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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:

  1. Benaglutide (贝那鲁肽, HYBR-014, GLP-1) was developed by Benemae Pharma (filing for STAR), approved in 2016/12/19, click here.
  2. 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.
  3. Mecapegfilgrastim (硫培非格司亭, 19K, G-CSF) was developed by Hengrui Medicine (SH: 600276), approved in 2018/5/18, click here.
  4. Pyrotinib (吡咯替尼, SHR-1258, HER2) was developed by Hengrui Medicine (SH: 600276), approved in 2018/8/12, click here.
  5. Fruquintinib (呋喹替尼, HMPL-013, VEGFR) was developed by Hutchison MediPharma (NASDAQ: HCM), approved in 2018/9/5, click here.
  6. 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.
  7. Sintilimab (信迪利单抗, IBI308, PD-1) was developed by Innovent Biologics (HK: 01801), approved in 2018/12/27, click here.
  8. Camrelizumab (卡瑞利珠单抗, SHR1210, PD-1) was developed by Hengrui Medicine (SH: 600276), approved in 2019/5/5, click here.
  9. Loxenatide (洛塞那肽, PEX168, GLP-1) was developed by Hansoh Pharma (HK: 03692), approved in 2019/5/9, click here.
  10. Flumatinib (氟马替尼, HS-10096, BCR-ABL), was developed by Hisun Pharma (SH: 600267), approved in 2019/11/25, click here.
  11. Ramimazolam (瑞马唑仑, GABAa) was developed by Hengrui Medicine (SH: 600276), approved in 2019/11/27, click here.  (2020.6.23 approved to add indication "colonoscopy", click here)
  12. Chidamide (西达本胺, HBI-8000, HDAC) was developed by Chipscreen Biosciences (STAR: 688321), approved in 2019/11/29, click here.
  13. Niraparib(尼拉帕利, TSR-042, PARP) was developed by  Zai Lab/Tesaro (HK: 9688), approved in 2019/12/26, click here, sNDA approved in 2020/9/8, click here.
  14. Almonertinib(阿美替尼, HS-10296, EGFR) was developed by  Hansen (HK: 3692), approved in 2020/3/17, click here.
  15. Tislelizumab(替雷利珠单抗, BGB-A317, PD-1) was developed by  Beigene (NASDAQ:BGNE, HK: 6160), approved in 2020/4/9, click here.
  16. Zanubrutinib(泽布替尼, BGB-3111, BTK) was developed by  Beigene (NASDAQ:BGNE, HK: 6160), approved in 2020/6/2, click here.

Chinese traditional medicine:
  1. Unknown (芍麻止痉颗粒) was developed by  Tasly Pharma($SH: 600535), approved in 2019/12/18, click here.
  2. Unknown (莲花清咳片) was developed by  Yiling Pharma($SZ: 002603), approved in 2020/5/12, click here.
  3. Unknown (桑枝总生物碱片) was developed by  Wehand Pharma, approved in 2020/3/18, click here.
  4. Unknown (筋骨止痛凝胶) was developed by  Jiangsu Kanion Pharma, approved in 2020/4/9, click here.

Other review package from MNC:
  1. Apalutamide (阿帕他胺, ARN-509, JNJ-56021927, JNJ-927) was developed by Janssen ($JNJ), approved in 2019/9/12, click here.
  2. Trametinib (曲美替尼, GSK1120212, MEK）was developed by GlaxoSmithKline ($GSK), approved in 2019/12/18, click here.
  3. Dabrafenib (达拉非尼, GSK2118436, BRAF）was developed by GlaxoSmithKline ($GSK), approved in 2019/12/18, click here.
  4. Avatrombopag (阿伐曲泊帕, E5501, YM-477) was developed by AkaRx ($JNJ), approved in 2020/04/16, click here.
  5. Brentuximab Vedotin (维布妥昔单抗, SGEN-35）was developed by Seattle Genetics ($SGEN) & Takeda ($4502.T), approved in 2020/05/12, click here.
  6. Nintedanib (尼达尼布, BIBF1120）was developed by Boehringer Ingelheim, approved in 2020/06/02, click here.
  7. Radium 233Ra Chloride (氯化镭 233Ra, BAY 88-8223）was developed by Bayer ($BAYN), approved in 2020/08/27, click here.
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