On July 8, 2024, Zhikang Hongyi announced that the highly selective endothelin receptor A (ETA) small molecule antagonist SC0062 project, one of its core pipelines, met the primary endpoint in the IgA nephropathy (IgAN) trial in a phase II 2-SUCCEED study of chronic kidney disease (CKD) with proteinuria. The results of the test show that:
SC0062 significantly reduced proteinuria compared with the placebo group, and showed a clear dose-response relationship between different dose groups, and the results were clinically and statistically significant.
SC0062 demonstrated a favorable safety profile, and no adverse effects such as sodium and water retention were observed in patients treated with SC0062. In addition, the combination of SC0062 and SGLT2 inhibitors in patients receiving SGLT2 inhibitors as primary therapy also demonstrated a favorable safety profile in the study.
These updated results will be presented at an upcoming international medical conference.
SC0062 is a novel molecular design for chronic kidney disease with highly selective endothelin receptor A (ETA) antagonists, which can improve renal blood flow, reduce proteinuria, and reduce inflammation and fibrotic processes. SC0062 was designed and developed to further enhance drug safety while maintaining efficacy, such as mitigating adverse effects such as sodium and water retention (sodium and water retention are associated with the blockade of endothelin receptor B (ETB)).
2-SUCCEED is an ongoing multicenter, randomized, double-blind, placebo-controlled, dose-scope-exploring, Phase II clinical trial designed in 2 cohorts (IgA nephropathy cohort and diabetic nephropathy cohort) to evaluate the efficacy and safety of SC0062 capsules in patients with chronic kidney disease with proteinuria.
Hiddo Lambers Heerspink教授
Member of the Clinical Advisory Committee of Zhikang Hongyi, International Authoritative Clinical Expert on Chronic Kidney Disease, University Medical Center Groningen, The Netherlands
在审阅以上研究结果后表示：“The SC0062 data are quite exciting, particularly the clear dose response relationship, the strong effects on proteinuria reduction, and the lack of peripheral edema related side effects. I look forward to collaborating with BioCity on the further development of SC0062 in order to make this new selective endothelin receptor antagonist available to patients with CKD.
The data from the SC0062 study are very exciting, particularly the clear dose-response relationship, the significant proteinuria reduction, and the good safety profile with no side effects associated with peripheral edema. We look forward to working with Zhikang Hongyi to further develop SC0062, a novel highly selective endothelin receptor antagonist, and hope that more patients with kidney disease will benefit from it in the future." ”
Dr. Yiwei Wang
Co-founder and Executive Vice President of Zhikang Hongyi
"In recent years, a number of international studies have reported that improving the selectivity of the molecule for ETA can reduce the adverse reactions such as water and sodium retention caused by its blockade of ETB, and it is expected to further improve the efficacy," he said.
SC0062 is a new molecule with unique high selectivity for ETA, and we are pleased to see the outstanding safety and efficacy of SC0062 in the 2-SUCCEED study, validating its original molecular design concept, which is a great encouragement to our team and a major step in our goal of providing a safer, more effective, and more reliable treatment for long-term use for chronic kidney disease patients around the world." It further strengthens our confidence in continuing to move forward with this project and strive to benefit patients around the world as soon as possible." ”
Dr. Hei Yongjiang
CEO of Zhikang Hongyi
"Although there are currently treatment options for CKD, the existing treatment options still need to be improved in terms of slowing the disease progression and safety," he said.
We are pleased to share the breakthrough results of SC0062 in the 2-SUCCEED study in terms of efficacy and safety, as well as positive feedback on patient compliance, which further demonstrates the potential of its best-in-class (BIC) molecule and makes it one of the key options for the treatment of CKD in the future." The other cohort of the diabetic nephropathy trial in this study has completed the enrollment of all participants, and we are confident in the results of the follow-up study for this cohort.
In the next phase, the company will share the latest research results with regulators, and will continue to give full play to its excellent clinical development capabilities to ensure that the Phase III clinical trial of this project is launched as scheduled, and actively promote the global clinical progress of this potential best-in-class molecule to benefit patients around the world as soon as possible. ”
About Professor Heerspink:
Professor Hiddo Lambers Heerspink is a renowned clinical expert and clinical pharmacologist in nephrology at the University Medical Center Groningen in the Netherlands, a 2016 Galen Prize winner, and a member of the Clinical Scientific Advisory Board of Zhikang Hongyi.
His main expertise includes clinical trial design, personalized medicine, and methodological and statistical analysis of clinical trials, with research interests focused on optimizing current treatment strategies and finding new treatments to stop the progression of kidney and cardiovascular disease in diabetic patients. He has successfully led and is leading several large international clinical trials with novel interventions to reduce diabetes-related renal and cardiovascular complications, including the DAPA-CKD, FIND-CKD, ALIGN, ZENITH, and FRONTIER trials.
Professor L. Heerspink has authored and co-authored more than 400 peer-reviewed journals, is an editorial board member of Diabetic Obesity and Metabolism and the Clinical Journal of the American Society of Nephrology, and is a reviewer and member of several international professional organization committees, including the American Diabetes Association and the American Society of Nephrology.
In addition, he has served as a consultant for pharmaceutical companies such as AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Gilead, Merck, Novartis, Novo Nordisk, and Chinook and Travere.
About SC0062
SC0062 is one of the world's top three endothelin receptor A (ETA) small molecule antagonists for the treatment of chronic kidney disease, and is a high-potential Best-in-Class drug. SC0062 is a novel molecular design for chronic kidney disease with unique ETA high selectivity, aiming to further improve drug safety while ensuring efficacy.
Preclinical studies have shown that SC0062 has good activity and can effectively improve pathology scores in acute kidney injury and chronic kidney disease models. In the completed Phase I clinical study, SC0062 demonstrated a favorable safety and tolerability profile and pharmacokinetic profile, while no side effects such as sodium and water retention were observed.
SC0062 is currently conducting a Phase II clinical study (2-SUCCEED) in chronic kidney disease with proteinuria, which is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging exploration, 2-cohort (IgA nephropathy cohort and diabetic nephropathy cohort) designed clinical study to evaluate the efficacy and safety of SC0062 capsules in patients with chronic kidney disease with proteinuria. Professor Chen Jianghua, former chairman of the Nephrology Branch of the Chinese Medical Association, served as the principal investigator, and it has been carried out simultaneously in more than 40 clinical institutions across the country.
The 2-SUCCEED study has now over-enrolled all subjects in two cohorts, of which the IgA nephropathy trial has met the primary clinical endpoint and the DKD trial is underway, with unblinded results expected in the fourth quarter of this year.
About Zhikang Hongyi
“做好药，为生命更美好/Better Medicine for Better Life”，是智康弘义的崇高使命。
Founded in December 2017, Zhikang Hongyi focuses on patients and diseases, attaches great importance to the fundamental role of disease biology in the development of new drugs, and gives priority to the research and development, clinical trials and commercialization of "BIC/FIC" innovative drugs for tumors, kidney diseases and other diseases.
Since the establishment of the company, it has carried out pipeline layout in different technical fields such as chemical small molecules, monoclonal antibodies, bispecific antibodies, antibody drug conjugates (ADCs), etc., and has a number of new drugs in the phase I/II stage with efficient R&D and operation mode, and the clinical PI is served by top experts in the field, and the quality and progress of clinical trials continue the advantages of preclinical research and development of products, all of which are at the world's leading level.
In the pipeline, SC0062, a highly selective endothelin receptor A (ETA) antagonist developed for chronic kidney disease (CKD), has met its primary endpoint in the IgA nephropathy trial in the Phase II 2-SUCCEED clinical trial, and the diabetic nephropathy (DKD) trial is underway, and the company aims to initiate a Phase III clinical trial within this year to further expand its leading position in the CKD field. BC3195, the company's world-only antibody-drug conjugate targeting CDH3, has been in clinical trials in China and the United States, and BC2027, the world's first antibody-drug conjugate targeting GPC3, has also recently been approved for clinical trials in the United States, further strengthening the advantages of the company's oncology pipeline in the world. In addition, the company has a number of FIC ADC and bispecific antibody products in preclinical development or pre-IND stage.
Zhikang Hongyi has established a core management team with a multidisciplinary background to lead the company's R&D business throughout the life cycle, and is also equipped with an operation team familiar with the market environment in China and the United States, which systematically ensures the quality and efficiency of the company's R&D in the whole process. The company will further enhance the layout of new technologies and global commercialization to consolidate the company's leading comprehensive R&D strength and help expand overseas markets.
With the goal of "rapidly growing into a leading biopharmaceutical company in China, with continuous innovation capabilities, core combination products, diversified innovative therapies, and in-depth commercialization capabilities", Zhikang Hongyi is committed to better and more benefits for patients around the world and contributing to the new round of development of China's biopharmaceutical industry.