Shilpa Medicare Ltd.

Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections RAICHUR, India, Nov. 11, 2025 /PRNewswire/ -- Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED) announced the successful completion of its fourth complex clinical program SMLINJ011, with positive topline Phase 3 results for Shilpa's OERIS™ (Ondansetron Extended-Release Injection)—an innovative formulation designed to improve prophylaxis of chemotherapy-induced nausea and vomiting (CINV). This milestone underscores Shilpa's growing leadership in differentiated drug-delivery systems and oncology supportive-care therapeutics, reflecting the company's commitment to advancing patient-centric innovation. Study Overview A Phase III, multicenter, randomized, double-blind, non-inferiority trial was conducted across multiple oncology centers in India to compare OERIS™ with conventional ondansetron injections in 240 patients receiving moderately or highly emetogenic chemotherapy. Design & Endpoints Population: 240 patients with CINV Primary Endpoint: Complete response (no emesis episodes through 120 hours post-chemotherapy) Comparator: Multiple doses of conventional ondansetron injection Secondary Endpoints: Safety profile, delayed-phase response, patient tolerability Results Complete response: 89% in OERIS™ arm vs. 82% in standard ondansetron arm Adverse events: No serious or severe adverse events reported Safety: Comparable or better tolerability than conventional therapy Transformative Innovation OERIS™ offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days, eliminating the need for multiple daily doses or oral follow-ups. This innovation enhances patient convenience, improves compliance, and streamlines clinical workflow. "We are proud to announce the successful completion of this pivotal Phase 3 study," said Mr. Vishnukant Bhutada, Managing Director, Shilpa Medicare Limited. "OERIS™ exemplifies Shilpa's ability to combine scientific innovation with patient-centric design, strengthening our oncology-supportive-care portfolio and our vision to become a global leader in specialty pharmaceuticals." Next Steps Shilpa plans to file for regulatory approval with the DCGI and pursue global registration and commercialization through the 505(b)(2) pathway in the US and other key markets. About CINV CINV affects up to 70–80% of patients undergoing chemotherapy, representing a market of approximately USD 375 million. Poorly controlled CINV can lead to treatment discontinuation and reduced quality of life, underscoring need for long-acting therapies such as OERIS™. About Shilpa Medicare Limited Shilpa Medicare is a leading Indian pharmaceutical company specializing in APIs, formulations, and biologics across oncology and specialty segments. For more information, visit . Logo - 21% more press release views with Request a Demo

Padcev and Keytruda's perioperative win, Chinese regulators' decision on Green Valley's Alzheimer's drug, and Fosun's DPP1 licensing deal made our news this week. The combination of Padcev and Keytruda delivered a phase 3 win in muscle-invasive bladder cancer. China did not renew the conditional approval for a controversial Alzheimer's disease drug. Fosun Pharma is out-licensing its DPP1 inhibitor for up to $645 million. And more.1. Pfizer and Astellas' Padcev, plus Keytruda, delivers 'breakthrough' win in new bladder cancer useAfter making waves in first-line metastatic bladder cancer, the combination of Pfizer and Astellas’ Padcev and Merck & Co.’s Keytruda has shown it can extend lives when used as a perioperative treatment around surgery for patients with cisplatin-ineligible muscle-invasive bladder cancer, according to a readout from the phase 3 EV-303 study, which is also known as Keynote-905.2. China did not renew approval of controversial Alzheimer's drug, regulator's records showChina’s drug regulator did not renew the conditional nod for Green Valley Pharmaceuticals’ controversial Alzheimer’s disease med sodium oligomannate (GV-971), according to public records. The move followed a protracted review that stretched past the expiration date of the drug’s existing licensure, triggering a production and marketing halt in May.3. Expedition inks $645M pact to pocket Fosun's lung disease asset in knapsackInflammatory disease startup Expedition Therapeutics is paying $17 million upfront, plus up to $628 million in potential milestones, for ex-China rights to Fosun Pharma’s DPP1 inhibitor XH-S004. The deal was inked right before the FDA approved Insmed’s brensocatib as the first DPP1 inhibitor. The approved indication for Insmed's therapy is non-cystic fibrosis bronchiectasis.4. Aurobindo acquires US drugmaker Lannett for $250M to bolster 'reshoring' effortAurobindo is paying $250 million to buy Lannett, which is known for manufacturing attention-deficit/hyperactivity disorder medicines and generic liquids. “The acquisition strengthens Aurobindo’s ability to serve the U.S. generics space and provides strategic diversification into a specialized, high-value therapeutic category,” the Indian company said in an announcement.5. HLB taps new Elevar CEO amid liver cancer setbacks, new FDA push (Korea Biomedical Review)Korea’s HLB has tapped Byan Kim as CEO of Elevar Therapeutics. Kim will continue as co-CEO of HLB Innovation and CEO of another HLB subsidiary, Verismo Therapeutics. The move comes after Elevar and Jiangsu Hengrui Pharmaceuticals’ PD-1/VEGFR combination suffered repeated FDA setbacks in liver cancer and as Elevar prepares to file an approval for lirafugratinib in FGFR2-altered cholangiocarcinoma.Other News of Note:6. RemeGen's telitacicept meets the mark in ph. 3 Sjögren's study in China7. Indian API maker Garonit Pharma plans $46.1M antiseptic product plant in New York8. Shilpa wins India approval for world's first NAFLD med, company says (Regulatory tracker)

Shilpa Medicare emerges as the global pioneer to receive approval for NorUDCA, offering new hope to over a billion people affected by Non-Alcoholic Fatty Liver Disease (NAFLD) NAFLD affects 1 in 4 people globally (1.2 billion), with 188 million patients in India—most undiagnosed until irreversible damage occurs. A Breakthrough in Liver Health: NorUDCA delivers a novel dual-action mechanism, combining anti-inflammatory benefits with enhanced bile acid regulation. This innovative therapy promises to halt the progression of NAFLD to severe liver conditions such as NASH, cirrhosis, and liver failure. Clinically Proven and Safe: Robust clinical trials demonstrate NorUDCA's significant superiority over placebo in efficacy, with an excellent safety profile and no major adverse events reported RAICHUR, India, Aug. 14, 2025 /PRNewswire/ -- In a landmark moment for global hepatology and Indian pharmaceutical innovation, Shilpa Medicare Limited (BSE: 530661) (NSE: SHILPAMED) has secured the world's first regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) for Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg, the first-ever approved therapy targeting NAFLD. Mr. Vishnukant Bhutada, Managing Director, Shilpa Medicare, hailed the approval as a "transformational leap": "Receiving approval for NorUDCA marks a transformational leap—not only for Shilpa Medicare but for millions silently suffering from liver disease. We are honored to be the first company globally to bring this innovative therapy to patients, reflecting our unwavering commitment to pioneering healthcare solutions and expanding access to life-changing treatments across India and beyond. We are excited to launch NorUDCA in India immediately and are actively pursuing approvals worldwide to ensure this vital therapy reaches patients everywhere in need." Shilpa Medicare is committed to rapidly commercializing NorUDCA in India and pursuing international regulatory pathways, aiming to bring this life-altering treatment to patients on a global scale About Shilpa Medicare Limited: Shilpa Medicare Limited is a fully integrated pharmaceutical group specializing in innovative Oncology and Non-Oncology APIs, Peptides, Polymers, New Biological Entities and differentiated finished dosage formulations such as Orally Dispersible Films and Transdermal Patches. The company offers end-to-end CDMO services to global pharmaceutical partners, supported by four advanced R&D centers and seven manufacturing facilities, consistently driving innovation and quality in healthcare. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED