BMS/Summit Pharma's Abatacept Injection Receives NMPA Approval for Rheumatoid Arthritis in China

On January 10, Bristol-Myers Squibb’s abatacept injection was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of rheumatoid arthritis in patients with an inadequate response to methotrexate. In July 2013, Bristol-Myers Squibb and Jiangsu Simcere Pharmaceutical Co., Ltd. entered into a collaboration on the development of this product in the Chinese market; upon approval, both parties will share the market revenues.

The figure below is from the Insight database application progress (https://db.dxy.cn)

Abatacept (trade name Orencia), developed by Bristol-Myers Squibb Company, is a soluble fusion protein composed of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) fused to the Fc region of human IgG1. As a selective T-cell co-stimulation modulator, Orencia binds to CD80 and CD86 on antigen-presenting cells, thereby blocking their interaction with CD28 on T cells and inhibiting T-cell activation. Activated T cells are implicated in the pathogenesis of various inflammatory diseases.

Orencia was first approved by the FDA in December 2005, by the EMA in May 2007, and by the PMDA in July 2010. Currently, Orencia is marketed in two formulations: intravenous (IV) infusion and subcutaneous (SC) injection. In the United States, it has been approved for three indications: rheumatoid arthritis (RA) in adults, juvenile idiopathic arthritis (JIA), and active psoriatic arthritis (PsA) in adults.

In addition to the three indications mentioned above, Orencia is also being developed for other diseases. As recently as last December, the FDA granted Breakthrough Therapy Designation to Orencia for the prevention of moderate-to-severe acute graft-versus-host disease (GvHD) in patients undergoing hematopoietic stem cell transplantation from unrelated donors.

Since its market launch in 2006, Orencia has benefited millions of patients worldwide thanks to its unique mechanism of action and superior clinical efficacy, with annual sales steadily climbing (see table below). In 2012, Orencia became a blockbuster product with annual sales exceeding $1 billion.

However, Orencia has not yet been approved for marketing in China. Nevertheless, as early as 2013, Bristol-Myers Squibb entered into a strategic collaboration with Simcere to jointly develop abatacept in China, aiming to accelerate its market approval process in the country.

In July 2018, the Center for Drug Evaluation (CDE) began accepting the marketing application for abatacept injection, with the indication sought in China being rheumatoid arthritis. The Insight database shows that an international multicenter Phase III clinical trial of abatacept injection for the treatment of active Class III or IV lupus nephritis is currently underway.

However, the prospects for abatacept injection in the treatment of rheumatoid arthritis in China are not optimistic. This is primarily because multiple biologics for rheumatoid arthritis have already been approved and launched in this field in China, among which 3SBio’s Yisaipu holds an absolute market advantage and has been included in the National Reimbursement Drug List.

According to the 2017 performance report released by 3SBio, Etanercept (Yisaipu) captured a 60.4% market share with annual sales of RMB 1.013 billion in 2017, while Johnson & Johnson’s Remicade held approximately a 20% market share. In contrast, the domestic market performance of several other aforementioned drugs was unsatisfactory.

Furthermore, due to the low market penetration of biologics in China and limited patient affordability, the future prospects for abatacept injection in the domestic market are not expected to be optimistic.

Original Title: BMS/Simcere's "Abatacept Injection" Approved for Market Launch