Shengsheng International Facilitates Industry's First Cross-border CAR-T Therapy Supply for IASO Bio, Enabling Successful Treatment in Hong Kong
IASO Biotechnology
Cancer Treatment New Drug Developer
In early February 2025, IASO Bio announced that its CAR-T cell product, Idecabtagene Vicleucel Injection (FUCASO), successfully achieved cross-border supply for patients in the Hong Kong region by the end of 2024.The Hong Kong Department of Health and Singapore's Health Sciences Authority officially accepted the New Drug Application (NDA) for IASO Bio's Equecabtagene Autoleucel Injection in February 2025, intended for the treatment of relapsed/refractory patients who have progressed after at least three prior lines of therapy.Relapsed/Refractory Multiple Myeloma (R/RMM)Adult patients. This is the first time that the health authorities of Hong Kong and Singapore have formally accepted the new drug marketing application for a CAR-T cell product made in China. After successful approval, patients in Hong Kong, Singapore, and other regions of Asia and the world will be able to directly use this product, prepared at Nanjing IASO Bio's production base, in hospitals within these two regions and countries.
With a Decade of CAR-T Service Experience, Embracing Challenges
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 presents significant challenges. As a CAR-T drug, it must comply with the declaration requirements for special items crossing borders. Moreover, as a "living drug," its raw materials and finished products impose extremely strict conditions on logistics transportation, including temperature control and time sensitivity.Shanghai Shengsheng, as a company with 15 years of experience in the biopharmaceutical cold chain service field, has been providing services to the CGT (Cell and Gene Therapy) industry since 2014, accumulating over 10 years of experience. Shengsheng International, as a member of the Shanghai Shengsheng Group, has gained increasing trust from more and more clients for its professional performance in international import and export.IASO Bio has entrusted this highly challenging "special mission" to Shengsheng International, marking a breakthrough from 0 to 1 in the industry.
Overcoming Challenges, Seeking the Best Solution
To overcome the challenges of this project, Shengsheng International has taken two approaches. On one hand, it has cooperated with IASO Bio to fulfill Jiangsu Province's initiative of developing Nanjing Airport into a specialized port for cell and gene therapy in China, innovatively implementing a multi-department joint supervision mechanism for special items entering and leaving the country, processing special item permits, and significantly improving customs clearance efficiency. On the other hand, Shengsheng International has broken through the time and security constraints of international freight for blood products, ensuring strict temperature control throughout the process in compliance with GMP standards. It has coordinated with airlines, HKG Airport, and hospital terminals to continuously experiment, providing extensive professional experience in operations in Hong Kong.In addition, the NERA temperature-controlled box specifically designed for cell therapy, independently developed by Yuan Ting Technology under Shanghai Shengsheng Group, was used. Pre-processing tests were conducted multiple times in Hong Kong, continuously adjusting the equipment to achieve optimal temperature control for apheresis. The backend project team monitored temperature changes and logistics nodes 24/7.After multiple systematic dynamic validations and simulation exercises, a single-sampling instruction was finally received in December 2024.
From Blood Collection to Delivery, Express Cross-Border Transportation
At 4 a.m., two dedicated vehicles, each following different routes and carrying two identical temperature-controlled boxes (emergency response plan), successively arrived at the Cell Laboratory of Hong Kong's Queen Mary Hospital to complete blood collection. The next day, flight CX356 from HKG to NKG carried "the patient's hope" and landed at Nanjing Airport. Staff from IASO Bio escorted the shipment all the way, ensuring smooth landing, customs clearance inspection, customs supervision, and release until it was successfully delivered to the factory. The entire process was free of X-ray exposure.This project took only 30 hours from blood collection to delivery, representing a best practice in cross-border international transportation.
Successful Infusion of the Product Brings Hope to Patients
Weeks later, the Idecabtagene Vicleucel Injection prepared at the Nanjing production base was placed in a dedicated liquid nitrogen tank by Shengsheng International. After a 24-hour static inspection at Lukou Airport, it flew to Hong Kong HKG Airport, completing airport customs clearance, pickup, warehousing, and final delivery to the hospital, all under stable temperature conditions.The professional operation ability and response speed of IASO Bio's staff have won customer praise. One week later, the first R/RMM patient from Hong Kong successfully received the infusion treatment of Equecabtagene Autoleucel Injection at Queen Mary Hospital.
This breakthrough marks IASO Bio as the first cell therapy company in China to complete the entire process of real patient treatment under Hong Kong's NPP (Named Patient Program), indicating that the injectable drug Equecabtagene Autoleucel has successfully achieved cross-border supply. This paves a new path for the international exploration of China’s Cell and Gene Therapy (CGT) enterprises. Shengsheng International, having participated with honor, expresses deep pride.As Ms. Zhang Jinhua, founder of IASO Bio, said, based on the significant clinical value of the Idecabtagene Vicleucel injection, she believes that CAR-T drugs with international competitiveness will go global and benefit more patients worldwide.IASO Bio will continue to work alongside cell therapy companies, promoting the development of the CGT industry and bringing the hope of a cure to more patients.
About IASO Bio
Nanjing IASO Biotherapeutics Co., Ltd.Co., Ltd.Is an industry-leading biopharmaceutical company focused on the research, development, manufacturing, and commercialization of innovative cell therapies. The company has built its innovative foundation on the development of hematological tumor cell-based drugs and is expanding into the fields of autoimmune diseases and antibody-based drugs, with comprehensive capabilities spanning the entire process from early drug discovery, clinical development, regulatory submission to commercialization.
About Shengsheng International
Shanghai Shengsheng International Logistics Co., Ltd.It is a wholly-owned subsidiary of Shanghai Shengsheng Group, with self-operated sites in Europe, the Americas, and the Asia-Pacific region. In China, it uses major international airports such as Shanghai, Beijing, Guangzhou, and Chengdu as primary import and export ports, providing global customers with end-to-end international pharmaceutical import and export temperature-controlled transportation, clinical supply chain services, as well as customs and trade compliance consulting. The company has a professional service team of 70+, a worldwide cooperative network, and a comprehensive quality management system. It has obtained GDP/GMP/ISO9001 certifications, established cooperative relationships with over 1,800 global clients, and its business covers more than 180 countries. Combined with Shengsheng's extensive network coverage within China, it has become a primary choice for pharmaceutical enterprise clients.
