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Glenmark partners with Hengrui Pharma to develop Trastuzumab Rezetecan, enhancing its oncology pipeline and addressing unmet cancer treatment needs.
Glenmark’s subsidiary aims to strengthen its Oncology pipeline with the addition of Hengrui’s HER2 targeting ADC.
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Glenmark Specialty announced an exclusive license and collaboration agreement with Hengrui Pharma for its next-generation HER2-targeting antibody drug conjugate (ADC), Trastuzumab Rezetecan (SHR-A1811).
“We are delighted to collaborate with Hengrui and build on the scientific momentum of SHR-A1811 as we continue expanding our oncology pipeline and leadership. This partnership 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,” said Glenn Saldanha, chairman and managing director, Glenmark Pharmaceuticals Limited.
Per the terms of the agreement, Glenmark is granted the exclusive rights to develop and commercialize Trastuzumab Rezetecan worldwide, excluding the following locations.
Glenmark is expected to pay an upfront cost upwards of $18 million to Hengrui, along with the potential for Hengrui to earn up to $1.093 billion in regulatory and commercial milestone payments. Glenmark is also expected to pay additional royalties to Hengrui based on Trastuzumab Rezetecan’s net sales.
“Facing the major global challenge of cancer treatment, Hengrui has over the years accelerated the research and development of cutting-edge innovative therapies such as ADCs and is committed to addressing clinical treatment challenges and meeting unmet medical needs. This collaboration 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,” said Jo Feng, president of Hengrui Pharma.
Trastuzumab Rezetecan (SHR-A1811) is a HER2-targeting ADC self-developed by Hengrui. Back in May of this year, Trastuzumab Rezetecan received approval in China as a treatment for adult patients with HER2 (ERBB2) activating mutations in unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) that received one prior systemic therapy. 1 Trastuzumab Rezetecan is the first China-developed ADC with approval for HER2-mutated NSCLC.
In September of this year, China’s NMPA accepted Trastuzumab Rezetecan for review along with being included in the priority review program for breast cancer. Trastuzumab Rezetecan in combination with adebrelimab and chemotherapy also obtained Orphan Drug Designation from FDA for gastric or gastroesophageal junction adenocarcinoma.1
Trastuzumab Rezetecan is additionally included in the NMPA’s Breakthrough Therapy Designation list for the following indications.
Glenmark touched on the impact of the collaboration in a press release, saying, “This collaboration marks a significant step forward in Glenmark’s focused oncology strategy, particularly in complex biologics. It reinforces Glenmark’s long-term commitment to delivering next-generation therapies across high-burden, underserved geographies.”1
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