According to the CDE official website, AstraZeneca’s Class 1 therapeutic biological product AZD0486 has obtained implicit approval for clinical trials and is intended to be used to treat relapsed or refractory B-cell acute lymphoblastic leukemia.

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

According to public information, AZD0486 can bind to CD19 on the surface of B lymphocytes and CD3 receptors on the surface of T lymphocytes, thereby initiating the immune response of T lymphocytes. A Phase I clinical study (NCT04594642) published in the journal "OncLive" in August 2023 showed that AZD0486 has a durable tumor inhibitory effect on relapsed/refractory follicular lymphoma, regardless of the expression level of CD20, and it is also independent of the type and dosage of existing drugs.

Currently, AZD0486 has entered the Phase I clinical stage overseas, and a total of 2 clinical trials are ongoing.

In China, the clinical trial application of AZD0486 was accepted by CDE in December 2023. The indications for which the clinical trial implicitly approved this time are relapsed or refractory B-cell acute lymphoblastic leukemia.

A few days ago, AstraZeneca released its 2023 financial report, with total annual revenue of US$45.811 billion (+3%). Total revenue after excluding COVID-19 products was US$45.488 billion, a year-on-year increase of 13%. Among them, the oncology business still performs strongly, with revenue in 2023 of US$18.447 billion, a year-on-year increase of 19%, mainly relying on osimertinib, durvalumab, olaparib, and Enhertu (trastuzumab) and other product support.

In addition, AstraZeneca has also completed a comprehensive and diversified layout for its follow-up pipeline in the field of oncology, and has made progress in multiple studies in the near future.

Capivasertib (Truqap)

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

Osimertinib (Tagrisso)

As AstraZeneca's key product in the field of lung cancer, the third-generation EGFR inhibitor osimertinib contributed US$5.799 billion in sales in 2023, and is even known as the most profitable targeted drug in the field of lung cancer. Recently, the FDA approved osimertinib combined with chemotherapy as first-line therapy for local advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations. At present, the indications for auxiliary treatment with osimertinib have been included in the latest version of the national medical insurance, and it is expected to further expand the market and achieve more outstanding results in 2024.

In addition, since 2024, AstraZeneca's clinical applications for a number of drugs (or new indications) in China have been accepted or implicitly approved by the CDE, including the next-generation ASI antihypertensive drug Baxdrostat tablets.

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

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