Hansoh Pharma's Dual-Target Antidiabetic Drug HS-20094 Enters Clinical Trials Amid Record-High New Drug Filings in 2021

On February 16, Hansoh Pharma's GLP1R/GIPR dual agonist HS-20094 was publicly announced to initiate clinical trials for the first time. The drug was first approved for clinical trials in July 2021 and completed its first patient enrollment in November of the same year.

Source: Insight Database (http://db.dxy.cn/v5/home/)

According to the latest report from IDF, there were as many as 537 million people with diabetes worldwide in 2021. GLP-1R agonist drugs are now dividing the market with insulin, reaching a market size of $12.4 billion in 2020 and still growing rapidly. In the Top 20 global drug sales of 2021, GLP-1 analogs firmly held two positions: Dulaglutide (Trulicity) and Semaglutide (Ozempic+Rybelsus) generated revenues of $6.472 billion (+28%) and $5.857 billion (+67%), respectively.

GLP-1 Drug Competition Heats Up, with Domestic Rivalry Intensifying. Following the release of promising clinical data, the next potential "blockbuster" diabetes medication could emerge in the multi-target agonist field. Globally, Eli Lilly's Tirzepatide is a frontrunner, with its market application submitted using a priority review voucher, aiming for the fastest possible launch by the first half of 2022, underscoring Lilly’s strong commitment to the project. In China, only four domestically produced drugs of this kind have entered clinical stages, and overall development remains in the early phases. However, due to continued active pharmaceutical transactions in this area, a surge in applications is expected in 2022 and beyond.

Hansoh Pharma's HS-20094 is the third dual-target diabetes drug produced in China to initiate clinical trials. The fastest progressing drug currently is IBI362, a GLP-1R/GCGR dual agonist developed in collaboration between Innovent Biologics and Eli Lilly. It has already entered Phase 2 clinical trials for type 2 diabetes and obesity, with Innovent expecting to advance its pivotal registration trial in 2022. HEC88473 (GLP-1R/FGF21) from Dongyang Guang Medicine and HS-20094 (GLP1R/GIPR) from Hansoh Pharma follow closely behind, both in Phase I clinical trials. HZ010 (GLP1R/GIPR), developed by Heze Pharmaceutical, has not yet entered clinical trials. As for preclinical projects, companies such as Hengrui, Huadong Medicine, and Salubris have either self-developed or acquired new drugs.

Dual-Target Antidiabetic Drugs: R&D and Submission Status in China

Hansoh Pharma has entered a boom period for new drug applications since 2021, with up to 14 new drug projects applying for clinical trials for the first time throughout the year. Most of them are chemical drugs, and there are also two biologic new drug applications.

Clinical Application Status of Innovative Drug Projects by Hansoh Pharma in the Past 5 Years

*Only the first declaration is counted

Source: Insight Database (http://db.dxy.cn/v5/home/)

In terms of therapeutic areas, apart from the two latest filing projects whose proposed indications are yet to be disclosed, the other new drugs are mainly for oncology indications (7). Among them, eight new drugs have already entered clinical trials.

Hansoh Pharma New Drug Application in 2021

From the perspective of late-stage clinical trials and new drug applications for market approval, Inebilizumab, a biologic drug licensed from Viela, is expected to be approved for marketing in the first half of 2022. This is a humanized CD19-directed monoclonal antibody and also the first CD19 antibody in China to be submitted for production, intended for treating adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin-4 (AQP4) antibodies. If approved, this will become the first antibody drug approved for marketing by Hansoh Pharma.

A New Drug for Renal Anemia, Pegsiticase, Which Is Administered Once a Month, Was Submitted for Market Approval in September 2021 and Is Expected to Be Approved for Marketing in the Second Half of 2022 or 2023. In Addition, the Fastest-Progressing Candidate is HS-10342, a CDK4/6 Inhibitor Currently in Phase II Clinical Trials.