君实生物获特瑞普利单抗常规批准
财中社1月6日电君实生物（688180/01877）发布自愿披露公告，宣布其特瑞普利单抗（商品名：拓益®）用于不可切除或转移性黑色素瘤的治疗已获得国家药品监督管理局的常规批准。这一批准意味着该药物在监管部门的要求下，完成了必要的验证性临床试验，证明了其在目标人群中的有效性和安全性。
特瑞普利单抗自2018年获得附条件上市批准以来，经过多项临床研究验证了其疗效和安全性。此次常规批准主要基于MELATORCH研究结果，显示特瑞普利单抗组的无进展生存期显著延长，疾病进展或死亡风险降低29.2%。该药物是中国首个批准上市的以PD-1为靶点的国产单抗药物，现已在全球多个国家和地区获得批准。
2024年前三季度，君实生物-U实现收入12.71亿元，归母净利润-9.27亿元。
（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.
Most Discussed
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10