重组抗BDCA2人源化单克隆抗体注射液(626)
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三生国健(688336):收到707授权许可首付款,自免创新积极推进
HUAXI Securities· 2025-11-27 13:03
证券研究报告|公司点评报告 [Table_Date] 2025 年 11 月 27 日 [Table_Title] 收到 707 授权许可首付款,自免创新积极推进 [Table_Title2] 三生国健(688336) [Table_Summary] 事件: 1、 抗 IL-17A 人源化单克隆抗体("608" ):中重度斑块状 银屑病适应症 NDA 申请已受理;强直性脊柱炎项目临床 III 期受试者入组中;放射学阴性中轴型脊柱炎临床 II 期获得主 要终点,结果积极。 2、 抗 IL-5 人源化单克隆抗体注射液("610" ):重度嗜酸 性粒细胞哮喘患者临床 III 期受试者入组中。成人重度嗜酸性 粒细胞哮喘延长给药间隔的 II 期临床入组中。 3、 抗 IL-4Rα 人源化单克隆抗体("611" ):成人中重度特 应性皮炎适应症临床 III 期主要终点已达到;慢性鼻窦炎伴鼻 息肉适应症临床 III 期受试者入组完成;青少年中重度特应性 皮炎适应症临床 III 期受试者入组中;儿童中重度特应性皮炎 适应症临床 II 期受试者入组中;联合 TCS 治疗 AD 的临床 III 期所有受试者入组完成;COPD 适 ...
三生国健药业(上海)股份有限公司 2025年第三季度报告
Xin Lang Cai Jing· 2025-10-23 23:17
Core Viewpoint - The company reported a significant increase in revenue and net profit for the first three quarters of 2025, driven by growth in licensing income and CDMO business, alongside ongoing investments in innovative research and development [5]. Financial Performance - The company achieved operating revenue of 1.116 billion RMB, representing a year-on-year growth of 18.80% [5]. - The net profit attributable to shareholders reached 399 million RMB, marking a substantial increase of 71.15% compared to the same period last year [5]. - Research and development expenses totaled 368 million RMB, with a year-on-year increase of 3.87%, and the R&D expense ratio remained at a healthy level [5]. Research and Development Progress - The company has several ongoing clinical trials and projects, including: 1. NDA application for anti-IL-17A monoclonal antibody for moderate to severe plaque psoriasis has been accepted [7]. 2. Clinical trials for anti-IL-5 monoclonal antibody for severe eosinophilic asthma are ongoing [8]. 3. Clinical trials for anti-IL-4Rα monoclonal antibody for various indications are progressing, with several phases completed [10]. 4. NDA application for anti-IL-1β monoclonal antibody for acute gouty arthritis has been accepted [11]. 5. Clinical trials for anti-BDCA2 monoclonal antibody for SLE are in progress [12]. 6. Clinical trials for anti-TLIA monoclonal antibody for ulcerative colitis are ongoing [13]. Corporate Governance - The board of directors and senior management have guaranteed the authenticity, accuracy, and completeness of the quarterly report, assuming legal responsibility for its content [2].
三生国健药业(上海)股份有限公司2025年第一季度报告
Shang Hai Zheng Quan Bao· 2025-04-22 19:48
Core Viewpoint - The company reported a steady revenue growth of 16.57% year-on-year for Q1 2025, driven by an increase in R&D projects and efficient internal operations [2][3]. Financial Performance - The company achieved an operating revenue of 311 million yuan in Q1 2025, with a net profit attributable to shareholders of 103 million yuan, reflecting a 12.99% increase compared to the same period last year [2][3]. - R&D expenses increased by 45.83% year-on-year, attributed to a higher number of R&D projects, while maintaining a reasonable expense ratio [2]. R&D Pipeline Progress - The company has made significant advancements in its research pipeline, including: 1. The NDA application for the anti-IL-17A monoclonal antibody ("608") for moderate to severe plaque psoriasis has been accepted [3]. 2. Clinical II phase for ankylosing spondylitis has completed all subject enrollments [3]. 3. Clinical III phase for anti-IL-5 monoclonal antibody ("610") for severe eosinophilic asthma is currently enrolling subjects [3]. 4. Multiple clinical phases for anti-IL-4Rα monoclonal antibody ("611") and anti-IL-1β monoclonal antibody ("613") have shown positive mid-term analysis results [3]. 5. The company has received IND approvals for several indications in the U.S. and China, indicating progress in its clinical trials [3]. Shareholder Information - The report includes details on the total number of ordinary shareholders and the shareholding status of the top ten shareholders, although specific numbers are not provided [4]. Other Important Information - The company emphasizes the importance of continuous innovation in drug development to ensure a pipeline of commercially viable products [6][7].