BeiGene/Amgen's Blinatumomab Nears Approval in China for Relapsed/Refractory B-cell ALL

On November 27, the Insight Drug Intelligence Monitoring System showed that Amgen’s “Blinatumomab for Injection” had entered the approval stage for its marketing application in China, with imminent approval expected for the treatment of adult patients with relapsed or refractory (R/R) precursor B-cell acute lymphoblastic leukemia (ALL). According to the prior collaboration between Amgen and BeOne Medicines, the commercialization of this product in China will be handled by BeOne Medicines.

Blinatumomab, developed by Amgen based on its advanced Bispecific T-cell Engager (BiTE) technology, is the first bispecific antibody product launched from Amgen’s BiTE platform. It activates the immune system to recognize and kill tumor cells by bridging CD19 protein on tumor cells with CD3 protein specifically expressed on T cells. It has been approved abroad for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Insight Annual Report sales data show that Blincyto’s sales have steadily increased since 2016, with global sales reaching $312 million in 2019.

In January this year, BeOne Medicines and Amgen reached a global strategic collaboration in oncology. Under this agreement, BeOne Medicines will be responsible for the commercialization and development in China of three approved or filed oncology drugs from Amgen: XGEVA® (denosumab injection), KYPROLIS® (carfilzomib for injection), and BLINCYTO® (blinatumomab bispecific antibody for injection). Additionally, the two companies will jointly develop 20 oncology pipeline drugs from Amgen.

Xgeva® has currently been approved in China, with product revenue in the Chinese market reaching USD 3.05 million in the third quarter of this year. This marks the first Amgen product to be commercialized by BeOne Medicines in China. The indication for carfilzomib for injection in the treatment of patients with relapsed/refractory (R/R) multiple myeloma is expected to be approved in 2021. Upon approval, blinatumomab for injection will become the second Amgen product commercialized by BeOne Medicines in China. In its recent third-quarter report, BeOne Medicines stated that it is currently preparing for the commercial launch of products pending imminent approval.

Currently, there are two bispecific antibodies approved and commercially available worldwide: Amgen’s blinatumomab and Roche’s emicizumab. Previously, the world’s first approved bispecific antibody, catumaxomab, was ultimately withdrawn from the market and discontinued in 2017 due to commercial failure.

The Insight database shows that Roche’s emicizumab was approved for import as early as November 30, 2018, for the treatment of hemophilia A, a rare disease. With the recent approval of Amgen’s blinatumomab bispecific antibody for import, both bispecific antibodies currently available globally have now been approved in China.