Shilpa Medicare gets nod for Phase III clinical trials of Human Albumin

Shilpa Medicare has informed that the subject expert committee (Haematology) (SEC) has accepted the results of its Phase I clinical trials for Recombinant Human Albumin (rHA) 20% and granted approval to proceed with Phase III clinical trials.

Albumin is in high demand for various medical treatments, including restoring blood volume and replacing lost fluids during accidents, serious burn injuries, fatal erythroblastosis, hypoproteinemia, and surgeries. However, the supply of human serum albumin is limited due to the reliance on whole blood or donated human plasma. Shilpas Recombinant Human Albumin 20% (rHA), derived from yeast, offers a highly purified, structurally and functionally equivalent alternative to human serum albumin.

The company has successfully completed its Phase I clinical trials on 7 August 2024. With todays announcement, the company confirms that the SEC has accepted the trial results and approved the progression to Phase III trials for rHA 20%.

 

The Phase III trials will be conducted according to the protocol approved by the SEC.

Shilpa is the first company in India to receive the approval for conducting Phase III clinical trials. This approval clears regulatory strategy for India and various emerging markets that accept Indian studies and is an important step towards providing a reliable and safe alternative to human serum albumin, addressing the global demand and supply challenges.

Raichur-based Shilpa Medicare is a vertically integrated, manufacturer and distributor of quality drugs to global markets; specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.

The companys consolidated net profit soared to Rs 17.94 crore in Q2 FY25 as against Rs 1.61 crore posted in Q2 FY24. Revenue from operations rose 9.8% to Rs 343.80 crore in the quarter ended 30 September 2024.

The scrip shed 0.66% to Rs 889.25 on the BSE.

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