China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced its decision to cancel a licensing agreement with compatriot firm Mabworks, along with a related equity investment deal, due to changes in the market landscape. This move signifies that Hengrui Pharmaceuticals will no longer hold exclusive commercialization rights to Mabworks’ third-generation CD20 monoclonal antibody (mAb) in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan, nor will it conduct clinical studies for the drug in combination with its products.
Background of the Partnership and MIL62 Development
In September 2021, Hengrui agreed to be the cornerstone investor in a USD 30 million finance round for Mabworks, marking the beginning of their partnership. MIL62, the drug in question, is considered China’s first and only home-grown third-generation anti-CD20 antibody to reach the Phase III stage. The drug is under development to treat multiple hematological tumors and autoimmune diseases. Approval to initiate a Phase III regulatory study for refractory follicular lymphoma was granted in China in April 2021. At that time, Roche’s Gazyva (obinutuzumab) was the only CD20 mAb on the market globally, and it was also available in China.
Market Evolution and Competition in CD20 mAb Space
Since then, the market has seen the commercial availability of three additional CD20 mAbs in China: Novartis’s Kesimpta (ofatumumab), Sinocelltech’s ripertamab, and Zhejiang BioRay Bio’s Anruixi (zuberitamab). The former two have been included in the National Reimbursement Drug List (NRDL), indicating the growing competition and evolution of the market for CD20 monoclonal antibodies.-Fineline Info & Tech
