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）有限公司初创企业

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 / Recruiting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）有限公司初创企业

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）

2023-06-05·Animals : an open access journal from MDPI

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

Article

作者: Bai, Sungchul C ; Lee, Yein ; Hamidoghli, Ali ; Hwang, Soyeon ; 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 (YH_0.5), 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, YH_0.5, 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, YH_0.5 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.

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.

项与 YH-001 相关的新闻（医药）

2024-09-28

·生物制品圈

恒瑞医药从基石药业引进的抗CTLA-4单抗启动一项晚期肝细胞癌的3期临床

9月26日，药物临床试验登记与信息公示平台公示，恒瑞医药子公司盛迪亚生物正式启动SHR-8068联合阿得贝利单抗及贝伐珠单抗对比信迪利单抗联合贝伐珠单抗治疗晚期一线肝细胞癌的3期临床研究。本次试验旨在通过评估客观缓解率（ORR）及总生存期（OS），评价SHR-8068联合阿得贝利单抗和贝伐珠单抗（试验组）对比信迪利单抗联合贝伐珠单抗（对照组）一线治疗晚期HCC患者的有效性。 2021年11月21日，基石药业宣布与恒瑞医药就CS1002(SHR-8068)达成在大中华地区的战略合作暨独占许可协议。依据协议条款，基石药业将有资格获得总计高达约两亿美金的首付款和潜在里程碑付款，以及两位数的特许权使用费。恒瑞医药将获得CS1002在大中华地区研发、注册、生产和商业化的独占授权。基石药业将保留CS1002在大中华地区以外地区的开发和商业化权利。 CTLA-4单抗竞争格局 BMS的伊匹木单抗伊匹木单抗是一种重组人IgG1免疫球蛋白单克隆抗体，可与细胞毒性T淋巴细胞相关抗原4（CTLA-4）结合。伊匹木单抗是全球第一个免疫检查点抑制剂，于2011年3月25日获FDA批准上市。伊匹木单抗包装目前获批的适应症有： 1.治疗无法切除或转移性黑色素瘤的成人和12岁或以上的儿童患者。 2.皮肤黑色素瘤(病理累及淋巴结超过1mm的患者且已经手术切除，包括总淋巴切除)的辅助治疗。 3.与纳武单抗联合治疗此前未曾治疗过的中低风险的晚期肾细胞癌患者。 4.与纳武单抗联合治疗在氟嘧啶、奥沙利铂、伊立替康等药物治疗后进展的微卫星不稳定 (MSI-H)或错配修复缺陷(dMMR)的转移性结直肠癌的成人和12岁或以上的儿童患者。 2021年6月11日，BMS宣布，纳武利尤单抗注射液联合伊匹木单抗注射液获中国国家药品监督管理局批准用于不可手术切除的、初治的非上皮样恶性胸膜间皮瘤成人患者。 2022年全球销售额为21.31亿美元，2023年全球销售额为22.38亿美元。阿斯利康的替西木单抗替西木单抗是由阿斯利康公司研发的一种细胞毒性 T 淋巴细胞相关抗原 -4（CTLA-4）全人源化 IgG2 单克隆抗体。替西木单抗包装 2022年10月，替西木单抗（tremlimumab）联合度伐利尤单抗（Durvalumab）的双免疫治疗方案获美国FDA批准，用于治疗成人不可切除肝细胞癌(uHCC)和无致敏性表皮生长因子受体(EGFR)突变或间变性淋巴瘤激酶(ALK)基因组肿瘤异常的转移性NSCLC成人患者。目前尚未在国内获批。康方生物的卡度尼利单抗卡度尼利单抗，由康方生物独立研发，是一种创新的PD-1和CTLA-4双特异性肿瘤免疫治疗药物。卡度尼利单抗包装 2022年6月，卡度尼利单抗在中国获批上市，单药用于治疗既往接受含铂化疗治疗失败的复发或转移性宫颈癌，填补了中国晚期宫颈癌免疫治疗的空白。卡度尼利单抗不仅是国内首个获批的双特异性抗体，也是全球首个PD-1/CTLA-4双特异性抗体药物。 2024年4月24日，卡度尼利单抗新适应症上市申请获CDE受理，用于加含铂化疗联合/不联合贝伐珠单抗一线治疗持续、复发或转移性宫颈癌。 2023年，卡度尼利单抗的销售额达到了13.58亿元人民币，2024 半年度报告中，卡度尼利单抗销售额约7.057亿元，同比增长16.5%。除了以上以上的的抗CTLA-4单抗外，目前国内在研的还有恒瑞药业的SHR-8068（肝细胞癌3期）、信达生物的IBI310（结肠癌3期）、昂科免疫的ONC-392（肺癌3期）、百奥赛图YH001（肉瘤2期）、贝达药业泽弗利单抗（宫颈癌3期），以上抗CTLA-4单抗进展较快。为促进抗体行业的交流与创新，2024年10月16-17日第七届金秋十月抗体产业发展大会如约而至。会议旨在为研究人员提供一个互动交流的平台，有助于推动抗体产业的进一步发展。会议内容时间：2024年10月16-17日地点：上海张江（酒店定向通知）规模：600-800人主办单位：生物制品圈、抗体圈演讲支持：Entegris、瑞孚迪、AS ONE CORPORATION 会议费用：免费FREE!（仅收取100元报名定金，含参会学习、茶歇、会议手册，定金概不退还），先到先得，报完即止！报名方式：扫描下方二维码或点击文章最底部“阅读原文”→ 填写表格 → 报名成功（报名志愿者，承担一定工作，请慎重考虑，免交定金）！组委会获得报名信息后，根据报名信息进行初筛，并进一步与报名者沟通确认，实现精准邀请。最终有机会进入大会微信群（严格审核通过）。日程安排更多嘉宾正在邀请中资料来源： 1.CDE官网 2.各公司官网识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床3期引进/卖出上市批准申请上市免疫疗法

2024-08-06

·百奥赛图

“千鼠万抗”合作成果丰硕，解锁新型药物开发的高效选择

“千鼠万抗”是百奥赛图依托其独有的RenMice技术平台开展的规模化抗体药物开发项目，自2020年3月启动以来，已在2023年7月取得重要里程碑进展，获得超过40万条现货型抗体分子库和40+PCC分子。这些抗体分子能够极大地缩短临床前药物开发的时间，提高转化医学研究效率。百奥赛图采用开放且灵活的商务模式，与全球合作伙伴共享资源，如今对外合作进入增速期。我们的技术平台和抗体及ADC分子已获得包括MNC在内的众多药企和生物技术企业的认可，合作伙伴遍及亚太和欧美重点国家和地区，当前可披露交易总额约达上百亿元。除首付款外，随着合作伙伴研发的推进，百奥赛图将获得不同阶段的研发或商业化里程碑付款。抗体偶联药物（ADC）凭借其独特的优势为靶向治疗带来了革命性的突破。百奥赛图具有自主知识产权的共轻链小鼠RenLite平台和新型Linker & Payload平台BLD1102在双抗ADC药物的开发中展现出了卓越的优势。自2024年初与Radiance就YH012（一款HER2×TROP2双抗ADC）达成授权合作后，我们又陆续与ABL Bio、SOTIO、IDEAYA等公司在双抗ADC领域展开合作。“千鼠万抗”产生的针对200+TAA靶点的抗体库，也为多家ADC企业开发新一代差异化ADC疗法提供了有力支持。百奥赛图部分ADC领域合作 “千鼠万抗”产生的40多万全人抗体分子库，不仅适用于ADC领域药物开发，还能应用于GPCR等创新靶点、细胞治疗、双/多抗等新分子形式的药物开发，以及神经、自免、代谢、感染等疾病领域的药物开发。百奥赛图全人抗体库具有高多样性、高亲和力等优势，已建立与包括Gilead、Merck KGaA等MNC以及Neurocrine、翰森制药等创新药企在多种药物形式、多种疾病领域的广泛合作。百奥赛图部分抗体分子合作此外，百奥赛图基于其专有的RenTCR-mimic平台筛选出的类TCR（TCR-mimic）抗体，可以识别胞内靶点抗原，与人内源性TCR相比具有更高的特异性和亲和力，适合进一步开发T细胞衔接器、双/多特异性抗体以及TCR-T、CAR-T细胞疗法。基于此，我们与乐普创一、泛恩生物和瑞士BioCopy等公司达成了合作，其中与乐普创一合作的WT1xCD3x4-1BB三抗开发取得了里程碑进展。百奥赛图类TCR抗体合作我们优选的抗体资产授予合作方推进临床试验，其中YH008/NWY001（PD-1×CD40双抗）的大中华区权益授予成都微芯新域，目前已完成I期临床试验的首例受试者入组，试验推进顺利；我们临床阶段的YH001（CTLA-4单抗）、YH003（CD40激动型单抗）以及YH002（OX40单抗）的全球权益授予Syncromune，用于基于SYNC-T技术的瘤内免疫疗法的开发和商业化，其中SV-102在I期临床试验中数据显示ORR达到85%，并已获FDA快速通道资格。这些临床试验的顺利推进，充分验证了百奥赛图体内大规模抗体筛选方法的可行性。百奥赛图临床阶段资产合作公司拥有独立知识产权的系列全人抗体/TCR小鼠RenMice平台是“千鼠万抗”顺利推进的基石，包括RenMab®、RenLite®、RenNano®、RenTCRTM和RenTCR-mimicTM，为全人单抗、双抗、双抗ADC、纳米抗体、全人TCR、类TCR抗体的药物研发提供了强有力的支撑。截至2023年12月31日，百奥赛图已与Merck KGaA、强生旗下杨森、Xencor、百济神州、君实生物等公司达成RenMice授权用于47个靶点项目开发。百奥赛图开放合作的抗体资产概览百奥赛图先进的技术平台和现货型抗体分子库可以为全球合作伙伴带来高效的新型药物开发选择，随着“千鼠万抗”高质量抗体分子库的持续产出，公司出海步伐显著加速。相信在合作伙伴的共同推进下，能够为全球患者带来更有效、更安全的创新疗法，也将百奥赛图产出的抗体带向全球各地，逐步实现公司成为全球新药发源地的愿景。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-mimicTM）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2023年12月31日，百奥赛图已签署了103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47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/。

细胞疗法抗体药物偶联物临床1期引进/卖出免疫疗法

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

100 项与 YH-001 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
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）有限公司初创企业	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）有限公司初创企业	2023-06-01
非小细胞肺癌IIIB期	临床2期	中国	祐和医药科技（北京）有限公司初创企业	2023-06-01
非小细胞肺癌IIIB期	临床2期	亚美尼亚	祐和医药科技（北京）有限公司初创企业	2023-06-01
非小细胞肺癌IIIB期	临床2期	澳大利亚	祐和医药科技（北京）有限公司初创企业	2023-06-01
非小细胞肺癌IIIB期	临床2期	奥地利	祐和医药科技（北京）有限公司初创企业	2023-06-01
非小细胞肺癌IIIB期	临床2期	中国台湾	祐和医药科技（北京）有限公司初创企业	2023-06-01
晚期非小细胞肺癌	临床2期	美国	祐和医药科技（北京）有限公司初创企业	2023-03-21
晚期非小细胞肺癌	临床2期	中国	祐和医药科技（北京）有限公司初创企业	2023-03-21
晚期非小细胞肺癌	临床2期	澳大利亚	祐和医药科技（北京）有限公司初创企业	2023-03-21

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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	積選觸醖憲範壓膚選簾(鹽壓襯範鹽夢鹹積顧憲) = 窪鬱壓蓋鏇簾憲簾觸蓋範蓋製衊觸繭範獵夢壓 (願膚簾繭鏇憲選選艱膚 ) 更多	积极	2022-06-02
CSCO2021	临床1期	HR阳性/HER2低表达实体瘤	17	YH001	衊鬱鹹淵觸窪齋鏇構鑰(壓窪襯廠蓋衊遞鹽繭憲) = 醖顧衊鬱淵獵餘鏇遞鬱壓鏇齋鹹構鬱願憲製製 (觸齋鏇淵夢簾夢製製淵 )	-	2021-09-25