Shilpa Medicare via its wholly-owned subsidiary, Shilpa Biologicals, has been permitted to conduct a Phase I human clinical study on its flagship novel product - recombinant Human Albumin (NavAlbumin), by the Central Drugs Standard Control Organisation (CDSCO).

The product is synthetically developed as compared to the current process of drawing the same from blood plasma and is backed by a granted global patent. It is designated a "New Biological Entity" and is amongst the first indigenously developed novel molecules entering clinical studies - a significant milestone for the company. The company continues to strengthen its patent protection around the product to ring-fence it from any potential competition.

The market for plasma Albumin as a drug is estimated at US $ 5.5 billion globally and growing at an average of 6% per annum. While India and Asia are the largest markets for the product by volume, the market for Albumin has been dogged by significant supply and safety constraints. The company's novel product is expected to have the following advantages compared to the existing product drawn from blood plasma. Predictable supply chain, as it is produced from a scalable fermentation process - likely to enhance the market size for the product. Significantly higher degree of purity and finally free from any potential contamination from HIV/HBV/HCV/Prions - since chemically defined media components are used throughout in its production

NavAlbumin, when approved for human use, will be used as a volume expander in indications like liver cirrhosis, major surgeries/bleeds. NavAlbumin is expected to disrupt the Albumin market in much the same way as Recombinant Factor VIII did to the plasma Factor VIII market in the early part of this century wherein Recombinant Factor VIII ended up capturing over 80% of the market share in less than a decade.

Additionally, the company will be collaborating with other innovator companies globally in developing novel drugs and temperature stable formulations using NavAlbumin. Initial trials at potential customers have been extremely encouraging and the company hopes to see traction shortly with global customers.

The product has undergone rigorous characterisation and preclinical testing at SBPL's development centre. This major milestone is the culmination of 12 years of development work conducted from its integrated biologics R&D cum Manufacturing centre at Dharwad, Karnataka. The program has been supported in part via grants / soft loans from the Department of Biotechnology, through BIRAC. The company views NavAlbumin as "Pipeline in a product" catering to various market segments by the same product. 

If approved as a drug after the human trials, NavAlbumin is expected to reach the market in 2023.