PCSK9 antibody marketing application received notification
October 9, 2024
Source: drugdu
96
On September 29, 2024, two acceptance numbers for Junshi Biosciences's PCSK9 antibody marketing application were notified, indicating that they have not been approved (possibly due to voluntary withdrawal or pending approval).
In April 2023, Junshi Biosciences received 4 acceptance numbers for its PCSK9 antibody market application, of which 2 were notified this time, and the other 2 have not yet received results. Four acceptance numbers involve two specifications (pre filled syringes, pre filled automatic syringes) and two indications. This two notifications indicate that a certain specification or indication has not been approved.
The competition for PCSK9 targets is particularly fierce. In addition to antibodies from Amgen and Sanofi, PCSK9 antibodies from Sinovac Biotech and PCSK9 siRNA from Novartis have already been approved for marketing. Among them, Novartis' PCSK9 siRNA only needs to be administered once every six months. For this target, there are more differentiated products under development, including Merck's PCSK9 oral macrocyclic peptide and Lilly's PCSK9 in vivo gene editing.
Source: https://pharm.jgvogel.cn/c1447501.shtml
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