Major Events - Ying Si Intelligent (03696), Tu Datong (02665), and Changfeng Pharmaceutical (02652) have been included in the Hang Seng Composite Index [1] - Hansoh Pharmaceutical (03692) has received EU approval for the marketing of Amivantamab for monotherapy [1] - Bole Vision Cloud-B (02592) has had its clinical trial application for CBT-199 approved, recognized as safe to proceed [1] - CSPC Pharmaceutical Group (01093) has received clinical trial approval in the US for a GLP-1/GIP receptor dual agonist long-acting injection [1] - CSPC Pharmaceutical Group (01093) has also received clinical trial approval in China for Ropivacaine long-acting injection (SYH9089) [1] - Fuhong Hanlin (02696) has received FDA approval for the Phase I clinical trial application of HLX15-SC for the treatment of multiple myeloma [1] Financial Data - Shougang Resources (00639) issued a profit warning, expecting a net profit attributable to shareholders of approximately HKD 600 million to 700 million for the fiscal year 2025 [1] - Shijiazhuang Pharmaceutical Group (02005) issued a profit warning, anticipating a year-on-year decline in net profit attributable to shareholders of approximately 45% to 60% [1] - Goodbaby International (01086) issued a profit warning, expecting a year-on-year decline in net profit of approximately 35% to 45% for 2025 [1] - Suoteng Juchuang (02498) reported continued growth in sales of laser radar products for fiscal year 2025, achieving profitability for the first time in Q4 [1]

智通财经APP讯，石药集团(01093)发布公告，集团开发的罗哌卡因长效注射液(SYH9089注射液)(该产 品)已获得中华人民共和国国家药品监督管理局批准，可在中国开展临床试验。 该产品可通过抑制神经细胞钠离子通道，阻断钠离子流入神经纤维细胞膜内，从而对沿神经纤维的衝动 传导产生可逆性的阻滞;亦能降低给药频率，满足临床术后的持续镇痛需求，减少患者对阿片类药物的 依赖，避免持续镇痛装置感染或移位风险，从而显著提高治疗依从性及用药安全性。依托集团的长效药 物递送技术平台，该产品可将单次给药镇痛持续时间延长至一周，有望成为中国首款镇痛持续时间达到 一周的超长效镇痛产品。 临床前研究显示，该产品未见全身系统毒性或新增毒性靶器官，与市售罗哌卡因注射液相比展现出显著 的长效镇痛优势，具有良好的安全性和有效性。 本次获批的临床适应症为术后镇痛。该产品临床试验的获批，有望填补超长效术后镇痛领域迫切的临床 需求，是集团在中枢神经领域的重要成果。 ...