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  • HLB applies for liver cancer drug approval to FDA
  • by Lee, Seok-Jun | translator Kim, Jung-Ju | May 19, 2023 05:47am
Gobal phase 3 of Rivoceranib + Camrelizumab results based NDA
Approved as the first drug in February this year in China
HLB submitted a New Drug Application (NDA) to the FDA for Rivoceranib, a targeted anti-cancer drug under development as a first-line liver cancer drug. This is the first time that a domestic bio company has completed its own clinical trials for its anti-cancer drug substance and proceeded with the new drug approval process in the global market. HLB started global clinical trials of Rivoceranib in 2011. Through its US subsidiary, Elevar Therapeutics, it has developed the combination of Rivoceranib and Camrelizumab as a first-line treatment for liver cancer. In the global phase 3 (CARES 310) study of 543 patients in 13 countries, compared to control sorafenib, 3 CR vs. 1 person, mOS 22.1 months vs. 15.2 months, mPFS 5.
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