Company: ZLAB
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001628280-25-008409
Chunk: 156

Company: Zai Lab Ltd
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1A
Chunk 156
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 have received required regulatory approvals. The process to develop, obtain regulatory approval, and commercialize product candidates is long, complex, and costly and varies among countries. The successful completion of clinical trials or regulatory approval in one country does not mean that clinical trials will be successful, or regulatory approval will be obtained, in any other country. Our product candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including the following:

•disagreement regarding the number, design, size, conduct, or implementation of our clinical trials; 

•failure to demonstrate to the satisfaction of the regulator(s) that a product candidate is safe and effective for its proposed indication, including as a result of safety issues, product recalls, or other incidents related to products approved and marketed in other jurisdictions; 

•failure of CROs, clinical study sites, or investigators to comply with the ICH-good clinical practice, or GCP, requirements imposed by the regulator(s); 

•failure of the clinical trial results to meet the required level of statistical significance; 

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•failure to demonstrate that clinical and other benefits outweigh safety risks; 

•disagreement regarding the interpretation of data from pre-clinical studies or clinical trials; 

•insufficient data collected from clinical trials to support the submission of an NDA, PMA, or other submission required to obtain regulatory approval in Greater China, the United States, the EU, or elsewhere; 

•failure to obtain approval of the manufacturing processes for our clinical and commercial supplies; 

•changes in the approval policies or regulations; and 

•actions by our CROs or licensors that materially and adversely affect the clinical trials. 

If we are not successful in gaining broad acceptance of our commercial products, our business would be harmed.

Sales of our commercial products will depend on our ability to educate and increase physician awareness of the benefits, safety, and cost-effectiveness of such products, in general and relative to any competing therapies. The degree of market acceptance of our commercial products among physicians, patients, healthcare payors, and the medical community may depend on a number of factors, including: 

•acceptable evidence of safety and efficacy; 

•relative convenience and ease of administration; 

•prevalence and severity of any adverse side effects; 

•availability of alternative treatments; 

•pricing, cost effectiveness, and value propositions; 

•effectiveness of our sales and marketing capabilities and strategies; 

•ability to obtain sufficient insurance coverage and reimbursement; 

•the clinical indications for which