Alphamab Oncology enlists Simcere Pharma to market its subcutaneous PD-L1 immunotherapy

Jiangsu-based Alphamab Oncology picked Simcere Pharmaceutical to help market KN035, its PD-L1 inhibitor, in China. Shanghai-based precision medicine company 3D Medicines joined the project in 2016 as a co-developer of the immunotherapy.

Under the terms of the deal, Alphamab will be the exclusive manufacturer of KN035, also known as envafolimab, while 3D Medicines will oversee its clinical development, registration, and commercialization. Simcere will market KN035 in China and charge 3D Medicines a marketing fee.

KN035 is administered subcutaneously, unlike current PD-1/PD-L1 therapies on the market, which are administered intravenously. Alphamab says this provides an advantage in terms of safety, convenience, and patient compliance. KN035 is currently being evaluated in a number of clinical trials in China, Japan, and the United States. Earlier this year, the FDA gave KN035 orphan drug designation for treating advanced biliary tract cancer.

"KN035 is likely the first PD-L1 inhibitor with subcutaneous administration to be approved globally," said Ting Xu, the founder, chairman, and CEO of Alphamab.