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目前显示的是标签为“Camrelizumab”的博文

国内药品审评报告Drug Review Package of Chinese New Chemical or Biologic Drug

Belows are the drug review package of Chinese new chemical or biologic drug:
Benaglutide(贝那鲁肽, HYBR-014, GLP-1) was developed by Benemae Pharma (filing for STAR), approved in 2016/12/19, click here.Anlotinib(安罗替尼, AL3818, VEGFR/FGFR/PDGFR) was developed by Chia Tai Tianqing Pharma (HK: 01177), approved in 2018/5/9, click here.Mecapegfilgrastim (硫培非格司亭, 19K, G-CSF) was developed by Hengrui Medicine (SH: 600276), approved in 2018/5/18, click here.Fruquintinib (呋喹替尼, HMPL-013, VEGFR) was developed by Hutchison MediPharma (NASDAQ: HCM), approved in 2018/9/5, click here.Toripalimab (特瑞普利单抗, JS001, PD-1) was developed by Junshi Biosciences (HK: 01877/filing for STAR), approved in 2018/12/17, click here.Sintilimab (信迪利单抗, IBI308, PD-1) was developed by Innovent Biologics (HK: 01801), approved in 2018/12/27, click here.Camrelizumab (卡瑞利珠单抗, SHR1210, PD-1) was developed by Hengrui Medicine (SH: 600276), approved in 2019/5/5, click here.Loxenatide(洛塞那肽, PEX168, GLP-1) was developed by Hansoh Pha…

Camrelizumab may be approved as 3rd line treatment fot r/r cHL in the coming days.

In 2019.5.5, the NDA left CDE to NMPA for the final approval. Finally it will be approved in the coming days soon.

LSK与恒瑞医药联合宣布美国FDA批准启动肝细胞癌III期临床研究(PD-1+VEGFR-2)

LSK与恒瑞医药联合宣布美国FDA批准启动肝细胞癌III期临床研究,以评价VEGFR-2抑制剂Rivoceranib(即Apatinib)与PD-1抑制剂Camrelizumab (SHR-1210)的临床疗效及安全性;目前Camrelizumab(SHR-1210)用于经典霍奇金淋巴瘤适应症已递交NDA上市申请,处于材料补充阶段。 LSK总裁Sung Chul Kim博士说:“We are happy with this important regulatory milestone in our global clinical collaboration. We are enthusiastic to work with Hengrui to hopefully help more HCC patients through development of this combination therapy." 恒瑞董事长孙飘扬博士说:“As one of the leading biopharmaceutical companies in China, Hengrui is committed to developing breakthrough medicines for patients worldwide. This milestone is another step towards our mission. We look forward to working with LSKB to jointly make a difference for HCC patients around the world." 目前恒瑞正在中国开展该组合疗法用于HCC的单臂多中心临床II期研究(NCT03463876) ,在ASCO 2018上公布相关数据,中国14位晚期肝癌受试者参与的I期临床中,ORR及DCR分别为50.0%和85.7%(Xu et al., NCT02942329),另外除了肝细胞癌之外,非小细胞肺癌、小细胞肺癌及胃癌联合疗法临床试验也在进行中。 基于早期的临床研究,rivoceranib及camrelizumab联用可能会增强自身免疫系统起到协同作用。