行业动态 |加科思原创新药JAB-3312获得NMPA新药临床试验许可

论坛 期权论坛 期权     
药学进展   2019-10-17 06:46   4177   0
2019年9月29日,加科思自主研发、具有全球知识产权的小分子口服抗肿瘤药JAB-3312在中国获得临床许可,将于近期在中、美同步开展临床试验,这也是加科思继JAB-3068后第二个同时在中、美两国获得临床许可的药物。

        JAB-3312将用于治疗携带KRAS G12突变、BRAF Class3、NF1LoF、以及RTK突变、扩增或重排等基因型异常的实体瘤患者,包括但不限于非小细胞肺癌、结直肠癌、胰腺癌、食管鳞癌、头颈部鳞癌。同时JAB-3312单药或JAB-3312联合PD-1抗体,也可用于经PD-1/PD-L1抗体治疗失败或耐药的非小细胞肺癌、结直肠癌、膀胱癌、三阴性乳腺癌患者等。
        伴随JAB-3068进入临床IIa期,JAB-3312临床试验的开展将为患者提供更多的治疗选择。


信息来源:加科思
   Phase III PEMPHIX Study Shows Genentech’s Rituxan (Rituximab) Superior to Mycophenolate Mofetil in Patients With Pemphigus Vulgaris
   40% of patients with pemphigus vulgaris (PV) achieved sustained complete remission, without the use of steroids for 16 weeks or more, when treated with Rituxan compared to 9.5% of patients on mycophenolate mofetil
Study reinforces efficacy and safety of Rituxan for treatment of PV, a rare autoimmune condition characterized by blistering of the skin and mucous membranes
Full data of the 52-week treatment period presented at 28th Congress of the European Academy of Dermatology and Venereology (EADV) in Madrid
South San Francisco, CA -- October 13, 2019 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced data from the Phase III PEMPHIX study evaluating the efficacy and safety of Rituxan (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). The study met the primary endpoint at week 52 and demonstrated that Rituxan is superior to MMF, with 40.3% of patients treated with Rituxan achieving sustained complete remission (CR) without the use of steroids for 16 consecutive weeks or more, compared to 9.5% in the MMF arm (p
分享到 :
0 人收藏
您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

积分:
帖子:
精华:
期权论坛 期权论坛
发布
内容

下载期权论坛手机APP