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30 October, 2023 – Jiangsu Hengrui Pharmaceuticals Co., Ltd (“Hengrui Pharma”), a global pharmaceutical company focused on scientific and technological innovation, today announced a licensing agreement with Merck, a leading science and technology company headquartered in Darmstadt, Germany, for its next-generation potent and selective PARP1 (poly (ADP-ribose) polymerase 1) inhibitor, HRS-1167. This is Hengrui’s first strategic collaboration with a global pharmaceutical company. The agreement includes an option to an exclusive license for its innovative Claudin-18.2 antibody-drug conjugate (ADC) SHR-A1904.

"Given the high unmet need in oncology, we are excited to work closely with Merck to bring Hengrui's innovations to cancer patients worldwide,” said Frank Jiang, board member and Chief Strategy Officer of Hengrui Pharma. “Partnering with Merck 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 will provide Hengrui Pharma with an upfront payment of €160 million. Hengrui Pharma will receive payments for technology transfer as well as an option exercise for the Claudin-18.2 ADC for up to €90 million. Upon the achievement of certain development, regulatory, and commercial milestones, Hengrui is eligible to receive royalty payments on net sales of such products by Merck. Potential payments may total up to €1.4 billion with up to double-digit royalty payments.

“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 sector of Merck. “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.”

Merck will receive exclusive rights to develop, manufacture, and commercialize HRS-1167 worldwide, outside of mainland China, an exclusive option to develop, manufacture, and commercialize SHR-A1904 worldwide, outside of mainland China, and an option to co-promote HRS-1167 and SHR-A1904 in mainland China.

About HRS-1167 and SHR-A1904

HRS-1167 is a selective, highly active and orally available PARP1 small molecule inhibitor internally developed by Hengrui with intellectual property rights, which belongs to the second generation of PARP inhibitors. Poly (ADP-ribose) polymerase (PARP) is key in DNA repair pathways. Compared to first-generation PARP inhibitors, HRS-1167 has higher selectivity and affinity for PARP1 and induces DNA trapping. HRS-1167 is currently in the early clinical development (Phase 1) and has the potential to be used as a monotherapy and as part of a combination therapy for treating a wider range of patients.

SHR-A1904 is an antibody-drug conjugate (ADC) targeting Claudin 18.2, internally developed by Hengrui with intellectual property rights. It binds to the target antigen on the surface of tumor cells, allowing the drug to be endocytosed by cells and releasing a small-molecule toxin to kill tumor cells. The product is currently in clinical phase I trials in China, U.S., and Australia. Currently, no Claudin 18.2 targeting ADC product has received marketing authorization.

About Hengui Pharma

Hengrui Pharma is an innovative global pharmaceutical company focused on unmet clinical needs, with a strong track record of scientific and technological innovation. Since its first innovative drug approval in 2011, Hengrui Pharma has invested more than 33 billion yuan in R&D and set up 14 R&D centers in Lianyungang, Shanghai, the U.S., and Europe. It has 8 major manufacturing sites and a global R&D team of more than 5,000 professionals. Hengrui Pharma has independently established a number of leading technology platforms such as its ADC platform, proteolysis targeting chimera (PROTAC), molecular gels, bi/multi-specific antibodies, and AI molecular design, which provide a strong foundation for innovative R&D. Hengrui strives for continued innovation and collaboration with global partners to serve a healthy China and benefit patients around the world.