IASO Bio receives FDA approval for Eque-cel for multiple sclerosis

CHINA – IASO Bio, a biopharmaceutical company focused on innovative cell therapy and antibody products, has been granted U.S. FDA approval for the Investigational New Drug (IND) application for Equecabtagene Autoleucel (Eque-cel) to treat multiple sclerosis (MS).

This approval marks the second FDA IND approval for Eque-cel in 2024 for autoimmune diseases, following its approval for refractory generalized myasthenia gravis (gMG) earlier this year.

In a statement, Dr. Yongke Zhang, Chief Scientific Officer of IASO Bio, highlighted that this approval was preceded by an investigator-initiated trial (IIT) conducted in China.

During this trial, Eque-cel demonstrated promising efficacy in treating six autoimmune diseases.

Dr. Zhang emphasized that the FDA’s IND approval for treating MS is a testament to IASO Bio’s commitment to advancing technology and addressing autoimmune diseases.

Dr. Zhang reiterated the company’s dedication to a research and development philosophy that prioritizes clinical value to address unmet medical needs. He also stressed the importance of implementing a global strategy to further their mission.

Through close collaboration and in-depth exchanges with international clinical research institutions, IASO Bio aims to expedite the development and commercialization of more innovative drugs, ultimately benefiting patients worldwide.

Multiple sclerosis (MS) is a neuroinflammatory disease of the central nervous system (CNS) characterized by demyelination and neuronal injury.

It is one of the most common causes of non-traumatic disability among young adults aged 18 to 40 years.

 According to Frost & Sullivan, approximately 3.07 million people worldwide suffered from MS in 2023, with around 400,000 cases in the United States alone.

MS is characterized by focal lymphocytic CNS infiltration, leading to myelin destruction and axonal damage. This results in various neurological syndromes and physical disabilities.

The clinical manifestations of MS depend on the location of lesions within the CNS. Symptoms may include sensory and visual disturbances, motor and coordination impairments, spasticity, fatigue, pain, and cognitive deficits.

Approximately 85% to 90% of MS patients develop a relapsing-remitting form of the disease, which is marked by periods of symptom exacerbation followed by remission.

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