财中社12月25日电康宁杰瑞制药-B(09966)发布自愿公告,宣布JSKN033的一项I/II期临床试验的IND申请已获国家药品监督管理局药品审评中心批准。JSKN033是一种HER2双特异性抗体偶联药物与PD-L1免疫检查点抑制剂的高浓度皮下注射复方制剂,旨在评估其在晚期转移性恶性肿瘤患者中的安全性、耐受性、药代动力学/药效学及抗肿瘤活性。
该临床试验将为JSKN033的最大耐受剂量及推荐II期剂量的确定提供数据。在此前于澳大利亚进行的JSKN033-101首次人体I/II期临床研究中,JSKN033显示出良好的安全性和抗肿瘤活性,相关的临床研究数据已在2024年癌症免疫治疗学会年会上公布。公司致力于开发创新的生物药物,未来将继续推进JSKN033及其他在研药物的研发进程。
(文章来源:财中社)
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.