Glenmark Pharmaceuticals Limited, a global pharmaceutical company, has made a significant move to strengthen its oncology portfolio by entering into a $1.1 billion agreement with Hengrui Pharma. The deal grants Glenmark exclusive rights to a promising HER2-targeting cancer therapy across multiple regions.

Deal Highlights

• Glenmark's wholly-owned subsidiary, Glenmark Specialty S.A. (GSSA), has secured exclusive licensing and collaboration rights for Trastuzumab Rezetecan (SHR-A1811), a next-generation HER2-targeting antibody drug conjugate (ADC).
• The agreement covers worldwide rights, excluding Mainland China, Hong Kong SAR, Macao SAR, Taiwan Region, USA, Canada, Europe, Japan, Russia, and several other specified countries.
• Glenmark will make an upfront payment of $18.00 million to Hengrui.
• Hengrui is eligible to receive up to $1.09 billion in regulatory and commercial milestone payments.
• Glenmark will pay royalties to Hengrui based on the net sales of Trastuzumab Rezetecan within the licensed territory.

Strategic Importance

Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Limited, emphasized the strategic importance of this partnership, stating, "This collaboration aligns strongly with our strategy to bring differentiated, high-value therapies to patients and reinforces our commitment to advancing innovation in areas of significant unmet need."

About Trastuzumab Rezetecan

Trastuzumab Rezetecan is Hengrui's self-developed HER2-targeted ADC with significant potential:

• Approved in China for treating HER2-mutated non-small cell lung cancer (NSCLC).
• Under review for a new indication in breast cancer by China's NMPA.
• Included in the NMPA's Breakthrough Therapy Designation list for nine indications, covering various cancers.
• Received Orphan Drug Designation from the US FDA for gastric or gastroesophageal junction adenocarcinoma in combination with adebrelimab and chemotherapy.

Expanding Oncology Focus

This deal marks a significant step in Glenmark's oncology strategy, particularly in complex biologics. It underscores the company's commitment to delivering next-generation therapies across high-burden, underserved geographies.

Jo Feng, President of Hengrui Pharma, commented on the collaboration, saying, "This partnership with Glenmark is a significant step in Hengrui's ongoing strategy to deepen its presence in emerging markets. We look forward to working together to enhance the accessibility of innovative therapies and to bring new hope to patients in more countries and regions."

The partnership between Glenmark and Hengrui represents a major development in the oncology field, potentially bringing advanced cancer treatments to patients across multiple regions. As both companies continue to invest in innovative therapies, this collaboration could pave the way for improved cancer care and treatment options in the future.

Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Limited, is set to introduce Eribulin Mesylate Injection in the United States market, with distribution scheduled to begin in September 2025. This marks a significant milestone for the company as it enters the complex generics arena in the US institutional segment.

Bioequivalent to Halaven

The company's Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials, is bioequivalent and therapeutically equivalent to Eisai Inc.'s Halaven® Injection, a widely prescribed oncology drug for breast cancer treatment.

Market Potential

According to IQVIA® sales data for the 12-month period ending July 2025, Halaven® Injection recorded annual sales of approximately $66.30 million in the United States.

Strategic Importance

Marc Kikuchi, President & Business Head, North America at Glenmark, commented on the launch: "As the first complex generic in our portfolio, this launch marks both our commitment to growing our product offerings within the institutional channel and reinforces our dedication to bringing quality and affordable alternatives to market for patients in need."

Regulatory Approval

It's important to note that Glenmark's Eribulin Mesylate Injection is approved only for the indications listed in Glenmark's approved label.

Conclusion

This launch represents a strategic move for Glenmark Pharmaceuticals as it expands its presence in the US generic oncology market, potentially offering a more affordable option for breast cancer patients while tapping into a significant revenue stream.

The company's ability to successfully develop and gain approval for this complex generic demonstrates its growing capabilities in the pharmaceutical sector, particularly in the challenging area of oncology treatments.