Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 91

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 91
---
 request. Finally, a sponsor
can request that a product that must be studied under PREA to be studied also under the BPCA to allow the sponsor to be eligible for six-months
of pediatric exclusivity. The pediatric studies requested under BPCA are usually more extensive and would generally also fulfill the PREA
requirement; however, even if the sponsor does not complete the studies outlined in the BPCA written request, it is still required to
complete any studies required under PREA.

Post-Marketing Requirements

Once an NDA or BLA is approved, the drug sponsor will be subject
to certain post-approval requirements, including requirements for adverse event reporting, submission of periodic reports, manufacturing,
labeling, packaging, advertising, promotion, distribution, record-keeping and other requirements. For example, the approval may be subject
to limitations on the uses for which the product may be marketed or conditions of approval, or contain requirements for costly post-marketing
testing and surveillance to monitor the safety or efficacy of the product or require the adoption of risk evaluation and mitigation strategies.
In addition, the FDA requires the reporting of any adverse effects observed after the approval or marketing of a therapeutic candidate
and such events could result in limitations on the use of such approved product or its withdrawal from the marketplace. Also, some types
of changes to the approved product, such as manufacturing changes and labeling claims, are subject to further FDA review and approval.
Additionally, the FDA strictly regulates the promotional claims that may be made about prescription drug products. In particular, the
FDA requires substantiation of any claims of superiority of one product over another including, in many cases, requirements that such
claims be proven by adequate and well controlled head-to-head clinical trials. To the extent that market acceptance of our therapeutic
candidates may depend on their superiority over existing products, any restriction on our ability to advertise or otherwise promote claims
of superiority, or any requirements to conduct additional expensive clinical trials to provide proof of such claims, could negatively
affect the sales of our therapeutic candidates and our costs.

Orphan Drug Designation

The Orphan Drug Act, or ODA, provides for granting special status
to a drug or biological product to treat a rare disease or condition (i. e., a disease or condition that affects fewer than 200,000 individuals
in the United States), or a disease or condition that affects more than 200,000 individuals in the United States but where there is no
reasonable expectation that the product development cost will be