United States securities and exchange commission logo





                              December 30, 2020

       William Cao, Ph.D.
       Chief Executive Officer
       Gracell Biotechnologies Inc.
       Building 12, Block B. Phase II
       Biobay Industrial Park
       218 Sangtian St.
       Suzhou Industrial Park, 215123
       People's Republic of China

                                                        Re: Gracell
Biotechnologies Inc.
                                                            Registration
Statement on Form F-1
                                                            Filed December 18,
2020
                                                            File No. 333-251494

       Dear Dr. Cao:

              We have reviewed your registration statement 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 this letter by amending your registration
statement and providing the
       requested information. If you do not believe our comments apply to your
facts and
       circumstances or do not believe an amendment is appropriate, please tell
us why in your
       response.

              After reviewing any amendment to your registration statement and
the information you
       provide in response to these comments, we may have additional comments.

       Registration Statement on Form F-1

       Overview, page 1

   1.                                                   We reissue comment 1 in
part. Please revise the summary to include information about
                                                        each of the risks for
which we sought disclosure in the summary in comment 1, in
                                                        particular the risk
that shareholders may be required to file a return and be taxed by the
                                                        PRC (as discussed on
page 82), and the risks related to the discretion of Chinese
                                                        governmental
authorities to influence your business and operations addressed in the last
                                                        bullet point of your
response. Finally, revise the summary to include the risk of being
                                                        delisted (discussed on
pages 89-90).
 William Cao, Ph.D.
Gracell Biotechnologies Inc.
December 30, 2020
Page 2
2.       We reissue comment 2. The disclosure changed from the initial claims
of safety, efficacy
         and potency, to "potentially enhanced efficacy and safety," to the
current disclosure
         regarding "potentially enhanced therapeutic effects" and similar
language. The revisions
         still claim some degree of safety and/or efficacy, which are
determinations solely within
         the authority of the FDA and comparable foreign regulators, and
determined throughout
         all phases of clinical trials. Please remove all such references.
3.       We reissue comment 3 insofar as you continue to state that the product
"is first-in-class in
         its design" on page 163.
4.       We reissue comment 4. Revise your pipeline table to equally
prominently label the
         arrows representing those product candidates in development in
investigator-initiated
         trials in China, i.e., label the blue arrows as you have done the
green arrows. To further
         avoid misinterpretation, revise to provide separate arrows for planned
INDs in the United
         States, indicating the preclinical status of each of those product
candidates. Also revise
         the table to clearly convey the limited scope of your involvement in
the investigator-
         initiated studies and lack of access to those studies. Revise the
added disclosure on page 8
         to disclose that you do not have access to the data from these
studies, and to balance your
         statement of your intent to "expedite [y]our global clinical
development activities" with
         disclosure clarifying there are no guarantees this strategy will be
successful or will speed
         development.
5.       To avoid confusion with the FDA's Center for Drug Evaluation and
Research (CDER),
         where you first mention the Center for Drug Evaluation, on page 6,
revise to clarify that it
         is a division of the NMPA. Define NMPA and FDA at their first use in
the new disclosure
         on page 5. Revise throughout your document to make these distinctions
clear.
Risks Related to this Offering, Our Securities and Our Status as a Public
Company, page 93

6.       Refer to the added exclusive forum risk factor on page 100. You
disclose that the United
         States District Courts will be the exclusive forum for Securities Act
claims. We note that
         Section 22 of the Securities Act creates concurrent jurisdiction for
federal and state courts
         over all suits brought to enforce any duty or liability created by the
Securities Act or the
         rules and regulations thereunder. Revise to state that investors
cannot waive compliance
         with the federal securities slaws and the rules and regulations
thereunder.
Risk Factors
General Risk Factors, page 102

7.     We note your revised disclosure in response to comment 5. To the extent
your operations
       and the investigator-initiated trials are located in China and the
pandemic could affect
FirstName LastNameWilliam Cao, Ph.D.
       your clinical trials, it appears at least that portion of the risk
factor should be addressed
Comapany
       moreNameGracell
             prominently Biotechnologies
                            in another part ofInc.
                                                the risk factors, rather than
as a "general" risk that
       any company    could
December 30, 2020 Page 2      face.
FirstName LastName
 William Cao, Ph.D.
FirstName  LastNameWilliam
Gracell Biotechnologies Inc. Cao, Ph.D.
Comapany30,
December   NameGracell
              2020       Biotechnologies Inc.
December
Page 3    30, 2020 Page 3
FirstName LastName
Intellectual Property, page 176

8.       Refer to comment 13. We note you filed the licensing agreements as
requested in
         comment 23 of our initial letter; however, you did not expand your
disclosure here or
         elsewhere, as appropriate, to provide the material terms of the
license agreement with
         ProMab, as referenced on page 68. Revise to provide this disclosure.
Taxation, page 239

9.       We reissue comment 15. Your disclosure continues to describe what
potential tax
         consequences are "likely," if certain events occur. You must provide
an opinion of
         counsel. To the extent the tax consequences are subject to
uncertainty, counsel may
         describe what the tax consequences "should" or are "more likely than
not" to be, but
         counsel must also describe why it cannot give a "will" opinion, and
describe the degree of
         uncertainty. In addition, revise statements such in this subsection,
to avoid statements
         such as "our company," so it is clear this section provides the
opinion of tax counsel, not
         the company.
Exhibits

10.      Revise Exhibit 5.1, the Cayman Islands legal opinion, to remove all
inappropriate
         assumptions and qualifications, including those reflected in Schedules
1, 2 and the third
         item of Schedule 3. Revise paragraph 3 to clarify that the shares will
be non-assessable.
         Refer to Section II.B.1.a. of Staff Legal Bulletin No. 19 for
guidance.
11.      Revise Exhibit 99.2 to provide an unqualified opinion. The language
"[b]ased on our
         understanding of the current PRC Laws," and the noted "substantial
uncertainties"
         outlined are inappropriate. Clarify in the opinion and the
accompanying text in the
         registration statement that counsel has opined on the material tax
consequences under
         PRC law, not that counsel opines the summary is accurate. Revise the
penultimate
         paragraph to clarify "your use," so that it is clear that security
holders are entitled to rely
         on this opinion.
 William Cao, Ph.D.
FirstName  LastNameWilliam
Gracell Biotechnologies Inc. Cao, Ph.D.
Comapany30,
December   NameGracell
              2020       Biotechnologies Inc.
December
Page 4    30, 2020 Page 4
FirstName LastName
        We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.

       Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.

        You may contact Franklin Wyman at (202) 551-3660 or Sasha Parikh at
(202) 551-3627
if you have questions regarding the financial statements and related matters.
Please contact
Abby Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with any other
questions.



                                                           Sincerely,

                                                           Division of
Corporation Finance
                                                           Office of Life
Sciences
cc:      Will Cai, Esq.