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United States securities and exchange commission logo
December 10, 2021
Billy Cho
Chief Financial Officer
Zai Lab, Ltd.
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong
Shanghai, China
Re: Zai Lab, Ltd.
Form 10-K for
Fiscal Year Ended December 31, 2020
Response dated
November 9, 2021
File No. 001-38205
Dear Mr. Cho:
We have reviewed your November 9, 2021 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
September 29, 2021 letter.
Form 10-K for Fiscal Year Ended December 31, 2020
Part I
Item 1. Business, page 1
1. At the onset of Part 1,
please disclose prominently that you are not a Chinese operating
company but a Cayman
Islands holding company that conducts its operations through
wholly owned
subsidiaries based in China and that investors will not hold direct
investments in the
Chinese operating companies. Your disclosure should acknowledge
that Chinese regulatory
authorities could disallow this structure, which would likely result
in a material change in
your operations and/or value of your ADSs, including that it could
cause the value of such
securities to significantly decline or become worthless.
Billy Cho
Zai Lab, Ltd.
December 10, 2021
Page 2
2. We note your response to prior comment two and disclosure on your Form
10-Q for the
quarterly period ending September 30, 2021 (the 2021 Q3 Form 10-Q
) and reissue in
part. On page 1 of the 2021 Q3 Form 10-Q under the heading "Usage of
Terms," we note
that you provide the domicile of each subsidiary. However, please
expand your disclosure
to include the entity (including the domicile) in which investors are
purchasing their
interest. In addition, we note your disclosure, on page 1, stating
that references in the
quarterly report on Form 10-Q to Zai Lab, the Company,
we, us, and our refer
to Zai Lab Limited, a holding company, and its subsidiaries, on a
consolidated basis.
However, we note you refer to Zai Lab Limited and its subsidiaries as
the "Group"
throughout the filing. Please revise your disclosure to be consistent
throughout.
Item 1A. Risk Factors, page 61
3. We note your response to prior comment three and your updated risk
factor disclosure on
page 50 of your 2021 Q3 Form 10-Q and reissue in part. Please address
the following
regarding your response to prior comment three:
Please disclose the consequences to you and your investors if you
inadvertently
conclude that approvals are not required, or applicable laws,
regulations, or
interpretations change.
Regarding your disclosure that you are required to get certain
approvals from Chinese
authorities before transferring certain scientific data abroad or
to foreign parties,
please revise to more clearly disclose whether have you have
received all requisite
permissions and whether any permissions have been denied.
4. We note your response to prior comment four and updated disclosure on
pages 2-3 of
your 2021 Q3 Form 10-Q. As requested in the prior comment, please
include the
disclosures requested in the comment as a separate risk factor as
well.
5. We note your response to prior comment seven. As requested in the
prior comment,
please expand the disclosures in your risk factors. For example, on
page 49 of your 2021
Q3 Form 10-Q, expand your disclosures to state that the Chinese
government may
intervene or influence your operations at any time, which could result
in a material change
in your operations and/or the value of your ADSs and any action 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 such securities to significantly decline or be worthless.
6. We note your response to prior comment eight and updated disclosure on
page 45 of
FirstName LastNameBilly Cho
your 2021 Q3 Form 10-Q. As requested in the prior comment, please expand
your risk
Comapany NameZai
factor Lab,
disclosure to Ltd.
explain to what extent you believe that you are
compliant with the
regulations
December 10, 2021orPage
policies
2 that have been issued by the CAC to date.
FirstName LastName
Billy Cho
FirstName LastNameBilly Cho
Zai Lab, Ltd.
Comapany10,
December NameZai
2021 Lab, Ltd.
December
Page 3 10, 2021 Page 3
FirstName LastName
7. Please revise both the risk factors summary and the Risk Factors
section to move forward
the risks related to doing business in the PRC so that such risks are
prominently disclosed
within each section in relation to other identified material risks.
You may contact Tracie Mariner at 202-551-3744 or Kevin Vaughn at
202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jason Drory at 202-551-8342 or Jeffrey Gabor at 202-551-2544 with any
other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Thomas Danielski