Coherus Biosciences And Partner Shanghai Junshi Biosciences Plan To Submit A Response To The FDA In June To Address The 3-Observations Received At The Close Of The Pre-Licensing Inspection Of Junshi Biosciences' Toripalimab Manufacturing Site In China; Co Is Planning The Commercial Launch Of Toripalimab In The U.S. Upon Approval
Portfolio Pulse from Happy Mohamed
Coherus Biosciences and Shanghai Junshi Biosciences plan to submit a response to the FDA in June to address the 3 observations received at the close of the pre-licensing inspection of Junshi Biosciences' Toripalimab manufacturing site in China.
May 31, 2023 | 5:06 pm
News sentiment analysis
Sort by:
Ascending
NEUTRAL IMPACT
Coherus Biosciences and its partner Shanghai Junshi Biosciences plan to address the FDA's 3 observations on their Toripalimab manufacturing site in China by June.
The news directly pertains to Coherus Biosciences (CHRS) and its partner Shanghai Junshi Biosciences. Addressing the FDA's observations is crucial for the approval of their Toripalimab manufacturing site in China. However, the short-term impact on CHRS stock price is uncertain as the outcome of their response to the FDA is yet to be determined.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100