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Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors


TMCnet News
Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
[December 28, 2020]
Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
– Company plans to complete rolling submission in the first half of 2021 –
– The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS of
non-pancreatic NET patients with an acceptable risk/benefit ratio –
– The pivotal Phase III SANET-p trial demonstrated surufatinib reduced risk of progression or death by 51%, extending PFS of
pancreatic NET patients with an acceptable risk/benefit ratio – ....

Mark Lee , Zhou Yi , Freddy Crossley Atholl Tweedie , Marek Kania , Ben Atwell Alex Shaw , Annie Cheng , Hutchison China Meditech Limited Chi , Drug Administration , Surufatinib Development , Exchange Commission , Committee For Medicinal Products Human , Hutchison Medipharma International , European Medicines Agency , National Medical Products Administration Of China , Virtual Congress , Med Initiates Rolling Submission , Advanced Neuroendocrine , China Meditech Limited , New Drug Application , Fast Track Designation , Marketing Authorization Application , Medicinal Products , Human Use , Managing Director , Chief Medical Officer , Expanded Access Protocol ,

Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of ...


Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of .
Hutchison China MediTech LimitedDecember 28, 2020 GMT
– Company plans to complete rolling submission in the first half of 2021 –
– The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS of non-pancreatic NET patients with an acceptable risk/benefit ratio –
– The pivotal Phase III SANET-p trial demonstrated surufatinib reduced risk of progression or death by 51%, extending PFS of pancreatic NET patients with an acceptable risk/benefit ratio – ....

Mark Lee , Zhou Yi , Freddy Crossley Atholl Tweedie , Marek Kania , Ben Atwell Alex Shaw , Annie Cheng , Hutchison China Meditech Limited Chi , Drug Administration , Surufatinib Development , Exchange Commission , Committee For Medicinal Products Human , Hutchison Medipharma International , European Medicines Agency , National Medical Products Administration Of China , Virtual Congress , China Meditech Limited , New Drug Application , Fast Track Designation , Marketing Authorization Application , Medicinal Products , Human Use , Managing Director , Chief Medical Officer , Expanded Access Protocol , Fast Track Designations , Orphan Drug Designation ,