AstraZeneca's CD19/CD3 Bispecific Antibody AZD0486 Granted IND Approval in China for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

According to the CDE official website, AstraZeneca's Class 1 therapeutic biological product AZD0486 has received clinical trial implied permission, intended for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia.

Source of the image: CDE official website

$1.3 Billion Bet
Potential Dual Antibody Targets Lymphoma

AZD0486 (TNB-486) is a novel, fully human CD19xCD3 IgG4 bispecific antibody originally developed by TeneoTwo. In 2022, AstraZeneca acquired TeneoTwo for $1.265 billion, simultaneously obtaining its clinical-stage drug TNB-486.

According to publicly available data, AZD0486 can bind to CD19 on the surface of B lymphocytes and CD3 receptors on the surface of T lymphocytes, thereby initiating an immune response in T lymphocytes. A Phase I clinical study (NCT04594642) published in the August 2023 issue of *OncLive* showed that AZD0486 demonstrated sustained antitumor effects in relapsed/refractory follicular lymphoma, regardless of CD20 expression levels and independent of existing drug types and dosages.

Image Source: clinicaltrials.gov

Currently, AZD0486 has entered Phase I clinical stage overseas, with two clinical trials currently underway.

Image Source: AstraZeneca

In China, the clinical trial application for AZD0486 was accepted by the CDE in December 2023. The indication granted tacit approval for clinical trials is relapsed or refractory B-cell acute lymphoblastic leukemia.

Accelerate Pipeline Layout
Strong performance in the oncology field

Recently, AstraZeneca released its 2023 financial report, with total annual revenue reaching $45.811 billion (+3%). Excluding COVID-19 products, total revenue was $45.488 billion, representing a year-on-year increase of 13%. Among this, the oncology business remained strong, generating $18.447 billion in revenue in 2023, a year-on-year increase of 19%, primarily driven by products such as Osimertinib, Durvalumab, Olaparib, and Enhertu (Trastuzumab Deruxtecan).

In addition, AstraZeneca has completed a comprehensive and diversified layout for its subsequent pipeline in the oncology field, with significant progress achieved in multiple studies recently.

Image Source: AstraZeneca

Capivasertib（Truqap）

Capivasertib was approved by the FDA in November 2023, becoming the world's first highly efficient and selective AKT1/2/3 inhibitor for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. According to AstraZeneca's financial report, Capivasertib generated $6 million in sales just over a month after its launch.

Osimertinib (Tagrisso)

As AstraZeneca's key product in the lung cancer field, the third-generation EGFR inhibitor osimertinib contributed $5.799 billion in sales in 2023, even being hailed as the most profitable targeted drug in the lung cancer field. Recently, the FDA also approved osimertinib combined with chemotherapy as a first-line therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations. Currently, the adjuvant treatment indication for osimertinib has been included in the latest national medical insurance, which is expected to further expand the market and achieve more impressive results in 2024.

In addition, since 2024, AstraZeneca has had multiple drugs (or new indications) accepted or tacitly approved for clinical trials by the CDE in China, including the next-generation ASI antihypertensive drug Baxdrostat tablets.

Conclusion

On February 22, AstraZeneca officially completed the acquisition of Gracell Biotechnologies; on February 26, AstraZeneca announced that Shanghai had become its fifth global strategic center. In the future, AstraZeneca may further deepen its innovative pipeline layout in China.

Editor: Mu Mian

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