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CORRESP
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CASI PHARMACEUTICALS, INC.

9620 Medical Center Drive, Suite 300

Rockville, MD, 20850

January 19, 2023

VIA EDGAR

Ms. Christine Torney

Mr. Kevin W. Vaughn

Ms. Ada Sarmento

Mr. Joe McCann

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

100 F Street, N.E.

Washington, D.C. 20549

    Re:
    CASI Pharmaceuticals, Inc.

    Form 10-K for the Fiscal Year Ended December 31, 2021 (the “2021 Annual Report”)

    Form 10-Q for the Interim Period Ended September 30, 2022 (the “2022 Quarterly Report”)

    File No. 000-20713 and Response dated December 16, 2022

Dear Ms.
Torney, Mr. Vaughn, Ms. Sarmento and Mr. McCann:

We refer to the letter
dated January 6, 2023 from the Division of Corporation Finance of the United States Securities and Exchange Commission (the “Staff”) regarding
certain comments on the 2021 Annual Report and the 2022 Quarterly Report of CASI Pharmaceuticals, Inc. (together with its subsidiaries,
the “Company” or “we”) filed with the Commission on March 28, 2022 and November 14, 2022, respectively. Set
forth below are our responses to the Staff’s comments. For your convenience, we have also restated the Staff’s comments
below in bold.

*          *          *

Annual Report on Form 10-K for the Fiscal Year Ended December
31, 2021

Part I

Item 1. Business, page 4

1. We note your proposed revisions in response to prior comment
1. In future filings, please revise the diagram of your corporate structure to indicate who owns the remaining 20% of CASI Pharmaceuticals
(Wuxi) Co., Ltd.

The Company respectfully submits that it will, in its future annual
reports (the “Annual Reports”) and subject to updates and adjustments to be made in connection with any material development
of the subject matter being disclosed, provide a diagram of the Company’s corporate structure under “Item 1. Business —
Business Development.” As an illustration, for the fiscal year ended December 31, 2022, the diagram of the Company’s corporate
structure would have read as follows:

2. We note your proposed revisions to the risk factors section in
response to prior comment 2. In future filings, please also revise Item 1. Business to provide prominent disclosure about the legal and
operational risks associated with being based in or having the majority of the company’s operations in China. Your disclosure should
make clear whether these risks could result in a material change in your operations and/or the value of your securities or could significantly
limit or completely hinder your ability to offer or continue to offer securities to investors and cause the value of such securities to
significantly decline or be worthless. Your disclosure should address how recent statements and regulatory actions by China’s government,
such as those related to data security or antimonopoly concerns, have or may impact the company’s ability to conduct its business,
accept foreign investments, or list on a U.S. or other foreign exchange.

The Company respectfully submits that it will, in its future Annual
Reports and subject to updates and adjustments to be made in connection
with any material development of the subject matter being disclosed, disclose under “Item 1. Business — Risks and Uncertainties
Relating to Doing Business in China” (immediately following the section titled “Business Development”) as set forth
below:

      2

Risks and Uncertainties Relating to Doing Business
in China

We face various risks and uncertainties related
to doing business in China. Our business operations are primarily conducted in China, and we are subject to complex and evolving PRC laws
and regulations. For a detailed description of risks related to doing business in China, please refer to risks disclosed under “Item
1.A Risk Factors — Risks Relating to Our Business Operations in China.”

PRC government’s significant authority in
regulating our operations and its oversight and control over offerings conducted overseas by, and foreign investment in, China-based issuers
could significantly limit or completely hinder our ability to offer or continue to offer securities to investors and cause the value of
our securities to significantly decline or be worthless. Implementation of industry-wide regulations, including data security or anti-monopoly
related regulations, in this nature could result in a material change in our operations and may cause the value of our securities to significantly
decline or become worthless. Risks and uncertainties arising from the legal system in China, including risks and uncertainties regarding
the enforcement of laws and quickly evolving rules and regulations in China, could result in a material adverse change in our operations
and the value of our common stock. For example, the China’s government has made in recent years statements and regulatory actions
to regulate certain market players or to improve its supervision of the market in general, such as those related to data security or anti-monopoly
concerns. While we currently do not believe such regulatory actions have materially impacted our business operations, our ability to accept
foreign investments, or our ability to maintain listing with Nasdaq, there is no assurance that any new rules or regulations promulgated
in the future will not impose additional requirements on us. If any such rules or regulations is adopted, we may be subject to more stringent
regulatory scrutinizes for our operation and financing efforts, which may in turn result in more compliance costs and expenses to be incurred
by us, delay our investment and financing activities, or otherwise impact our ability to conduct our business, accept foreign investments,
or list on a U.S. or other foreign exchange. For more details, see “Item 1.A Risk Factors — Risks Relating to Our Business
Operations in China — The legal system in China embodies uncertainties which could impose additional requirements and obligations
on our business, and PRC laws, rules, and regulations can evolve quickly with little advance notice, which may materially and adversely
affect our business, financial condition, and results of operations.”

3. We note your proposed revisions to the risk factors section in
response to prior comment 3. In future filings, please also revise Item 1. Business to prominently disclose that your auditor is subject
to the determinations announced by the PCAOB on December 16, 2021 and disclose whether and how the Holding Foreign Companies Accountable
Act and related regulations will affect your company. In addition, disclose that trading in your securities may be prohibited under the
Holding Foreign Companies Accountable Act if the PCAOB determines that it cannot inspect or investigate completely your auditor, and that
as a result an exchange may determine to delist your securities.

The Company respectfully submits that it will, in its Annual Reports
and subject to updates and adjustments to be made in connection with
any material development of the subject matter being disclosed, disclose under “Item 1. Business — Risks Relating to Our
Auditor” (immediately following the section titled “Risks and Uncertainties Relating to Doing Business in China”) as
set forth below:

      3

Risks Relating to Our Auditor

Our auditor, the independent registered public
accounting firm that issues the audit report contained elsewhere in this annual report, as an auditor of companies that are traded publicly
in the United States and a firm registered with the PCAOB, is subject to laws in the United States pursuant to which the PCAOB conducts
regular inspections to assess its compliance with the applicable professional standards. Our auditor is located in mainland China, a jurisdiction
where the PCAOB was historically unable to conduct inspections and investigations completely before 2022. As a result, we and investors
in CASI’s common stock were deprived of the benefits of such PCAOB inspections. Pursuant to the Holding Foreign Companies Accountable
Act, or the HFCAA, if the SEC determines that we have filed audit reports issued by a registered public accounting firm that has not been
subject to inspections by the PCAOB for two consecutive years, the SEC will prohibit our securities from being traded on a national securities
exchange or in the over-the-counter trading market in the United States.

On December 16, 2021, the PCAOB issued a report
to notify the SEC of its determination that the PCAOB was unable to inspect or investigate completely registered public accounting firms
headquartered in mainland China and Hong Kong and our auditor was subject to that determination. In April 2022, the SEC conclusively listed
us as a Commission-Identified Issuer under the HFCAA following the filing of our annual report on Form 10-K for the fiscal year ended
December 31, 2021. On December 15, 2022, the PCAOB issued a report that vacated its December 16, 2021 determination and removed mainland
China and Hong Kong from the list of jurisdictions where it is unable to inspect or investigate completely registered public accounting
firms. For this reason, we do not expect to be identified as a Commission-Identified Issuer under the HFCAA after we file this annual
report on Form 10-K.

Each year in the future, the PCAOB will determine
whether it can inspect and investigate completely audit firms in mainland China and Hong Kong, among other jurisdictions. If the PCAOB
determines in the future that it no longer has full access to inspect and investigate completely accounting firms in mainland China and
Hong Kong and we use an accounting firm headquartered in one of these jurisdictions to issue an audit report on our financial statements
filed with the Securities and Exchange Commission, we would be identified as a Commission-Identified Issuer following the filing of the
annual report for the relevant fiscal year. In accordance with the HFCAA, our securities would be prohibited from being traded on a national
securities exchange or in the over-the-counter trading market in the United States if we are identified as a Commission-Identified Issuer
for two consecutive years in the future. If our securities are prohibited from trading in the United States, there is no certainty that
we will be able to list on a non-U.S. exchange or that a market for our securities will develop outside of the United States. A prohibition
of being able to trade in the United States would substantially impair your ability to sell or purchase our common stock when you wish
to do so, and the risk and uncertainty associated with delisting would have a negative impact on the price of such securities. Also,
such a prohibition would significantly affect our ability to raise capital on terms acceptable to us, or at all, which would have a material
adverse impact on our business, financial condition, and prospects.

      4

For more details, see “Item 1.A Risk Factors
 — Risks Relating to Our Auditor.”

4. We note your proposed revisions in response to prior comment
4. In future filings, please also revise Item 1. Business to provide a clear description of how cash is transferred through your organization.
Disclose your intentions to distribute earnings. Quantify any cash flows and transfers of other assets by type that have occurred between
the holding company and its subsidiaries, and direction of transfer. Quantify any dividends or distributions that a subsidiary has made
to the holding company and which entity made such transfer, and their tax consequences. Similarly quantify dividends or distributions
made to U.S. investors, the source, and their tax consequences. Your disclosure should make clear if no transfers, dividends, or distributions
have been made to date. Describe any restrictions on foreign exchange and your ability to transfer cash between entities, across borders,
and to U.S. investors. Describe any restrictions and limitations on your ability to distribute earnings from the company, including your
subsidiaries, to the parent company and U.S. investors. We also note your disclosure that CASI Pharmaceuticals, Inc. paid service fees
of $19.5 million to CASI Pharmaceuticals (China) Co., Ltd. in the year ended December 31, 2021 and that no assets other than cash were
transferred through the organization during that time. Please revise to make it clear whether the service fees were the only cash that
was transferred during the fiscal year. If not, please specifically disclose the other transfers that were made.

The Company respectfully submits that it will, in its Annual Reports
and subject to updates and adjustments to be made in connection with any
material development of the subject matter being disclosed, disclose under “Item 1. Business — Cash and Asset Transfer among
the Company and its Subsidiaries” (immediately following the section titled “Risks Relating to Our Auditor”).

As
an illustration, for the fiscal year ended December 31, 2021, the disclosure would have read as follows:

Cash and Asset Transfer among the Company
and its Subsidiaries

CASI Pharmaceuticals, Inc. provides funding to
its subsidiaries from time to time through capital contributions or loans, subject to satisfaction of applicable government registration
and approval requirements. For the year ended December 31, 2021, CASI Pharmaceuticals, Inc. made $10.0 million funding through capital
contributions to one of its subsidiaries.

The subsidiaries of CASI Pharmaceuticals, Inc.
may pay dividends and make other distributions to CASI Pharmaceuticals, Inc, subject to satisfaction of applicable government filing and
approval requirements. Such dividend or other distributions may be subject to limitations and certain tax consequences, a discussion on
which is set forth below. For the year ended December 31, 2021, no dividends or other distributions were made by subsidiaries of CASI
Pharmaceuticals, Inc.

      5

CASI Pharmaceuticals, Inc. also pays service fees to its PRC subsidiaries
pursuant to certain sales support service agreement and research and development support service agreement. For the year ended December
31 2021, CASI Pharmaceuticals, Inc. paid service fees of $19.5 million to CASI Pharmaceuticals (China) Co., Ltd., one of its PRC subsidiaries.
Under PRC tax laws and regulations, earning of our subsidiaries under such agreements are subject to a statutory tax rate of 25%.

In the year ended December 31, 2021, no assets
other than cash were transferred through our organization.

All cash transfers among CASI Pharmaceuticals,
Inc. and its subsidiaries have been eliminated in the Company’s consolidated statement of cash flows.

The existing PRC foreign exchange regulations may
limit our ability to initiate and complete the cash transfers within our group. Approval from China’s State Administration of Foreign
Exchange (“SAFE”) and the People’s Bank of China (“PBOC”) may be required where RMB are to be converted
into foreign currencies, including U.S. dollars, and approval from SAFE and the PBOC or their branches may be required where RMB are to
be remitted out of mainland China. Please see “Item 1A. Risk Factors —
Risks Relating to Our Business Operations in China — Governmental control of currency conversion and payments of RMB out
of mainland China may limit our ability to utilize our cash balances effectively and affect the value of your investment.”

The Company has never declared or paid dividends
on its Common Stock or any other securities and does not anticipate paying any dividends in the foreseeable future. We may rely on dividends
from our subsidiaries in China to pay dividend and other distributions on our Common Stock. PRC regulations may restrict the ability of
our PRC subsidiaries to pay dividends to us. In addition to applicable foreign exchange limitations, under the current regulatory regime
in China, a PRC company may pay dividends only out of their accumulated profit, if any,