ROCKVILLE, Md. and BEIJING, Dec. 15,
2022 /PRNewswire/ -- CASI Pharmaceuticals, Inc.
(Nasdaq: CASI), a U.S. biopharmaceutical company focused on
developing and commercializing innovative therapeutics and
pharmaceutical products, today announces that China National
Medical Products Administration (NMPA) has accepted the new drug
application (NDA) from Juventas Cell Therapy, Ltd., (Juventas) for
CNCT19 (Inaticabtagene Autoleucel), an investigational CD-19
directed CAR-T therapy, for the treatment of adult patients with
relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (r/r
B-ALL).
CNCT19 is the first CAR-T cell therapy for the treatment of
B-ALL submitted for NDA and has the potential to be the first
approved domestic developed CD19 directed CAR-T therapy in
China. Owing to the unique CD19
scFv(HI19a)structure and the leading CMC manufacturing techniques,
CNCT19 indicated an 100% success rate of drug production from r/r
B-ALL patients in the registrational trial. It has been granted the
Orphan Drug Designation from the FDA and the Breakthrough
Designation status by the China Center of Drug Evaluation
(CDE).
The r/r B-ALL NDA submission for CNCT19 contains the initial
data from study NCT04684147, a Phase II, single-arm, open-label,
single-dose, multicenter clinical trial. The study results reveal
that CNCT19 has demonstrated a high level of efficacy, durable
remissions, and substantially reduced CAR-T related toxicity for
the treatment of adults with r/r B-ALL. Professor Wang Jianxiang,
the Principal Investigator of CNCT19 from the Institute of
Hematology and Blood Diseases Hospital, and his team presented the
study results at the 64th Annual Meeting of American Hematology
(2022 ASH) on December 12th,
2022.
CNCT19 CAR-T cell therapy achieved outstanding ORRs with high
rates of MRD-negative complete remission in adult patients with r/r
B-ALL within three months and by the end of the third month. Of the
39 evaluable patients, 32 (82.1%) patients reached CR/CRi within
three months and 25 (64.1%) patients remained CR/CRi by the end of
the third months. The CR rates were 66.7% (26/39) and 51.3% (20/39)
respectively. The MRD-negative rate was 100% (32/32) within three
months and persisted at 92% (23/25) by the end of the third month.
Median duration of response (DOR) has not been reached.
The most common CNCT19 related adverse events (AEs) were
cytokine release syndrome (CRS) and neuro toxicity (NT). There were
4 cases of Grade ≥3 CRS (n=4, 10.3%) and 3 cases of Grade ≥ 3 NT
(n=3, 7.7%). Following CNCT19 infusion, all the patients recovered
without any unexpected AEs reported.
Dr. Wei-Wu He, CASI's Chairman
and CEO commented, "CNCT19 NDA acceptance by NMPA represents a
significant milestone. We are in preparation for the anticipated
CNCT-19 commercial launch. This product is truly exciting as it
proved to have significant clinical benefits for unmet medical
needs. CASI and Juventas will work side by side to deliver CNCT19
to patients in China, and
eventually worldwide."
About CASI
Pharmaceuticals
CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company
focused on developing and commercializing innovative therapeutics
and pharmaceutical products in China, the United
States, and throughout the world. The Company is focused on
acquiring, developing, and commercializing products that augment
its hematology oncology therapeutic focus as well as other areas of
unmet medical need. The Company intends to execute its plan to
become a leader by launching medicines in the Greater China market, leveraging the Company's
China-based regulatory and
commercial competencies and its global drug development expertise.
The Company's operations in China
are conducted through its wholly-owned subsidiary, CASI
Pharmaceuticals (China) Co., Ltd.,
located in Beijing, China. The
Company has built a commercial team of more than 100 hematology and
oncology sales and marketing specialists based in China. More information on CASI is available
at www.casipharmaceuticals.com.
About Juventas Cell Therapy
Ltd.
Juventas is a biopharmaceutical company headquartered in
China dedicated to the development
and commercialization of cell therapies globally. Utilizing
innovative and integrated technology platforms, the company has
developed a diverse pipeline of cellular immunotherapies for
treatment of hematological malignancies, solid tumors, and other
non-oncological conditions both in China and globally. At present, the company is
conducting two pivotal clinical trials of CNCT19 for treating adult
r/r-B-ALL and r/r-B-NHL in China.
CNCT19 has the potential to become the first launched domestically
developed CD19 CAR-T therapy in China and the first CAR-T product for the
treatment of adult R/R B-ALL in China.
Forward-Looking
Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act with
respect to the outlook for expectations for future financial or
business performance, revenue growth, strategies, expectations, and
goals. Forward-looking statements are subject to numerous
assumptions, risks, and uncertainties, which change over time.
Forward-looking statements speak only as of the date they are made,
and we assume no duty to update forward-looking statements. New
factors emerge from time to time, and it is not possible for us to
predict which factors will arise. In addition, we cannot assess the
impact of each factor on our business or the extent to which any
factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements. Actual results could differ materially from those
currently anticipated due to a number of factors.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
Phone: 240.864.2643
Email: ir@casipharmaceuticals.com
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SOURCE CASI Pharmaceuticals, Inc.