New Beijing News (Reporter Zhang Zhaohui) On September 4th, the official website of the National Medical Products Administration announced that a new clinical application for Amgen's Class 1 new drug AMG 451 (rocatinlimab) has been approved, with indications for nodular prurigo. It is reported that the drug is a fully humanized anti-OX40 monoclonal antibody under development, and Anjin has obtained the rights to jointly develop and commercialize the product through a cooperation of up to $1.25 billion.
Multiple clinical studies have been initiated in China
OX40 (also known as CD134) is an important class of T cell co stimulatory molecules and one of the cutting-edge targets in new drug development in recent years. On the one hand, it can enhance immune activity by regulating the proliferation and survival of effector T cells, and on the other hand, it can inhibit the activity and proliferation of regulatory T cells (Tregs). Therefore, the design of OX40 agonists that stimulate immune responses aims to enhance T cell efficacy and strengthen immune responses. The development of OX40 targeted antibodies is expected to bring therapeutic effects to various immune diseases.
As a fully humanized monoclonal antibody targeting OX40, rocatinlimab was developed by Kyowa Kirin and its proprietary technology was used to enhance the antibody dependent cell-mediated cytotoxicity (ADCC) of the product. In 2021, Anjin and Xiehe Qilin reached a global exclusive licensing agreement to jointly develop the potential of rocatinlimab for the treatment of atopic dermatitis and other autoimmune diseases. According to the terms, Anjin will lead the development, production, and commercialization of rocatinlimab in all global markets except Japan, while Concord Kirin reserves the rights in Japan. Concord Kirin will receive a $400 million advance payment and potentially up to $850 million in milestone payments, as well as royalties for future global sales.
The newly approved clinical indication for nodular prurigo is a stubborn chronic itching disease and the most common subtype of chronic prurigo. Its main manifestations are hyperkeratosis and itchy dome shaped nodule damage, with severe and persistent itching, sometimes accompanied by burning pain. Among various chronic itching diseases, PN has extremely high intensity and frequency of itching, and long-term repeated severe itching is very distressing, seriously affecting the quality of life of patients.
According to the China Drug Clinical Trial Registration and Information Disclosure Platform, Anjin has initiated multiple clinical studies on AMG 451 in China, with indications including atopic dermatitis and asthma. The approval of AMG 451 for clinical trials once again means that the product is about to explore clinical trials in the new field of nodular prurigo disease.
Sanofi and Chuangxiang Biotechnology also have similar monoclonal antibodies under development
In recent years, humanized anti-OX40 monoclonal antibody drugs have received widespread attention, especially showing potential in the treatment of autoimmune diseases such as atopic dermatitis (AD).
In addition to the jointly developed rocatinlimab by Anjin and Xiehe Qilin, Sanofi's Amlitelimab (KY1005) and Chuangxiang Biotechnology's IMG-007 are also highly regarded in the industry.
Amlitelimab (KY1005) was developed by the British biotechnology company Kymab and later acquired by Sanofi. At present, Sanofi has launched a phase 2 open label, long-term study of Amlitelimab for moderate to severe atopic dermatitis in China to evaluate its safety and efficacy. The drug achieved its primary endpoint in the Phase 2b study (Stream-AD) and has potential therapeutic effects on both type 2 and non-2 inflammation. The data shows that the average eczema area and severity index (EASI) score of patients treated with amlitelimab improved by 61.5% compared to baseline at week 16, and continued to improve over the course of 24 weeks.
In addition, Sanofi has registered two Phase III clinical trials of Amlitelimab, expected to be completed in September October 2025.
IMG-007 is a potential "best in class" long-acting anti-OX40 monoclonal antibody being developed by Chuangxiang Biotechnology, which has achieved positive mid-term results in a phase 2a clinical study of atopic dermatitis. The drug has shown good safety and tolerability in a single dose escalation study in healthy subjects. IMG-007 may not only significantly reduce safety risks associated with T cell depletion, but also achieve a dosing frequency of once every 12 weeks in AD induction therapy.
Humanized anti-OX40 monoclonal antibody drugs have shown broad prospects in the treatment of autoimmune diseases such as atopic dermatitis. With the continuous deepening of research, these drugs may bring better therapeutic effects and quality of life to patients.