[ET Net News Agency, 29 December 2021] Shanghai Junshi Biosciences Co., Ltd. (01877)
said the company has received the Acceptance Notice issued by the National Medical
Products Administration (the NMPA). The investigational new drug application for the JS107
for injection (project code: JS107) has been accepted. The application matter is Clinical
Trial of Domestic Production Registration of Pharmaceutical Product.
JS107 is a recombinant humanised anti-Claudin18.2 monoclonal antibody-MMAE (Monomethyl
auristatin E) conjugate for injection self-developed by the company, which is one of
antibody-drug conjugates (ADCs) targeting the tumour-associated protein Claudin18.2, and
is intended to be used for the treatment of advanced malignant tumours, such as gastric
cancer and pancreatic cancer. (RC)