Business Update7 Aug 2024, 05:27 pm
Shilpa Medicare Successfully Completes Phase 1 Clinical Trial for Recombinant Human Albumin 20% (rHA)
AI Summary
Shilpa Medicare Limited has announced the successful completion of its Phase 1 clinical trial for recombinant human albumin 20% (rHA). The trial demonstrated clinical benefits, safety, and comparable bioavailability to human-derived albumin. The success of this trial brings Shilpa Medicare closer to providing a reliable and safe alternative to human serum albumin, addressing global demand and supply challenges. The company plans to commence Phase 3 clinical trials by Q4 of FY25 and expects to file for product approval in various geographies in FY26.
Key Highlights
- Shilpa Medicare successfully completes Phase 1 clinical trial for rHA 20%
- rHA demonstrated clinical benefits, safety, and comparable bioavailability to human-derived albumin
- rHA offers a highly purified, structurally and functionally equivalent alternative to human serum albumin
- Company plans to commence Phase 3 clinical trials by Q4 of FY25
- Product approval filings expected in various geographies in FY26