科济药业CT0596（异体BCMA CAR-T）中国注册性I期临床完成首例患者给药

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CARsgen Therapeutics Holdings Limited
科濟藥業控股有限公司
(Incorporated in the Cayman Islands with limited liability)

(Stock Code: 2171)

VOLUNTARY ANNOUNCEMENT
FIRST PATIENT DOSE OF CT0596 IN CHINA PHASE I
REGISTRATIONAL TRIAL
This announcement is made by CARsgen Therapeutics Holdings Limited (the “ Company ” ,
together with its subsidiaries and consolidated affiliated entities, the “Group” or “CARsgen”) on a
voluntary basis to inform the shareholders and potential investors of the Company about the latest
business update of the Group.
The board of directors of the Company (the “Board”) announces that CT0596, an allogeneic
CAR T-cell product targeting BCMA, has completed first patient dose in its registrational Phase I
clinical trial in China for the treatment of patients with relapsed/refractory multiple myeloma (R/R
MM). The IIT results of CT0596 have been presented as the poster presentation at the 2026 Annual
Congress of the European Hematology Association (EHA). Details have been provided on our
corporate website www.carsgen.com.
ABOUT CT0596
CT0596 is an allogeneic BCMA-targeted CAR T-cell therapy developed using CARsgen ’ s
proprietary THANK-u Plus® platform. It is currently being evaluated in registrational Phase I
trial for R/R MM. Previous IITs have shown that CT0596 demonstrated preliminary favorable
tolerability and encouraging efficacy signals in R/R MM and primary plasma cell leukemia. Further
investigation is planned in additional plasma cell malignancies and autoimmune diseases mediated
by autoreactive plasma cells.
ABOUT THE COMPANY
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.
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DEFINITIONS
“CAR”

chimeric antigen receptor

“CAR T-cell”

chimeric antigen receptor T cell

“IIT”

clinical trial sponsored and conducted by independent
investigators

“Phase I”

a study in which a drug is introduced into healthy human subjects
or patients with the target disease or condition and tested for
safety, dosage, tolerance, absorption, metabolism, distribution,
excretion, and if possible, to gain an early indication of its
effectiveness

Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of
Securities on The Stock Exchange of Hong Kong Limited: The Company cannot guarantee that
it will be able to develop, or ultimately market, CT0596, successfully. Shareholders and potential
investors of the Company are advised to exercise caution when dealing in the shares of the
Company.
Cautionary-Language Regarding Forward-Looking Statements
All statements in this announcement 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 announcement. 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 announcement 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
announcement.
By order of the Board
CARsgen Therapeutics Holdings Limited
Dr. Zonghai LI
Chairman
Hong Kong, October 13, 2026

As at the date of this announcement, the Board comprises Dr. Zonghai LI, Dr. Huamao WANG
and Dr. Hua JIANG as executive Directors; Mr. Ronggang XIE as non-executive Director; Dr.
Guangmei YAN, Ms. Xiangke ZHAO and Dr. Wen ZHOU as the independent non-executive
Directors.
In the case of inconsistency, the English text of this announcement shall prevail over the Chinese text.

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