#China #CAR-T therapy #Macao #IASO Bio #Equecabtagene

IASO Bio Secures New Drug Approval for Equecabtagene Autoleucel in Macau

In a significant advancement for biopharmaceuticals, IASO Biotherapeutics, commonly known as IASO Bio, recently announced the achievement of its first New Drug Application (NDA) approval outside of Mainland China. The approval was granted by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region and is for Equecabtagene Autoleucel, a cutting-edge CAR-T cell therapy designed specifically for adult patients suffering from relapsed or refractory multiple myeloma (R/RMM).

Equecabtagene Autoleucel, marketed under the trade name FUCASO, has been recognized for its potential to treat patients who have already undergone at least three different lines of therapies, including a combination of a proteasome inhibitor and an immunomodulatory agent. This therapy offers new hope to individuals battling this challenging condition, which has been notoriously difficult to manage with conventional treatments.

Milestone in CAR-T Therapy

The Macau approval represents a pivotal milestone for IASO Bio and its innovative product portfolio. Equecabtagene Autoleucel previously received approval from China's National Medical Products Administration (NMPA) in June 2023, making this recent recognition a critical step in the drug’s international journey. Notably, this approval marks the company's commitment to advancing talent on a global scale, as it has taken efforts in expanding accessibility to CAR-T therapies across various regions.

The approval process in Macau was informed by results from the pivotal FUMANBA-1 trial (CTR20192510, NCT05066646), a clinical study carried out across multiple sites in China. The trial demonstrated that Equecabtagene Autoleucel provides outstanding efficacy and a favorable safety profile, reinforcing trust in this revolutionary treatment methodology for multiple myeloma.

Statement from IASO Leadership

Reflecting on this achievement, Ms. Zhang Jinhua, Founder, Chairperson, and CEO of IASO Biotherapeutics, expressed her excitement, saying, "We are delighted that the New Drug Application (NDA) for equecabtagene autoleucel has been approved by the Macau Drug Administration—the product's first NDA approval outside Mainland China, marking a significant milestone. Through our innovative 'Manufactured in Nanjing, Supplied Globally' model, we will ensure timely access to this CAR-T therapy for multiple myeloma patients in Macau."

IASO Bio has showcased its commitment by successfully delivering CAR-T therapy to patients in Hong Kong via the Named Patient Program as of December 2024. Furthermore, it has actively facilitated the acceptance of NDAs for this therapy in other regions, such as Singapore and Hong Kong, which are currently under review.

Understanding Multiple Myeloma

Multiple myeloma stands as the second most prevalent hematological malignancy in the world. With the global incidence rising to 1.8 per 100,000 people, and a five-year prevalence at 6.8 per 100,000, the disease presents an ongoing therapeutic challenge. Despite various advances in treatments, multiple myeloma often proves to be incurable, leading to numerous relapses and increasing drug resistance.

Given such circumstances, the introduction of innovative solutions like Equecabtagene Autoleucel is increasingly critical. This therapy embodies a new frontier in addressing unmet medical needs for patients facing relapsed or refractory multiple myeloma.

Innovative Therapy Framework

Equecabtagene Autoleucel is developed as a fully human anti-BCMA CAR-T cell therapy. It utilizes lentivirus technology to transfect autologous T cells. The CAR configuration includes a fully human scFv along with co-stimulatory and activation domains fundamental to T cell response. Rigorous analysis indicates that FUCASO exhibits incredibly robust efficacy, characterized by lasting in vivo persistence, which stands to enhance response rates, thereby offering extended protection and improved care for multiple myeloma patients.

Future Perspectives for IASO Bio

Founded in 2017, IASO Bio has established itself as a key player in biopharmaceutical innovations focusing on revolutionary treatments. With a myriad development pipeline encompassing over ten cutting-edge products—including additional CAR-T therapies targeting various diseases—the company is steadfast in its mission to expand its global footprint in therapeutic solutions. Their strategic partnerships with premier cell therapy entities further underscore the company’s commitment to leading innovations in the biopharmaceutical domain.

As IASO Bio continues to navigate through regulatory landscapes and expand its therapeutic reach, they remain anchored in their dedication to delivering transformative therapies that are responsive to pressing medical needs around the world. For further details about their developments, visit IASO Bio's official site.