# CARsgen Therapeutics Announces 2026 Interim Results

- Link: https://www.thailand-business-news.com/pr-news/carsgen-therapeutics-announces-2026-interim-results
- Published: 2026-08-19T07:15:00+07:00
- Author: PR Newswire

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SHANGHAI, Aug. 19, 2026 /PRNewswire/ — CARsgen Therapeutics Holdings Limited (Stock
Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies,
has announced its 2026 Interim Results.

**Business Highlights**

 ◦ Cash and cash equivalents were around RMB1,400 million as of June 30, 2026. Cash
   and cash equivalents at the end of 2026 are expected to be not less than RMB1,200
   million. In light of operational factors, we expect to have adequate cash into
   2030.
 ◦ During H1, 2026, CARsgen has received a total of 110 confirmed orders of zevor-
   cel from its commercialization partner Huadong Medicine.
 ◦ Satri-cel receives NMPA approval in June 2026 as world’s first and only CAR-T
   for solid tumors. Data of satri-cel as sequential therapy after 1L treatment 
   in patients with G/GEJA have been presented at the 2026 ASCO Annual Meeting.
 ◦ Multiple allogeneic CAR T-cell products are under development based on the proprietary
   THANK‑u Plus^(®) platform. Among them, research results for CT0596 in the treatment
   of R/R MM and PCL, as well as for CT1190B in the treatment of R/R B‑NHL, have
   been presented at the EHA2026 Congress. In August 2026, both products successively
   received IND approvals from the NMPA.
 ◦ _In vivo_ CAR T-cell products are under development based on the proprietary 
   CARvivo™ platform. An IIT of KJ‑C2529, which targets CD19/CD20 for the treatment
   of B‑cell malignancies, has been initiated.

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief
Scientific Officer of CARsgen Therapeutics, said, "In the first half of 2026, CARsgen
achieved a historic breakthrough—satri-cel became the world’s first approved CAR‑
T product for solid tumors. This milestone not only validates our decade‑long dedication
and persistence in the solid tumor field, but also underscores our leading position
in the global CAR T-cell therapy landscape. Meanwhile, the commercialization of 
zevor-cel is progressing steadily, with continuous improvements to the diversified
payment system and increasing product accessibility. The Company maintains a sound
financial position, and our ample cash reserves provide a solid foundation for our
ongoing global expansion, advancement into earlier lines of treatment, and development
of next‑generation allogeneic/_in vivo_ CAR‑T technologies. Looking ahead, we will
remain true to our founding mission of ‘Making Cancer Curable,’ accelerate forward‑
looking therapeutic explorations, and actively expand into both domestic and international
markets, bringing more innovative CAR T-cell therapy products to cancer patients
worldwide."

**Financial Highlights**

CARsgen’s revenue was around RMB62 million for the six months ended June 30, 2026
mainly from zevorcabtagene autoleucel (an autologous BCMA CAR T-cell product), in
which the primary revenue of zevorcabtagene autoleucel was calculated on the basis
of ex-works price, rather than on the basis of 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 RMB42 million for the six months ended June 30, 2026. 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 cash equivalents were around RMB1,400 million as of June 30, 2026. Cash
and cash equivalents at the end of 2026 are expected to be not less than RMB1,200
million. In light of operational factors, we expect to have adequate cash into 2030.

[⌊Pipeline⌉⌊Pipeline⌉[
Pipeline

**Steady Commercialization Progress of Zevor-cel**

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 National
Medical Products Administration (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) in 2024. In December 2025, zevor-cel was included in China’s Commercial Health
Insurance Innovative Drug Catalogue (2025).

CARsgen entered into a collaboration agreement with Huadong Medicine (000963.SZ)
for the commercialization of zevor-cel in Chinese Mainland. 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 2026,
certification and regulatory filings for zevor-cel have been completed in more than
20 provinces or cities and we have received a total of 110 confirmed orders from
Huadong Medicine.

**Satri-cel Receives NMPA Approval as World’s First CAR-T for Solid Tumors**

Satricabtagene autoleucel (satri-cel, R&D code: CT041) is a world’s first-in-class,
autologous humanized CAR T-cell product against Claudin18.2. Satri-cel targets the
treatment of Claudin18.2-positive solid tumors with a primary focus on gastric/gastroesophageal
junction cancer (G/GEJA) and pancreatic cancer (PC).

The New Drug Application (NDA) for satri-cel was approved by NMPA for patients with
Claudin18.2-positive, HER2-negative advanced G/GEJA who have failed at least two
prior lines of therapy in China in June 2026. This marks the world’s first and only
approved CAR T-cell therapy for solid tumor treatment. The approval is supported
by confirmatory Phase II trial (CT041-ST-01, NCT04581473) data, published in _The
Lancet_ and presented as an oral presentation at the 2025 ASCO Annual Meeting in
June 2025.

The latest clinical data of a case report on long-term peritoneal metastasis control
in 3 patients with advanced gastric cancer treated with satri-cel monotherapy has
been published in the _Journal of Hematology & Oncology _in July 2026. All patients
achieved both clinical and radiographic benefits post-treatment, with durable control
of peritoneal disease observed. The maximum follow-up period reached 48 months, 
significantly outperforming the historical survival data for patients with gastric
cancer and peritoneal metastasis and demonstrating remarkable potential to fundamentally
alter the natural course of the disease.

To translate this landmark clinical value into commercial impact, we have established
a competitive in-house commercial team to lead domestic sales. Backed by deep oncology
domain expertise and proven clinical promotion experience, the team is well positioned
to drive efficient hospital access and product commercialization. In the early commercialization
phase, we will prioritize satri-cel rollout across leading oncology hospitals and
cell therapy centers at top-tier general hospitals nationwide. Leveraging expert
collaborations, we will rapidly set clinical benchmarks and build market recognition.

Satri-cel has been included in 2026 China Society of Clinical Oncology (CSCO) Guidelines
for Diagnosis and Treatment of Gastric Cancer issued by CSCO, and China Anti-Cancer
Association (CACA) Guidelines for Commercial Insurance Application of Innovative
Oncology Diagnosis and Treatment Technology issued by the CACA. Satri-cel also passed
preliminary formal review for 2026 National Commercial Insurance Innovative Drug
Catalogue. The multi-payment system is to be established to reduce the financial
burden of Chinese patients.

After satri-cel received marketing approval from the NMPA, the Company persistently
pushes forward its global development strategy. Prioritizing key regions with high
unmet medical needs and accessible regulatory pathways, the Company will adopt diversified
overseas development models, with core overseas markets and major regional hubs 
listed as the top priorities for registration expansion. The Company plans to conduct
well-planned marketing authorization filings in selected regional hub markets, aiming
to harness the radiating advantages of these hubs to establish a firm foundation
for commercial launches in various regions going forward.

Building on its proven clinical benefit in later-line populations, satri-cel is 
being actively advanced into earlier lines of therapy and perioperative care to 
unlock deeper therapeutic value. The Company is actively expanding satri-cel application
in early-line treatment and perioperative treatment of cancer: including an ongoing
Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217),
an IIT for consolidation treatment following adjuvant therapy in patients with resected
G/GEJA (CT041-CG4010, NCT06857786) and an IIT for sequential therapy following first-
line treatment for G/GEJA (CT041-CG4011, NCT07179484).

Promising data for early line treatment have been presented at top global oncology
congresses. The long-term analysis results of satri-cel, as sequential therapy after
first-line treatment in patients with advanced G/GEJA, have been presented as a 
poster presentation at the 2026 ASCO Annual Meeting. Two patients received satri-
cel infusions following first-line sequential therapy and subsequently underwent
surgery; one had an OS of more than 58 months, and the other had an OS of more than
51 months. We believe satri-cel has tremendous room for value growth as it moves
into earlier lines of care, with the potential to redefine standard of care and 
bring long-term survival benefits to a wider patient population.

**Robust Pipeline of Allogeneic CAR T-Cell Products**

In addition to autologous products, CARsgen has also been advancing differentiated
allogeneic CAR-T-cell products utilizing the THANK-u Plus^(®) platform, an update
version of THANK-uCAR^(®) technology platform.

CT0596 is a BCMA-targeting allogeneic CAR T-cell product candidate deploying our
THANK-u Plus^(®) technology. IITs have been initiated in China to evaluate the safety
and efficacy of CT0596 for the treatment of R/R MM and plasma cell leukemia (PCL).
In August 2026, the IND clearance was achieved from NMPA in China for R/R MM. CT0596
will initiate a Phase I registrational trial. Updated IIT results have been presented
at the 2026 Annual Congress of the European Hematology Association ("EHA") in June
2026.

CT1190B (KJ-C2219) is an allogeneic CAR T-cell product candidate targeting CD19/
CD20 deploying our THANK-u Plus^(®) technology, for B-cell malignancies. IITs for
refractory/relapsed B-cell non-Hodgkin lymphoma (R/R B-NHL) have been initiated.
In August 2026, the IND clearance was achieved from NMPA in China for the treatment
of patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) who have failed
at least two prior lines of standard therapy. CT1190B will initiate a Phase I registrational
trial. Updated IIT results have been presented at the 2026 Annual Congress of the
EHA in June 2026.

In addition, multiple products against different targets are currently under development:
CT1390B against CLL1 for AML; KJ-C2526 against NKG2DL for AML, other malignancies
and senescence; KJ-C2527 against Claudin18.2 for G/GEJA, etc.; KJ-C2630 against 
GPC3 for hepatocellular carcinoma (HCC), etc.

**Development of ****_In Vivo_**** CAR T-Cell Products**

CARsgen is developing a portfolio of differentiated _in vivo_ CAR T-cell product
candidates based on the proprietary CARvivo™ platform, featuring self-developed,
patent-protected viral envelopes and T-cell-specific promoters. The platform achieves
exceptionally high transduction efficiency and robust cell-type specificity, which
reduces the risk of off-target transduction in tumor cells and lowers the incidence
of antigen masking and therapeutic resistance.

KJ-C2529 is an _in vivo_ CAR T-cell product candidate against CD19/CD20 deploying
our CARvivo™ platform for the treatment of B-cell lymphoma. An IIT has been initiated
in 2026 for the treatment of R/R B-NHL.

Other _in vivo_ CAR T-cell products currently being developed include KJ-C2632 against
BCMA/GPRC5D for R/R MM; KJ-C2633 against CD19/BCMA for R/R MM and autoimmune disease;
KJ-C2634 against Claudin18.2 for G/GEJA, etc.; KJ-C2635 against GPC3 for HCC, etc.

**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](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/](https://www.carsgen.com/)

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