According to the China National Medical Products Administration Pharmaceutical Evaluation Center (CDE) official website's latest announcement on September 4th, Amgen's (AMGN.US) Class 1 new drug AMG 451 has obtained approval for a new clinical application, indicated for nodular prurigo. Public information shows that AMG 451 (rocatinlimab) is a fully humanized anti-OX40 monoclonal antibody investigational new drug. Amgen has secured the rights for joint development and commercialization of the product through a collaboration deal worth up to $1.25 billion.

Screenshot source: CDE official website

It is reported that OX40 (also known as CD134) is an important co-stimulatory molecule of T cells and one of the leading targets in recent years of new drug development. On one hand, it can enhance immune activity by regulating the proliferation and survival of effector T cells, while on the other hand it can inhibit the activity and proliferation of regulatory T cells (Tregs). Therefore, the design of OX40 agonists aimed at stimulating immune responses is intended to enhance T cell effector function and boost immune response. The development of OX40-targeting antibodies holds promise for the treatment of various immune diseases.

According to the China Drug Clinical Trial Registration and Information Disclosure Platform, Amgen has initiated multiple clinical studies of AMG 451 in China, with indications including atopic dermatitis and asthma. The re-approval of AMG 451 for clinical trials indicates that the product is about to undergo clinical exploration in the new area of nodular prurigo disease.