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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].
华领医药20250630
2025-07-01 00:40
华领医药 20250630 摘要 华领医药 2025 年 1-2 月销售额达 7,300 万元,预计上半年销售额为 1.8-2 亿元,计划扩大销售团队,目标 2026 年销售额达 7-8 亿元, 2027 年超 10 亿元,以实现扭亏为盈。 公司核心研发项目包括第二代 GKA(已完成美国 1A 期临床,即将启动 1B 期)和一代 GKA 适应症扩展(糖尿病认知障碍、MODY 2、糖尿病 预防),二代 GKA 预计 2026 年 Q2/Q3 公布 1B 期结果,并积极寻求 海外合作。 华领医药计划下半年向香港和澳门递交上市申请,并已发表研究验证药 物改善糖尿病患者虚弱指数等,为抗衰老方向提供支持。与二甲双胍复 方制剂预计 2027 年底或 2028 年初获批,并于 2028 年底进入医保。 公司预计 2025 年上半年将拜耳支付的 12 亿元合同负债计入收入,全 年预计盈利 9 亿元以上,显著改善财务报表。若 2026 年二代 GKA 顺利 落地,预计首付款至少数亿美元,将带来显著盈利。 公司预计 2027 年毛利率达 65%以上,销售费用控制在 30%左右,实 现整体盈利。2025 年生产成本将逐渐下降,产品 ...