Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 14

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 14
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 the manufacturing
operations for such products will be subject to continuing regulatory review, including FDA inspections. The outcome of this ongoing review
may result in the withdrawal of a product from the market, the interruption of the manufacturing operations and/or the imposition of labeling
and/or marketing limitations. Since many more patients are exposed to a drug product following its marketing approval, serious but infrequent
adverse reactions that were not observed in clinical trials may be observed during the commercial marketing of the product. In addition,
the manufacturer and the manufacturing facilities we or our licensees, as applicable, will use to produce any therapeutic candidate will
be subject to periodic review and inspection by the FDA and other similar foreign regulators. Later discovery of previously unknown problems
with any product, manufacturer or manufacturing process, or failure to comply with regulatory requirements, may result in actions such
as:

  restrictions on such product, manufacturer  

9

  warning letters from the FDA or other regulatory  

  withdrawal of the product from the market;  

  suspension or withdrawal of regulatory approvals;  

  refusal to approve pending applications                                   

  voluntary or mandatory recall;  

  fines;  

  refusal to permit the import or export of  

  product seizure or detentions;  

  injunctions or the imposition of civil or  

  adverse publicity.  

If we, or any licensee, supplier, third-party contractor, partner
or clinical investigator is slow to adapt, or are unable to adapt, to changes in existing regulatory requirements or the adoption of new
regulatory requirements or policies, we or any licensee may lose marketing approval for any of our products, if any of our therapeutic
products are approved, resulting in decreased or lost revenue from milestones, product sales or royalties.

We generally rely on third
parties to conduct our preclinical studies and clinical trials and to provide other services, and those third parties may not perform
satisfactorily, including by failing to meet established deadlines for the completion of such services.

We do not have the ability to conduct certain preclinical studies
and clinical trials independently for motixafortide, and we rely on third parties, such as contract laboratories, contract research organizations,
medical institutions, clinical investigators and other collaborators to conduct these studies and clinical trials. Our reliance on these
third parties limits our control over these activities. The collaborators may not assign as great a priority to our clinical development
programs or pursue them as diligently as we would if we were undertaking such programs directly. Accordingly, these collaborators may
not complete activities on schedule, or may