Merck KGaA, Darmstadt, Germany, Strengthens Oncology Pipeline Through Strategic Partnership with Hengrui for Next-Generation Selective PARP1 Inhibitor and Antibody-Drug Conjugate

• Collaboration to develop, manufacture and commercialize next-generation selective PARP1 inhibitor HRS-1167, with option to develop, manufacture and commercialize Claudin18.2 antibody-drug conjugate SHR-A1904
• Agreement represents strong strategic fit that leverages the company’s internal DNA damage response expertise and in-house ADC capabilities

Not intended for UK-based media

DARMSTADT, Germany–(BUSINESS WIRE)–Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced a strategic collaboration with Jiangsu Hengrui Pharmaceuticals Co. Ltd. (Hengrui). The partnership includes an exclusive license worldwide (ex-China) to develop, manufacture and commercialize Hengrui’s next-generation potent and selective PARP1 (poly (ADP-ribose) polymerase 1) trapping inhibitor HRS-1167. The agreement also includes an option to an exclusive license worldwide (ex-China) to develop, manufacture and commercialize Hengrui’s Claudin-18.2 antibody-drug conjugate (ADC) SHR-A1904. In addition, Merck KGaA, Darmstadt, Germany, has the option to co-promote both assets in China.

“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,” said Danny Bar-Zohar, Global Head of Research & Development and Chief Medical Officer for the Healthcare business of Merck KGaA, Darmstadt, Germany. “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 with first-generation PARP inhibitors, the selectivity and differentiated safety profile of PARP1-specific inhibitors could offer the opportunity to expand their therapeutic impact in established and new indications. HRS-1167 has shown encouraging signs of clinical activity and patient benefit in Phase I trials as a monotherapy and has higher potential to combine with chemotherapy as well as novel agents, compared with previous attempts with first-generation PARP inhibitors. This aligns with the company’s overarching development approach of DNA damage response (DDR) inhibitors, exploring their synergistic activity and maximizing their potential impact in combination with other anticancer therapies and approaches. Merck KGaA, Darmstadt, Germany, is researching the potential to treat cancer through inhibition of multiple targets in the DDR cascade, including ATR, ATM, DNA-PK, and PARP.

Additionally, should the company exercise its option, SHR-A1904 would complement Merck KGaA, Darmstadt, Germany’s internal preclinical and clinical ADC portfolio applying different linker payload technologies. The first ADC developed using Merck KGaA, Darmstadt, Germany’s own technology, M9140, a CEACAM5-targeting ADC, is being evaluated in an ongoing Phase Ia/b study in patients with metastatic colorectal cancer.

“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,” said Frank Jiang, board member and Chief Strategy Officer of Hengrui Pharma. “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.”

Under the terms of the agreement, Merck KGaA, Darmstadt, Germany, will provide Hengrui with an upfront payment of €160 million. Hengrui will receive payments for the achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Merck KGaA, Darmstadt, Germany. Potential payments may total up to €1.4 billion.

Advancing the Future of Cancer Care

At Merck KGaA, Darmstadt, Germany, we strive every day to improve the futures of people living with cancer. Our research explores the full potential of promising mechanisms in cancer research, focused on synergistic approaches designed to hit cancer at its core. We are determined to maximize the impact of our standard-of-care treatments and to continue pioneering novel medicines. Our vision is to create a world where more cancer patients will become cancer survivors. Learn more at www.emdseronooncology.com.

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About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 64,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2022, Merck KGaA, Darmstadt, Germany, generated sales of € 22.2 billion in 66 countries.

The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

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