Delving into the Latest Updates on YH01 with Synapse

Overview

Basic Info

Drug Type

Oncolytic virus

Synonyms

YH 01, YH-01, YH01

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseUrogenital Diseases

Active Indication

Ovarian CancerCarcinoma of urinary bladder, invasiveNon-Muscle Invasive Bladder Neoplasms+ [1]

Inactive Indication-

Originator Organization

Beijing Yinmei Future Biomedical Technology Co., Ltd.

Active Organization

Beijing Yinmei Future Biomedical Technology Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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主要目的：比较不同给药方案YH01注射液膀胱灌注治疗经BCG灌注治疗无效或失败的中高危NMIBC患者的有效性。次要目的：评价不同给药方案YH01注射液膀胱灌注治疗经BCG灌注治疗无效或失败的中高危NMIBC患者的安全性。评价不同给药方案YH01注射液膀胱灌注治疗经BCG灌注治疗无效或失败的中高危NMIBC患者的生物分布特征、病毒排出和免疫原性。探索性目的：评价不同给药方案YH01注射液膀胱灌注治疗经BCG灌注治疗无效或失败的中高危NMIBC患者的药效动力学特征（仅Ⅱa期）。评价不同给药方案YH01注射液膀胱灌注治疗经BCG灌注治疗无效或失败的中高危NMIBC患者的肿瘤组织中潜在的疗效预测生物标记物（仅Ⅱa期）。

[Translation]

Primary objective: To compare the effectiveness of different dosing regimens of YH01 injection intravesical instillation in the treatment of patients with medium- and high-risk NMIBC who have failed or failed BCG instillation. Secondary objective: To evaluate the safety of different dosing regimens of YH01 injection intravesical instillation in the treatment of patients with medium- and high-risk NMIBC who have failed or failed BCG instillation. To evaluate the biodistribution characteristics, viral shedding and immunogenicity of different dosing regimens of YH01 injection intravesical instillation in the treatment of patients with medium- and high-risk NMIBC who have failed or failed BCG instillation. Exploratory objective: To evaluate the pharmacodynamic characteristics of different dosing regimens of YH01 injection intravesical instillation in the treatment of patients with medium- and high-risk NMIBC who have failed or failed BCG instillation (Phase IIa only). To evaluate the potential efficacy predictive biomarkers in tumor tissues of different dosing regimens of YH01 injection intravesical instillation in the treatment of patients with medium- and high-risk NMIBC who have failed or failed BCG instillation (Phase IIa only).

Start Date30 Nov 2024

Sponsor / Collaborator

Beijing Yinmei Future Biomedical Technology Co., Ltd.

CTR20233676

/ RecruitingPhase 1

YH01 注射液瘤内注射治疗标准治疗无效或失败的晚期实体瘤的多中心的 I 期临床试验

[Translation] A multicenter Phase I clinical trial of intratumoral injection of YH01 injection for the treatment of advanced solid tumors that have failed or failed standard treatment

第一阶段（剂量递增阶段）主要终点：安全性：评估YH01注射液给药后的安全性和耐受性。次要终点：生物分布特征和病毒排出，免疫原性，RECIST v1.1评估的疗效：探索性终点：药效动力学评价第二阶段（剂量扩展阶段）主要目的：研究者根据RECIST v1.1评估在推荐剂量下YH01注射液在标准治疗无效或失败的晚期实体瘤患者中的客观缓解率（ORR）。次要目的：研究者根据RECIST v1.1评估的其他疗效指标，安全性，免疫原性。探索性目的：药效动力学特征，生物标记物。

[Translation]

Phase I (dose escalation phase) Primary endpoint: Safety: To evaluate the safety and tolerability of YH01 injection after administration. Secondary endpoints: Biodistribution characteristics and viral shedding, immunogenicity, efficacy evaluated by RECIST v1.1: Exploratory endpoint: Pharmacodynamic evaluation Phase II (dose expansion phase) Primary objective: Investigators evaluate the objective response rate (ORR) of YH01 injection at the recommended dose in patients with advanced solid tumors who are ineffective or failed with standard treatment according to RECIST v1.1. Secondary objectives: Other efficacy indicators, safety, immunogenicity evaluated by researchers according to RECIST v1.1. Exploratory objectives: Pharmacodynamic characteristics, biomarkers.

Start Date06 Dec 2023

Sponsor / Collaborator

Beijing Yinmei Future Biomedical Technology Co., Ltd.

100 Clinical Results associated with YH01

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100 Translational Medicine associated with YH01

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100 Patents (Medical) associated with YH01

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2

Literatures (Medical) associated with YH01

01 Sep 2021·Retinal cases & brief reports

A CASE OF CAT SCRATCH DISEASE DIAGNOSED BY INDIRECT FLUORESCENT ANTIBODY ASSAY OF IgM SPECIFIC FOR A JAPANESE STRAIN OF Bartonella henselae

Author: Kimura, Kazuhiro ; Yanai, Ryoji ; Otsuyama, Ken-ichiro ; Sonoda, Koh-Hei ; Tsuneoka, Hidehiro ; Uchi, Sho-Hei

Purpose::

To report a case of cat scratch disease–associated retinitis diagnosed with an indirect fluorescent antibody (IFA) assay for immunoglobulin M (IgM) specific for a strain (YH-01) of Bartonella henselae recently identified in Japan.

Methods::

Case report of a 24-year-old pregnant woman presented with general fever, fatigue, as well as blurred vision, and a central visual field deficiency in her right eye and was suspected as cat scratch disease because she had started to feed a feral dog a month ago.

Results::

The patient's serum tested negative, however, with an IFA assay for IgG or IgM specific for the Houston-1, common strain of B. henselae. Further testing with an IFA assay for IgM specific for the YH-01 strain yielded a positive result. On the basis of the clinical findings and the IFA results, we were thus able to make a definitive diagnosis of cat scratch disease.

Conclusion::

An IFA assay based on the YH-01 or combination of both YH-01 and Houston-1 strains of B. henselae may show increased sensitivity for the diagnosis of cat scratch disease in Japan.

16 Feb 2021·ACS omegaQ3 · CHEMISTRY

Antibacterial Potential of Termite-Associated Streptomyces spp

Q3 · CHEMISTRY

ArticleOA

Author: Li, Shuai ; Zhou, Ling-Feng ; Yin, Cai-Ping ; Li, Qi ; Wu, Jun ; Zhang, Ying-Lao ; Jin, Li-Ping

Twenty-one strains of termite-associated actinomycetes were tested for their activities against three bacteria. The results showed that nine strains showed bacteriostatic activities against at least one tested bacterium, and the actinomycete YH01, which was isolated from the body surface of the queen of Odontotermes formosanus, had potent antibacterial activity. The YH01 was further identified as Streptomyces davaonensis. Two metabolites roseoflavin (1) and 8-methylamino-8-demethyl-d-riboflavin (2) were isolated and purified from S. davaonensis YH01. Their structures were determined by NMR, MS, and the related literature. The metabolite 1 showed strong inhibition activities against Bacillus subtilis (MIC = 1.56 μg/mL) and Staphylococcus aureus (MIC = 3.125 μg/mL), which were comparable to referenced gentamycin sulfate, with MIC values of 1.56 and 1.56 μg/mL, respectively. Furthermore, the anti-MRSA potential of compound 1 was determined against nine kinds of MRSA strains, with inhibition zones in the ranges of 12.7-19.7 mm under a concentration of 15 μg/6 mm discs and 18.3-22.7 mm under a concentration of 30 μg/6 mm discs. However, metabolite 1 had no inhibitory effect on Gram-negative bacteria. These results suggested that roseoflavin produced by YH01 holds promise for use against Gram-positive bacteria, especially to MRSA.

100 Deals associated with YH01

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ovarian Cancer	Phase 2	China	Beijing Yinmei Future Biomedical Technology Co., Ltd.	22 May 2026
Carcinoma of urinary bladder, invasive	Phase 2	China	Beijing Yinmei Future Biomedical Technology Co., Ltd.	17 Mar 2025
Non-Muscle Invasive Bladder Neoplasms	Phase 2	China	Beijing Yinmei Future Biomedical Technology Co., Ltd.	30 Nov 2024
Advanced Malignant Solid Neoplasm	Phase 1	China	Beijing Yinmei Future Biomedical Technology Co., Ltd.	06 Dec 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Phase 2	Non-Muscle Invasive Bladder Neoplasms	11	YH01	jsbioamxjx(arqiyfxgmx) = oiyyicowha epvqfgisfs (iqegnfakrz ) View more	Positive	16 Jan 2026
				YH01 (6次给药)	jsbioamxjx(tikiepqnpd) = zxzyrzytcn lxvfzghiqv (ewrdmyacdu ) View more