Hong Kong's First! Equecabtagene Autoleucel (FUCASO) Achieves Cross-border Drug Supply and Receives Formal NDA Acceptance from Hong Kong Department of Health

On February 14, 2025, IASO Bio announced,IASO Bio's CAR-T cell product, Icaritin Injection (FUCASO), has been formally accepted by the Hong Kong Department of Health for a New Drug Application (NDA)., applicable for the treatment of adult patients with relapsed/refractory multiple myeloma (R/RMM) who have progressed after at least three prior lines of therapy.

This is the first time that the Hong Kong Department of Health has formally accepted a new drug marketing application for a CAR-T cell product produced in China.Since the cross-border supply of IASO Bio's Cilta-cel injection to patients in Hong Kong has already been achieved, once it is successfully approved, patients in Hong Kong will be able to directly use the product manufactured at Nanjing IASO Biotherapeutics Co., Ltd.

Since the second half of 2024, to meet the urgent demand for innovative therapies among R/RMM patients in Hong Kong and surrounding areas, IASO Bio rapidly initiated the application for Hong Kong's Named Patient Program (NPP). However, enabling Hong Kong patients to use Idecabtagene Vicleucel Injection produced in Nanjing without leaving Hong Kong posed significant challenges. CAR-T drugs must not only comply with the declaration requirements for special items crossing borders, but as "living drugs," their raw materials and finished products also have extremely stringent requirements for logistics, such as temperature control and transport duration, and cannot pass through airport X-ray inspections.

To tackle this challenge, the Nanjing Customs and multiple government departments in the Jiangbei New Area have provided full support to IASO Bio. Under the guidance of the Health Quarantine Department of Nanjing Customs, Jinling Customs and Nanjing Lukou Airport Customs conducted multiple field investigations into the company's production lines in collaboration with various units. They innovatively implemented a multi-department joint supervision mechanism for special items entering and leaving the country. Various agencies under Nanjing Customs, with the aim of serving enterprises, optimized risk assessment, inspection, and release procedures for import and export items, significantly improving the efficiency of import and export operations. Meanwhile, the Jiangsu Provincial Medical Products Administration actively provided professional guidance to the enterprise and efficiently completed the processing of the export sales certificate for the drug Idecabtagene Vicleucel Injection, jointly providing solid support for China-produced CAR-T therapy to enter the international market.

In December 2024, the first R/RMM patient from Hong Kong successfully received the infusion treatment of Icarosalen Injection, prepared at the Nanjing production base, at Hong Kong's Queen Mary Hospital.This breakthrough marks IASO Bio as the first cell therapy company in China to complete the entire process of treating real patients under Hong Kong's NPP, and also signifies the successful cross-border drug supply of Idecabtagene Vicleucel Injection, paving a new path for the international exploration of China’s Cell and Gene Therapy (CGT) companies.

In 2023, Eficus Capital Ruikang Fund participated in the Series C1 financing of IASO Bio.

Multiple Myeloma (MM) is the second most common hematologic malignancy globally. According to Globocan data, the global incidence rate of multiple myeloma was 1.8/100,000 in 2022, with a 5-year prevalence rate of 6.8/100,000. Despite advances in current anti-myeloma treatments, MM remains largely incurable and is prone to multiple relapses, often developing resistance to various drug classes, posing significant challenges for treatment. Therefore, for the treatment of relapsed or refractory MM, there is still an urgent need for new therapeutic options beyond existing anti-myeloma therapies to achieve deep and durable responses.

Idecabtagene Vicleucel Injection (FUCASO) is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA). It uses lentivirus as a gene vector to transfect autologous T cells. The CAR comprises a fully human scFv, CD8α hinge and transmembrane domain, 4-1BB co-stimulatory molecule, and CD3ζ activation domain. Based on stringent molecular structure screening and comprehensive in vivo and in vitro functional evaluation, Fucaso® demonstrates rapid and potent efficacy with remarkable in vivo persistence, enabling patients to achieve deep and sustained remission, continuously safeguarding patients with multiple myeloma.

IASO Bio, established in 2017, is a leading biopharmaceutical company focusing on the research, production, and sales of innovative cell therapies. The company builds its innovation foundation on the development of hematological tumor cell drugs and expands into the fields of autoimmune diseases and antibody drugs, possessing full-process capabilities from early drug discovery, clinical development, regulatory submission to commercialization.

The company currently has more than 10 innovative drug candidates at various stages of development. Among them, the world's first fully human CAR-T product, Idecabtagene Vicleucel Injection (brand name: Focasor®), independently developed by IASO Bio, was approved for marketing by China’s National Medical Products Administration (NMPA) in June 2023. It is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma (R/RMM) who have progressed after receiving at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent). Its front-line indication for treating 2-3 line multiple myeloma (MM) has entered Phase III clinical trials. Additionally, Idecabtagene Vicleucel Injection has received multiple Investigational New Drug (IND) approvals in both China and the United States for autoimmune diseases. Meanwhile, CT120, a dual-target (CD19/CD22) product for lymphoma, is about to enter Phase II clinical trials. Another product targeting GPRC5D for the treatment of relapsed and refractory multiple myeloma, IASO118, has received IND approval in China.

In addition to cell therapy products, IASO Bio's fully human anti-CD19 antibody product, IASO-782, has received IND approval in both China and the United States for the treatment of multiple autoimmune diseases, while further indications for additional autoimmune diseases are still under exploration.

The company has successively reached global business development licensing or R&D collaborations with overseas cell therapy companies Sana Therapeutics, Cabaletta Bio, and Umoja Biopharma, actively exploring the development of next-generation cell therapy products.