[Translation] A single-center, open-label, fixed-sequence study evaluating the effects of itraconazole or rifampicin on the pharmacokinetic profile of SC0062 in healthy participants

主要目的：评价在健康成年参与者中多次服用 CYP3A4 强抑制剂伊曲康唑胶囊或CYP3A4 强诱导剂利福平胶囊对单次服用 SC0062 胶囊后 SC0062 和代谢产物M18 药代动力学特征的影响。次要目的：评价在健康成年参与者中 SC0062 和伊曲康唑或利福平联合给药的安全性和耐受性。

[Translation]

Primary objective: To evaluate the effect of multiple doses of itraconazole capsules, a strong CYP3A4 inhibitor, or rifampicin capsules, a strong CYP3A4 inducer, on the pharmacokinetic characteristics of SC0062 and metabolite M18 after a single dose of SC0062 capsules in healthy adult participants. Secondary objective: To evaluate the safety and tolerability of co-administration of SC0062 and itraconazole or rifampicin in healthy adult participants.

Start Date13 Jan 2026

Sponsor / Collaborator

Wuxi Zhikang Hongyi Biological Technology Co Ltd

NCT06072326

/ Not yet recruitingPhase 2

Individual and Combined Endothelin Receptor and SGLT2 Antagonism in Adults With Type 1 Diabetes Mellitus and Chronic Kidney Disease: a Phase 2, Multicenter, Open-label Randomized Cross-over Trial

The aim of this study is to test the hypothesis that dapagliflozin (SGLT2 inhibitor) and SC0062 (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through complementary and synergistic mechanisms of actions.

Start Date01 Jan 2026

Sponsor / Collaborator

Universitair Medisch Centrum Groningen

[+2]

CTR20252540

/ CompletedPhase 1

[14C]SC0062在中国成年健康受试者体内的物质平衡临床研究

[Translation] Clinical study of material balance of [14C]SC0062 in healthy adult Chinese subjects

主要研究目的： 1、定量分析受试者口服[14C]SC0062后排泄物中的总放射性，获得人体放射性回收率数据和主要排泄途径； 2、获得受试者口服[14C]SC0062后人血浆、尿液和粪便的放射性代谢物谱，鉴定主要代谢产物，确定代谢途径及消除途径； 3、定量分析受试者单次口服[14C]SC0062后全血和血浆中的总放射性，获得血浆总放射性的药代动力学参数，并考察全血和血浆中总放射性的分配情况。次要研究目的： 1、采用已验证的LC-MS/MS方法定量分析血浆SC0062及其代谢产物M18和其他代谢产物（如适用）的浓度，获得血浆中SC0062及其代谢产物M18和其他代谢产物（如适用）的药代动力学参数； 2、观察[14C]SC0062单次给药后健康男性受试者的安全性和耐受性。

[Translation]

Main study objectives: 1. Quantitatively analyze the total radioactivity in the excreta of subjects after oral administration of [14C]SC0062, and obtain the data on the recovery rate of human radioactivity and the main excretion pathway; 2. Obtain the radioactive metabolite spectrum of human plasma, urine and feces after oral administration of [14C]SC0062, identify the main metabolites, determine the metabolic pathways and elimination pathways; 3. Quantitatively analyze the total radioactivity in whole blood and plasma of subjects after a single oral administration of [14C]SC0062, obtain the pharmacokinetic parameters of total radioactivity in plasma, and investigate the distribution of total radioactivity in whole blood and plasma. Secondary study objectives: 1. Quantitatively analyze the concentration of plasma SC0062 and its metabolite M18 and other metabolites (if applicable) using a validated LC-MS/MS method, and obtain the pharmacokinetic parameters of SC0062 and its metabolite M18 and other metabolites (if applicable) in plasma; 2. Observe the safety and tolerability of healthy male subjects after a single dose of [14C]SC0062.

Start Date28 Jul 2025

Sponsor / Collaborator

Wuxi Zhikang Hongyi Biological Technology Co Ltd

100 Clinical Results associated with Diosuxentan

100 Translational Medicine associated with Diosuxentan

100 Patents (Medical) associated with Diosuxentan

Literatures (Medical) associated with Diosuxentan

01 Apr 2025·JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY

The Selective Endothelin Receptor Antagonist SC0062 in IgA Nephropathy

Article

Author: Wan, Jianxin ; Luo, Qun ; Xu, Chengyun ; Zhong, Aimin ; Zhou, Bo ; Chen, Jianghua ; Liu, Bin ; Wu, Henglan ; Cao, Liou ; Heerspink, Hiddo J.L. ; Xu, Lixia ; Fan, Qiuling ; Bi, Guangyu ; Zhang, Liqin ; Wang, Yiwei ; Du, Xiaoying ; Zhang, Yanning ; Wang, Rong ; Peng, Qingfeng ; Hei, Yongjiang ; Xu, Yan ; Huang, Jiyi ; Cheng, Hong

Key Points:

Patients with IgA nephropathy and significant proteinuria are at high risk of progressive kidney function loss and kidney failure.We report the results of a clinical trial assessing the selective endothelin receptor antagonist SC0062 for the treatment of IgA nephropathy.SC0062 led to clinically meaningful improvements in proteinuria and did not increase risk of peripheral edema at higher doses.

Background:

Endothelin receptor type A activation contributes to kidney injury in patients with IgA nephropathy. SC0062 is a novel selective endothelin receptor type A antagonist. We report the results of a phase 2 dose-finding trial to characterize the efficacy and safety of SC0062 in patients with IgA nephropathy.

Methods:

We conducted a randomized, placebo-controlled, double-blind, clinical trial in adults with biopsy-proven IgA nephropathy and eGFR ≥30 ml/min per 1.73 m2 with urine protein-creatinine ratio (UPCR) ≥0.75 g/g or proteinuria ≥1 g/24 hour despite using maximum tolerated doses of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Patients were randomized 1:1:1:1 to 24-week treatment with SC0062 5, 10, and 20 mg or matching placebo once daily. The primary efficacy outcome was percent change from baseline in UPCR in 24-hour urine samples after 12 weeks of treatment. Secondary end points included changes in eGFR. Safety outcomes including treatment-emergent adverse events and serious adverse events were recorded.

Results:

Overall, 131 patients (mean age 42 years [SD 11]; mean eGFR 72 ml/min per 1.73 m2 [SD 24] and median 24-hour UPCR 1.2 g/g [25th–75th percentile, 0.9–1.5 g/g]) were randomized to placebo (n=34) or SC0062 5 mg (n=33), 10 mg (n=32), or 20 mg (n=32). All SC0062 doses reduced UPCR versus placebo throughout treatment. At week 12, placebo-corrected geometric mean changes (95% confidence interval) from baseline in UPCR with SC0062 5, 10, and 20 mg were−27.6% (−43.0 to −8.2), −20.5% (−37.4 to 1.0), and −38.1% (−51.4 to −21.0), respectively, and at week 24 they were−22.4% (−42.2 to 4.3), −30.9% (−48.6 to −7.0), and −51.6% (−64.2 to −34.6), respectively. No differences in eGFR were observed among treatment groups. The proportion of participants with treatment-emergent adverse events or serious adverse events was balanced among treatment groups. Peripheral edema was reported by two (6%), one (3%), one (3%) participants in the 5, 10, and 20 mg SC0062-treated groups, respectively, compared with five (15%) in the placebo group.

Conclusions:

In patients with IgA nephropathy, SC0062 reduced proteinuria and did not increase risk of peripheral edema.

Clinical Trial registry name and registration number::

A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of CKD, NCT05687890.

Podcast:

This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/JASN/2024_10_26_KTS_October2024.mp3

01 Apr 2025·JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY

Unlocking the Potential of SC0062

Article

Author: Jinghong Zhao ; Jiachuan Xiong

We have read with great interest the article by Heerspink et al.1 titled "The Selective Endothelin Receptor Antagonist SC0062 in IgA Nephropathy: A Randomized Double-Blind Placebo-Controlled Clinical Trial," published in JASN, which presents the findings of a phase 2 dose-finding trial assessing the efficacy and safety of the highly selective endothelin receptor antagonist SC0062 in 131 patients with IgA nephropathy across multiple centers in China over a 6-month treatment period. According to the findings, SC0062 reduced the urine protein-creatinine ratio (UPCR) in a dose-dependent manner. Interestingly, over 71% and 51.6% of patients in the SC0062 treatment group at a dose of 20 mg experienced a 30% and 50% reduction in UPCR at week 24, respectively, compared with the baseline UPCR level. However, only 33.3% and 12.1% of placebo-treated patients experienced the same percentage reduction in UPCR. In general, throughout the same treatment period, the net UPCR reduction of SC0062 was similar to the other endothelin receptor antagonists, including sparsentan, which demonstrated a reduction of roughly 48.8% at week 24 (48.8% versus 13.9%),2 and atrasentan, which showed a reduction of 35.7% at week 24 (35.7% versus 2.8%).3 In addition, the safety profile of SC0062 appears favorable, with no significant differences between treatment groups in treatment-emergent adverse events or serious adverse events. The clinical data from the phase 2 study indicate that SC0062 has demonstrated the ability to significantly reduce proteinuria in patients with IgA nephropathy, showing potential as a treatment option that warrants further investigation. However, several questions arise from the study. First, the pathological results of kidney biopsies, specifically the Oxford mesangial hypercellularity, endocapillary hypercellularity, segmental glomerulosclerosis, tubular atrophy/interstitial fibrosis, crescents score, were not provided, and it remains unknown whether these parameters are comparable among the four groups. Second, we noticed that the selected patients had an average eGFR >70 ml/min per 1.73 m2. It remains unclear whether patients with moderate-to-severe kidney impairment would experience similar benefits from the SC0062 treatment. More importantly, the main goal of treating IgA nephropathy is to prevent the progression of the disease to kidney failure.4 There is still uncertainty as to whether SC0062 has a protective role in preserving eGFR, which is essential for having a 2-year observation period and enrolling more participants. Finally, the small sample size limits the power of subgroup analyses, preventing us from determining whether the benefits are consistent across different populations, such as sex, age, and grading of different kidney pathologies. While the study suggests that the effects of SC0062 are consistent regardless of sodium-glucose cotransporter 2 inhibitor use, future studies with a larger number of participants, including those using sodium-glucose cotransporter 2 inhibitors, are necessary to fully elucidate any potential synergistic or antagonistic effects between these two drug classes. In conclusion, the study by Heerspink et al.1 provides promising initial evidence for the use of SC0062 in IgA nephropathy. Although the results are encouraging, they also underscore the need for larger, longer-term, and geographically diverse studies to fully assess the role of SC0062 in the treatment of IgA nephropathy.

01 Apr 2025·JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY

Authors' Reply: Unlocking the Potential of SC0062: A New Horizon in IgA Nephropathy Treatment?

Article

Author: Heerspink, Hiddo J.L. ; Chen, Jianghua

We thank Xiong and Zhao1 for their interest in our JASN article about the albuminuria-lowering effects of the selective endothelin receptor antagonist SC0062 in patients with IgA nephropathy.2 Our trial enrolled participants with a biopsy-proven IgA nephropathy with similar inclusion criteria compared with other recent clinical trials that enrolled patients with IgA nephropathy.3–5 We did not record Oxford mesangial hypercellularity, endocapillary hypercellularity, segmental glomerulosclerosis, tubular atrophy/interstitial fibrosis, crescents scores as the main goal of the study was to find optimal doses of SC0062 for future phase 3 clinical trials. In these future trials, we will consider collection of Oxford mesangial hypercellularity, endocapillary hypercellularity, segmental glomerulosclerosis, tubular atrophy/interstitial fibrosis, crescents scores. Since our trial was a phase 2 dose-finding trial of 24-week duration, we were unable to assess the longer-term efficacy and safety of SC0062, which is the main objective of a recently started phase 3 clinical trial in participants with IgA nephropathy (NCT06819826). This trial will also enroll more patients with a GFR below 60 ml/min per 1.73 m2 to assess the efficacy and safety of SC0062 in people with more severe kidney impairment. Finally, the finding that the albuminuria-lowering effects were consistent in participants using and not using sodium-glucose cotransporter 2 inhibitors is in keeping with the results from clinical trials with other endothelin receptor antagonists, including atrasentan and zibotentan.4,6 We therefore do not consider our results a chance finding because of the small sample size. We agree that larger clinical trials, such as the ongoing SC0062 phase 3 trial, will provide more robust evidence.

News (Medical) associated with Diosuxentan

26 Jun 2025

·www.prnewswire.com

BioCity's ETA-Selective Antagonist SC0062 Granted Breakthrough Therapy Designation in China for Diabetic Kidney Disease with Albuminuria

Second BTD Recognition Highlights Compound's Potential as Next-Generation Broad-Spectrum Renal Therapy SHANGHAI, June 25, 2025 /PRNewswire/ -- BioCity Biopharma ("BioCity") announced today that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to its highly selective endothelin receptor type A (ETA) antagonist SC0062 for the treatment of diabetic kidney disease (DKD) with albuminuria. This marks the second BTD for SC0062, following its initial designation for IgA nephropathy (IgAN) with proteinuria, which is conducting in Phase III, underscoring the compound's transformative potential across multiple chronic kidney disease (CKD) indications. The designation is supported by compelling data from the DKD cohort of the Phase 2 2-SUCCEED study, where SC0062 demonstrated: 1) Statistically and clinically significant albuminuria reduction at the 20 mg dose versus placebo. 2) Favorable safety profile with no increase in the risk of fluid retention observed in the SC0062 group. 3) Good safety both as monotherapy and in combination with standard-of-care therapies including SGLT2 inhibitors, RAAS inhibitors, GLP-1 receptor agonists, insulin, and Finerenone (MRA).Most participants in the trial received SGLT2 (sodium-glucose co-transporter-2) inhibitors and RAAS (renin-angiotensin-aldosterone system) inhibitors as background therapies, over 70% received GLP-1 (Glucagon-like peptide-1) receptor agonists and/or insulin, and approximately one-third were on Finerenone (a mineralocorticoid receptor antagonist, MRA). "With over 700 million people affected globally, kidney disease represents one of our greatest unmet medical challenges," said Dr. Ivy Wang, BioCity Co-founder and Executive President. "This dual BTD recognition validates SC0062's potential to redefine treatment paradigms across renal diseases. We're accelerating development to deliver this promising therapy to patients worldwide." Clinical and Commercial Context The completed Phase 2 2-SUCCEED program met all efficacy and safety endpoints in both IgAN and DKD cohorts at 12- and 24-week timepoints. Full DKD results will be presented at an upcoming international congress. DKD, affecting ~20.9 million patients in China (2021), drives the nation's CKD epidemic. Without innovation, age-standardized incidence rates（ASIR）are projected to rise 25% by 2036. Current therapies provide limited protection against progression to end-stage renal disease (ESRD). As an ETA antagonist showing optimized effect for CKD, SC0062 represents a mechanistically distinct approach that: Modulates renal hemodynamics Reduces proteinuria/albuminuria Counters inflammation and fibrosis With its demonstrated clinical benefits and superior selectivity profile, SC0062 is positioned to potentially become a best-in-class renal therapeutic. BioCity remains committed to advancing this promising candidate through late-stage development for multiple kidney disease indications. About SC0062 SC0062 is a novel and unique ETA antagonist characterized by its high selectivity for ETA compared to the endothelin receptor B (ETB). Its strong selectivity for ETA suggests that it has greater potential than non-selective endothelin receptor antagonists for slowing the progression of CKD while avoiding the side effects associated with non-selective medications in the same class used to treat IgAN and DKD and other types of CKD. Preclinical studies showed that SC0062 significantly improved pathological scores in acute and chronic kidney disease models. Completed Phase 1 studies demonstrated good safety, tolerability, and pharmacokinetics, with no signs of fluid retention. SC0062 has completed enrollment in both cohorts (IgAN and DKD) of the Phase 2 2-SUCCEED study. The IgAN cohort has met primary and secondary endpoints, with results published in JASN. The DKD cohort has now also met its primary and secondary endpoints. SC0062 has now received BTD twice from the CDE – first for IgAN with proteinuria and now for DKD with albuminuria. BioCity is conducting initiate two Phase 3 trials: SUCCESS-01 (IgAN) and SUCCESS-02 (CKD). SUCCESS-01 has been launched at Guangdong Provincial People's Hospital, led by Professor Xueqing Yu, President of the hospital and President of the Asia-Pacific Society of Nephrology. About BioCity Biopharma Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including CKD. BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC). Currently, SC0062 a highly selective ETA antagonist owned by BioCity, is in development for CKD. A Phase 3 confirmatory trial for IgAN has been initiated in China and a Phase 3 multi-regional clinical trial (MRCT) is being planned. In addition, BioCity has five core novel oncology assets in clinical development, including first-in-class CDH3- and GPC3-targeting antibody drug conjugates (ADCs), WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3. For more information, please visit: LinkedIn: BioCity Biopharma Business & Investment Inquiries: [email protected] | [email protected] SOURCE BioCity Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3Breakthrough TherapyPhase 1

26 Jun 2025

·www.pharmaceutical-technology.com

BioCity’s SC0062 gains NMPA breakthrough therapy designation

The programme achieved all efficacy and safety endpoints at 12 and 24-week timepoints. Credit: PanuShot/Shutterstock. The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted BioCity’s endothelin receptor type A (ET A ) antagonist, SC0062, a second breakthrough therapy designation (BTD). This new designation is intended to treat diabetic kidney disease (DKD) with albuminuria and highlights the therapy’s potential for chronic kidney disease indications. The BTD was supported by data from the DKD cohort of the Phase II 2-SUCCEED trial, and SC0062 showed major reductions in albuminuria at the 20mg dose against placebo. The safety profile was favourable both as monotherapy and when combined with treatments such as SGLT2 inhibitors, GLP-1 receptor agonists, RAAS inhibitors, insulin and Finerenone. BioCity co-founder and executive president Dr Ivy Wang stated: “With over 700 million people affected globally, kidney disease represents one of our greatest unmet medical challenges. “This dual BTD recognition validates SC0062’s potential to redefine treatment paradigms across renal diseases. We’re accelerating development to deliver this promising therapy to patients worldwide.” GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The completed 2-SUCCEED programme achieved all efficacy and safety endpoints at 12 and 24-week timepoints for both Immunoglobulin A nephropathy (IgAN) and DKD cohorts. SC0062 may slow CKD progression compared to non-selective treatments while minimising side effects. Preclinical studies have shown that it significantly improved pathological scores in acute and CKD models. The therapy has completed Phase I trials, demonstrating good tolerability, safety and pharmacokinetics without signs of fluid retention. It has now concluded enrolment for both IgAN and DKD cohorts in the Phase II 2-SUCCEED study and the cohorts have met their primary endpoints. With these developments underway, BioCity is initiating two Phase III clinical trials that include SUCCESS-01 (IgAN) and SUCCESS-02 (CKD). Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

Clinical ResultPhase 2Breakthrough Therapy

13 Mar 2025

·www.prnewswire.com

BioCity Biopharmaceutics Co., Ltd. Announces Clinical Collaboration to Evaluate BC3195 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Locally Advanced or Metastatic Solid Tumors

SHANGHAI, March 13, 2025 /PRNewswire/ -- BioCity Biopharmaceutics Co., Ltd., a clinical-stage biopharmaceutical company, today announced that it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to evaluate the combination of BioCity's BC3195 and MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in a global phase 1/2 trial in patients with locally advanced or metastatic solid tumors. Under the terms of the agreement, BioCity will conduct a phase 1/2 clinical trial to evaluate the safety and efficacy of BC3195 in combination with KEYTRUDA. BioCity and MSD each retain all commercial rights to their respective compounds. The recruitment in the clinical study is expected in Q4 2025. "We are encouraged by the clinical data we have seen thus far for BC3195 as monotherapy, which have demonstrated improved anti-tumour activity in patients with certain non-small cell lung and breast cancers. We now look forward to exploring the potential of BC3195 in combination with KEYTRUDA through this collaboration, as we continue to advance our clinical program and seek to further validate our differentiated drug discovery and development approach." Said by Ivy Wang, Co-founder and Executive President of BioCity. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About BC3195 BC3195 is currently the only ADC targeting CDH3 (P-Cadherin) in clinical development globally. In preclinical studies, BC3195 binds to membrane CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated, cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted cancer cells, as well as surrounding cells, which is known as the bystander effect. In animal models, BC3195 demonstrated a favorable safety profile and robust antitumor activity with tumor growth inhibition ≥100% in some animals bearing well established cancers. BC3195 is currently undergoing concurrent Phase I dose optimization and dose expansion in China and in US. BC3195 demonstrated a manageable safety profile and favorable PK characteristics, significant antitumor activity with confirmed PRs observed across multiple tumor types. About BioCity Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including chronic kidney diseases. BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC). Currently, BioCity has five core oncology assets in Phase 1/2 clinical development, including first-in-class CDH3-targeting ADC and GPC3-targeting ADCs, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3 in collaboration with AstraZeneca. In addition, BioCity's SC0062, a highly selective ETA antagonist, is in phase 3 clinical development for IgA nephropathy and a global phase 3 registration trial is being planned. For more information, please visit Or LinkedIn BioCity Biopharma Contact: [email protected] [email protected] SOURCE BioCity Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1License out/inPhase 3ADC

100 Deals associated with Diosuxentan

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glomerulonephritis, IGA	Phase 3	China	Wuxi Zhikang Hongyi Biological Technology Co Ltd	14 Feb 2025
Proteinuria	Phase 3	China	Wuxi Zhikang Hongyi Biological Technology Co Ltd	14 Feb 2025
Albuminuria	Phase 2	China	Wuxi Zhikang Hongyi Biological Technology Co Ltd	23 May 2023
Chronic Kidney Diseases	Phase 2	China	Wuxi Zhikang Hongyi Biological Technology Co Ltd	23 May 2023
Diabetic Nephropathies	Phase 2	China	Wuxi Zhikang Hongyi Biological Technology Co Ltd	23 May 2023
Pulmonary Arterial Hypertension	Phase 1	China	Shijiazhuang Zhikang Hongren New Drug Development Co., Ltd.	16 Dec 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05687890 (2-SUCCEED, PRNewswire) Manual	Phase 2	Diabetic Nephropathies	-	SC0062	sizpxoeymf(rahkkspolo) = SC0062 significantly reduced proteinuria in the high-dose group (20mg) compared to the placebo group. kknghfcsdy (afibkpsgnd ) Met View more	Positive	25 Feb 2025
				Placebo
NCT05687890 (2-SUCCEED, PRNewswire \| NEWS) Manual	Phase 2	Glomerulonephritis, IGA	131	SC0062 5 mg	qibvkallzd(jswxtgzifd) = zfvqtmbrpg apcmppzkxp (ibbkmringi ) Met View more	Positive	04 Nov 2024
				SC0062 10 mg	qibvkallzd(jswxtgzifd) = etrchzbtxe apcmppzkxp (ibbkmringi ) Met View more
NCT05687890 (2-SUCCEED, ASN2024)	Phase 2	Glomerulonephritis, IGA	131	SC0062 5 mg	mkqtdqevcf(hredcezgsh) = The proportion of participants with TEAEs or SAEs was balanced among treatment groups. susvyegbti (wontwguofr ) View more	Positive	26 Oct 2024
				SC0062 10 mg
NCT05687890 (2-SUCCEED, NEWS) Manual	Phase 2	Glomerulonephritis, IGA	-	SC0062	goslbexsss(ddjvfhtcud) = 与安慰剂组相比能够显著降低 mgjwibpzpw (aqwmxhzwnt ) Met View more	Positive	08 Jul 2024
				Placebo
NCT05687890 (2-SUCCEED, PRNewswire) Manual	Phase 2	Glomerulonephritis, IGA	-	SC0062	plnnwbschn(vybtwnmztp) = SC0062 resulted in a clinically meaningful and statistically significant reduction in proteinuria lkjkclrzwl (vnxjqdthpc ) Met View more	Positive	08 Jul 2024
				Placebo
CTR20201868 (Literature) Manual	Phase 1	-	-	SC0062	ucunliofhc(tcftcrqmkz) = Single doses of 10 to 100 mg and multiple daily doses of 20 and 50 mg for 6 days were well tolerated. mlxdufwgqx (oinweikjyu )	Positive	07 Mar 2024

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