In February 2024, AstraZeneca officially incorporated Gracell into the group, setting a precedent for MNCs to acquire Chinese biotechs on a large scale. Gracell is AstraZeneca's first acquisition in the CAR-T track, with its outstanding technology and pipeline - FasTCAR and AZD0120 at its core.

AZD0120 is a BCMA/CD19 dual-targeted CAR-T cell therapy developed based on the FasTCAR rapid production platform, which has the potential to become a new generation of treatment options for malignant blood tumors and autoimmune diseases. As one of the core pipelines in AstraZeneca's cell therapy matrix, the development strategy and clinical progress of AZD0120 have attracted much attention.


The field of autoimmunity has been “tempered and upgraded”, and its value continues to increase

At the EULAR 2025 Annual Meeting, Gracell Biopharma announced for the first time the safety and preliminary efficacy data of the IIT study of AZD0120 for the treatment of refractory systemic lupus erythematosus (rSLE). A total of 10 SLE patients with SLEDAI-2K scores ≥8, all with lupus nephritis, were recruited in the study, with a median follow-up time of 313.5 days. The results showed that the safety results of AZD0120 in rSLE patients were basically consistent with those previously observed in the field of blood cancer. No dose-limiting toxicity was observed, and no ≥3 CRS and ICANS were reported. In terms of efficacy, all patients (100%) had normal complement levels after completing a single infusion, 70% of patients achieved continuous serological conversion of ANA, ENA spectrum and anti-dsDNA antibodies, and 90% of patients achieved DORIS standard remission at the 9th month. All patients (100%) had a significant reduction in proteinuria, with 60% of patients achieving complete remission (CR) as defined by KDIGO-2024 at month 9 and 40% of patients achieving partial remission (PR).

During the same period, Gracell Biopharma announced the IIT study data of another center with the same indication through a poster at the EHA2025 Annual Meeting (NCT05846347, the First Affiliated Hospital of Zhejiang University School of Medicine, a total of 15 rSLE patients were recruited), which also achieved good results.

From blood cancer to autoimmunity, AZD0120's "wall-breaking" conforms to the important development trend of the CAR-T track in the past two to three years. As of June 3, 2025, there are more than 140 autoimmune CAR-T projects under development worldwide, and related clinical trials have exploded. The breakthrough progress of CAR-T in treating autoimmune diseases was successfully selected as one of the top ten scientific breakthroughs of Science in 2024, marking a key step in the application of this technology in the field of autoimmunity.


Advancing into the “first-line treatment” for blood cancer, long-term follow-up data is perfect

At the EHA 2025 Annual Meeting, Gracell Biopharma presented two latest clinical data on AZD0120 as a first-line therapy for newly diagnosed multiple myeloma (NDMM). In a study of high-risk NDMM patients (TE NDMM) eligible for transplantation, the median follow-up time was 32.3 months as of February 10, 2025, which is said to be the longest prospective follow-up of CAR-T treatment for NDMM patients to date. ORR and MRD-negative rates remained 100%, the sCR rate was 95.5%, and the 30-month PFS rate was 85.7%. The safety data were highly consistent with the early results, and no ≥3 CRS or ICANS were observed.

In a study of elderly patients with NDMM who were not eligible for transplantation (TI NDMM), the median follow-up time was 13.9 months as of February 10, 2025. The results showed that after AZD0120 treatment, the ORR and sCR rates of patients were both 100%, all patients treated achieved MRD negativity, and no disease progression was observed as of the data cutoff date. In terms of safety, 50% of patients experienced grade 1 CRS, all patients recovered from CRS within 5 days, and no grade 2 CRS or ICANS of any level were observed.

Ingenious layout of cell therapy to create a new growth engine

AstraZeneca has acquired the key chips for the next generation of CAR-T therapy through the acquisition of Gracell Biopharmaceuticals. The FasTCAR technology platform can significantly shorten the production time to the next day, significantly shorten the waiting period for patients, and reduce the risk of disease progression. Compared with cells prepared by traditional CAR-T processes, FasTCAR-T cells have a younger phenotype and better health, which enables them to have better in vivo expansion ability, thereby reducing the dosage of drugs and achieving safer and more effective treatment expectations.
AstraZeneca's layout in the cell therapy track is not limited to CAR-T, but also includes TCR-T and Treg therapies. In 2022, AstraZeneca acquired Neogene to deploy TCR-T therapy; in 2023, it joined hands with Quell to deploy Treg therapy for the treatment of autoimmune diseases. In addition, AstraZeneca also cooperated with Cellbiman to explore solid tumor CAR-T, and spent $1 billion to acquire EsoBiotec in 2025, betting on in vivo cell therapy.

AstraZeneca has also invested heavily in production. In February 2024, the company invested $300 million to build a new cell therapy production base in Maryland, USA; in May 2025, the production base officially "opened". In China, Gracell Bio announced that it will continue to expand its cell therapy production capacity in Suzhou Biomedicine Industrial Park (BioBAY).

Looking back at December 2023, AstraZeneca's groundbreaking acquisition of Gracell Biopharmaceuticals for $1.2 billion not only created an unprecedented development path in the history of China's biotech, but was also an important practice of AstraZeneca's "in China-For Global" strategy. In 2024, AstraZeneca's revenue in China achieved double-digit growth, and with a performance of $6.4 billion, it returned to the top of multinational pharmaceutical companies in China in terms of revenue. In March 2025, AstraZeneca announced a $2.5 billion investment plan to establish its sixth strategic R&D center in the world and its second in China in Beijing.

In the future, AstraZeneca will use Shanghai as an important R&D base in the field of cell therapy, and further promote the progress of cell therapy with the help of China, a source of innovation. As the "Chinese innovation force" in AstraZeneca's cell therapy map, as the integration deepens, how Gracell Bio's pioneering technology and the global platform of multinational pharmaceutical companies complement each other, and how to further nurture AstraZeneca's new "blockbuster products" will be the highlights of the future of the blockbuster transaction between the two parties.

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