Amgen's Blincyto (Blinatumomab) Nominated for Priority Review by China's CDE

Yesterday, according to the New Drug R&D Monitoring Database (CPM), the CDE proposed to include Amgen’s bispecific antibody Blincyto (blinatumomab) in the priority review.

▲ Spatial conformation of blinatumomab

Blinatumomab is a BiTE molecule developed by Amgen based on its bispecific T-cell engager (BiTE) platform, which simultaneously targets CD19 and CD3. It is also the first bispecific antibody from the company’s BiTE technology platform to receive FDA approval. One end of the molecule binds to the CD19 antigen on the surface of B cells, while the other end binds to the CD3 receptor on the surface of effector T cells. As a result, the drug recruits T cells to the vicinity of cancer cells, promoting their cytotoxic activity against these cells.

Currently, Blincyto has been approved for the treatment of patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), marking it as the first FDA-approved drug that leverages human T cells to destroy leukemia cells. Compared to the highly popular PD-1/L1 antibodies and CAR-T cell therapies, this emerging niche is 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 on one antigen), allowing them to simultaneously act on target cells and effector cells (typically T cells), thereby enhancing the "killing power" against target cells.

Data Source: Yao Fenxiang Plus

To date, three bispecific antibodies have been approved globally. However, given that Removab, the first to be approved, was withdrawn from the market in 2017, only two bispecific antibodies are currently available: Amgen’s Blincyto and Roche’s Hemlibra (emicizumab), the latter being a factor VIII mimetic.

According to the Pharmaceutical Data Bank (PDB), Blincyto has demonstrated strong performance in the global market, reaching $210 million in 2018, with a compound annual growth rate exceeding 45%.

Data Source: PDB Comprehensive Drug Database

The New Drug R&D Monitoring Database (CPM) shows that blinatumomab was accepted by the Center for Drug Evaluation (CDE) on October 25, 2019. Its indication is relapsed/refractory (R/R) precursor B-cell acute lymphoblastic leukemia, consistent with the indication approved by the FDA.

In June, at the European Hematology Association (EHA) Congress, Amgen announced long-term efficacy results of blinatumomab in treating patients with acute lymphoblastic leukemia (ALL). The data showed that, with a median follow-up period of 59.8 months, the median overall survival (OS) for patients receiving this treatment reached 36.5 months. In September, Amgen further announced that two Phase 3 trials evaluating the drug in pediatric patients with high-risk B-cell ALL experiencing first relapse were terminated early for enrollment due to significantly superior efficacy compared to the chemotherapy control group.

In China, new drug development in the field of bispecific antibodies is also particularly vibrant. For instance, Alphamab Oncology and HEC Pharm announced a collaboration to develop a combination therapy involving a PD-L1/CTLA-4 bispecific antibody alongside nergutinin tosylate for the treatment of hepatocellular carcinoma; Betta Pharmaceuticals announced a partnership with Merus N.V., securing the rights to develop and commercialize in China the latter’s bispecific antibody targeting both EGFR and c-Met; I-Mab Biopharma and Roche announced a joint study on the combination use of the bispecific antibody TJD5 with Tecentriq.

In recent years, China has comprehensively implemented reforms to its drug review and approval system, accelerating the approval of innovative drugs urgently needed for clinical use. The proposed inclusion of Amgen’s bispecific antibody Blincyto into the priority review program once again demonstrates the nation’s commitment to accelerating these regulatory reforms. It is anticipated that more clinically urgent innovative drugs will receive accelerated approval in China in the future, thereby benefiting a greater number of patients.