THE PROBLEM
Africa's dependency,
a life threatening reality.
Biologics and vaccines are among the most supply-sensitive medicines.
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When production is concentrated outside the continent, access to life saving medicines becomes vulnerable to global demand shocks, long lead times, cold-chain complexity, and foreign-currency exposure.
Strengthening local supply security requires regional production capacity and robust quality systems. By building local capability, we reduce single-point dependencies and improves continuity of supply for essential medicines.
VACCINES
99%
of vaccines used in Africa are imported
MEDICINES
70-90%
of drugs consumed in sub-Saharan Africa are imported
ACTIVE PHARMACEUTICAL INGREDIENTS
≥95%
of APIS used in Africa are imported
Local manufacturing for accessible biologics in Africa.
Immobazyme is developing biosimilars and vaccines in South Africa to strengthen supply security and reduce import reliance.
A SILENT EPIDEMIC
Diabetic Foot Ulcers
Diabetic foot ulcers (DFUs) arise from neuropathy, vascular impairment,
and infection risk.
They are clinically challenging to treat and can progress rapidly, with a strong likelihood of hospitalisation, amputation, and mortality if wound healing is delayed.
DIABETES IN SOUTH AFRICA
≥2.3 million
South Africans are affected by diabetes
28%
of diabetic patients present to primary healthcare clinics with diabetic foot ulcers
80%
of diabetic foot amputations in the public sector are attributed to DFUs
More than half of amputees dying within four years.
ILLUSTRATIVE DFU SERVERITY
Stage 1
Superficial ulcers on the skin and subcutaneous tissue ​
Stage 2
Deep ulcer involving tendon or capsule
Stage 3
Deep ulcer with bone involvement (osteomyelitis) and/or abscess
Stage 4:
Localised gangrene
TM
REGENZA
PRODUCT OUTLINE
Regenza™ is Immobazyme’s recombinant human epidermal growth factor (EGF), developed as a bioactive ingredient for wound-healing research and future therapeutic development.
EGF is a well-characterised signalling protein involved in epidermal repair processes, including cell proliferation and migration.
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In diabetic foot ulcers, delayed healing and infection risk can escalate rapidly. Regenza™ is being developed to support improved wound repair outcomes by providing a consistent, locally manufactured source of recombinant EGF alongside a development pathway aligned to quality documentation and regulatory expectations.
Effect of EGF on cell migration
A scratch assay showing the effect of EGF on cell migration over 48 hours. Representative phase-contrast images were taken at 0 hours (T0), 24 hours (T24), and 48 hours (T48). The left column represents the control condition (DMEM), while the right column represents cells treated with DMEM supplemented with EGF. The initial wound area is outlined in blue. In the control condition, the wound closure is limited over time. In contrast, cells treated with hEGF exhibit significantly enhanced migration, resulting in near-complete wound closure by 48 hours. This demonstrates the pro-migratory effect of hEGF in promoting cell proliferation and wound healing.
Regenza: Key Milestones & Timeline To Market.
2025
2026
2027
2028
Proof of concept
Regenza: preclinical proof of concept (DFU indication)
Assay package: potency + functional readouts (in vitro)
Early formulation / delivery feasibility + stability scoping
Process finalisation
Finalise manufacturing process (upstream + downstream)
GMP-grade production run + release testing plan
CMC documentation build (specifications, COAs, traceability)
Preclinical / clinical development
Expanded preclinical package
(in vitro + in vivo)
Clinical strategy + protocol design (endpoints, comparators)
Continued stability + validation of analytical methods
Regulatory submission & approval pathway
SAHPRA submission preparation (Module 3 CMC + supporting data)
QMS/GMP inspection readiness and responses
Approval pathway and market access planning