Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 88

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 88
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 if a therapeutic candidate receives regulatory approval,
later discovery of previously unknown problems with a product may result in restrictions on the product or even withdrawal of marketing
approval for the product.

Foreign clinical trials may or may not be conducted under an IND.
However, their safety assessments should be submitted annually.

48

We conduct clinical trials typically in three sequential phases
(1-3), but the phases may overlap or be combined. An institutional review board, or IRB, must review and approve each trial before it
can begin. Phase 1 includes the initial administration of a tested drug to a small number of humans. These trials are closely monitored
and may be conducted in patients but are usually conducted in healthy volunteer subjects. These trials are designed to determine the metabolic
and pharmacologic actions of the drug in humans and the side effects associated with increasing doses as well as, if possible, to gain
early evidence of effectiveness. Phase 2 usually involves trials in a limited patient population to evaluate dosage tolerance and appropriate
dosage, identify possible adverse effects and safety risks and preliminarily evaluate the efficacy of the drug for specific indications.
Phase 3 trials are large trials used to further evaluate clinical efficacy and test further for safety by using the drug in its final
form in an expanded patient population. There can be no assurance that we or our licensees will successfully complete Phase 1, Phase 2
or Phase 3 testing with respect to any therapeutic candidate within any specified period of time, if at all. Furthermore, clinical trials
may be suspended at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable
health risk. We and our licensees perform some of our nonclinical and clinical testing outside of the United States. The acceptability
of the results of our preclinical and clinical testing by the FDA will be dependent upon adherence to applicable U. S. and foreign standards
and requirements, including GLP, GCP and the Declaration of Helsinki for protection of human subjects.

Marketing Applications (NDAs and BLAs)

After successful completion of the required clinical testing, an
NDA, or in the case of certain biological products, a BLA, is prepared and submitted to the FDA. FDA approval of the NDA or BLA is required
before product marketing may begin in the United States. The NDA/BLA must include the preclinical and clinical testing results and a compilation
of detailed information relating to the product’s pharmacology, toxicology, chemistry, manufacture and