THE PROBLEM
Africa's dependency,
a life threatening reality.
Biologics and vaccines are among the most supply-sensitive medicines.
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
REGENZA
TM
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.
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.
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