BeiGene OX40 agonist approved, clinical IL-6 inhibitor is expected to be approved in the near future

ArticleMedicine Guanlan

Recently, BeiGene's product pipeline has ushered in two important developments

Differentiated OX40 agonist gets clinical approval in China

According to CDE public information, this is the first time that BGB-A445 has been clinically approved in China, and it is planned to be developed for the treatment of advanced solid tumors

Screenshot source: CDE official website

OX40 (also known as CD134) is an important class of T cell costimulatory molecules

According to BeiGene's public information, as a non-ligand competitive anti-OX40 monoclonal antibody under development, the difference between BGB-A445 and other OX40 antibodies is that it does not block the binding of OX40-OX40L, so that it can Maintain the signal of the antigen presenting cell OX40L, and stimulate the natural ligand to reach the maximum activation of OX40

In preclinical studies, BGB-A445 has shown extensive single-agent efficacy in preclinical studies including PD-1 resistance models, and has been shown to inhibit tislelizumab, TLR9 agonists, and P13Kδ.

Previously, BeiGene has initiated a phase 1 clinical trial (NCT04215978) of BGB-A445 combined with tislelizumab in Australia for the treatment of patients with advanced solid tumors.

IL-6 inhibitor is expected to be approved in the near future

The latest announcement of the results of the drug registration progress query of the National Medical Products Administration (NMPA) of China, the review status of the new drug listing application for the IL-6 inhibitor injection stuximab introduced by BeiGene has been updated to: Pending approval, which means The drug is expected to be approved in China in the near future

Screenshot source: NMPA official website

Public information shows that Stuximab was originally developed by Johnson & Johnson and then licensed to EUSA Pharma

Multicentric Castleman disease is a rare, life-threatening, debilitating lymphoproliferative disease, which can produce abnormal proliferation of immune cells, and has many similarities with lymphoma in symptoms and histological features

Studies have shown that interleukin-6 (IL-6), as a pleiotropic cytokine involved in inflammation, immunity and hematopoiesis, plays a key role in the pathogenesis and clinical symptoms of multicentric Castleman disease

Overseas, Stuximab has been approved for the treatment of human immunodeficiency virus (HIV) negative and human herpes virus 8 (HHV-8) negative since it was first approved in the United States in 2014.

In China, Stuximab has been included in the list of the "First Batch of New Drugs Urgently Needed for Clinical Use" for rare disease drugs

Reference materials:

[1] Center for Drug Evaluation of China National Medical Products Administration.

[3] China National Medical Products Administration (NMPA) drug registration progress query.

[4] Gathering hope, the International Castleman Sick Day patient care activity was held in Shanghai.

[5] EUSA Pharma and BeiGene signed an exclusive development and commercialization agreement for SYLVANT® and QARZIBA®▼ in Greater China.