Jefferies sees high likelihood of U.S. approval for four China-developed drugs

EQRx

22/04/2022 12:45

** Jefferies expects favorable outcome for four
China-developed drugs currently seeking U.S. FDA approval,
unlike the outcome for Eli Lilly's  LLY.N  lung cancer drug,
sintilimab
    ** In March, FDA declined to approve sintilimab that had
been studied only in China; LLY was testing the drug with
Chinese partner Innovent Biologics Inc  1801.HK 
    ** Four drugs seeking approval - Novartis  NOVN.S  and
Beigene's  6160.HK  cancer drug tislelizumab, Coherus  CHRS.O 
and Junshi Biosciences' Toripalimab, Hutchmed's  0013.HK 
Surufatinib, and EQRx Inc  EQRX.O  and partner CStone Pharma's
 2616.HK  Sugemalimab
    ** Brokerage says the drugs have multi-regional or non-China
trial data which will help FDA better access their applicability
in the U.S.
    ** Adds that all four drugs are for rare diseases and have
received FDA's 'orphan drug' and 'breakthrough therapy' tags
which historically bodes well for approval
    ** Expects more China-developed drugs to enter the U.S.
market in future as more companies are adopting thoughtful
global drug development strategy

 (Reporting by Mrinalika Roy in Bengaluru)
 ((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223
8780, outside U.S. +91 806749 8325;))