Summary
Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, has treated a number of multiple myeloma patients from New Zealand. One patient, 50-year-old Sara, was diagnosed three years ago and relapsed this year. Her local doctor told her CAR-T therapy might be the last effective option, but the treatment is not yet available in New Zealand.
On the recommendation of other New Zealand patients who had been treated in Shanghai with good results, she was admitted to Renji Hospital in September and received an infusion of her customised CAR-T cell product, Fucaso, in mid-September. The product was independently developed by Chinese innovative company IASO Biotherapeutics and specifically targets relapsed or refractory multiple myeloma. Clinical data show that more than 70 per cent of patients achieve complete remission, with tumours disappearing within three months, and the longest survival has reached eight to nine years.
It is also the world's first fully human BCMA-targeted CAR-T therapy. Founder and CEO Zhang Jinhua said the company found in 2015 that animal-derived antibodies triggered a high level of anti-antibody response in the body, so it chose a fully human sequence to reduce immunogenicity and achieve longer efficacy. CAR-T involves live biological samples, and the process from blood collection to arrival at the factory must be completed within 48 hours.
The Waigaoqiao Free Trade Zone has introduced a joint regulatory and whitelist facilitation policy for special human biological items, and the Pudong New Area Enterprise Go-Global Comprehensive Service Centre helps connect cold-chain logistics and shorten airport pickup and customs clearance times. The drug was approved in Singapore in June this year, its marketing application in Australia has been accepted, and clinical trials and registration are progressing in parallel in South Korea, the Middle East and other regions. The company is working on next-generation CAR-T therapies that could one day be injected directly into the body to generate anti-cancer cells without extracting a patient's immune cells, with the potential for lower prices.
Commentary
New Zealand multiple myeloma patients travelling to Shanghai for Chinese CAR-T treatment reflects the rapid rise of China's cell therapy industry. Fucaso, independently developed by IASO Biotherapeutics, is the world's first fully human BCMA-targeted CAR-T therapy. Clinical data show more than 70 per cent of patients achieve complete remission, with the longest survival reaching eight to nine years, demonstrating internationally competitive efficacy.
For New Zealand small and medium-sized business owners, this development signals new opportunities in China-New Zealand medical cooperation: New Zealand has not yet approved CAR-T therapy, while the Chinese product has already filed for marketing approval in Australia. If approved in the Australia-New Zealand region in future, it could create niche markets in cross-border medical intermediation, cold-chain logistics and patient support services. At the same time, the internationalisation of Chinese pharmaceutical companies offers potential collaboration opportunities for New Zealand biotechnology firms, for example in clinical trials, data management or localisation services.
On the other hand, New Zealand's domestic health system faces accessibility challenges with high-cost innovative therapies, and the government may seek cooperation with more cost-effective Chinese pharmaceutical companies, creating space for consultancies familiar with the regulatory environments of both countries. From an industry perspective, the global CAR-T market is dominated by giants such as Novartis and Gilead, but Chinese pharmaceutical companies are rewriting the competitive rules by using fully human technology to reduce immunogenicity and free trade zone customs facilitation to compress costs. New Zealand businesses should monitor the registration progress of Chinese pharmaceutical companies in the Australia-New Zealand region and prepare supporting services in advance, rather than waiting until therapies are launched before acting.
Keywords: CAR-T, multiple myeloma, Renji Hospital, IASO Biotherapeutics, Fucaso, fully human BCMA, New Zealand patients, Waigaoqiao Free Trade Zone, Singapore approval
Photo by TheDigitalArtist on Pixabay
Source: Kankan News Network
Disclaimer: This article is compiled from publicly available sources for general information only. The analysis and commentary are editorial opinions. MiDeer Observer does not guarantee the accuracy or completeness of the information provided. Readers should seek independent professional advice before relying on this content, or contact us for more information.
