IASO Bio Secures NDA Approval on Equecabtagene Autoleucel for Multiple Myeloma in Macau

IASO Biotherapeutics has received approval from the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF) for the New Drug Application (NDA) of Equecabtagene Autoleucel. 

Multiple myeloma is the second most common blood cancer globally, with a reported incidence of 1.8 per 100,000 people in 2022, according to Globocan data. 

The disease remains largely incurable, with frequent relapses and resistance to various treatment classes, highlighting the need for new therapeutic approaches that offer deeper and more durable responses.

Equecabtagene Autoleucel is a fully human anti-BCMA CAR-T cell therapy that uses lentivirus to genetically modify autologous T cells.

The CAR-T therapy is indicated for adult patients with relapsed or refractory multiple myeloma (R/RMM) who have previously undergone at least three lines of treatment, including a proteasome inhibitor and an immunomodulatory agent.

This marks the first regulatory approval for Equecabtagene Autoleucel outside Mainland China. The therapy, marketed under the trade name FUCASO, was first approved by China’s National Medical Products Administration (NMPA) on 30 June 2023 for the same indication. 

Additionally, the Health Sciences Authority of Singapore and the Department of Health of Hong Kong accepted NDAs for the therapy on 29 January and 14 February 2025, respectively.

IASO Bio has implemented a ‘Manufactured in Nanjing, Supplied Globally’ model to ensure timely access to its CAR-T therapy. In late 2024, the company successfully delivered its Nanjing-produced CAR-T therapy to patients in Hong Kong through the Named Patient Program (NPP). 

Following this, regulatory applications in Singapore and Hong Kong progressed, with ongoing efforts to expand access in additional regions.

IASO Bio continues to work closely with regulatory authorities to facilitate broader access to its CAR-T therapies and expand treatment options for multiple myeloma patients worldwide.

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