Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 65

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 65
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ixafortide in combination with G-CSF, versus plerixafor in combination with G-CSF, demonstrated
a statistically significant decrease in HRU during the ASCT process. Based on the significantly higher number of mobilized cells and the
lower number of apheresis sessions, lifetime estimates showed QALY benefits and net cost savings of approximately $30,000 (not including
the cost of motixafortide), versus plerixafor plus G-CSF. The study findings strengthened the assessment that the use of motixafortide
in combination with G-CSF, as the potential new standard of care in mobilization for ASCT, would be a cost-effective option in the United
States, based on accepted willingness-to-pay (WTP) values for healthcare payers.

In September 2022, we submitted an NDA to the FDA for motixafortide
in stem cell mobilization for autologous bone marrow transplantation for multiple myeloma patients and as noted above in September 2023,
the FDA approved motixafortide in combination with G-CSF to mobilize hematopoietic stem cells to the peripheral blood for collection and
subsequent autologous transplantation in patients with multiple myeloma.

In November 2023, we initiated pivotal bridging study preparation
activities with Gloria, our Asia partner, to support potential approval and commercialization of motixafortide in stem-cell mobilization
in China. In February 2024, an IND was filed with the Center for Drug Evaluation of the National Medical Products Administration, which
was approved in May 2024. The study in China was originally planned to commence in the first half of 2025, with data approximately 18
months later. Gloria is not currently advancing this study according to schedule and it is unclear when such study will be initiated,
if at all. There can be no assurance that Gloria will meet its obligations under the Gloria License Agreement. See “ Item 4. B. Information
on the Company - Business Overview - Our Product Pipeline - Out licensing of Motixafortide in Asia”.

Sickle Cell Disease

Sickle cell disease, or SCD, is one of the most common genetic
diseases globally, affecting millions of people throughout the world and disproportionately impacting persons of color. It is estimated
that 5% of the world’s population carries trait genes for hemoglobin disorders (including SCD) and in the U. S. it is estimated that
100,000 Americans are