Bristol-Myers Squibb's `` Abassicept Injection '' Approved for Market Listing
Release date: 2020-01-10 Views: 0
On January 10, Bristol-Myers Squibb's "Abassicept Injection" was approved by the State Food and Drug Administration for marketing and is used for rheumatoid arthritis with poor methotrexate efficacy. In July 2013, Bristol-Myers Squibb and Jiangsu Xiansheng Pharmaceutical Co., Ltd. reached a cooperation on the research and development of this variety in the Chinese market. After approval, the two parties shared their market revenue.
The following figure is from the Insight database declaration progress (http://db.dxy.cn)
Abatacept (brand name Orencia) is a soluble form of human cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) extracellular region and human IgG1Fc region developed by Bristol-Myers Squibb Company. Fusion protein. As a selective T-cell co-stimulatory modulator, Orencia blocks T-cell activation by binding to CD80 and CD86 on antigen-presenting cells, blocking the latter's interaction with CD28 on T-cells. Activated T-cells are thought to be involved in a variety of inflammatory diseases.
Orencia was first approved by the FDA in December 2005, approved by the EMA in May 2007, and approved by the PMDA in July 2010. Orencia is currently marketed in intravenous (IV) and subcutaneous (SC) formulations in the United States. There are three approved indications: adult human rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) and adult active psoriatic arthritis (PsA).
In addition to the above three indications, Orencia has also been developed for other diseases. As recently as December of last year, the FDA granted Orencia a breakthrough in preventing moderate to severe acute graft-versus-host disease (GvHD) for non-related donor hematopoietic stem cell transplants. Qualification for sex therapy.
Since its launch in 2006, Orencia has benefited millions of patients worldwide with its unique mechanism of action and outstanding clinical results, and its annual sales have also climbed (see the table below for details). In 2012, Orencia became an annual sales over A billion-dollar blockbuster.
However, Orencia has not yet been approved for listing in China. However, as early as 2013, Bristol-Myers Squibb reached a strategic cooperation with Xiansheng Pharma to jointly develop Abexap in China, with a view to speeding up the process of Abexap listing in China.
In July 2018, CDE began to accept the application for the marketing of Abbascept injection, and the indication for the application of Abathion injection in China is rheumatoid arthritis. The Insight database shows that the international multi-center phase III clinical trial of Abbascept injection for active type III or IV lupus nephritis is ongoing.
However, the prospect of Abbascept injection in the treatment of rheumatoid arthritis in China is not optimistic, mainly because a number of biological agents for rheumatoid arthritis have been approved for marketing in this field in China, and the Sansheng Health Supplement Pu has an absolute market advantage and has entered medical insurance.
According to the performance report released by Sansheng Pharmaceutical in 2017, Yisaipu held a 60.4% market share with its annual sales of 1.013 billion yuan in 2017. Johnson & Johnson's Lectra has approximately 20% market share. The performance in the domestic market is unsatisfactory.
In addition, due to the current low penetration rate of the domestic biologics market and the national ability to pay, etc., it is expected that the future of Abbascept injection in China will not be very optimistic.
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