941 在分子机制研究中发现华堂宁 和葡萄糖激酶的结合位点与 MK-0941 不同，从临床结果来看，华堂宁成 药机制有独特优势。 第二代 GKA 布局出海赛道。公司在第一代华堂宁的基础上，通过缓释技 术等布局了第二代 GKA，可以延长药物在体内的作用时间。目前公司已在 2023 年末向 FDA 提交了第二代 GKA 的临床研究申请并获受理。从目前早 期临床数据显示，HM-002-100 ...

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].