Glenmark Pharmaceuticals Ltd. has achieved a significant milestone in its global expansion strategy with the approval of its respiratory treatment product, RYALTRIS®, by China's National Medical Products Administration (NMPA). This development marks a crucial step in strengthening Glenmark's position in respiratory innovation and expanding its presence in the Chinese pharmaceutical market.

Key Highlights of the Approval

• Product: RYALTRIS® Compound Nasal Spray (GSP 301 NS)
• Approved For: Treatment of Allergic Rhinitis (AR) in adults and children
• Specific Indications:
  • Moderate to severe seasonal AR in adults and children 6 years and older
  • Moderate to severe perennial AR in adults and children 12 years and older

Clinical Trial Success

The NMPA approval follows the successful completion of a Phase III clinical trial (GSP 301-308) conducted in China. The trial, which enrolled 535 patients across multiple centers, demonstrated RYALTRIS®'s superior efficacy compared to monotherapy alternatives.

Global Footprint Expansion

RYALTRIS® has already secured approvals in several major markets, including:

• United States
• European Union
• United Kingdom
• Australia
• South Korea
• Russia

RYALTRIS® was launched in 11 international markets, bringing its global presence to 45 countries.

Strategic Partnership

Glenmark has entered into an exclusive licensing agreement with Grand Pharmaceuticals Group Limited for the commercialization of RYALTRIS® in China, demonstrating the company's commitment to strategic partnerships for market expansion.

Management Commentary

Christoph Stoller, President and Business Head – Europe and Emerging Markets at Glenmark Pharmaceuticals Ltd., stated, "The approval of RYALTRIS® in China is a significant step in expanding our specialty respiratory portfolio. China is a priority market for Glenmark, and together with Grand Pharmaceuticals, our focus is on enabling access to this treatment for patients and healthcare professionals."

This approval not only reinforces Glenmark's position in the respiratory innovation space but also aligns with the company's global strategy to expand its specialty product portfolio. As Glenmark continues to advance its innovative therapies for patients with chronic conditions, the Chinese market presents a substantial opportunity for growth and impact in the pharmaceutical sector.

Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Limited, has announced a significant move in the injectable pharmaceuticals market. The company launched its 8.4% Sodium Bicarbonate Injection USP, 50mEq/50mL Single-Dose Vial in November 2025, marking its entry into a market segment with substantial annual sales.

Product Details and Market Potential

The newly launched product is bioequivalent and therapeutically equivalent to Abbott Laboratories' reference drug. This strategic launch positions Glenmark to compete in a market that, according to IQVIA sales data, achieved annual sales of approximately $63.80 million for the 12-month period ending August 2025.

Expansion of Injectable Portfolio

Marc Kikuchi, President Business Head, North America, emphasized the significance of this launch, stating that it expands Glenmark's injectable portfolio. The move underscores the company's commitment to providing quality and affordable alternatives to patients in need.

Financial Implications

While specific financial projections for this product launch are not provided, the entry into a market with annual sales of $63.80 million suggests potential for revenue growth. Investors and market analysts may want to watch for the impact of this launch on Glenmark's future financial results.

Upcoming Financial Results

Glenmark Pharmaceuticals Limited has scheduled a Board of Directors meeting for November 14, 2025. The meeting agenda includes consideration and approval of the company's Unaudited Financial Results for the second quarter and half year ended September 30, 2025.

Trading Window Closure

As per regulatory requirements, Glenmark has implemented a trading window closure from September 30, 2025, to November 16, 2025. This closure applies to the company's Directors and other designated persons, in line with the "Code of Conduct for Prevention of Insider Trading" and SEBI regulations.

Glenmark's latest product launch and upcoming financial disclosures highlight the company's ongoing efforts to expand its market presence and maintain transparency with investors.