▎WuXi AppTec Content Team Report

Screenshot source: CDE official website

OX40 (also known as CD134) is an important co-stimulatory molecule of T cells and one of the frontier targets in recent drug research and development.It can enhance immune activity by regulating the proliferation and survival of effector T cells, while also inhibiting the activity and proliferation of regulatory T cells (Tregs). Therefore, the design of OX40 agonists aims to stimulate immune responses by enhancing T-cell effects and boosting immune responses. The development of OX40-targeting antibodies holds promise for therapeutic effects in various immune diseases.

Rocatinlimab is a fully human monoclonal antibody targeting OX40.According to Kyowa Kirin（Kyowa Kirin）According to public data, rocatinlimab was developed by the company.，And adopt its proprietary technologyEnhanced the product's Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC)。In 2021, Amgen and Kyowa Kirin reached an exclusive global licensing agreement.Agreement, jointly develop rocatinlimab for the potential treatment of atopic dermatitis and other autoimmune diseases.According to the terms,Amgen will lead the development, manufacturing, and commercialization of rocatinlimab in all global markets except Japan., Kyowa Kirin reserves the rights in Japan.Kyowa Kirin will receive a $400 million upfront payment and potential milestone payments of up to $850 million, as well as royalties on future global sales.

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.This timeAMG 451 has been approved for clinical trials again, which means that the product is about to enter a newPrurigo NodularisDisease areas for clinical exploration.

Prurigo Nodularis (PN) is a refractory chronic pruritic disease and the most common subtype of chronic prurigo. Its main manifestations are hyperkeratosis and pruritic dome-shaped nodular lesions, with itching often being severe, persistent, and sometimes accompanied by a burning pain.Among various chronic pruritic diseases, the intensity and frequency of itching in PN are extremely high. The long-term, repeated, and severe itching is extremely tormenting, seriously affecting the patient's quality of life.

Image Source:Screenshot of the China Drug Clinical Trial Registration and Information Disclosure Platform

We look forward to the smooth progress of subsequent clinical development of this new drug, bringing better treatment options to patients with various autoimmune diseases.

[1] Clinical Trial Registry and Information Disclosure Platform of China. Retrieved Sep 4, 2024, from http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml

[2]China National Medical Products Administration Center for Drug Evaluation official website. Retrieved Sep 4, 2024. From https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d