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Primary purpose: To evaluate the efficacy of Bonretinib tablets in the treatment of PV subjects with HU resistance/intolerance. Secondary purpose: To evaluate the sustainability of the efficacy of Bonretinib tablets in the treatment of PV subjects with HU resistance/intolerance; To evaluate the safety of Bonretinib tablets in the treatment of PV subjects with HU resistance/intolerance.

Start Date28 May 2024

Sponsor / Collaborator

Hangzhou Guangliang Biomedical Co., Ltd.

[+1]

CTR20232462

/ CompletedPhase 1

[14C]邦瑞替尼在中国成年男性健康受试者体内的物质平衡研究

[Translation] Study on the material balance of [14C]bonevitinib in healthy adult male subjects in China

主要研究目的： 1 定量分析男性健康受试者口服[14C]邦瑞替尼后，排泄物中的总放射性，获得人体放射性的累计排泄率和主要排泄途径； 2 考察男性健康受试者单次口服[14C]邦瑞替尼后，全血和血浆中的分配情况，血浆中总放射性的药代动力学； 3 鉴定男性健康受试者口服[14C]邦瑞替尼后，血浆、尿液、粪便中的主要代谢产物，确定主要生物转化途径和主要代谢产物（接近或大于10%总放射性AUC）； 4 采用已验证的LC-MS/MS方法定量分析血浆中邦瑞替尼及其主要代谢产物（如适用）的浓度，获得血浆中邦瑞替尼及其主要代谢产物（如适用）的药代动力学参数。次要研究目的：观察[14C] 邦瑞替尼单次给药后男性健康受试者的安全性。

[Translation]

Main study objectives: 1 To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]bangretinib to healthy male subjects, and obtain the cumulative excretion rate and main excretion pathway of human radioactivity; 2 To investigate the distribution of [14C]bangretinib in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of [14C]bangretinib to healthy male subjects; 3 To identify the main metabolites in plasma, urine and feces after oral administration of [14C]bangretinib to healthy male subjects, and determine the main biotransformation pathways and main metabolites (close to or greater than 10% of the total radioactivity AUC); 4 To quantitatively analyze the concentration of bangretinib and its main metabolites (if applicable) in plasma using a validated LC-MS/MS method, and obtain the pharmacokinetic parameters of bangretinib and its main metabolites (if applicable) in plasma. Secondary study objectives: To observe the safety of healthy male subjects after a single dose of [14C]bangretinib.

Start Date21 Aug 2023

Sponsor / Collaborator

Hangzhou Bangshun Pharmaceutical Co Ltd

[+1]

100 Clinical Results associated with Bezacitinib

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100 Translational Medicine associated with Bezacitinib

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100 Patents (Medical) associated with Bezacitinib

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1

Literatures (Medical) associated with Bezacitinib

15 Oct 2025·CANCER

Efficacy and safety of OB756 (a novel selective JAK2 inhibitor) for essential thrombocythemia in patients intolerant of or resistant to hydroxyurea or intolerant of interferon: A phase 2, open‐label, multicenter study

Article

Author: Jiao, Zongjiu ; Zhou, Yile ; Zhang, Yi ; Zhao, Lidong ; Huang, Jian ; Zhang, Feng ; Li, Rumeng ; Chen, Lili ; Shou, Lihong ; Wu, Guocai ; Guo, Pengxiang ; Liu, Qinchi ; Jin, Jie ; Gong, Tiejun ; Zhou, Hu

Abstract:

Background:

OB756 is a novel oral selective JAK2 inhibitor targeting the JAK‐STAT pathway. This study assessed its safety and efficacy in patients with essential thrombocythemia (ET) who were resistant to or intolerant of hydroxyurea or intolerant of interferon.

Methods:

This phase 2, single‐arm, open‐label, multicenter clinical trial evaluated the efficacy and safety of OB756 in patients with ET who were intolerant of or resistant to hydroxyurea, or intolerant of interferon. The primary end point was the complete hematologic response (CHR) rate at week 24, whereas secondary end points included hematologic response (HR), the proportion of patients with ≥35% spleen volume reduction at week 24, molecular response, and safety.

Results:

At week 24, the CHR was 22% (11 of 50) based on intention‐to‐treat analysis. Among evaluable patients, the HR rate reached 65.6% at week 24. At week 24, 94.7% of patients (36 of 38) experienced spleen volume reduction, with 50.0% achieving ≥35% reduction. Additionally, 74.2% of patients (23 of 31) had a ≥50% reduction in myeloproliferative neoplasm symptom assessment form total symptom score. Among evaluable patients, 84.7% (11 of 13) had a reduction in JAK2‐V617F allele burden post‐treatment. In terms of safety, most treatment‐related adverse events (TEAEs) were grade 1–2. Grade ≥3 hematologic TEAEs included anemia (10%) and neutropenia (6%). The incidence of grade ≥3 infections was 16% and grade ≥3 thrombotic events was 2%.

Conclusions:

Overall, OB756 was well‐tolerated and demonstrated acceptable efficacy, offering a promising therapeutic option for ET patients who are resistant to or intolerant of hydroxyurea or intolerant of interferon.

100 Deals associated with Bezacitinib

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Post-essential thrombocythemia myelofibrosis	China	Hangzhou Bangshun Pharmaceutical Co Ltd	29 Apr 2026
Post-polycythemia vera myelofibrosis	China	Hangzhou Bangshun Pharmaceutical Co Ltd	29 Apr 2026
Primary Myelofibrosis	China	Hangzhou Bangshun Pharmaceutical Co Ltd	29 Apr 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Polycythemia Vera	Phase 3	China	Hangzhou Bangshun Pharmaceutical Co Ltd	28 May 2024
Polycythemia Vera	Phase 3	China	Hangzhou Guangliang Biomedical Co., Ltd.	28 May 2024
Acute Graft Versus Host Disease	Phase 2	China	Hangzhou Bangshun Pharmaceutical Co Ltd	28 Jun 2022
Chronic graft-versus-host disease	Phase 2	China	Hangzhou Bangshun Pharmaceutical Co Ltd	28 Jun 2022
Diabetes Mellitus, Type 1	Phase 1	China	Hangzhou Bangshun Pharmaceutical Co., Ltd.	31 Jul 2026
Rheumatoid Arthritis	Phase 1	China	Hangzhou Aojin Biomedical Technology Co Ltd	05 Jun 2019
Rheumatoid Arthritis	Phase 1	China	Hangzhou Guangliang Biomedical Co., Ltd.	05 Jun 2019
Colitis, Ulcerative	IND Approval	China	Hangzhou Bangshun Pharmaceutical Co Ltd	16 Aug 2022
Systemic Lupus Erythematosus	IND Approval	China	Hangzhou Bangshun Pharmaceutical Co Ltd	17 Jan 2022
Dermatitis, Atopic	IND Approval	China	Hangzhou Bangshun Pharmaceutical Co Ltd	17 Dec 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20211396 (EHA2026)	Phase 2/3	Myelofibrosis	12	OB756 20 mg BID	eyqcwkymos(jcremwqrbp) = gryudxwxkp vnlcvgplar (etvqlutqyf ) View more	Positive	12 May 2026
Pubmed \| Cancer Manual	Phase 2	Thrombocythemia, Essential	50	OB756	muvngjhdpu(ohwpjidudd) = yupcbmgdvw oluraipdgh (rlgvwxmkgg ) View more	Positive	15 Oct 2025
ASH2024	Not Applicable	Polycythemia Vera	-	OB756 16 mg BID	tfgxssodgd(ygaaxmgegv) = jkhyxxmqsc bhrgdcuiqr (fsvmylgzdl ) View more	-	08 Dec 2024
				OB756 20 mg BID	tfgxssodgd(ygaaxmgegv) = ivxasppeff bhrgdcuiqr (fsvmylgzdl ) View more
CTR20211396 (BEWELL-301, NEWS)	Phase 2/3	Myelofibrosis	-	邦瑞替尼	favdivxbwb(mrmhcxwcgl) = Clinical results have reached the endpoint zkhxpnkfar (aurbenhufx )	Superior	22 Aug 2024
				羟基脲