智通财经APP获悉，三生制药(01530)盘中涨超8%，截至发稿，涨8.13%，报29.8港元，成交额5.5亿港元。
消息面上，据三生制药官微消息，10月15日，三生制药宣布，公司自主研发的重组抗VEGF人源化单抗(通用名：贝伐珠单抗眼内注射溶液，研发代号：601A)用于BRVO所致黄斑水肿病变适应症，已向国家药监局递交该产品首个上市申请并获受理。
据介绍，目前601A在BRVO中开展的III期临床研究已顺利完成，达到主要终点，即：601A治疗BRVO所致黄斑水肿病变患者24周后，受试者最佳矫正视力(BCVA)较基线的改善非劣于雷珠单抗。在其他次要疗效终点上，治疗12、24、52周后，目标眼BCVA较基线增加≥5个字母、≥10个字母和≥15个字母的受试者比例，601A与雷珠单抗相当，证实了601A治疗对视力改善的明确和持续作用。
另外，在体现黄斑水肿改善的中央视网膜厚度(CRT)较基线变化等疗效指标上，601A在第12、24、52周的数值上也均与雷珠单抗相当，验证了601A改善黄斑水肿的疗效。安全性方面，601A治疗后总体安全性和耐受性良好，整体获益风险正向。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.