CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2022 FINANCIAL RESULTS BEIJING, China (

CASI PHARMACEUTICALS ANNOUNCES

FOURTH QUARTER AND FULL-YEAR 2022 FINANCIAL

BEIJING, China (April

26, 2023) CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing

and commercializing innovative therapeutics and pharmaceutical products, today reported financial results for the year ended December

31, 2022, and provided an update on key highlights for 2022.

Wei-Wu He, Ph.D., CASI's Chairman and Chief

Executive Officer, commented, "We are pleased to report $10.2 million in EVOMELA revenues for the fourth quarter,

$38 million for the full-year 2022. We have achieved our goal for our full-year 2022 revenue growth to exceed 2021 revenues, with a 26.7%

increase in year on year sales revenue. Our team in China delivered strong performance despite the adverse impact of COVID-19 including

of a Q3-4 rapid national spread of the pandemic and lockdowns in several major cities in China. Through the efforts of the CASI team and

our commercial group of hematology sales and medical marketing specialists in China, we have built a strong foundation for our commercial

franchise. We plan to continue building our commercial franchise throughout 2023 and beyond."

Dr. He continued, "Advancement, development,

and commercialization of the portfolio remains our strategic focus. 2022 marks a major milestone for CASI and our partner Juventas; the

CNCT-19 New Drug Application (NDA) was accepted by National Medical Products Administration (NMPA) in December 2022. We are now diligently

preparing for the anticipated CNCT-19 launch in China, as we continue the development of the regulatory framework for BI-1206 in China.

We completed dosing the first patient in the BI-1206 phase I trial in China. CB-5339 also received Clinical Trial Application approval

from the NMPA in January 2023. The Phase 1 dose escalation and expansion study of CID-103, in patients with previously treated, relapsed

or refractory multiple myeloma is closed to further accrual in France and the UK. We plan to build on the momentum to drive our portfolio

forward by executing on several milestones in the quarters ahead."

Key Highlights for 2022

EVOMELA (melphalan for injection)

Prior to EVOMELA's entry into the Chinese

market, an average of 800 stem cell transplants per year were conducted in the multiple myeloma (MM) treatment setting. Following EVOMELA's

launch in August of 2019, CASI worked closely with KOLs to drive market awareness and expedite adoption in the Chinese market. In 2022,

nearly 10,000 patients were treated with EVOMELA. CASI continues to pursue a similar strategy with respect to marketing efforts and physician

visits to further the adoption of stem cell transplantation as a standard of care in the MM treatment setting and will continue working

to address the persistent high unmet need in this patient population.

CNCT19 (CD19 targeted CAR-T)

Our partner, Juventas Cell Therapy Ltd ("Juventas"),

continues the development of CNCT19, an autologous CD19 CAR-T investigative product for which CASI has co-commercial and profit-sharing

rights. CNCT19 is being developed as a potential treatment for patients with hematological malignancies which express CD19 including,

B-cell acute lymphoblastic leukemia ("B-ALL") and B-cell non-Hodgkin lymphoma ("B-NHL"). The Phase 1 studies in

B-ALL and B-NHL in China have been completed by Juventas. The Phase 2 B-ALL and B-NHL registration studies are both currently enrolling.

In December 2020, CNCT19 received Breakthrough Therapy Designation based on initial data from the ongoing single-arm, open-label, non-randomized,

dose-escalation, Phase 1 study designed to determine the safety and efficacy of CNCT19 in B-ALL. Since then, the National Medical Products

Administration (NMPA) granted CTA approval for CNCT19 in two indications (relapsed/refractory B-All and B-NHL) in Nov. 2019. Additionally,

earlier this year, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Juventas, for CNCT19, for the

treatment of patients with Acute Lymphoblastic Leukemia (ALL). Currently, there are no domestically developed CD-19 CAR-T therapy marketed

in China. CASI intends for CNCT (CD19 CAR-T) to be locally developed and manufactured to be more affordable and widely accessible to patients.

Dec. 15, 2022, China National Medical Products Administration (NMPA) has accepted the new drug application (NDA) from Juventas Cell Therapy,

Ltd., (Juventas) for CNCT19.

CB-5339 (VCP/p97 inhibitor)

CB-5339 CTA application for the Multiple Myeloma

indication is in preparation after receiving an acceptance letter for the CB-5339 IND package from the China Center of Drug Evaluation.

Cleave Therapeutics is responsible for the ex-China development of CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor,

and is evaluating the molecule in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome

BI-1206 (Anti-FcyRIIB antibody)

Along with our partner, BioInvent, we continue

to progress the development and regulatory framework for BI-1206 in China. The National Medical Products Administration (NMPA) granted

BI-1206 Clinical Trial Application (CTA) approval in December 2021. EC approval from a leading investigational site was granted in January

2022. BI-1206 is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the

treatment of non-Hodgkin lymphoma, which includes patients with FL, MCL and marginal zone lymphoma (MZL) who have relapsed or are refractory

to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab)

in solid tumors. Earlier this year the U.S. FDA granted orphan drug designation, for BI-1206, for the treatment of follicular lymphoma

(FL), the most common form of slow-growing non-Hodgkin lymphoma (NHL).

CID-103 (Anti-CD38 Mab)

CID-103 is a fully human IgG1 anti-CD38 monoclonal

antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38

monoclonal antibodies. CASI maintains exclusive global rights and is developing CID-103 for the treatment of patients with multiple myeloma.

The Phase 1 dose escalation and expansion study of CID-103 in patients with previously treated relapsed or refractory multiple myeloma

is closed to further accrual in France and the UK. Future multiple myeloma development activities will be focused on China. In May 2022,

CASI entered into a sublicense agreement with Precision Autoimmune Therapeutics, who will carry out the development activities for the

autoimmune indications for CID-103.

Fourth Quarter & Full-Year 2022 Financial Results

Further information regarding the Company, including

its Annual Report on Form 20-F for the year ended December 31, 2022, can be found at www.casipharmaceuticals.com.

About CASI Pharmaceuticals

CASI Pharmaceuticals, Inc. is a 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. More information on CASI is available at www.casipharmaceuticals.com.

Forward-Looking Statements

This announcement contains forward-looking statements.

These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995.

These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates,"

"future," "intends," "plans," "believes," "estimates," "confident"

and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's

strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements

in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in in its annual report to shareholders,

in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements

that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements.

Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially

from those contained in any forward-looking statement, including but not limited to the following: the risk that we may be unable to continue

as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be

delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the

market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty

of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development,

commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments

in China that adversely affect our ability to operate in China, our lack of experience in manufacturing products and uncertainty about

our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products

and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability

to predict when or if our product candidates will be approved for marketing by the U.S. Food and Drug Administration, European Medicines

Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to enter into strategic partnerships

for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the risks

relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated