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葡萄糖激酶激活剂(GKA)
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港股异动 华领医药-B(02552)尾盘涨超4% 公司第二代GKA已向FDA提交临床申请 行业研发处于领先地位
Jin Rong Jie· 2025-12-01 08:17
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].
国盛证券:首予华领医药-B买入评级 全球GKA降糖赛道领军者
Zhi Tong Cai Jing· 2025-11-24 15:36
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 globally after decades of research failures [1][2] - The company initiated its Daglitin research project in 2012, achieving successful Phase II and Phase III clinical trials by 2020, leading to its market approval in 2022 [1] Sales Growth and Commercialization - After 2025, the company will take over the commercialization of Huadongning from Bayer, leading to rapid sales growth [2] - In the first half of 2025, the company reported revenue of 217 million yuan, a year-on-year increase of 110.17%, and received a one-time deferred income from Bayer of 1.244 billion yuan, 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 [3] - A clinical research application for the second-generation GKA has been submitted to the FDA and accepted, with early clinical data indicating that HM-002-1005 can quickly convert to Daglitin in the body, enhancing patient compliance [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 company is valued at 8.586 billion HKD for 2025, with a "buy" rating recommended [4]