Shilpa Medicare Ltd.

Shilpa Medicare Serves as Lead Investor, Positioning Alveolus Bio for Phase 2 Clinical Trials and First-in-Human Studies

CAMBRIDGE, Mass. and BIRMINGHAM, Ala. and RAICHUR, India, Aug. 4, 2025 /PRNewswire/ -- Alveolus Bio, a pioneering respiratory drug development biotech company founded by Dr. Vivek Lal from University of Alabama at Birmingham, AL, has announced a strategic financing round led by Shilpa Medicare Limited (BSE: 524742) (NSE: SHILPAMED), a prominent global pharmaceutical company with extensive expertise in respiratory therapeutics manufacturing and biotechnology innovation.

Through this collaboration, Shilpa Biologics, the biologics arm of Shilpa Medicare, will become Alveolus Bio's exclusive global development and manufacturing partner. This partnership propels Alveolus Bio's live biotherapeutics and small molecule platform towards Phase 2 and first-in-human clinical trials, with a lead asset for COPD progressing rapidly.

Shilpa Medicare brings deep experience in drug discovery, development, and manufacturing, along with strong regulatory capabilities. Their investment and strategic involvement will accelerate the clinical advancement of Alveolus Bio's resMIT (respiratory microbiota-based inhaled therapeutics) platform. This novel platform enables targeted delivery of inhaled therapies to deep lung regions, addressing unmet needs in diseases such as COPD, Bronchopulmonary Dysplasia (BPD), and Pulmonary Fibrosis.

"Securing Shilpa as our lead investor is a transformative step," said Gaurav Mehta, CEO of Alveolus Bio. "Their global pharmaceutical leadership aligns perfectly with our vision to redefine how lung diseases are treated."

"Alveolus Bio's breakthrough science is poised to transform respiratory care. Through this strategic partnership with Shilpa, we combine disruptive biotech innovation with world-class commercialization, bringing life-changing therapies faster to the market," said Dr. C. Vivek Lal, Founder and CSO, Alveolus Bio.

"Shilpa has always focused on enabling breakthrough biologics," said Vishnukant Bhutada, Managing Director, Shilpa Medicare. "This partnership strengthens our innovation pipeline and reinforces our role as a trusted global partner for biotech development."

The financing round remains open to other strategic investors who share Alveolus Bio's vision of transforming respiratory medicine.

About Shilpa Medicare

Shilpa Medicare is a global pharmaceutical company with capabilities across drug discovery to commercialization, specializing in respiratory therapeutics and biotech innovation. Visit www.vbshilpa.com.

About Alveolus Bio

A Biostack Ventures company, Alveolus Bio is developing first-in-class therapies for lung diseases using its proprietary resMIT platform. Its pipeline includes programs for COPD, BPD, Pulmonary Fibrosis, Cystic Fibrosis, and more.

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SOURCE Shilpa Medicare Limited

RAICHUR, India , March 12, 2025 /PRNewswire/ -- Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED), a leading API and formulation manufacturer, announces that the Subject Expert Committee (SEC) of CDSCO has approved its Investigational New Drug (IND) – Nor Ursodeoxycholic Acid (Nor UDCA) Tablets 500 mg – and recommended marketing authorization for treating non-alcoholic fatty liver disease (NAFLD).

NAFLD, the most prevalent liver disease, affects approximately 25% of the global population (1.2 billion people), including 188 million in India. Left untreated, NAFLD can progress to non-alcoholic steatohepatitis (NASH), a severe and potentially fatal condition.

Shilpa Medicare Ltd. had earlier completed phase-3 clinical studies of this novel product SMLNUD07 – Nor Ursodeoxycholic Acid (Nor UDCA) tablets - and presented the results of the trial titled, "A phase - III, Randomized, Double- Blind, placebo controlled, multicenter, Parallel group study", to evaluate the safety and efficacy of Nor-Ursodeoxycholic Acid 500 mg in patients suffering from Non-alcoholic Fatty Liver Disease to the SEC.

The trial met all primary efficacy endpoints, demonstrating a significant improvement in fatty liver stage. Key findings include:

• Liver Fibrosis Reversal: 83.3% of participants showed fibrosis reversal, with stabilization in the rest.
• ALT Normalization: Elevated alanine transaminase (ALT) levels, a key NAFLD marker, normalized in ~90% of participants within 12 weeks.

These results position Nor UDCA as a breakthrough therapy for NAFLD, offering advantages over conventional UDCA, including enhanced choleretic effect, resistance to amidation, anti-inflammatory properties, and fibrosis reduction.

Commenting on the development, Mr. Vishnukant Bhutada – Managing Director, Shilpa Medicare Limited, said, "We are very pleased with this approval from SEC and hope to get the marketing approval soon. We are committed to working closely with regulatory authorities to bring this innovative treatment to patients as quickly as possible and are hopeful of launching it in India in the coming financial year. This NCE molecule approval exemplifies the true spirit of Shilpa, 'Innovating for affordable healthcare', keeping in mind the unmet needs of a large patient pool. Based on the approval in India, we plan to reach out to Global regulatory authorities to seek scientific advice for introduction of this novel product internationally."

Founded in 1987, Shilpa Medicare offers APIs, Formulations, and Biologics, with facilities approved by major regulatory agencies. The company is also recognized for providing complete turnkey CDMO solutions for clients globally.

For inquiries : info@vbshilpa.com.

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SOURCE Shilpa Medicare Limited