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CORRESP
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CASI PHARMACEUTICALS, INC.

9620 Medical Center Drive, Suite 300

Rockville, MD, 20850

December 16, 2022

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

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

We refer to the letter
dated December 7, 2022 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. At the onset of Part I, please disclose prominently that you
are not a Chinese operating company but a US holding company with operations conducted by your Chinese subsidiaries. In addition, please
provide early in the Business section a diagram of the company’s corporate structure.

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, disclose prominently on the
onset of the Annual Reports as set forth below:

Holding Company Structure

CASI
Pharmaceuticals, Inc. is not a Chinese operating company but a U.S. holding company with a significant portion of the business
operations conducted by its Chinese subsidiaries. See “Item 1. Business — Business Development,” “Item 1. Business
 — CASI Pharmaceuticals (China) Co., Ltd.,” “Item 1. Business — CASI Pharmaceuticals (Wuxi) Co., Ltd.” and
 “Item 1. Business — China Operations” for further information.

This holding company structure and our operation
in China may involve risks. See “Item 1A. Risk Factors — Risks Relating to Our Business Operations in China.”

In addition, the Company will, in its future Annual Reports, 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, 2021, the diagram of the Company’s corporate structure would have read
as follows:

    2

2. 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 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.

The Company respectfully submits that it will, in its future Annual
Reports, add a risk factor titled “[t]he 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”
as set forth below, subject to updates and adjustments to be made in connection with any material development of the subject matter
being disclosed:

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.

We conduct a significant
portion of our business through our PRC subsidiaries. Our operations in China are governed by PRC laws and regulations. The legal system
in China evolves rapidly, and the interpretations of laws, regulations, and rules may contain uncertainties. These uncertainties
could limit the legal protections available to us. In addition, we cannot predict the effect of future developments in the PRC legal system,
including the promulgation of new laws, changes to existing laws or the interpretation or enforcement thereof, or the preemption of local
regulations by national laws. Such unpredictability towards our contractual, property (including intellectual property) and procedural
rights could adversely affect our business and impede our ability to continue our operations, which may in turn cause the value of our
securities to significantly decline or be worthless. From time to time, we may have to resort to court and administrative proceedings
to enforce our legal rights. However, since the authorities in China have significant discretion in interpreting and implementing statutory
and contractual terms, it may be more difficult to predict the outcome of a judicial or administrative proceeding in China than in other
legal systems.

As of the date of this
annual report, our PRC subsidiaries have obtained the requisite licenses and permits from the PRC government authorities that are material
for our business operations, including, among others, the Business License, the Drug Distribution License, the Clinical Trial Application
with China National Medical Products Administration, and the notification filing for international collaborative clinical trial or the
application for international collaborative scientific research with the China Human Genetic Resources Administrative Office( “HGRAO”).
We also work with our business partners which have obtained the requisite license and permits for their business collaboration with us,
including among others the Import Drug Registration for product(s) we promote and distribute in China. Given the uncertainties of interpretation
and implementation of relevant laws and regulations and the enforcement practice by relevant government authorities, we may be required
to obtain additional licenses, permits, or approvals in the future, failure to obtain which may hinder our ability to carry out our business
plan or continue our business operations.

    3

As of the date of this
annual report, we and our PRC subsidiaries (i) are not required to obtain permissions from the China Securities Regulatory Commission,
or the CSRC, (ii) are not required to go through cybersecurity review by the Cyberspace Administration of China, or the CAC, and
(iii) have not been asked to obtain or were denied such permissions by any PRC authority. On July 7, 2022, the CAC published the
Guidelines for Data Export Security Assessment (《数据出境安全评估办法》)
(the “Guidelines”), which took effect on September 1, 2022. Pursuant to the Guidelines, the data processor who intends to
transfer certain important data or large volume of personal information outside of China shall complete a prior CAC-led data outbound
transfer security assessment. However, as the Guidelines has just come into effect, there is no specific enforcement guidelines or interpretation
for such security assessment, including what constitutes “important data”, or how to define “outbound transfer”,
which results in uncertainties whether our business will be subject to such CAC-led assessment. For the data we accessed through or obtained
from clinical trials, we have complied with the laws and regulations then-in-effective, and completed the registration with HGRAO, but
it is unclear if we will be required to go through the CAC-led or CAC-involved security assessment or the current HGRAO registration procedure
will be changed in the future. We will closely monitor and review any regulatory development and comply with any new approval or license
requirement when necessary. If (i) we inadvertently conclude that such permissions or approvals are not required, or (ii) applicable laws,
regulations, or interpretations change and we are required to obtain such permissions or approvals in the future, we may have to expend
significant time and costs to procure them. If we are unable to do so, on commercially reasonable terms, in a timely manner or otherwise,
we may become subject to sanctions imposed by the PRC regulatory authorities, which could include fines and penalties, proceedings against
us, and other forms of sanctions, and our ability to conduct our business, invest into China as foreign investments or accept foreign
investments, or be listed on a U.S. or other overseas exchange may be restricted, and our business, reputation, financial condition, and
results of operations may be materially and adversely affected.

In addition, new laws
and regulations may be enacted from time to time, and PRC laws, rules, and regulations can evolve quickly with little advance notice.
Substantial uncertainties exist regarding the interpretation and implementation of current and any future PRC laws and regulations applicable
to our businesses. In particular, the PRC government authorities may continue to promulgate new laws, regulations, rules and guidelines
with respect to a wide range of issues, such as competition and antitrust, intellectual property, and other matters, which may result
in additional obligations imposed on us, and may impact our ability to conduct our business, accept foreign investments, or list on a
U.S. or other foreign exchange. Compliance with these laws, regulations, rules, guidelines, and implementations may be costly, and any
incompliance or associated inquiries, investigations, and other governmental actions may divert significant management time and attention
and our financial resources, bring negative publicity, subject us to liabilities or administrative penalties, or materially and adversely
affect our business, financial condition, and results of operations.

    4

The PRC government authorities may exert more control
and strengthen oversight over offerings that are conducted overseas and/or foreign investment in overseas-listed China-based issuers like
us. Such actions taken by the PRC government authorities may intervene and/or influence our operations at any time, which are beyond our
control. There is no assurance that any new rules or regulations promulgated in the future will not impose additional requirements
on us. If the PRC government authorities later promulgate new rules or explanations requiring that we obtain their approvals or complete
filing procedures with them for our future overseas offerings, we may be unable to obtain such approvals or complete such filing procedures
in a timely manner, or at all, and such approvals or filings may be rescinded even if obtained or completed. Any such circumstance could
significantly limit or completely hinder our ability to continue to offer securities to investors and cause the value of such securities
to significantly decline or be worthless. In addition, implementation of industry-wide regulations directly targeting our operations could
cause the value of our securities to significantly decline or become worthless. Therefore, investors of our company and our business face
potential uncertainty from actions taken by the PRC government affecting our business.

3. We note your disclosure on page 40 that your auditor is subject
to the determinations announced by the PCAOB on December 16, 2021. Please prominently disclose that in this section 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 future Annual
Reports, revise the risk factor titled “[o]ur Common Stock will be prohibited
from trading in the United States under the Holding Foreign Companies Accountable Act, or the HFCAA, in 2024 if the PCAOB is unable to
inspect or fully investigate auditors located in China, or in 2023 if proposed changes to the law are enacted. The delisting of our Common
Stock, or the threat of such Common Stock being delisted, may materially and adversely affect the value of your investment” (marked
against the language as set forth in the Company’s quarterly report on Form 10-Q for the three months ended June 30, 2022 filed
on August 12, 2022), subject to updates and adjustments to be made in connection with any material development of the subject matter
being disclosed:

Our Common Stock will be prohibited
from trading in the United States under the Holding Foreign Companies Accountable Act, or the HFCAA, in 2024 if the PCAOB is unable to
inspect or fully investigate auditors located in China, or in 2023 if proposed changes to the law are enacted. The delisting of our Common
Stock, or the threat of such Common Stock being delisted, may materially and adversely affect the value of your investment.

    5

The Holding Foreign Companies
Accountable Act, or the HFCAA, was signed into law on December 18, 2020. The HFCAA states if the SEC determines that we have filed audit
reports issued by a registered public accounting firm that has not been subject to inspection for the PCAOB for three consecutive years
beginning in 2021, the SEC shall prohibit our Common Stock from being traded on a national securities exchange or in the over-the-counter
trading market in the United States. On December 2, 2021, the SEC adopted final amendments implementing the disclosure and submission
requirements of the HFCAA, pursuant to which the SEC will identify an issuer as a “Commission Identified Issuer” if the issuer
has filed an annual report containing an audit report issued by a registered public accounting firm that the PCAOB has determined it is
unable to inspect or investigate completely, and will then impose a trading prohibition on an issuer after it is identified as a Commission-Identified
Issuer for three consecutive years. On December 16, 2021, the PCAOB issued a report to notify the SEC of its determination that the PCAOB
is unable to inspect or investigate completely registered public accounting firms headquartered in mainland China and Hong Kong. The PCAOB
identified our auditor as one of the registered public accounting firms that the PCAOB is unable to inspect or investigate completely.
We have been identified by the SEC as a “Commission Identified Issuer” after the filing of our annual report on 10-K for the
fiscal year ended December 31, 2021. If we are so identified for another two consecutive years, our Common Stock will be prohibited
from being traded on a national securities exchange or in the over-the-counter trading market in the United States, and as a result our
Common Stock may be delisted from the Nasdaq Capital Market.

Whether the PCAOB will
be able to conduct inspections of our auditor before the issuance of our financial statements on Form 10-K for the year ending December
31, 2023 which is due by March 31, 2024, or at all, is subject to substantial uncertainty and depends on a number of factor