On November 15, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that AstraZeneca's Class 1 new drug AZD0486 was approved for two clinical trials with implicit approval, which are intended to be used for the treatment of previously untreated follicular lymphoma in adults; and relapsed and refractory follicular lymphoma in adults who have received at least 2 lines of systemic treatment or more.

Public information shows that AZD0486 is a CD19/CD3-targeted bispecific T cell adaptor protein under development by AstraZeneca, which is a next-generation T cell adaptor. This is the first time that a drug has been approved for clinical trials in China for the indication of follicular lymphoma (FL). In a clinical study recently published by AstraZeneca, the product showed an overall response rate (ORR) of up to 96% when used to treat patients with relapsed/refractory FL (R/R FL). The press release stated that the product is expected to enhance the treatment of current clinical lymphoma patients.

One end of AZD0486 can bind to the CD19 antigen expressed on the surface of B cells, and the other end can bind to the CD3 receptor on the surface of T cells, thereby redirecting T cells to tumor cells and inducing T cells to kill tumor cells. In August 2022, AstraZeneca announced the completion of its acquisition of TeneoTwo for a total amount of more than US$1.2 billion, thereby acquiring the latter's research product (formerly known as TNB-486).

At this year's American Society of Hematology (ASH) Annual Meeting, AstraZeneca announced the clinical results of several of its hematology pipelines. The results of one of the Phase 1 clinical trials showed that patients with relapsed/refractory follicular lymphoma (R/R FL) responded highly to AZD0486 at doses of 2.4 mg and above, with an overall response rate of 96%, a complete remission (CR) rate of 85%, and a high minimal residual disease (MRD) negative rate.

Source: https://mp.weixin.qq.com/