Hengrui Medicine's Strategic Partnership with Merck Marks a Milestone in International Expansion

Introduction:

Internationalization has long been a key focus for Hengrui Medicine, but it has faced challenges in attracting substantial investments from international giants compared to local biotech companies that secure multi-million-dollar deals with MNCs. However, this missing piece of the puzzle has now been filled. On October 30, Hengrui Medicine announced its first-ever strategic collaboration with global multinational corporation Merck. Under an exclusive licensing agreement, Hengrui Medicine will grant Merck the rights to two of its self-developed drugs, including the PARP1 inhibitor HRS-1167 and the Claudin18.2ADC drug injection SHR-A1904.

Partnership Details:
Specifically, Merck will gain exclusive rights to develop, manufacture, and commercialize HRS-1167 globally outside mainland China. Merck will also have the exclusive option to develop, manufacture, and commercialize SHR-A1904 globally outside mainland China, as well as the option to co-commercialize HRS-1167 and SHR-A1904 in mainland China with Hengrui Medicine. As part of the agreement, Merck will make an initial payment of €160 million to Hengrui Medicine, along with technology transfer fees and milestone payments of up to €90 million, totaling more than €1.415 billion. Additionally, Merck will provide Hengrui Medicine with sales royalties in the double-digit percentage range.

HRS-1167: A Second Generation PARP Inhibitor:
HRS-1167, one of the core drugs in this partnership, belongs to the second generation of PARP inhibitors. Publicly available data indicates that HRS-1167 has shown promising benefits in Phase I clinical trials and has a higher potential for combination use with chemotherapy and novel drugs, including patients who were previously ineligible for PARP inhibitors.

SHR-A1904: A TOPOi Payload:
SHR-A1904 is an ADC (Antibody-Drug Conjugate) with a topoisomerase inhibitor (TOPOi) payload. If Merck chooses to exercise its option, SHR-A1904 will complement Merck's internal preclinical and clinical ADC product portfolio with different linker-payload technologies. Currently, the product is undergoing Phase I clinical trials in China, the United States, and Australia.

Alignment with Merck's Development Strategy:
This collaboration aligns with Merck's overall development strategy in the DNA damage response (DDR) inhibitors field. The aim is to explore the synergistic effects of combining these drugs with other therapies or drugs to maximize their potential impact. Merck is researching the potential of targeting multiple DDR pathway components, including ATR, ATM, DNA-PK, and PARP, to treat cancer.

Merck's Perspective:
Merck representatives stated that this collaboration aligns with Merck's expectations for external innovation and its internal oncology research and development strategy, and it is expected to enrich its product pipeline. In the future, the two drugs will synergize with Merck's existing product portfolio to offer more effective treatment options.

Conclusion:
It is worth mentioning that currently, there are no approved Claudin18.2ADC products worldwide, and there is a lack of highly selective PARP1 inhibitors on the market. Similar products are still in clinical trial stages both domestically and internationally, with no available sales data.

In fact, Hengrui Medicine has been making continuous efforts to accelerate its integration into the global pharmaceutical innovation network, as evidenced by its overseas business development achievements this year, including four overseas BD (Business Development) deals.

These include the exclusive rights granted to Elevar Therapeutics for the global development and commercialization of its PD-1 inhibitor, camrelizumab, excluding Greater China and South Korea, in combination with Rivoceranib for the treatment of hepatocellular carcinoma. Additionally, Hengrui Medicine entered into agreements with Dr. Reddy's in India for the development and commercialization of its HER1/HER2/HER4 inhibitors and with OneBio in the United States for the development and commercialization of its TSLP antibody.

These strategic collaborations with renowned multinational corporations demonstrate Hengrui Medicine's commitment to expanding its global presence and driving innovation in the pharmaceutical industry. With a focus on international partnerships and the development of novel drugs, Hengrui Medicine is poised to make significant contributions to healthcare worldwide.