Amgen Submits BLINCYTO (Blinatumomab) for Marketing Approval in China

Today (October 29), the CDE website showed that Amgen, a multinational pharmaceutical company, has submitted a marketing application in China for its blockbuster bispecific antibody drug, blinatumomab for injection (brand name: Blincyto), with acceptance number JXSS1900060.

Data indicate that Blincyto is a BiTE developed by Amgen. One end binds to the CD19 antigen expressed on the surface of B cells, while the other end binds to the CD3 receptor on the surface of T cells, thereby recruiting T cells to the vicinity of cancer cells and enhancing their cytotoxic activity against these cells. Currently, Blincyto has received FDA approval for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). It is the first FDA-approved therapy that leverages human T cells to destroy leukemia cells.

Compared with the highly popular PD-(L)1 antibodies and CAR-T cell therapies, this emerging niche is also becoming a “new favorite” in new drug R&D investment. The greatest appeal of bispecific antibodies lies in their mechanism of action. Unlike monoclonal antibodies, bispecific antibodies possess two specific antigen-binding sites (or two different epitopes of one antigen), enabling them to simultaneously act on target cells and effector cells (typically T cells), thereby enhancing the “killing power” against target cells.

Data shows that the two bispecific antibodies currently approved and marketed are Amgen’s blinatumomab and Roche’s emicizumab. Previously, catumaxomab, the world’s first approved bispecific antibody, was ultimately withdrawn from the market and discontinued in 2017 due to commercial failure. Currently, the two marketed bispecific antibody drugs have shown comparable market performance. In 2018, blinatumomab achieved global sales of USD 230 million, while emicizumab recorded global sales of CHF 234 million.

• Amgen’s blinatumomab was approved by the U.S. FDA in December 2014 and by the European EMA in November 2015, respectively.
• In November 2017, Roche's emicizumab received FDA approval for the treatment of hemophilia A.
• In December 2018, emicizumab received accelerated approval from the National Medical Products Administration (NMPA), becoming the first bispecific antibody drug approved for marketing in China.

If Amgen’s blinatumomab is approved, both bispecific antibody drugs currently on the market will become available in China, bringing significant benefits to patients with blood cancers in the country.