Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 27

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 27
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renewal of manufacturing agreements with our third-party CMOs in a manner or at a time that is costly or damaging to us;

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reliance on single sources for drug components;

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potential supply chain concentration if the agreements with our third-party CMOs require any purchase commitment from us;

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lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;

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our third-party CMOs may not devote sufficient resources to our product candidates;

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we may not own, or may have to share, the intellectual property rights to any improvements made by our third-party CMOs in the manufacturing process for our product candidates and future products;

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operations of our third-party CMOs or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier, or any force majeure events under the agreements with our third-party CMOs; and

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carrier disruptions or increased costs that are beyond our control.

Any of these events could lead to clinical trial delays, failure to obtain regulatory approval or impact our ability to successfully commercialize our product candidates and future products, if approved. Some of these events could be the basis for FDA action, including injunction, request for recall, seizure, or total or partial suspension of production.

Certain of our clinical supplies may be manufactured by our third-party CMOs outside of the U.S. The current administration has recently imposed significant “reciprocal” tariffs in imports from other countries, which have prompted retaliatory measures from several countries and which may further escalate. The imposition of tariffs by the U.S. and any retaliatory trade measures taken in response by other countries could impose additional costs on our clinical and commercial supplies, which could adversely affect the development of our product candidates and future products, and our business operations.

For any manufacturing activities conducted by our third-party CMOs in China, we face increased risks of supply disruptions and higher costs in the event of changes in the policies of the U.S. or Chinese governments,

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political unrest or unstable economic conditions including sanctions on China or any of our China-based suppliers or as a result of the escalation of tariffs or other trade restrictions. Our manufacturing costs could also increase as a result of future appreciation of the local currency in China or increased labor costs if the demand for skilled laborers increases and/or the availability of skilled labor declines in China. In addition, certain Chinese biotechnology companies may become