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Shilpa Medicare enters Phase I Clinical Trial for its New Biological Entity, recombinant Human Albumin

The facility at Dharwad would cater to the requirements of the fast-growing biologics field, that include the DNA vaccine, adenoviral, subunit vaccines, monoclonal antibodies & fusion proteins, the company said.

November 01, 2021 3:57 IST | India Infoline News Service
Shilpa Medicare
Shilpa Medicare Limited (SML), via its wholly-owned subsidiary, Shilpa Biologicals Pvt Ltd (SBPL), 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).

In the filing, the product is a synthetically developed product 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 and potentially large impact for the nation.

The Company continues to strengthen its patent protection around the product to ring fence it from any potential competition.

The company is now using this as a platform for some of its novel formulations. 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 in the near future with global customers.

The product has undergone rigorous characterisation and preclinical testing at SBPL’s development centre. This major milestone is culmination of 12 years of development work conducted from its integrated biologics R&D cum Manufacturing center 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 same product. If approved as a drug after the human trials, NavAlbumin is expected to reach the market in 2023.

The biologics business has been identified as a strategic growth engine by SML and it has made significant investments in setting up a high end, flexible biologics facility in SBPL. The company has recently entered into CDMO tie-ups with Cadila Healthcare Ltd and Dr. Reddy’s Laboratories Ltd for production of Covid19 vaccines.

The facility at Dharwad would cater to the requirements of the fast-growing biologics field, that include the DNA vaccine, adenoviral, subunit vaccines, monoclonal antibodies & fusion proteins. The company is also in the process of setting up a world class 150,000 Liter fermentation capacity based NavAlbumin GMP production facility – which is expected to be completed in the latter half of 2022 – in time to enable the company to penetrate the global markets with NavAlbumin aggressively.

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