Hansoh Pharma and Merck Enter into $1.9 Billion Global Licensing Deal for Oral GLP-1 Receptor Agonist HS-10535

Positive Results from Pivotal Phase 3 (Code Name: LUNA 3) Clinical Trial Confirm Efficacy and Safety of Rilzabrutinib (an Oral, Reversible, Covalent BTK Inhibitor) in Adult Patients with Persistent or Chronic Immune ThrombocytopeniaOn December 7, 2024, positive results from the pivotal Phase 3 (code name: LUNA 3) clinical trial confirmed the efficacy and safety of rilzabrutinib (an oral, reversible, covalent BTK inhibitor) in adult patients with persistent or chronic immune thrombocytopenia (ITP), a rare immune-mediated condition, further demonstrating the potential of rilzabrutinib as a first-class treatment for ITP. In the rilzabrutinib group, 65% (n=86) of patients achieved platelet response, compared to 33% (n=23) in the placebo group. The study met its primary endpoint, showing that rilzabrutinib demonstrated sustained platelet response in 23% of adult patients with ITP, versus 0% in the placebo group (p<0.0001). Additionally, key secondary endpoints were met, including reduced bleeding, number of weeks with platelet response, need for rescue therapy, and improvements in physical fatigue and quality of life indicators.

Dr. Dean Y. Li, President of Merck Research Laboratories, stated: "We will continue to leverage science-driven business development to enhance and complement our robust pipeline. Through this agreement, we aim to utilize our expertise in incretin biology to evaluate HS-10535 and its potential to provide additional cardiometabolic benefits beyond weight loss."

According to the agreement, Hansoh Pharma has granted Merck & Co., Inc. the global exclusive license to develop, manufacture, and commercialize HS-10535. Hansoh Pharma will receive an upfront payment of $112 million and is eligible for up to $1.9 billion in milestone payments related to the development, regulatory approval, and commercialization of the candidate drug, as well as sales royalties. Hansoh Pharma may co-promote or independently commercialize HS-10535 in China under certain conditions.

Eliza Sun, Executive Director of Hansoh Pharma's Board of Directors, stated: "We are pleased to announce that our oral GLP-1 has been licensed by Merck & Co., which holds a leading position in the cardiometabolic disease field. Hansoh Pharma is emerging as a new leader in the metabolic disease space, and we believe that Merck’s expertise and capabilities are crucial for accelerating the development of this promising asset to benefit patients worldwide."

According to incomplete statistics, currently, about eight major international pharmaceutical companies have entered the GLP-1 weight loss market, including Novo Nordisk, Eli Lilly, Pfizer, Amgen, Roche, AstraZeneca, Gilead, and Merck. Among them, three companies entered this field through deals. For instance, in November 2023, AstraZeneca acquired ECC5004, an oral small-molecule GLP-1 receptor agonist in Phase 2 clinical trials, via a deal with Chongqing Chengyi Biotechnology. In December 2023, Roche acquired Carmot Therapeutics, obtaining a peptide-based GLP-1/GIP dual receptor agonist in Phase 2 clinical trials and an oral small-molecule GLP-1 receptor agonist CT-996 in Phase 1 trials. The third company is Merck, which has now partnered with Hansoh Pharma.

In terms of deals involving oral small-molecule GLP-1 receptor agonists, in addition to Chengyi Bio, Carmot, and Hansoh Pharma, Hengrui Medicine also transferred the overseas rights of its GLP-1 portfolio (including small molecules) through a NewCo in May 2024. This shows that the development enthusiasm for oral small-molecule GLP-1 receptor agonists has been very high in the past two years.

But for Pfizer, the more intense the development enthusiasm for oral small molecule GLP-1 receptor agonists becomes, the more it highlights its own disappointment.

Pfizer can be considered one of the earlier large international pharmaceutical companies to advance oral small-molecule GLP-1 receptor agonists into the clinical stage, with as many as three candidate drugs for oral small-molecule GLP-1 receptor agonists entering the clinical stage.

The one who dares to eat the first crab is a hero, but those who wish to become heroes often end up as martyrs.

In June 2023, Pfizer's second oral small-molecule GLP-1 receptor agonist to enter clinical trials, lotiglipron (PF-07081532), was discontinued due to liver toxicity issues; in December 2023, Pfizer's first oral small-molecule GLP-1 receptor agonist to enter clinical trials, danuglipron (PF-06882961), was halted from advancing to Phase 3 clinical trials due to a high discontinuation rate.

The future market space for the GLP-1 weight loss track is large enough to accommodate a significant number of pharmaceutical companies competing simultaneously. Small molecule drugs, due to their excellent convenience and lower production costs, will inevitably become an important part of the GLP-1 weight loss track. Currently, among the eight international major drugs in the GLP-1 weight loss category that are in the clinical stage, only five have invested in small molecule drugs. As efforts continue, there may be more transactions similar to those between Merck and Hansoh Pharma in the future, rapidly deploying oral small molecule GLP-1 receptor agonists through acquisitions.

References

1.https://www.merck.com/news/merck-enters-into-exclusive-global-license-agreement-with-hansoh-pharma-for-investigational-oral-glp-1-receptor-agonist/

2.https://investors.pfizer.com/Investors/News/news-details/2023/Pfizer-Provides-Update-on-GLP-1-RA-Clinical-Development-Program-for-Adults-with-Obesity-and-Type-2-Diabetes-Mellitus/default.aspx

3.https://investors.pfizer.com/Investors/News/news-details/2023/Pfizer-Announces-Topline-Phase-2b-Results-of-Oral-GLP-1R-Agonist-Danuglipron-in-Adults-with-Obesity/default.aspx

4.https://www.astrazeneca.com/media-centre/press-releases/2023/agreement-with-eccogene-for-clinical-stage-glp-1ra.html

5.https://www.roche.com/media/releases/med-cor-2023-12-04

6.https://www.sse.com.cn/disclosure/listedinfo/announcement/c/new/2024-05-17/600276_20240517_URE4.pdf

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