April 8, 2025
Yajing Chen
Chief Financial Officer
Zai Lab Limited
4560 Jinke Road
Bldg. 1, 4th Floor
Pudong
Shanghai, China
Re: Zai Lab Limited
Form 10-K for Fiscal Year Ended December 31, 2024
Filed February 27, 2025
File No. 001-38205
Dear Yajing Chen:
We have reviewed your filing and have the following comment.
Please respond to this letter 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 comment applies to your facts and circumstances, please tell us why in your
response.
After reviewing your response to this letter, we may have additional
comments.
Form 10-K for Fiscal Year Ended December 31, 2024
General
1. We note the changes to your disclosure appearing at the outset of your
annual report,
in Item 1. Business and Item 1A. Risk Factors relating to legal and
operational risks
associated with operating in China. It is unclear to us that there have
been changes in
the regulatory environment in the PRC since our prior 10-K review
completed on June
10, 2022, warranting revised disclosure to mitigate the challenges you
face and related
disclosures. The Sample Letters to China-Based Companies sought specific
disclosure
relating to the risk that the PRC government may intervene in or
influence your
operations at any time, or may exert control over operations of your
business, which
could result in a material change in your operations and/or the value of
your
securities. We remind you that, pursuant to federal securities rules,
the term control
(including the terms controlling, controlled by, and
under common control
with ) as defined in Securities Act Rule 405 means the possession,
direct or indirect,
April 8, 2025
Page 2
of the power to direct or cause the direction of the management and
policies of a
person, whether through the ownership of voting securities, by contract,
or
otherwise. We do not believe that your revised disclosure conveys the
same risk. In
future filings, please restore your disclosures in these areas to the
disclosures as they
existed in prior filings. For example, and without limitation, we note
that your
disclosure in your Annual Report on Form 10-K does not (i) state that
the PRC
government may intervene in or influence your operations at any time;
(ii) explain
how cash is transferred through your organization; and (iii) discuss the
regulatory
systems affecting your business in China.
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.
Please contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494
if you
have questions regarding comments on the financial statements and related
matters. Please
contact Tyler Howes at 202-551-3370 or Chris Edwards at 202-551-6761 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences