Pharma Focus Europe

Merck KGaA, Darmstadt, Germany, Strengthens Oncology Pipeline with Hengrui Partnership

Monday, October 30, 2023

Merck KGaA, Darmstadt, Germany, a prominent science and technology company, has announced a strategic partnership with Jiangsu Hengrui Pharmaceuticals Co. Ltd. (Hengrui). This collaboration involves an exclusive global (excluding China) license to develop, manufacture, and commercialize Hengrui's advanced and selective PARP1 (poly (ADP-ribose) polymerase 1) trapping inhibitor, HRS-1167. The agreement also contains an option for an exclusive global (excluding China) license to develop, manufacture, and commercialize Hengrui's Claudin-18.2 antibody-drug conjugate (ADC) SHR-A1904. Additionally, Merck KGaA, Darmstadt, Germany, has the option to jointly promote both assets in China.

Merck KGaA, Darmstadt, Germany, stated, "This partnership with Hengrui fully aligns with both our external innovation ambition and our oncology research and development strategy by diversifying our robust internal pipeline in our focus areas of DNA damage response inhibition and antibody-drug conjugates. The synergies of these assets with our portfolio offer broad potential for development and the opportunity to advance more therapeutic options for patients with difficult-to-treat cancers. We look forward to leveraging the significant expertise of Hengrui and our strong collaboration ahead."

Compared to first-generation PARP inhibitors, PARP1-specific inhibitors offer a more selective and differentiated safety profile, potentially expanding their therapeutic applications. HRS-1167 has demonstrated promising clinical activity and patient benefits in Phase I trials as a monotherapy, with the potential for combination therapy with chemotherapy and novel agents, a step beyond first-generation PARP inhibitors. This aligns with Merck KGaA, Darmstadt, Germany's overall approach to the development of DNA damage response (DDR) inhibitors, exploring their synergistic effects when combined with other anticancer therapies. The company is researching the potential to treat cancer through the inhibition of multiple targets in the DDR cascade, including ATR, ATM, DNA-PK, and PARP.

Additionally, if the company exercises its option, SHR-A1904 would complement Merck KGaA, Darmstadt, Germany's internal preclinical and clinical ADC portfolio using various linker payload technologies. The first ADC developed using Merck KGaA, Darmstadt, Germany's proprietary technology, M9140, a CEACAM5-targeting ADC, is currently undergoing evaluation in an ongoing Phase Ia/b study in patients with metastatic colorectal cancer.

Hengrui Pharma, said, "Given the high unmet need in oncology, we are excited to work closely with Merck KGaA, Darmstadt, Germany, to bring Hengrui's innovations to cancer patients worldwide. Partnering with Merck KGaA, Darmstadt, Germany, on our PARP franchise is an important milestone on Hengrui's globalization journey. We look forward to advancing our molecules rapidly through development and reaching patients in need."

As part of the agreement, Merck KGaA, Darmstadt, Germany, will provide Hengrui with an upfront payment of €160 million. Hengrui will receive additional payments upon achieving certain development, regulatory, and commercial milestones, as well as tiered royalties based on net sales by Merck KGaA, Darmstadt, Germany. The potential payments may reach up to €1.4 billion.

Merck KGaA, Darmstadt, Germany, is dedicated to advancing the future of cancer care. Their research focuses on innovative approaches to cancer treatment, aiming to maximize the impact of standard-of-care treatments and pioneer novel medicines. Their goal is to create a world where more cancer patients can become survivors.



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