August 2023: Cancer patients who previously had few options now have hope because to CAR-T cell therapy, which has revolutionized the area of cancer treatment. With several clinical trials being conducted to increase the efficacy and safety of CAR-T cell therapy, China has emerged as a leader in this ground-breaking sector. These studies demonstrate the nation’s dedication to improving medical research and offering patients cutting-edge care. Currently there are more than 250 ongoing clinical trials on CAR T Cell therapy in China.
The number of CAR-T therapy trials in China surpassed those in the United States by 2018 as a result of this thriving ecosystem. As of June 2022, Chinese companies have conducted 342 clinical CAR-T trials. Malignancies of the B lineage were among the most prevalent manifestations. Two CAR-T products have commercial applications, Yescarta in June 2021 and Relma-cel in September 2021, among numerous drug candidates.
According to Frost & Sullivan, the domestic CAR-T market is projected to increase from CNY 0.2 billion in 2021 to CNY 8 billion in 2025, and then to CNY 28.9 billion in 2030, at a CAGR of 45% from 2022 to 2030. Despite the fact that the Chinese CAR-T market is still in its infancy, a robust driving force exists.
Although the two approved CAR-T products are from Sino-US joint ventures Fosun Kite and JW Terapeutics, domestic players have made breakthroughs and caught up to global players in recent years. Legend Biotech, IASO Biotherapeutics, and CARsgen Therapeutics all obtain NDA approval for their BCMA CAR-T products, establishing them as the leaders in BCMA CAR-T therapy. CD19 CAR-T products are a focus for Juventas Therapeutics, Gracell Biotechnologies, Hrain Biotechnology, ImunoPharm, Shanghai Cell Therapy Group, and numerous domestic companies. Juventas Therapeutics is the leader in Chinese CD19 CAR-T therapy now that the NMPA has accepted its NDA for CNCT19. CARsgen Therapeutics is a global leader in solid tumours, and CT041 is the first CAR-T candidate for treating solid tumours to enter Phase II clinical trials. Bioheng Biotech and BRL Biotech (Chinese: ) create new allogeneic CAR-T markets.
The State Drug Administration (“NMPA”) has conditionally approved the product of Fosun Kite Biotechnology Co., Ltd., jointly established by Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Kite Pharma of the United States (trade name: Yikaida®) for the treatment of adult patients with large B-cell lymphoma (r/r LBCL) who failed first-line immunochemotherapy or relapsed within 12 months (“this new indication”). The formal debut of Yikaida® for second-line indication occurs at this time as well.
For the treatment of adult large B-cell lymphoma patients who did not react to first-line immunochemotherapy or who relapsed within a year of receiving it, there was previously no CAR-T cell therapy product available in China. A second-line indication was added by Fosun Kite’s Yikaida®. The drug’s approval for marketing has successfully sparked new developments in the management of adult large B-cell lymphoma, giving hope to more patients whose first-line immunochemotherapy has failed or relapsed. The first CAR-T cell therapy product to be licenced in China for this new indication is now Yikaida®.
For adult patients with relapsed or refractory multiple myeloma (RRMM) who have had at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, FUCASO is the first fully-human BCMA-directed chimeric antigen receptor (CAR) T-cell therapy.
A BCMA-directed CAR T cell treatment called FUCASO (Equecabtagene Autoleucel) uses lentivirus as a gene vector to transfect autologous T cells. A fully human scFv, CD8a hinge and transmembrane, 4-1BB-mediated co-stimulation, and CD3 activation domains are all present in the CAR.
FUCASO has showed quick and powerful efficacy as well as prolonged persistency in RRMM patients, delivering higher and deeper responses and long-term clinical benefit, based on selection and screening of the molecular structures, in vivo and in vitro evaluation. The combined development and marketing of FUCASO for the treatment of RRMM in China is the work of Innovent and IASO Bio.
The FUMANBA-1 clinical study, a multi-center phase I/II registrational clinical trial undertaken in China to assess the efficacy of equecabtagene autoleucel in patients with RRMM, was the basis for the NDA approval.
China is leading on clinical trials
Clinical studies for CAR-T cell therapy have advanced significantly in China, where multiple eminent institutes have led ground-breaking study. These clinical trials are designed to assess the efficacy of CAR-T cell therapy in the management of solid tumours, leukaemia, and lymphoma.
Image: One of the hospital’s that runs clinical trials on Car T-cell therapy in China.
A significant study at the Peking University Cancer Hospital examined the use of CAR-T cells to treat acute lymphoblastic leukaemia (ALL) that has relapsed or is resistant to treatment. The research showed promise for CAR-T cell therapy as an effective treatment choice for patients with few other options thanks to its outstanding remission rates.
Additionally, a number of clinical trials have been conducted in China to examine the use of CAR-T cell treatment in solid tumours, a difficult condition with a historically low response to immunotherapies. These trials make use of cutting-edge techniques to increase CAR-T cell efficacy and get around the immunosuppressive tumour microenvironment.
International partnerships have contributed to the clinical trials of CAR-T cell therapy’s success in China. Chinese scholars have worked with well-known organisations all around the world to exchange knowledge and experience, advancing this discipline. Such collaborations have aided in the creation of sophisticated CAR-T cell therapies, including the investigation of combinatorial therapies and the use of cutting-edge gene-editing methods.
Chinese researchers have also been in the forefront of the development of off-the-shelf CAR-T cell products in an effort to circumvent the logistical difficulties posed by personalised CAR-T cell therapy. If successful, these universal CAR-T cell products could provide patients all over the world a more convenient and affordable therapeutic alternative.
The CAR-T cell therapy clinical trials done in China are evidence of the nation’s dedication to developing medical research and enhancing patient outcomes. These trials have the potential to change the face of cancer treatment by showing excellent outcomes in treating both haematological malignancies and solid tumours, providing new hope for patients everywhere.
The groundbreaking cancer treatment CAR T-cell therapy has attracted a lot of attention lately due to its astounding efficacy in curing some tumors. China has emerged as a global leader in the sector, achieving substantial advancements in CAR T-cell research and implementation, despite the fact that the therapy was initially discovered in the United States. CAR-T therapy
is a novel form of cancer treatment using the immune system to eradicate cancer cells. Where other therapies have failed, it has occasionally been able to heal patients. This article will highlight all that you need to know about this procedure and current status of CAR T-Cell therapy in China.
The goal of CAR T-cell therapy is to specifically target cancer cells by reprogramming a patient’s T-cells, which are part of their immune system. In treating hematological malignancies, such as leukemia and lymphoma, where conventional medicines have frequently failed, this individualized therapeutic method has shown encouraging outcomes.
The development of CAR T-cell treatment in China is the result of a number of reasons. The nation’s big patient population, which offers a sizable pool of people for clinical trials and treatment, comes first. Due of the large number of patients, Chinese researchers have been able to collect extensive data and improve their methodologies.
The regulatory climate in China has also facilitated the quick development and widespread use of CAR T-cell treatments. Fast-track approval procedures have been established in the nation for novel medical technology, enabling quick review and uptake of new treatments. For Chinese patients, this has improved the accessibility and availability of CAR T-cell therapies.
Numerous clinical trials have been done to assess the safety and efficacy of these treatments, with Chinese biotech companies and research institutions at the forefront of CAR T-cell therapy research. Notably, the Chinese biotechnology company Juno Therapeutics, working with Chinese medical facilities, has had outstanding success treating patients with B-cell acute lymphoblastic leukemia who have relapsed or are resistant to treatment.
China’s innovations in CAR T-cell treatment have had an impact on the world as well as its own people. Chinese scholars have actively shared their research and worked with international colleagues, advancing the field as a whole. Furthermore, China’s industrial prowess has allowed for the mass production of CAR T-cell therapies, increasing its accessibility and affordability for patients all around the world.
To sum up, China has become a significant actor in the creation and use of CAR T-cell therapy. The nation has advanced in this ground-breaking cancer treatment thanks to its sizable patient population, a supportive regulatory framework, and cooperative research activities. China’s position as a global leader in CAR T-cell treatment is set to grow with ongoing research and innovation, giving cancer patients there and around the world hope.
What is the scope of CAR-T Cell Therapy in China?
The use of chimeric antigen receptor (CAR) T-cell treatments in the treatment of hematological malignancies has been incredibly effective. The application of CAR T-cell treatments has grown in China over the past nine years.
The first CAR T cell clinical studies started in 2013, and by 2017 there were more CAR T cell clinical trials than ever before. Soon after, China announced that it would provide a total of US$237 billion in funding for cell therapy businesses in 2021, which represented a huge increase in the number of clinical trials and fundamental research projects involving CAR T cells.
Strong government support, money inflow, high patient demand, a distinctive healthcare system, and the efforts of Chinese doctors and scientists all contributed to this significant surge in activity in China.