Company: ZLAB
Filing Date: 2025-04-18
Form Type: CORRESP
Source: 0001628280-25-018396
Chunk: 3

Company: Zai Lab Ltd
Filing Date: 2025-04-18
Form: CORRESP
Chunk 3
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 outside of mainland China (as disclosed on page 23 of the Annual Report).

With respect to the disclosures in the Annual Report regarding the regulatory systems affecting the Company’s business in China, we respectfully draw the Staff’s attention to the disclosures under the heading “We are or may be required to obtain certain permissions from Chinese

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authorities to operate in mainland China, transfer certain scientific data, and issue our securities to foreign investors” prior to Item 1 in the Annual Report. The Company has updated these disclosures since the 2021 Annual Report for the purpose of eliminating duplicative disclosure and refocusing the disclosure on the potential impact to the Company of the relevant regulations that represent material risks, rather than on a fulsome and detailed explanation of the history of the regulations. Furthermore, the Company has enhanced this description as compared to the 2021 Annual Report with additional detail regarding the risk arising from regulations on approvals required to transfer scientific data abroad or to foreign parties and to address risks arising from updates to the Trial Measures. The Company also respectfully draws the Staff’s attention to additional disclosures regarding the regulatory systems affecting the Company’s business in China, including without limitation those under the following headings:

• Government Regulation, pages 13-18

• The Chinese government may intervene in or influence our business, which could result in a material change in our operations, strategy, research and development activities, commercial activities, business, financial condition, results of operations, and prospects, page 27

• We are required to obtain certain approvals and licenses from Chinese authorities to operate our Chinese subsidiaries, page 29

• Under Chinese laws and regulations, we may be required by the CSRC or other Chinese regulatory authorities to obtain approval or follow certain procedures to issue our securities to foreign investors, and we cannot predict whether or when we will be able to obtain such approval or complete such procedures, page 29

• We may face further restrictions (or even prohibitions) on our ability to transfer our scientific data abroad if Chinese regulators impose new restrictions (or change their interpretation of existing restrictions) on life sciences companies like us and the scientific data we obtain, generate, and maintain, page 55

The Company respectfully submits that the disclosures described above comply with sample comment 8 of the Staff’s Sample Letter to China-Based Companies. Specifically, the Company respectfully submits that the existing disclosure provides a description of the material permissions or approvals that the Company and its subsidiaries are required to obtain from Chinese authorities to operate its business and to issue securities to foreign investors, including those permissions