Hansoh Pharma Launches Phase I Clinical Trial of Class 1 Nephrology Drug HS-10398 Capsule for IgA Nephropathy and Membranous Nephropathy

According to the Drug Clinical Trial Registration and Information Disclosure Platform, Jiangsu Hansoh Pharmaceutical Group Co., Ltd./Shanghai Hansoh Biomedical Science and Technology Co., Ltd. (a subsidiary of Hansoh Pharma) registered a Phase I clinical trial for the HS-10398 capsule, targeting Immunoglobulin A Nephropathy (IgA Nephropathy) and Membranous Nephropathy. Public information indicates that HS-10398 is classified as a Category 1 new chemical drug.

Source of the image: Drug Clinical Trial Registration and Information Disclosure Platform

IND approved in February
Sword Pointing at "Kidney Disease"

IgA Nephropathy and Membranous Nephropathy are currently the most common primary glomerular diseases worldwide, with membranous nephropathy being one of the main pathological types of nephrotic syndrome in adults. The major risk factors for the progression of IgA nephropathy include persistent proteinuria, hypertension, declining renal function, and the extent of pathological damage. Statistics show that 20% to 40% of IgA nephropathy cases progress to end-stage renal disease within 20 years of diagnosis.

According to Frost & Sullivan's forecast, the number of global IgA nephropathy patients may reach 10.1652 million by 2030. In China, the number of newly diagnosed IgA nephropathy cases in 2022 was approximately 100,000, with over 1 million existing patients. If including those who have not been definitively diagnosed with IgA nephropathy, the number exceeds 4 million. HS-10398 is a Class 1 new drug developed by Hansoh Pharma, intended for the treatment of IgA nephropathy and membranous nephropathy. It filed for clinical trials in November 2023 and successfully obtained IND approval in February this year.

Source of the image: Pharma Intelligence Enterprise Edition —— Global Drug Analysis System Database

According to the Drug Clinical Trial Registry and Information Disclosure Platform, the Phase I clinical trial initiated by Hansoh Pharma this time is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics, and the effect of food on pharmacokinetics of HS-10398 in healthy subjects, as well as to evaluate the pharmacokinetic characteristics of HS-10398 in subjects with renal impairment. It is expected to enroll 116 participants.

Innovation-Driven Pipeline Development
Revenue Breaks Through the 10 Billion Yuan Mark for the First Time

In 2023, Hansoh Pharma's total revenue successfully surpassed the 10 billion yuan mark, with a year-on-year increase of approximately 26.9% in net profit, reaching 3.278 billion yuan. Among this, innovative drugs and collaboration products contributed 6.865 billion yuan to Hansoh Pharma’s revenue, accounting for 67.9% of the total income. It is evident that innovation has become the core driver of Hansoh Pharma’s performance growth.

At the same time, Hansoh Pharma continues to expand its innovative pipeline and has established a comprehensive innovation R&D platform in the treatment areas of oncology, infectious diseases, metabolism, central nervous system, and autoimmune diseases. Several drugs made key progress in 2023.

Image Source: Hansoh Pharma

HS-20117

HS-20117 is an EGFR/c-Met bispecific antibody, a Class 1 new drug introduced by Hansoh Pharma from Promab Biotechnologies for over 1.4 billion yuan. According to publicly available data, HS-20117 can simultaneously block the signal transduction of EGFR and c-Met, demonstrating therapeutic potential in inhibiting tumor growth and survival. In 2023, HS-20117 successfully obtained IND approval and is currently undergoing Phase I clinical trials for advanced solid tumors.

HS-10516

HS-10516 targets the HIF-2α site and is a Class 1 new drug co-developed by Hansoh Pharma and NiKang. Currently, NiKang is conducting clinical trials of HS-10516 for renal cell carcinoma overseas, and its IND in China was approved in June 2026.

HS-10518

HS-10518 is a Class 1 new drug targeting GnRH, intended for the treatment of moderate to severe pain associated with endometriosis, heavy menstrual bleeding related to uterine fibroids, and other conditions. Currently, HS-10518 is in Phase I clinical trials and will be studied in healthy premenopausal adult female subjects in China.

HS-20105

HS-20105 is an ADC drug targeting Trop2, using a Trop2 antibody of the IgG1 subtype, conjugated with a topoisomerase I inhibitor (FNA) through a cleavable linker. In September 2023, the CDE approved HS-20105's clinical trial application for advanced solid tumors; in November, Hansoh Pharma registered a clinical trial for HS-20105 on the Clinicaltrials.gov website.

HS-20106

HS-20106 is an "engineered ligand trap," a Class 1 therapeutic biologic product that Hansoh Pharma introduced for nearly 200 million USD. It is currently being developed for the treatment of cytopenia (including anemia and thrombocytopenia) in patients with myelodysplastic syndromes (MDS) and myelofibrosis.

In addition, Hansoh Pharma has several promising drugs in its pipeline, including the KRAS G12C inhibitor HS-10370, the B7-H3 ADC drug HS-20093, and the GLP-1/GIP dual receptor agonist HS-10241.

Conclusion

In 2023, Hansoh Pharma's R&D expenditure reached approximately 2.097 billion yuan, increasing to 20.8% of total revenue. To date, Hansoh Pharma has accumulated over 30 innovative drugs in its pipeline, continuously advancing clinical research progress.

By accelerating the progress of pipelines under research in various fields, Hansoh Pharma is expected to achieve more results in 2024.

Editor: Muyan

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