Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 26

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 26
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 candidates and related raw materials for future preclinical and clinical development, as well as for commercial manufacture of our products once regulatory and marketing approvals have been obtained. We expect to enter into arrangements with a limited number of third-party contract manufacturing organizations, or CMOs, as part of our development of Tinlarebant or other product candidates and future products.

We are entirely dependent on our third-party CMOs for compliance with cGMP for manufacture of both active drug substances and finished drug products. If our third-party CMOs cannot successfully manufacture active drug substances and finished drug product that conform to our specifications and the strict regulatory requirements of the FDA and comparable foreign regulatory authorities, we will not be able to secure or maintain regulatory approval for our product candidates. In addition, we have no control over the ability of our third-party CMOs to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of

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our product candidates and future products, or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our timelines and ability to develop, obtain regulatory approval for, or market of our product candidates and the commercial manufacture of our future products, if approved.

The facilities used by our third-party CMOs to manufacture our product candidates must be approved by the FDA pursuant to inspections that will be conducted after we submit an NDA for any of our product candidates. We also expect to rely on our third-party CMOs to supply us with sufficient quantities of our future products to be used, if approved, for commercialization.

Our reliance on our third-party CMOs entails risks to which we would not be subject if we manufactured our product candidates or future products ourselves, including:

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inability to meet our product specifications and quality requirements consistently;

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delay or inability to procure or expand sufficient manufacturing capacity;

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issues related to scale-up of manufacturing;

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costs and validation of new equipment and facilities required for scale-up;

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our third-party CMOs may not be able to execute our manufacturing procedures and other logistical support requirements appropriately;

•

our third-party CMOs may fail to comply with cGMP and other inspections by the FDA or comparable foreign regulatory authorities;

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our inability to negotiate manufacturing agreements with third-party CMOs under commercially reasonable terms, if at all;

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breach, termination or non