Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 11

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 11
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the possibility that the therapeutic candidate will not be shown to be sufficiently safe and/or effective for approval by regulatory authorities.
In addition, we cannot assure you that any such products that are approved will be manufactured or produced economically, successfully
commercialized or widely accepted in the marketplace, or will be more effective than other commercially available alternatives.

In the United States, we are required to submit a New Drug Application,
or NDA, to obtain FDA approval before marketing any of our current or future therapeutic candidates. An NDA must include extensive preclinical
and clinical data and supporting information to establish the therapeutic candidate’s safety, purity and potency, or efficacy, for
each desired indication. The NDA must also include information regarding the product’s pharmacology, toxicology, chemistry, manufacture
and manufacturing controls. Obtaining approval of an NDA is a lengthy, expensive and uncertain process, and approval may not be obtained.
Upon submission of an NDA, the FDA must make an initial determination that the application is sufficiently complete to accept the submission
for filing. We cannot be certain that any submissions will be accepted for filing and review by the FDA, or ultimately be approved. The
FDA may require that we conduct additional clinical or preclinical trials, or take other actions before it will approve or reconsider
any application we make. If the FDA requires additional studies or data, we will incur increased costs and delays in the marketing approval
process, which may require us to expend more resources than we have available. In addition, the FDA may not consider any additional information
to be complete or sufficient to support approval.

Any delay in obtaining, or the failure to obtain, required regulatory
approvals will materially and adversely affect our ability to generate future revenues from a particular therapeutic candidate. Any regulatory
approval to market a product may be subject to limitations on the indicated uses for which we may market the product or may impose restrictive
conditions of use, including cautionary information, thereby limiting the size of the market for the product. We and our collaborators,
as applicable, also are, and will be, subject to numerous foreign regulatory requirements that govern the conduct of clinical trials,
manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process includes all
the risks associated with the FDA approval process that we describe above, as well as risks attributable to the satisfaction of foreign
requirements. Approval by the FDA does not ensure approval by regulatory authorities outside the United States. Foreign jurisdictions
may have different approval processes than those required by the FDA and may