Company: ZLAB
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001628280-25-008409
Chunk: 155

Company: Zai Lab Ltd
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1A
Chunk 155
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 healthcare payors, patients, and the medical community; 

•improve access to, and affordability of, our commercial products, such as through NRDL listings or supplemental insurance coverage in the private-pay market; 

•maintain compliance with ongoing regulatory labeling, packaging, storage, advertising, promotion, recordkeeping, safety, and other post-marketing requirements; 

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•manage our growth and spending as costs and expenses increase due to commercialization; and 

•manage business interruptions resulting from the occurrence of any public health crisis, international war or conflict, natural disaster, extreme weather event, or other significant or catastrophic event outside of our control. 

We have several product candidates in late-stage clinical development and various others in earlier stage clinical and pre-clinical development. Our ability to generate revenue from our product candidates is dependent on the results of clinical and pre-clinical development, our receipt of regulatory approval, and successful commercialization of such products, which may not occur on the anticipated timeline or at all. The success of our product candidates will depend on several factors, including the following:

•successful enrollment of patients in, and completion of, clinical trials and pre-clinical studies; 

•receipt of regulatory approvals from applicable regulatory authorities for planned clinical trials, future clinical trials or drug registrations, manufacturing, and commercialization; 

•successful completion of all safety and efficacy studies required to obtain regulatory approval in Greater China, the United States, and other jurisdictions for our product candidates; 

•adapting our commercial manufacturing capabilities to the specifications for our product candidates for clinical supply and commercial manufacturing and/or making and maintaining necessary arrangements with third-party manufacturers or suppliers; 

•obtaining, maintaining, and successfully enforcing or defending patent, trade secret, and other intellectual property protection and/or regulatory exclusivity for our product candidates; 

•launching commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; 

•the success of our marketing efforts and market acceptance of the product candidates by patients, the medical community, and third-party payors; 

•effectively competing with any competing products or therapies; 

•obtaining and maintaining healthcare coverage and adequate reimbursement; 

•successfully enforcing and defending intellectual property rights and claims; and 

•maintaining a continued acceptable safety, tolerability, and efficacy profile of the product candidates following regulatory approval.

We are not permitted to market any of our products or product candidates in mainland China, the United States, the EU, or any other jurisdictions until we