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SHANGHAI, Aug. 15, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, has announced its 2025 Interim Results.
Business Highlights
- Cash and bank balances were around RMB1,261 million as of June 30, 2025. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than RMB1,100 million. We expect to have adequate cash into the 2028 excluding subsequent cash inflows.
- During H1 2025, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces or cities. CARsgen has received a total of 111 confirmed orders from its commercialization partner Huadong Medicine.
- The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for satri-cel.
- The results of satri-cel confirmatory Phase II trial in China have been published in The Lancet and at the 2025 ASCO Annual Meeting.
- Multiple allogeneic CAR-T products are in development, covering treatment areas such as hematologic malignancies, solid tumors, and autoimmune diseases.
- CARsgen introduced Zhuhai SB Xinchuang to accelerate allogeneic CAR-T development in mainland China.
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "In the first half of 2025, we made significant strides across technology innovation, product development, and commercialization. Zevor-cel sales surged, while satri-cel became the world's first CAR-T targeting solid tumors to file an NDA. We are also advancing multiple allogeneic CAR-T therapies to enhance clinical outcomes and expand patient access."
Financial Highlights
CARsgen's revenue was around RMB51 million for the six months ended June 30, 2025, mainly from zevor-cel, which was calculated on the basis of ex-works price, rather than end-of-market prices. Our revenue is recognized upon completion of ex-works delivery of products. Due to the inherent time cycle of CAR-T manufacturing, there is a discrepancy between the number of orders obtained from Huadong Medicine and number of ex-works deliveries. CARsgen's gross profit was around RMB29 million for the six months ended June 30, 2025. In the commercialization stage, we are demonstrating a strong cost competitive advantage, which is mainly due to self-manufacture for plasmids and vectors with stable output and high yield per batch.
Cash and bank balances were around RMB1,261 million as of June 30, 2025, representing a decrease of around RMB218 million from around RMB1,479 million as of December 31, 2024. The decrease was mainly due to the payment of research and development expenses, administrative expenses and investment of capital expenditure. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than RMB1,100 million. We expect to have adequate cash into the 2028 excluding subsequent cash inflows.
Zevor-cel Demonstrates Rapid Sales Growth
Zevorcabtagene autoleucel (zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product against B-cell maturation antigen (BCMA) approved by the NMPA of China for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent).
CARsgen entered into a collaboration agreement with Huadong Medicine (000963.SZ) for the commercialization of zevor-cel in mainland China. In terms of commercialization, Huadong Medicine has established a dedicated, professional, and comprehensive commercial team to promote the use of zevor-cel and has been utilizing China's multi-layered insurance system to improve patient accessibility. During the first half of 2025, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces or cities and we have received a total of 111 confirmed orders from Huadong Medicine. We anticipate that growth of sales revenue of zevor-cel will further accelerate with continuous marketing activities and broader insurance coverage.
Satri-cel NDA Accepted for Review in China
Satricabtagene autoleucel (satri-cel, R&D code: CT041) is an autologous humanized CAR T-cell product against Claudin18.2 (CLDN18.2). In June 2025, the CDE of NMPA of China has accepted the New Drug Application (NDA) for satri-cel for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Satri-cel is the first and only CAR T-cell product globally for which an NDA submitted for the treatment of solid tumors. Satri-cel was granted Priority Review in May 2025 and Breakthrough Therapy Designation (BTD) in March 2025 by the CDE.
The results of satri-cel confirmatory Phase II trial (NCT04581473) in China have been published in The Lancet and were orally presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Satri-cel demonstrated significant progression-free survival (PFS) improvement and a clinically meaningful overall survival (OS) benefit with a manageable safety profile, compared to standard therapy.
Multiple Allogeneic CAR-T Product Candidates in Development
CARsgen has been advancing differentiated allogeneic CAR T-cell products utilizing the proprietary THANK-uCAR® platform. CARsgen has recently developed the THANK-u PlusTM platform as an enhanced version of THANK-uCAR® to address the potential impact of NKG2A expression levels on therapeutic efficacy of the allogeneic CAR T-cells.
CT0596 is an allogeneic BCMA-targeted CAR T-cell product utilizing THANK-u Plus™ platform for the treatment of R/R MM and R/R plasma cell leukemia (PCL). The investigator-initiated trials (IITs) are ongoing in China. Preliminary clinical data for CT0596 were released in May 2025 on CARsgen's official website. Based on the preliminary safety and efficacy data, CT0596 demonstrated favorable tolerability and encouraging efficacy signals in R/R MM patients across all predefined dose levels, with CAR-T expansion observed.
In addition, there are several allogeneic CAR T-cell products under development:
- KJ-C2219: Targeting CD19/CD20, for the treatment of hematologic malignancies and autoimmune diseases. An IIT for relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) has been initiated at the end of 2024. A separate IIT for systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) has been initiated in the first half of 2025.
- KJ-C2320: Targeting CD38, for the treatment of acute myeloid leukemia (AML). An IIT has been initiated at the end of 2024.
- KJ-C2114: For the treatment of solid tumors.
- KJ-C2526: Targeting NKG2DL, for the treatment of AML, other malignancies, and senescence.
On February 25, 2025, CARsgen has entered into the agreements (the "Agreements") with an investment fund (the "Investor") managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership), pursuant to which, among others, the Investor has agreed to subscribe to additional registered capital of UCARsgen Biotech Limited ("UCARsgen") at a cash consideration of RMB80,000,000, representing 8% stake of the enlarged registered capital of UCARsgen. Upon the completion of the capital increase, CARsgen's share in UCARsgen will be diluted from 100% to 92%.
UCARsgen is a China-based new drug discovery biotechnology company focused on allogeneic CAR T-cell therapies for the treatment of hematologic malignancies. Under the Agreements, UCARsgen has secured the exclusive rights in mainland China for the research, development, manufacture, and commercialization of the following allogeneic CAR T-cell products from CARsgen: the BCMA-targeted allogeneic CAR T-cell therapy for the treatment of multiple myeloma and plasma cell leukemia and the CD19/CD20 dual-targeted allogeneic CAR T-cell therapy for the treatment of B-cell malignancies (excluding indications for the treatment of autoimmune diseases).
About CARsgen Therapeutics Holdings Limited
CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable.
Forward-looking Statements
All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.
For more information, please visit https://www.carsgen.com/
SHANGHAI, Aug. 15, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, has announced its 2025 Interim Results.
Business Highlights
- Cash and bank balances were around RMB1,261 million as of June 30, 2025. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than RMB1,100 million. We expect to have adequate cash into the 2028 excluding subsequent cash inflows.
- During H1 2025, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces or cities. CARsgen has received a total of 111 confirmed orders from its commercialization partner Huadong Medicine.
- The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for satri-cel.
- The results of satri-cel confirmatory Phase II trial in China have been published in The Lancet and at the 2025 ASCO Annual Meeting.
- Multiple allogeneic CAR-T products are in development, covering treatment areas such as hematologic malignancies, solid tumors, and autoimmune diseases.
- CARsgen introduced Zhuhai SB Xinchuang to accelerate allogeneic CAR-T development in mainland China.
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "In the first half of 2025, we made significant strides across technology innovation, product development, and commercialization. Zevor-cel sales surged, while satri-cel became the world's first CAR-T targeting solid tumors to file an NDA. We are also advancing multiple allogeneic CAR-T therapies to enhance clinical outcomes and expand patient access."
Financial Highlights
CARsgen's revenue was around RMB51 million for the six months ended June 30, 2025, mainly from zevor-cel, which was calculated on the basis of ex-works price, rather than end-of-market prices. Our revenue is recognized upon completion of ex-works delivery of products. Due to the inherent time cycle of CAR-T manufacturing, there is a discrepancy between the number of orders obtained from Huadong Medicine and number of ex-works deliveries. CARsgen's gross profit was around RMB29 million for the six months ended June 30, 2025. In the commercialization stage, we are demonstrating a strong cost competitive advantage, which is mainly due to self-manufacture for plasmids and vectors with stable output and high yield per batch.
Cash and bank balances were around RMB1,261 million as of June 30, 2025, representing a decrease of around RMB218 million from around RMB1,479 million as of December 31, 2024. The decrease was mainly due to the payment of research and development expenses, administrative expenses and investment of capital expenditure. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than RMB1,100 million. We expect to have adequate cash into the 2028 excluding subsequent cash inflows.
Zevor-cel Demonstrates Rapid Sales Growth
Zevorcabtagene autoleucel (zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product against B-cell maturation antigen (BCMA) approved by the NMPA of China for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent).
CARsgen entered into a collaboration agreement with Huadong Medicine (000963.SZ) for the commercialization of zevor-cel in mainland China. In terms of commercialization, Huadong Medicine has established a dedicated, professional, and comprehensive commercial team to promote the use of zevor-cel and has been utilizing China's multi-layered insurance system to improve patient accessibility. During the first half of 2025, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces or cities and we have received a total of 111 confirmed orders from Huadong Medicine. We anticipate that growth of sales revenue of zevor-cel will further accelerate with continuous marketing activities and broader insurance coverage.
Satri-cel NDA Accepted for Review in China
Satricabtagene autoleucel (satri-cel, R&D code: CT041) is an autologous humanized CAR T-cell product against Claudin18.2 (CLDN18.2). In June 2025, the CDE of NMPA of China has accepted the New Drug Application (NDA) for satri-cel for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Satri-cel is the first and only CAR T-cell product globally for which an NDA submitted for the treatment of solid tumors. Satri-cel was granted Priority Review in May 2025 and Breakthrough Therapy Designation (BTD) in March 2025 by the CDE.
The results of satri-cel confirmatory Phase II trial (NCT04581473) in China have been published in The Lancet and were orally presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Satri-cel demonstrated significant progression-free survival (PFS) improvement and a clinically meaningful overall survival (OS) benefit with a manageable safety profile, compared to standard therapy.
Multiple Allogeneic CAR-T Product Candidates in Development
CARsgen has been advancing differentiated allogeneic CAR T-cell products utilizing the proprietary THANK-uCAR® platform. CARsgen has recently developed the THANK-u PlusTM platform as an enhanced version of THANK-uCAR® to address the potential impact of NKG2A expression levels on therapeutic efficacy of the allogeneic CAR T-cells.
CT0596 is an allogeneic BCMA-targeted CAR T-cell product utilizing THANK-u Plus™ platform for the treatment of R/R MM and R/R plasma cell leukemia (PCL). The investigator-initiated trials (IITs) are ongoing in China. Preliminary clinical data for CT0596 were released in May 2025 on CARsgen's official website. Based on the preliminary safety and efficacy data, CT0596 demonstrated favorable tolerability and encouraging efficacy signals in R/R MM patients across all predefined dose levels, with CAR-T expansion observed.
In addition, there are several allogeneic CAR T-cell products under development:
- KJ-C2219: Targeting CD19/CD20, for the treatment of hematologic malignancies and autoimmune diseases. An IIT for relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) has been initiated at the end of 2024. A separate IIT for systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) has been initiated in the first half of 2025.
- KJ-C2320: Targeting CD38, for the treatment of acute myeloid leukemia (AML). An IIT has been initiated at the end of 2024.
- KJ-C2114: For the treatment of solid tumors.
- KJ-C2526: Targeting NKG2DL, for the treatment of AML, other malignancies, and senescence.
On February 25, 2025, CARsgen has entered into the agreements (the "Agreements") with an investment fund (the "Investor") managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership), pursuant to which, among others, the Investor has agreed to subscribe to additional registered capital of UCARsgen Biotech Limited ("UCARsgen") at a cash consideration of RMB80,000,000, representing 8% stake of the enlarged registered capital of UCARsgen. Upon the completion of the capital increase, CARsgen's share in UCARsgen will be diluted from 100% to 92%.
UCARsgen is a China-based new drug discovery biotechnology company focused on allogeneic CAR T-cell therapies for the treatment of hematologic malignancies. Under the Agreements, UCARsgen has secured the exclusive rights in mainland China for the research, development, manufacture, and commercialization of the following allogeneic CAR T-cell products from CARsgen: the BCMA-targeted allogeneic CAR T-cell therapy for the treatment of multiple myeloma and plasma cell leukemia and the CD19/CD20 dual-targeted allogeneic CAR T-cell therapy for the treatment of B-cell malignancies (excluding indications for the treatment of autoimmune diseases).
About CARsgen Therapeutics Holdings Limited
CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable.
Forward-looking Statements
All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.
For more information, please visit https://www.carsgen.com/
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
CARsgen Therapeutics Announces 2025 Interim Results
ALULA, Saudi Arabia, Jan. 16, 2026 /PRNewswire/ -- Today marks the official opening of Desert X AlUla 2026, the landmark fourth edition of the international, open-air biennial exhibition. Arts AlUla, in collaboration with Desert X, welcomes visitors to experience a stellar line-up of Saudi and international multi-generational artists whose site-responsive earthworks, sculptures, and installations will engage in a powerful dialogue with the awe-inspiring landscapes and layered heritage of AlUla.
As a premier destination rich in ancient history and breathtaking nature, AlUla, located in Northwest Saudi Arabia, solidifies its position on the global stage as a dynamic, emerging land art destination with Desert X AlUla, the region's first public art biennale, and a key highlight of the AlUla Arts Festival.
The 2026 edition of Desert X AlUla brings together 11 acclaimed artists whose diverse works reflect a wide spectrum of ideas, materials, and traditions. From monumental kinetic sculpture to sound-based explorations above and below ground, each commission is deeply rooted in relationships to AlUla's distinctive environment, further cementing Desert X AlUla's reputation as a globally significant platform for site-responsive land art.
Desert X AlUla runs until February 28, 2026, as a cornerstone of the annual AlUla Arts Festival. Curated by Wejdan Reda, Zoé Whitley, with artistic direction by Neville Wakefield, and Raneem Farsi, its fourth edition explores 'Space Without Measure.' Inspired by Kahlil Gibran, the theme fosters contemplation of imagination within AlUla's natural settings. The exhibition, set in the desert canyons of AlUla, serves as a pre-opening programme for Wadi AlFann, offering a pivotal glimpse into AlUla's plans to create a permanent land art 'Valley of the Arts.'
Hamad Alhomiedan, Director of Arts & Creative Industries at the Royal Commission for AlUla (RCU), said: "At Desert X AlUla 2026, audiences will engage with art that deeply converses with AlUla's unique landscapes and rich heritage. These compelling commissions highlight AlUla's dynamic transformation into a major global destination, where ancient and contemporary expressions converge. This exhibition is part of our broader revitalisation of AlUla as a culturally rich destination to live, work and visit and integral to positioning AlUla in the global dialogue of contemporary art and as a precursor to monumental projects like Wadi AlFann."
Participating artist/artworks are:
- Sara Abdu, A Kingdom Where No One Dies: Contours of Resonance
- Mohammad Alfaraj, What was the Question Again?
- Mohammed AlSaleem, The Thorn, AlShuruf Unit, The Triangles, Flower Bud, and Al Ahilla (courtesy of Royal Commission for Riyadh City)
- Tarek Atoui, The Water Song
- Bahraini-Danish, Bloom
- Maria Magdalena Campos-Pons, Imole Red
- Agnes Denes, The Living Pyramid
- Ibrahim El-Salahi, Haraza Tree
- Basmah Felemban, Murmur of Pebbles
- Vibha Galhotra, Future Fables
- Héctor Zamora, Tar HyPar
For further information, please contact:
Sabrine.Shaw@bursonglobal.com
AlUlaArtsFestival@bursonglobal.com
Multimedia gallery:
High-resolution photos of all 11 artists and their artworks can be found here.
About AlUla and Arts AlUla
Located 1,100 km from Riyadh, in North-West Saudi Arabia, AlUla is a place of extraordinary natural and human heritage. The vast area, covering 22,561km², includes a lush oasis valley, towering sandstone mountains and ancient cultural heritage sites dating back thousands of years to when the Lihyan and Nabataean kingdoms reigned.
The most well-known and recognised site in AlUla is Hegra, the principal southern city of the Nabataean Kingdom and Saudi Arabia's first UNESCO World Heritage Site. AlUla is also home to ancient Dadan, the capital of the Dadan and Lihyan Kingdoms and considered to be one of the most developed 1st millennium BCE cities of the Arabian Peninsula, and Jabal Ikmah, an open air library of hundreds of inscriptions and writings in many different languages. AlUla Old Town Village, a labyrinth of more than 900 mudbrick homes was developed from at least the 12th century and has been revitalised as the vibrant hub for visitors and residents.
The creation of Arts AlUla within The Royal Commission for AlUla (RCU) is a commitment to crafting the next chapters in a millennia of artistic creation – celebrating cultural inheritance and shaping a future inspired by artists built be artists. The work of Arts AlUla seeks to preserve this legacy: fuse the old with the new; the local with the international, keeping the arts central to the spirit of AlUla as a place of extraordinary natural and human heritage.
Wadi AlFann, meaning 'Valley of the Arts,' will be a global cultural destination for land art, unveiling from 2028 onwards, where era-defining works by artists from around the world will be permanently sited in the monumental landscape of AlUla, the extraordinary desert region of north-west Saudi Arabia.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Desert X AlUla 2026: monumental land art exhibition opens in the ancient oasis of AlUla