Iaso Bio’s Equecabtagene Autoleucel (FUCASO), China’s First Homegrown CAR-T Therapy, Receives NDA Acceptance from Hong Kong Department of Health

Feb 15, 2025 10:36 CST Updated 10:36

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February 15, 2025

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On February 14, IASO Bio announced that the Hong Kong Department of Health has formally accepted the New Drug Application (NDA) for its CAR-T cell product, Ixazomib Injection (FUCASO), intended 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 isHong Kong Department of Health Officially Accepts the New Drug Marketing Application for a CAR-T Cell Product Produced in China for the First TimeSince the cross-border supply of IASO Bio's equecabtagene autoleucel 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 this 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 quickly initiated the application for Hong Kong’s Named Patient Program (NPP). However, enabling Hong Kong patients to use Ixazomib Injection produced in Nanjing without leaving Hong Kong presents significant challenges.CAR-T drugs not only need to meet the declaration requirements for special items entering and leaving the country, but as a "living drug," its raw materials and finished products also have extremely strict requirements for logistics transportation conditions such as temperature control and duration, and cannot pass through airport X-ray inspections.

To overcome this challenge,Nanjing Customs and multiple government departments in the Jiangbei New Area have provided full support to IASO Bio. Jinling Customs and Nanjing Lukou Airport Customs, under the guidance of the Health Quarantine Department of Nanjing Customs, multiple units jointly conducted numerous on-site investigations of enterprise production lines. They innovatively implemented a multi-department joint supervision mechanism for special import and export items. With the aim of serving enterprises, all agencies of Nanjing Customs optimized risk assessment, inspection, and release procedures for import and export items, significantly improving import and export efficiency. Meanwhile,The Jiangsu Provincial Medical Products Administration actively provided professional guidance to enterprises and efficiently completed the processing of the export sales certificate for IASO Bio's Ixazomib Injection., jointly providing a solid guarantee for Chinese-produced CAR-T therapy to enter the international market.

In December 2024, the first R/RMM patient from Hong Kong successfully received reinfusion treatment with IASO Bio's ide-cel injection, manufactured at the Nanjing production base, at Queen Mary Hospital in Hong Kong. This breakthrough...This marks IASO Bio as the first cell therapy company in China to complete the entire treatment process for real patients under Hong Kong's NPP, and also signifies the successful cross-border supply of Ixalocel injection, paving a new path for the international exploration of China's Cell and Gene Therapy (CGT) enterprises.。

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Founder, Chairman and Chief Executive Officer of IASO BioMs. Zhang Jinhua stated: "Based on the significant clinical value of Equecabtagene Autoleucel Injection, we believe that CAR-T drugs with international competitiveness should go global to benefit more patients worldwide. As an important window for China's biopharmaceutical companies to expand into the international market, Hong Kong is a crucial step for IASO Bio’s global market strategy. In December last year, the first Hong Kong NPP patient successfully received reinfusion treatment with Equecabtagene Autoleucel Injection."This proves the effectiveness of IASO Bio's innovative "Nanjing production, supply outside China" model and also marks the successful cross-border supply of this drug.We hope this breakthrough will be an inspiration to our fellow professionals in the CGT industry.

This achievement would not have been possible without the strong support and guidance from government departments at all levels in Jiangsu Province and Nanjing City. We sincerely thank Nanjing Customs and the Jiangsu Provincial Medical Products Administration for their professional guidance, Jinling Customs and Nanjing Lukou Airport Customs for their efficient collaboration, as well as the comprehensive support from various departments of Jiangbei New Area, the Lin Kong Economic Demonstration Zone, and Nanjing Lukou International Airport, among other relevant organizations.

Today, we are pleased to announce that the NDA for IASO Bio's Equecabtagene Autoleucel Injection has been officially accepted by the Hong Kong Department of Health.Relying on Hong Kong's "1+" innovative approval mechanism, we quickly completed the submission of the application., fully demonstrating the profound understanding and efficient execution of IASO Bio's registration team regarding drug registration policies in different regions. Here, I would like to express my special thanks to the team for their professional dedication and relentless efforts. Moving forward, we will fully cooperate with the approval process of relevant departments, striving to achieve the approval of this innovative CAR-T product in the Hong Kong region of China as soon as possible, bringing hope to more patients."

About MultiMultiple Myeloma (MM)）

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, prone to multiple relapses, and tends to develop resistance to various classes of drugs, presenting 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.

AboutEquecabtagene Autoleucel Injection (FUCASO)

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, CD8a hinge and transmembrane domain, 4-1BB co-stimulatory molecule, and CD3ζ activation domain. Based on rigorous 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.

About IASO BioBiological

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 comprehensive capabilities across the entire process from early drug discovery, clinical development, regulatory submission to commercialization.

References:

1.IASO Bio Official WeChat

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Disclaimer: This article aims to convey industry development information and explore the frontier progress of biomedicine. The content of the article represents the author's viewpoint and does not represent the position of Eureka Bio, nor does it constitute any value judgment, investment advice, or medical guidance. If necessary, please consult a professional for investment or visit a regular hospital for medical advice.

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