Recently, the international professional journal Expert Opinion on Investigational Drugs (EOID) (2022 IF:6.5, JCR, Q1) in the field of pharmacology and pharmacy published online the PK comparison (Phase I trial) study paper of the RANKL inhibitor - HS-20090 Injection (120mg/1.7mL) - under development by Hansoh Pharma, demonstrating its future high level clinical value in patients with tumor bone metastases and reflecting the full recognition of the industry authority for this clinical study.
Equivalent safety potential to meet patient needs
This randomized, double-blinded, parallel-controlled clinical study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity of HS-20090 versus Xgeva in healthy subjects. The results showed that HS-20090 was highly similar to Xgeva in terms of PK, PD, safety and immunogenicity, reflecting its high level of clinical value.
HS-20090 is the first biosimilar drug under development by Hansoh Pharma for the prevention or delay of bone-related events in patients with bone metastases from solid tumors. According to statistics, patients with advanced cancer have a very high risk of bone metastases, specifically: 65-75% for prostate cancer, 65-75% for breast cancer, and 30%-40% for lung cancer. Once bone metastases occur, patients are more likely to have bone-related events, and their survival rate and quality of life will be greatly reduced, so bone-related events of bone metastases have become a difficult problem in the field of oncology treatment. For a long time, there has been a clinical need for innovative treatments with higher accessibility to meet the huge patient demand.
Xgeva is the world's first fully humanized RANKL monoclonal antibody that prevents osteolysis and bone-related events by blocking RANKL/RANK-mediated osteoclast differentiation, maturation and activation, with proven safety and efficacy. HS-20090, as an equivalent biosimilar of Xgeva with high safety and quality, is expected to become a new treatment option for patients with bone metastases in China to control disease progression, improve quality of life and reduce economic burden.
Two-wheel (independent development + BD) drive to build a global innovation ecosystem
The inclusion of the HS-20090 PK comparison (Phase I trial) study paper in EOID not only reflects the full recognition of the industry authority for the study of the high-quality biosimilar, but also re-affirms Hansoh Pharma's unremitting innovation efforts and R&D strength.
Since its inception, Hansoh Pharma has been patient-centered, taking innovative R&D as its core development strategy and focusing on major disease treatment fields such as oncology, anti-infectives, CNS, metabolism and autoimmunity. With four R&D centers in Maryland of the U.S. and Shanghai, Lianyungang and Changzhou of China, Hansoh Pharma has successfully marketed six innovative drugs, with over 25 innovative drug programs in various stages of clinical development and over 40 clinical studies underway. The continued successful commercialization of innovative drugs has become a core driver of growth for Hansoh Pharma.
Driven by the dual-engine (independent development + BD) strategy, Hansoh Pharma has taken effective actions in recent years to establish presence in cutting-edge innovative technology fields such as monoclonal antibodies, dual antibodies, siRNA, ADCs and oral anti-COVID-19 drugs and accelerate the building of a global innovation ecosystem. Adhering to the corporate mission to create excellence in pharmaceuticals and enhance innovation in China, Hansoh Pharma will continue its focus on the unfulfilled medical needs in clinical practice, and strive to explore and develop more innovative therapeutic drugs meeting international high-quality standards, so as to bring benefits to patients in China and around the world.
