An Open-Label, Non-Randomized, Multi-center Phase 2 Study of YH001 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) and Hepatocellular Carcinoma (HCC)

This is an Open-label, Non-Randomized, Multi-center Phase 2 study of YH001 in Combination with Toripalimab，The study is designed to determine the safety ，tolerability and antitumor activity of YH001 in combination with Toripalimab in subjects with advanced NSCLC and HCC.

开始日期2023-06-01

申办/合作机构

祐和医药科技（北京）有限公司

NCT05448820

/ Active, not recruiting临床1/2期

A Phase 1/2 Study of YH001 in Combination With Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma

This is a multicenter, open label, Phase 1/2 study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma, followed by Phase 2 cohorts of patients with select histologies of advanced or metastatic sarcoma.

开始日期2022-11-14

申办/合作机构

TRACON Pharmaceuticals, Inc.

CTR20221336

/ Completed临床1期

一项评价YH003、YH001 和帕博利珠单抗联合治疗晚期实体瘤受试者的安全性、耐受性和药代动力学的多中心、开放标签、I 期剂量递增研究。

评估YH003、YH001 和帕博利珠单抗联合治疗（递增剂量水平）晚期实体瘤受试者的安全性和耐受性；确定YH003、YH001 和帕博利珠单抗联合治疗的最大耐受剂量（MTD）和/或推荐的II 期剂量（RP2D）。

开始日期2022-07-18

申办/合作机构

祐和医药科技（北京）有限公司

100 项与 YH-001 相关的临床结果

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100 项与 YH-001 相关的转化医学

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100 项与 YH-001 相关的专利（医药）

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项与 YH-001 相关的文献（医药）

2022-12-01·Ecotoxicology and environmental safety

A starch-based controlled-release targeted nutrient agent to stimulate the activity of volatile chlorinated hydrocarbon-degrading indigenous microflora present in groundwater

Article

作者: Wang, Jili ; Zhang, Yuling ; Shi, Yujia ; Yang, Qingchun ; Liu, Ting ; Wang, Xi ; Yin, Siqi

Volatile chlorinated hydrocarbons (VCHs) contaminated groundwater has a low indigenous microorganism population, and lack of nutrient substrates involved in degradation reactions, resulting in a weak natural remediation ability of groundwater ecosystems. In this study, based on the principle of degradation of VCHs by indigenous microorganisms in groundwater, and combined with biostimulation and controlled-release technology, we developed a starch-based encapsulated targeted bionutrient (YH-1) with easy uptake, good stability, controllable slow-release migration, and long timeliness for the remediation of groundwater contaminated by VCHs by indigenous microorganisms. The results showed that YH-1 is easily absorbed by microorganisms and can rapidly initiate itself to stimulate the microbial degradation of VCHs, and the degradation rate of various VCH components within 7 days was 82.38-92.38 %. The release rate of nutrient components in YH-1 increases with increasing VCH concentrations in groundwater; this could effectively prolong the action time of nutrient components, while also improving the degradation efficiency of pollutants with a sustained effect of more than 15 days. Simultaneously, owing to the fluidity, water solubility, and biodegradability of YH-1 in lithologic media, YH-1 injection did not cause blockage of the lithologic media in the aquifer. Through YH-1 stimulation, indigenous microorganisms grew rapidly in the underground environment, the diversity of microbial communities and the total number of species increased, and the correlation between genera strengthened. Simultaneously, YH-1 improved the ability of microbial community to convert inorganic electron donors/acceptors, thereby strengthening the co-metabolic mechanism between microorganisms. Additionally, there was a significant increase in the percentage of many microorganisms (e.g., Sphingomonas, Janthinobacterium, Duganella, etc.) that mediated the reductive dechlorination process and were redox inorganic electron donors/acceptors. This was conducive to the reductive dechlorination process of VCHs and achieved the efficient degradation of VCHs.

2016-01-01·Nutrition research and practice4区 · 医学

Effects of Cyclo-His-Pro-enriched yeast hydrolysate on blood glucose levels and lipid metabolism in obese diabeticob/obmice

4区 · 医学

Article

作者: Hong, Yang Hee ; Jung, Eun Young ; Park, Chung ; Suh, Hyung Joo

BACKGROUND/OBJECTIVES:

We examined the hypoglycemic and anti-hyperlipidemic effect of yeast hydrolysate (YH) enriched with Cyclo-His-Pro (CHP) in the C57BL/6J ob/ob mouse model.

MATERIALS/METHODS:

Mice were separated into 4 groups (8 mice/group) on the basis of blood glucose and body weight: WT control, lean mice given vehicle; ob/ob control, ob/ob mice given vehicle; YH-1, ob/ob mice given 0.5 g/kg of YH; YH-2, ob/ob mice given 1 g/kg of YH. YH in saline or vehicle was administered orally in the same volume every day for 3 weeks.

RESULTS:

Mice treated with YH (0.5 and 1 g/kg) for 3 weeks displayed a significant reduction in overall body weight gain and perirenal and epididymal adipose tissue weight compared to the ob/ob control group. Additionally, high-density lipoprotein (HDL) cholesterol, glucose, and atherogenic indexes were significantly decreased in the blood of YH-1 and YH-2 groups compared to the ob/ob control. In ob/ob mice, YH administration significantly improved glucose tolerance and blood insulin levels. These data indicate that YH treatment produces potent hypoglycemic and anti-hyperlipidemic effects by controlling body weight, fat mass, blood lipid, insulin levels, and glucose tolerance.

CONCLUSION:

YH could potentially be used as a treatment option for diabetes and hyperlipidemia. The CHP-enriched YH may be a promising strategy in the development of hypoglycemic peptide nutraceuticals.

Animals : an open access journal from MDPI

Evaluation of Yeast Hydrolysate in a Low-Fishmeal Diet for Whiteleg Shrimp (Litopenaeus vannamei)

Article

作者: Lee, Yein ; Hwang, Soyeon ; Hamidoghli, Ali ; Bai, Sungchul C. ; Choi, Wonsuk ; Choi, Youn-Hee

An eight-week feeding trial was performed to evaluate the effects of yeast hydrolysate (YH) supplementation in a low-fishmeal diet on the growth, immune responses, intestinal histology and disease resistance of whiteleg shrimp (Litopenaeus vannamei). Five experimental diets were produced by supplementing YH at 0 (CON), 0.5 (YH0.5), 1 (YH1), 2 (YH2) and 4 (YH4) % to a basal diet containing 10% fishmeal and compared with a positive control with 25% fishmeal (FM25). Shrimp with an initial average weight of 0.43 ± 0.005 g (mean ± SD) were stocked in 18 tanks and fed the experimental diets (38% protein and 8% lipid) four times a day. Results showed that shrimp fed the FM25 diet exhibited significantly higher final body weight, weight gain, specific growth rate and protein efficiency ratio than those fed CON, YH0.5, YH1 and YH2 diets (p < 0.05). However, there were no significant differences between shrimp fed the YH4 and FM25 diets (p > 0.05). In addition, there were no significant differences in whole-body proximate composition, hemolymph biochemical parameters and non-specific immune responses among treatments. Intestinal villi length and muscular layer thickness of shrimp fed the YH4 and FM25 diets were significantly higher than the other groups. At the end of the bacterial (Vibrio parahaemolyticus) challenge test, shrimp fed YH4 and FM25 diets showed a significantly higher survival rate than those of shrimp fed CON, YH0.5 and YH1 (p < 0.05). These results suggest that supplementing 4% YH in diet containing 10% fishmeal could beneficially influence growth, intestinal morphology and disease resistance of whiteleg shrimp.

项与 YH-001 相关的新闻（医药）

2024-12-26

·百奥赛图

百奥赛图合作伙伴Syncromune获1亿美元A轮融资，加速创新肿瘤免疫疗法发展！

百奥赛图已与美国Syncromune公司就多个抗体项目建立了技术转移和抗体授权的多方位战略合作关系。2022年10月，百奥赛图全资子公司祐和医药与Syncromune签署了抗体授权协议，根据协议，Syncromune将获得由YH002及其他活性成分组成的瘤内免疫疗法。此后，双方进一步达成协议，将YH001和YH003作为选定的活性成分纳入合作范围。基于百奥赛图子公司祐和医药引进的抗CTLA-4单抗（YH001）和CD40激动型单抗（YH003），结合抗PD-1抗体、TLR9激动剂等活性成分，Syncromune公司利用其创新的SYNC-T原位个性化疗法平台，成功开发了SYNC-T SV-102抗肿瘤疗法。该疗法已在墨西哥开展临床试验，并取得了初步的良好抗肿瘤活性数据。2024年6月28日，SYNC-T SV-102疗法获得美国FDA快速通道资格，成为治疗转移性去势抵抗性前列腺癌（mCRPC）患者的主要候选疗法。近日，Syncromune宣布成功完成1亿美元A轮融资。此轮融资由一家未披露的机构投资者领投，现有投资方Wasatch Equity Partners亦参与其中。此外，融资还引发了约4500万美元可转换债券的转股。这是南佛罗里达今年规模最大的一轮融资之一，并且在医疗健康领域也属于两笔重要融资之一。（来源：ENDPOINTS官方新闻稿，请点击“阅读原文”查看完整内容） Syncromune表示，此次融资将用于推进其候选药物SV-102的Ⅱa期临床试验，主要针对mCRPC的治疗。该临床试验的患者招募已在费城的Lankenau医学研究所启动。该公司表示，当前大多数转移性实体肿瘤癌症尚无法治愈，且存在巨大的未满足医疗需求。作为新一代疫苗类肿瘤治疗方法的一部分，Syncromune正在开发一种创新疗法，利用冷冻技术处理肿瘤并结合多种免疫疗法药物进行治疗。通过冷冻肿瘤并释放其内部物质，激活患者的T细胞以攻击肿瘤细胞。在CEO Eamonn Hobbs的带领下，Syncromune目前专注于开发针对转移性非小细胞肺癌、转移性乳腺癌以及转移性去势抵抗性前列腺癌的新型疗法。作为深度合作伙伴，百奥赛图对Syncromune公司在A轮融资中取得的成功表示热烈祝贺！此次融资为Syncromune推动其创新疗法的发展提供了有力支持，为肿瘤治疗领域带来了新的希望。展望未来，百奥赛图将继续与更多合作伙伴携手，共同致力于创新疗法的研发与应用，推动更多突破性成果造福全球患者。请点击“阅读原文”查看相关新闻，了解更多内容。关于百奥赛图百奥赛图（股票代码：02315.HK）是一家创新技术驱动新药研发的国际性生物技术公司，致力于成为全球新药发源地。基于底层基因编辑技术，百奥赛图自主研发了RenMice®（RenMab®、RenLite®、RenNano®、RenTCR-mimic®）平台，用于全人治疗性单克隆抗体、双/多特异性抗体、双抗ADC、纳米抗体和类TCR抗体的发现。百奥赛图正在对1000多个潜在可成药的靶点进行规模化药物开发（“千鼠万抗TM”计划），并已建立起40多万条全人抗体序列库，用于全球合作。截至2024年6月30日，百奥赛图已签署了约150项药物合作开发/授权/转让协议，并与包括多家MNC在内的企业达成了近50个靶点项目RenMice®平台授权开发合作，多个临床阶段抗体分子也达成了对外授权合作。公司子品牌BioMice®提供几千种包括靶点人源化小鼠在内的基因编辑动物和细胞模型，同时为全球客户提供临床前药理药效和基因编辑服务。百奥赛图总部位于北京，在中国（江苏海门、上海）、美国（波士顿、旧金山）及德国海德堡等地设有分支机构。欲了解更多信息，请访问官网https://www.biocytogen.com.cn/。

免疫疗法快速通道疫苗细胞疗法临床1期

2024-07-02

·Pharmaceutical Technology

Tracon mulls strategic options after sarcoma drug fails Phase II trial

Tracon licensed the North American rights to envafolimab from China-based Jiangsu Alphamab Biopharmaceuticals and 3D Medicines in 2019. Image Credit: TarikVision / Shutterstock. TRACON Pharmaceuticals has terminated the Phase II ENVASARC trial for its sarcoma therapy, envafolimab , as the therapy is unlikely to show the level of efficacy required to support a biologics licence application (BLA). The decision to scrap the Phase II ENVASARC trial (NCT04480502) was informed by a blinded independent central review analysis that showed that the therapy’s objective response rate (ORR) is 5% in the 82 patients evaluated for the analysis. This is lower than the 11% ORR needed to meet the trial’s primary endpoint and support a BLA. Tracon has discontinued all its clinical development activities related to envafolimab and plans to reduce its cash burn. The company also plans to explore strategic alternatives, including a “merger, reverse merger, acquisition, other business combination, sales of assets, licensing or other strategic transactions”. The main asset that the company plans to leverage is its in-house product development platform. Tracon claims that the platform can offer cost and time savings while remaining independent of contract research organisations (CROs). Following the news, the company stock was down by 30.6% at market close on 1 July, compared to market close on 28 June. Tracon’s market cap now stands at $2.97m. Sarcomas are rare cancers that develop in the bones and soft tissues. Tracon investigated envafolimab as a treatment for two types of advanced or metastasised soft tissue sarcomas, undifferentiated pleomorphic sarcoma, or myxofibrosarcoma. See Also: CAN-3110 by Candel Therapeutics for High-Grade Glioma: Likelihood of Approval ICTCAR-028 by Innovative Cellular Therapeutics for Hematological Tumor: Likelihood of Approval Envafolimab is a programmed death ligand 1 (PD-L1) targeting single-domain antibody. Tracon licenced North American rights to the therapy from China-based Jiangsu Alphamab Biopharmaceuticals and 3D Medicines in 2019. In 2021, envafolimab was approved in China as a treatment for advanced microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) advanced solid tumours, including advanced colorectal cancer. The therapy also received a breakthrough designation last year as a second-line treatment for non-MSI-H/non-dMMR advanced endometrial cancer, in China. Other therapies in Tracon’s pipeline include YH001, a cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)-targeting antibody being developed in partnership with China-based Eucure Biopharma, and TRC102 (methoxyamine), a small molecule inhibitor of the DNA base excision repair pathway.

临床2期上市批准突破性疗法

2024-05-25

·佰傲谷BioValley

祐和医药陈兆荣：遵循监管政策，加速新药研发 | QbD2024风云录

嘉宾简介陈兆荣博士深耕医药研发行业三十余载，在新药临床研发、新药审评、医药注册，医学事务和药物安全等领域有着丰厚经验。在加入祐和前曾在Citrine Medicine, JHL等几家Biotech公司担任CMO。在GSK曾担任副总裁兼卓越注册中心负责人、中国/香港区医学总监。在此之前，他历任Bayer-Schering Pharma、Sanofi高管职位。陈兆荣博士毕业于山东医科大学医疗系，并在澳大利亚阿德莱德皇家医院获得临床药理学博士学位。他曾获阿德雷得皇家医院Florey 研究基金及NH&MRC研究基金。也曾在澳大利亚药品管理局（TGA）从事药物审评与审批工作。祐和医药作为百奥赛图的全资子公司，祐和医药承担着为百奥赛图研发管线进行临床开发的使命。依托强大的临床开发团队及其丰富的临床开发经验，祐和医药聚焦于肿瘤和非肿瘤的抗体药物治疗。公司已构建起针对十多个靶点的强大研发管线。现阶段1个产品已启动国际多中心（MRCT）II期临床研究，3个产品在临床I期，1个产品获得IND批件。详情请访问：www.eucure.com。发展历程201611月，祐和医药科技（北京）有限公司成立12月，获得百奥财富和国投创业的A轮投资20177月，获得百奥财富和国投创业的A+轮投资20183月，完成由招银国际资本领投，本草资本跟投的B轮投资20195月，成立波士顿子公司10月，组建国际化临床开发团队10月，YH001项目IND获得FDA批准2020YH001项目：①联合君实生物PD-1澳洲I期临床研究完成首例患者筛选②项目IND获得NMPA批准YH002项目：①项目IND获得FDA批准②澳洲I期临床研究完成首例患者筛选③项目IND获得NMPA批准YH003项目：联合君实生物PD-1澳洲I期临床研究完成首例患者筛选2021YH001项目：①中国I期临床研究完成首例患者筛选②和YH003在美国进入II期临床研究③II期国际多中心临床试验（MRCT）获NMPA批准YH003项目：①联合君实生物PD-1在澳洲顺利进入II期临床研究②项目IND获得NMPA批准③中国I期临床研究完成首例患者用药④II期国际多中心临床试验（MRCT）获NMPA批准⑤联合PD-1抗体的国际多中心（MRCT）II期临床试验完成首例患者给药YH004项目：澳洲I期临床研究完成首例患者给药技术平台基于RenMice®（RenMab®，RenLite®和RenNano®）平台，百奥赛图建立了六大全人抗体技术平台，满足多种靶点、多种成药形式的抗体药物开发。产品管线Innovative Drug Pipeline质量源于设计，又贯穿始终。QbD大会历经四载，在行业同仁的持续关注和支持下，2024第五届QbD生物药质量科学大会（QbD2024）将于7月26-27日在北京悠唐皇冠假日酒店再次召开。将重点围绕创新生物药的质控、分析、法规等内容展开讨论。从案例、实践去解读创新药质量研究管理的进程，持续深化QbD理念。祐和医药首席执行官&首席医学官陈兆荣将在大会会场四：国际药品监管法规专场为大家带来主题为“遵循监管政策，加速新药研发”的报告，诚邀各位同仁与会！药企福利-享免费观摩门票推荐阅读归来花满树，携手再破千层浪！金斯瑞蓬勃生物倾情加盟QbD2024第五届生物药质量科学大会茵冠生物质量总监邹沛华：间充质干细胞质量控制与质量体系的搭建 | QbD2024风云录泽辉生物质量负责人单晓鹏：细胞治疗产品控制策略 | QbD2024风云录原启生物质量副总裁陶铜静：CGT药物CMC质量控制策略 | QbD2024风云录景达生物CEO杨月峰：通用现货型NK细胞的工艺开发及质量控制 | QbD2024风云录贝思奥生物创始人罗光佐：AAV药物关键质量属性及其分析质控难点 | QbD2024风云录

临床申请临床1期临床2期

100 项与 YH-001 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
晚期肝细胞癌	临床2期	中国	祐和医药科技（北京）有限公司	2023-06-01
晚期肝细胞癌	临床2期	亚美尼亚	祐和医药科技（北京）有限公司	2023-06-01
晚期肝细胞癌	临床2期	澳大利亚	祐和医药科技（北京）有限公司	2023-06-01
晚期肝细胞癌	临床2期	奥地利	祐和医药科技（北京）有限公司	2023-06-01
晚期肝细胞癌	临床2期	中国台湾	祐和医药科技（北京）有限公司	2023-06-01
转移性非小细胞肺癌	临床2期	中国	祐和医药科技（北京）有限公司	2023-06-01
转移性非小细胞肺癌	临床2期	亚美尼亚	祐和医药科技（北京）有限公司	2023-06-01
转移性非小细胞肺癌	临床2期	澳大利亚	祐和医药科技（北京）有限公司	2023-06-01
转移性非小细胞肺癌	临床2期	奥地利	祐和医药科技（北京）有限公司	2023-06-01
转移性非小细胞肺癌	临床2期	中国台湾	祐和医药科技（北京）有限公司	2023-06-01

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04357756 (ASCO2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	24	toripalimab+YH001	簾網齋鹹憲願簾遞獵壓(築網網網繭鏇糧憲衊齋) = 顧選鹹醖顧襯繭糧鑰憲艱鑰糧構範壓衊憲鏇壓 (鑰醖壓積顧廠鏇網網壓 ) 更多	积极	2022-06-02
CSCO2021	临床1期	HR阳性/HER2低表达实体瘤	17	YH001	淵鑰顧餘構製網襯膚網(選壓鹽餘網鑰範淵觸選) = 衊糧憲衊製夢願鹽襯艱築獵繭蓋窪遞網醖鏇鏇 (鹽網鬱齋積壓鑰夢鬱窪 )	-	2021-09-25