IASO Biotechnology (IASO Bio), a company that focuses on developing new cell therapies and biologic treatments for blood cancers and autoimmune diseases, has announced that its treatment Fucaso (also known as Equecabtagene Autoleucel) has been approved by the Hong Kong Department of Health. This approval is for adult patients with relapsed or refractory multiple myeloma (a type of blood cancer) who have already had at least three previous treatments, including one with a proteasome inhibitor and one with an immunomodulatory agent.
This approval is significant because Fucaso is the first CAR-T therapy developed in China to be authorized in Hong Kong, and it is the first China-developed advanced therapy product (ATMP) to receive recognition from PIC/S GMP, an international standard for manufacturing quality.
The approval was based on clinical evidence from a study called FUMANBA-1, and it follows a special regulatory pathway in Hong Kong called the "1+" innovative mechanism, which considers previous approvals in Mainland China and clinical data.
Since November 2024, Fucaso has been available in Hong Kong through a program for specific patients. Now, with this official approval, IASO Bio plans to expand the availability of Fucaso to more regions, following local regulations.
As per Coherent Market Insights, the Biopharmaceutical and Biomedicine Market will grow at a 12.1% compound annual growth rate (CAGR) from 2025 to 2032, from USD 640.26 Bn in 2025 to around USD 1,425.17 Bn by 2032. Advancements in biomedical research have fueled the development of innovative therapeutic drugs and diagnostics. Significant investments by industry players and government organizations in R&D of novel biologics, cell, and gene therapies for the treatment of chronic diseases such as cancer and diabetes are also supporting market growth.
Ms. Jinhua Zhang, Founder, Chairperson, and CEO of IASO Bio, commented: "This approval in Hong Kong represents an important milestone in our global strategy. We appreciate the rigorous and efficient review conducted by the Hong Kong Department of Health as well as the clarity of the '1+' pathway. We remain committed to quality, patient safety, and global regulatory collaboration to bring innovative cell therapies to more patients worldwide."
Founded in 2017, the company is one of the few biopharmaceutical companies that are actively bringing China’s innovative medical treatments to the global market. It specialize in cell therapies and biologics to treat blood cancers and autoimmune diseases. Advanced approach covers every stage of a product's life—from discovering and developing new treatments, to manufacturing and making them available to patients.
Source:
News: IASO Biotechnology (IASO Bio)
