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January 6, 2023
Larry Zhang
Principal Financial Officer
CASI Pharmaceuticals, Inc.
9620 Medical Center Drive
Suite 300
Rockville, MD 20850
Re:CASI Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2021
Form 10-Q for the Interim Period Ended September 30, 2022
File No. 000-20713
Dear Larry Zhang:
            We have reviewed your December 16, 2022 response to our comment letter and have the
following comments.  In some of our comments, we may ask you to provide us with information
so we may better understand your disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional
comments.  Unless we note otherwise, our references to prior comments are to comments in our
December 7, 2022 letter.
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.
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

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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 anti-
monopoly 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.
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.
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.
5.We note your proposed revisions to the risk factors section in response to prior comment
5. In future filings, please also revise Item 1. Business to disclose each permission or
approval that you or your subsidiaries are required to obtain from Chinese authorities to
operate your business and to offer securities to foreign investors. State whether you or
your subsidiaries are covered by permissions requirements from the China Securities
Regulatory Commission (CSRC), Cyberspace Administration of China (CAC) or any
other governmental agency that is required to approve your operations, and state
affirmatively whether you have received all requisite permissions or approvals and

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CASI Pharmaceuticals, Inc.
January 6, 2023
Page 3
whether any permissions or approvals have been denied. Please also describe the
consequences to you and your investors if you or your subsidiaries: (i) do not receive or
maintain such permissions or approvals, (ii) inadvertently conclude that such permissions
or approvals are not required, or (iii) applicable laws, regulations, or interpretations
change and you are required to obtain such permissions or approvals in the future.
Item 1 A. Risk Factors, page 20
6.We note your proposed revision to add a risk factor in response to prior comment 6 and
re-issue. In your summary of risk factors, disclose the risks that your corporate structure
and being based in or having the majority of the company’s operations in China poses to
investors. In particular, describe the significant regulatory, liquidity, and enforcement
risks. For example, specifically discuss risks arising from the legal system in China,
including risks and uncertainties regarding the enforcement of laws and that rules and
regulations in China can change quickly with little advance notice; and the risk that the
Chinese government may intervene or influence your operations at any time, or may exert
more control over offerings conducted overseas and/or foreign investment in China-based
issuers, which could result in a material change in your operations and/or the value of
your securities. Acknowledge any risks that any actions by the Chinese government to
exert more oversight and control over offerings that are conducted overseas and/or foreign
investment in China-based issuers could significantly limit or completely hinder your
ability to offer or continue to offer securities to investors and cause the value of your
securities to significantly decline or be worthless.
General
7.Please provide us with a copy of your proposed disclosure for comments one through six
in your response letter.
            You may contact Christine Torney at 202-551-3652 or Kevin Vaughn at 202-551-3494 if
you have questions regarding comments on the financial statements and related matters.  Please
contact Ada Sarmento at 202-551-3798 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences