Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 83

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 83
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 if approved, is likely to be their safety, efficacy, convenience, price, the level of proprietary
and generic competition, and the availability of coverage and reimbursement from government and other third‑party payors. Our competitors
may also obtain FDA or other regulatory approval for their therapeutic candidates more rapidly than we may be able to do so for any existing
or new product candidates of ours, which could result in their establishing a strong market position before we are able to enter the market.

Motixafortide

Stem cell mobilization

Motixafortide competes directly with Mozobil® (plerixafor), which is marketed by
Sanofi Genzyme as a stem cell mobilizer for autologous stem cell transplantation. During the third quarter of 2023, Mozobil’s last
to expire patent expired. As a result, several companies have launched generic formulations of plerixafor at a substantially reduced price
to Mozobil including Dr. Reddy’s Laboratories Ltd, Teva Pharmaceuticals USA Inc, Zydus Pharmaceuticals USA Inc, MSN Laboratories
Private Ltd, Eugia Pharma Specialities Ltd, Amneal EU Ltd, Gland Pharma Ltd. and Meitheal Pharmaceuticals Inc.

The competitive development pipeline in stem cell mobilization
is currently very scarce, but we are aware of GPCR Therapeutic’s burixafor +propranolol combination under clinical investigation
for stem cell mobilization in multiple myeloma, which may compete with motixafortide in the future.

CXCR4 landscape

A new CXCR4 inhibitor entered the market, X4 Pharmaceuticals' mavorixafor was approved
by the FDA and EMA in 2024 and is commercialized as XOLREMDI for WHIM syndrome. Further, we are aware of other CXCR4 inhibitors in various
stages of development including further development of mavorixafor for chronic neutropenia, burixafor developed by GPCR Therapeutics for
stem cell mobilization in multiple myeloma, AD-214 developed by AdAlta for idiopathic pulmonary fibrosis (IPF), and Balixafortide previously
developed by Spexis AG for the treatment of PDAC and TNBC. In addition, PentixaPharm is developing a radiotherapeutic targeting CXCR4-expressing
cells for various cancer indications.

Pancreatic cancer

Immuno-oncology is an area of great interest in the pharmaceutical
market, specifically, immuno-oncology combination therapies. Currently