Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 101

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 101
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 approval process varies from country to country
and may involve additional product testing and additional administrative review periods. As a result, the time may be longer or shorter
than that required for FDA approval. The requirements governing the conduct of clinical trials and product licensing vary greatly from
country to country. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or
delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others.

Related Matters

From time to time, legislation is drafted, introduced and passed
in governmental bodies that could significantly change the statutory provisions governing the approval, manufacturing and marketing of
products regulated by the FDA or EMA and other applicable regulatory bodies to which we are subject. In addition, regulations and guidance
are often revised or reinterpreted by the national agency in ways that may significantly affect our business and our therapeutic candidates.
It is impossible to predict whether such legislative changes will be enacted, whether FDA or EMA regulations, guidance or interpretations
will change, or what the impact of such changes, if any, may be. We may need to adapt our business and therapeutic candidates and products
to changes that occur in the future.

Pharmaceutical Coverage, Pricing and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement
status of products approved by the FDA and other government authorities. Sales of products will depend, in part, on the extent to which
third-party payors, including government health programs in the United States such as Medicare and Medicaid, commercial health insurers
and managed care organizations, provide coverage, and establish adequate reimbursement levels for, such products. The process for determining
whether a payor will provide coverage for a product may be separate from the process for setting the price or reimbursement rate that
the payor will pay for the product once coverage is approved. Third-party payors are increasingly challenging the prices charged, examining
the medical necessity, and reviewing the cost-effectiveness of medical products and services and imposing controls to manage costs. Third-party
payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the approved products
for a particular indication.

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In order to secure coverage and reimbursement for any product that
might be approved for sale, a company may need to conduct expensive pharmacoeconomic, health outcome studies in order to demonstrate the
medical necessity, quality of life benefits, and cost-effectiveness of the product, in addition to the costs required to obtain FDA or