J&J's Subcutaneous Bispecific Antibody Approved in China with 5-Minute Administration Time

SmartCom APP learned on December 25 that Johnson & Johnson (JNJ.US) announced the official approval by China's NMPA of its innovative therapeutic drug, Rykivet® (Amivantamab Injection, subcutaneous injection), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) mutations. The subcutaneous injection formulation of Amivantamab offers higher convenience to patients, reducing administration time from several hours to approximately 5 minutes, while also decreasing infusion-related adverse reactions by 80% compared to intravenous formulations.

Amivantamab is a fully human EGFR×MET bispecific antibody. The subcutaneous formulation of amivantamab contains recombinant human hyaluronidase (rHuPH20) and utilizes Halozyme's ENHANZE® drug delivery technology, with an administration time of only about 5 minutes. This innovation not only has the potential to improve patients' quality of life by giving them more time to return to normal life but also helps optimize the allocation of medical resources and promotes the sustainable development of China's healthcare system.

Cherry Huang, President of Johnson & Johnson Innovative Medicine China, stated that approximately 40% of lung cancer patients in China carry the EGFR mutation. This approval marks a significant milestone, further solidifying the important role of Amivantamab in the treatment of EGFR-mutated non-small cell lung cancer. This patient population has significant unmet medical needs, and the subcutaneous injection formulation of Amivantamab offers patients and clinicians a more convenient method of administration and better tolerability, while maintaining good efficacy and manageable safety.