排名前五的靶点	数量

TNF-α(肿瘤坏死因子α)	2
PD-1(细胞程序性死亡-1)	2
SIRPα(信号调节蛋白α)	2
CD40(肿瘤坏死因子受体超家族成员5)	2
CD20(B淋巴细胞抗原CD20)	2

关联

项与百奥泰生物制药股份有限公司相关的药物

Batifiban

枸橼酸倍维巴肽

靶点

GP IIb/IIIa

作用机制

GP IIb/IIIa拮抗剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2024-06-25

BAT-4406F

靶点

CD20

作用机制

CD20抑制剂

在研机构

百奥泰生物制药股份有限公司

原研机构

百奥泰生物制药股份有限公司

在研适应症

视神经脊髓炎

非在研适应症-

最高研发阶段临床3期

首次获批国家/地区-

首次获批日期-

Recombinant humanized anti-VEGF monoclonal antibody(Bio-Thera Solutions)

重组抗VEGF人源化单克隆抗体 (百奥泰生物)

靶点

VEGF

作用机制

VEGF抑制剂

在研机构

百奥泰生物制药股份有限公司

原研机构

百奥泰生物制药股份有限公司

在研适应症

糖尿病性黄斑水肿 [+1]

非在研适应症-

最高研发阶段临床3期

首次获批国家/地区-

首次获批日期-

122

项与百奥泰生物制药股份有限公司相关的临床试验

NCT06545617 / Not yet recruiting临床1/2期

A Phase 1b/2, Multicenter, Open-Label Study of BAT8006, an Anti- FRα Antibody Drug Conjugate (ADC) for Platinum-resistant Ovarian Cancer Subjects

This is a Phase 1b/2, open-label, 2-part, global study designed to investigate the anti-tumor activity as well as the safety and efficacy of BAT8006 in subjects with platinum resistance ovarian cancer

开始日期2025-01-31

申办/合作机构

百奥泰生物制药股份有限公司

CTR20242449 / Recruiting临床1/2期

一项评价BAT8006联合BAT1308在晚期实体瘤患者中的安全性、耐受性、药代动力学特征和初步疗效的多中心、开放的Ⅰb/Ⅱ期临床研究

剂量递增阶段主要目的：评估BAT8006联合BAT1308治疗晚期实体瘤患者的安全性与耐受性；探索联合给药的最大耐受剂量（MTD）并为Ⅱ期或后续临床研究提供推荐剂量及合理的给药方案；扩展阶段主要目的：进一步评估BAT8006联合BAT1308在晚期卵巢癌、晚期子宫内膜癌中的安全性与耐受性，为后续研究确定优化的RP2D及给药方案；评估BAT8006联合BAT1308在晚期卵巢癌、晚期子宫内膜癌中的初步疗效；

开始日期2024-08-21

申办/合作机构

百奥泰生物制药股份有限公司

NCT06280196 / Recruiting临床3期

A Phase I/III, Multi-center, Randomized, Double-blind Study of BAT3306 Plus Chemotherapy Versus Keytruda® Plus Chemotherapy to Evaluate Pharmacokinetics, Efficacy, and Safety in Participants With Stage IV Non-squamous Non-small Cell Lung Cancer.

To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.

开始日期2024-07-19

申办/合作机构

百奥泰生物制药股份有限公司

100 项与百奥泰生物制药股份有限公司相关的临床结果

登录后查看更多信息

0 项与百奥泰生物制药股份有限公司相关的专利（医药）

登录后查看更多信息

项与百奥泰生物制药股份有限公司相关的文献（医药）

2024-09-01·International Journal of Pharmaceutics

Histidine as a versatile excipient in the protein-based biopharmaceutical formulations

Review

作者: Liu, Cuihua ; Ingle, Rahul G ; Fang, Wei-Jie ; Wu, Hao ; Lv, Jia-Yi

Adequate stabilization is essential for marketed protein-based biopharmaceutical formulations to withstand the various stresses that can be exerted during the pre- and post-manufacturing processes. Therefore, a suitable choice of excipient is a significant step in the manufacturing of such delicate products. Histidine, an essential amino acid, has been extensively used in protein-based biopharmaceutical formulations. The physicochemical properties of histidine are unique among amino acids and could afford multifaceted benefits to protein-based biopharmaceutical formulations. With a pKa of approximately 6.0 at the side chain, histidine has been primarily used as a buffering agent, especially for pH 5.5-6.5. Additionally, histidine exhibited several affirmative properties similar to those of carbohydrates (e.g., sucrose and trehalose) and could therefore be considered to be an alternative approach to established protein-based formulation strategies. The current review describes the general physicochemical properties of histidine, lists all commercial histidine-containing protein-based biopharmaceutical products, and discusses a brief outline of the existing research focused on the versatile applications of histidine, which can act as a buffering agent, stabilizer, cryo-/lyo-protectant, antioxidant, viscosity reducer, and solubilizing agent. The interaction between histidine and proteins in protein-based biopharmaceutical formulations, such as the Donnan effect during diafiltration of monoclonal antibody solutions and the degradation of polysorbates in histidine buffer, has also been discussed. As the first review of histidine in protein biopharmaceuticals, it helps to deepen our understanding of the opportunities and challenges associated with histidine as an excipient for protein-based biopharmaceutical formulations.

2024-07-01·BioDrugs

Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab

Article

作者: Li, Zhuxiang ; Xie, Jianhua ; Li, Shengfeng ; Engle, Linda ; Cao, Di ; Liu, Cuihua ; Ebbers, Hans C ; Liu, Yujie ; Mei, Xiong ; Liu, Suli

BACKGROUND AND OBJECTIVETocilizumab is an immunoglobulin G1 monoclonal antibody targeting the interleukin-6 receptor (IL-6R). BAT1806/BIIB800 (tocilizumab-bavi) has been developed as a biosimilar to the reference product tocilizumab (TCZ). The objective of this study was to demonstrate physicochemical and functional similarity between BAT1806/BIIB800 and TCZ in a comprehensive comparability exercise.METHODSA comprehensive panel of over 20 methods was used to generate datasets comparing critical and non-critical product quality attributes for 10 BAT1806/BIIB800 lots and 44 TCZ lots (16 sourced from China, 16 from the EU, and 12 from the US). Primary structure, higher-order structure, and physicochemical properties were assessed using liquid chromatography, mass spectrometry, various spectroscopy techniques/methods, capillary electrophoresis, and thermoanalytical techniques. Fragment antigen-binding (Fab)- and fragment crystallizable (Fc)-mediated biological properties were assessed using cell-based assays, immunoassays, flow cytometry, and kinetic binding assays.RESULTSBAT1806/BIIB800 and TCZ (irrespective of source) were shown to be similar in terms of structural and functional properties. No differences were observed in terms of the most critical quality attributes, that is, soluble-IL-6R binding and inhibition of IL-6-mediated cell proliferation. BAT1806/BIIB800 and TCZ demonstrated similarity in terms of Fab- and Fc-mediated binding and biological activity. Minor differences were observed in glycosylation (afucosylation and sialylation), glycation, aggregation, and charge variants, which were demonstrated to be not clinically relevant.CONCLUSIONBAT1806/BIIB800 and TCZ were highly similar for all critical quality attributes. Where differences were observed in less critical quality attributes, additional analytical assessments and clinical study results determined these to be not clinically meaningful.

2024-06-01·Journal of Clinical Oncology

Phase 1 study of BAT8006, a folate receptor α antibody drug conjugate with strong bystander effect, in subjects with advanced solid tumors.

作者: Qiu, Hui ; Lin, An ; Zhang, Xinlang ; Zhang, Songling ; Tang, Jie ; Liu, Jihong ; Sun, Yuping ; Rao, Qunxian ; Mai, Jiajia ; Yu, Jin-Chen ; Zhong, Di ; Zhang, Huifeng ; Wei, Zhentong ; Jia, Haiyan ; Fu, Ziyi ; Shi, Yehui ; Wei, Juncheng ; Huang, Jianying ; Sun, Li ; Zhang, Hong

5550 Background: BAT8006 is an antibody-drug conjugate targeting to folate receptor α (FRα). In this phase 1 study, the authors investigated BAT8006 in subjects with solid tumors. Methods: Subjects with advance solid tumor received BAT8006 on day 1 of a 21-day cycle until subject intolerance or disease progression. The study objectives were tolerability, safety, pharmacokinetic characteristics, immunogenicity, preliminary efficacy. Results: As of January 5, 2024, 100 Chinese subjects with advanced solid tumor were allocated into six cohorts, including 1.2, 1.8, 2.1, 2.4mg/kg and 84, 93mg/m2 dose levels. Fifty-two subjects with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer (OC) were enrolled and treated with BAT8006 doses of 1.8 mg/kg (n = 2), 2.1 mg/kg (n = 16), 2.4 mg/kg (n = 15), 84mg/m2 (n = 10) or 93mg/m2 (n = 9). The median duration of follow-up of these 52 subjects was 4.5 (1.1, 16.4) months. There was 1 dose-limiting toxicity, Grade 4 thrombopenia, reported in 2.4 mg/kg dose cohort in the dose escalation study. The maximum tolerated dose has not yet been reached. In 52 subjects with OC, at least one treatment-emergent adverse events (TEAEs) were reported in 49/52 (94.2%) subjects who have received at least one dose of BAT8006. The most common TEAEs (≥20%) of any grade were thrombocytopenia, neutropenia, anemia, leukopenia, nausea, vomiting and constipation. The majority of the TRAEs were Grade 1 or 2; 57.7% subjects experienced Grade 3 or greater AEs as the worst grade, including thrombocytopenia 11/52 (21.2%), neutropenia 15/52 (28.8%), anemia 11/52 (21.2%), leukopenia 15/52 (28.8%). In the 84 and 93mg/m2 dose cohorts, which were selected to be further explored in the dose expansion study, the incidences of ≥ Grade 3 thrombocytopenia and neutropenia were 0% vs 22.2% and 30% vs 33.3%, respectively. Three subjects (3/52, 5.8%) experienced dose reduction, and 11 (11/52, 21.2%) subjects had study drug interruption during the study. One (1/52, 1.9%) subject terminated the study treatment due to TEAE. There was one case of death reported during the study due to neoplasm progression. In these 52 subjects, 60.0% of them (31/52) had undergone>3 lines prior systemic treatment. Thirty-six of them have at least one tumor assessment. The ORR per investigator including unconfirmed partial response (PR) is 41.7% (15/36), regardless of the FRα expression. The disease control rate (DCR) is 86.1% (31/36). In 25 subjects with FRα TPS≥50%, the ORR is 11/25 (44.0%), DCR is 22/25 (88.0%). In 12 subjects with FRα TPS≥75%, the ORR is 6/12 (50.0%), DCR is 22/25 (91.7%). Conclusions: BAT8006 was well-tolerated with manageable toxicity and demonstrated preliminary antitumor activity in ovarian cancer. Clinical trial information: NCT05378737 .

2,135

项与百奥泰生物制药股份有限公司相关的新闻（医药）

2024-10-31

·医药笔记

安进：第2款实体瘤CD3双抗，Xaluritamig将启动前列腺癌三期临床

▎Armstrong 2024年10月30日，安进发布三季度财报，介绍了研发管线的最新进展，肿瘤业务板块中重点提到STEAP1/CD3双抗Xaluritamig将在本季度启动紫杉醇后线的前列腺癌三期临床试验。 Xaluritamig采用Xencor的XmAb 2+1技术设计，目前处于一期临床阶段，意味着安进将直接推进到三期临床。 Xencor还有其他多款实体瘤CD3双抗在推进中，覆盖靶点包括ENPP3、Claudin6、B7H3等，均采用XmAb 2+1技术。今年AACR会议上，安进披露了Xaluritamig的一期临床数据，PSA和RECIST评估疗效数据如下，PSA50为49%，PSA90为28%。以RECIST评估，高剂量组ORR为41%，DCR为79%。总结作为最老牌的biotech，安进研发管线中还有多哥潜在爆款产品，除了前述两款实体瘤CD3双抗，还有自免领域的OX40抗体Rocatinlimab，代谢领域的GIPR抗体融合GLP-1分子MariTide等。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

AACR会议临床3期财报抗体药物偶联物

2024-10-31

·医药笔记

安进：CD3/CD19双抗启动狼疮肾炎二期临床

▎Armstrong 2024年10月30日，安进发布三季度三包，营收81.51亿美元，同比增长23%，扣除收购Horizon的影响，营收增长8%。肿瘤业务板块，CD3/CD19双抗Blincyto三季度销售额3.27亿美元，同比增长49%，小细胞肺癌的DLL3/CD3双抗Imdelltra首季度销售额3600万美元。 Blincyto正在探索皮下剂型，B-ALL的1/2期临床已经完成入组，预计2025年下半年推进到二期注册临床。安进正在积极开拓自免领域，CD3/CD19双抗和CD19单抗已经启动狼疮肾炎的二期临床试验。 2a期临床计划入组50例，其中CD3/CD19双抗采用皮下注射剂型。安全性终点观察52周，疗效终点观察12周和24周。总结 Blincyto为全球首个也是唯一一个获批上市的CD3/CD19双抗，这一波自免浪潮中第一个推进到二期临床。Cullinan刚刚启动1b期临床，计划入组24例狼疮患者。默沙东7亿美元引进了同润生物的CD3/CD19双抗，葛兰素史克8.5亿美元引进恩沐生物的CD3/CD19/CD20双抗。Xencor宣布CD3/CD20双抗、CD3/CD19双抗转战自免领域。Candid收购了嘉和生物的CD3/CD20双抗、岸迈生物的CD3/BCMA双抗。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

临床2期并购临床1期抗体药物偶联物

2024-10-30

·Armstrong生物药资讯

礼来：替尔泊肽前三季度大卖110亿美元

▎Armstrong 2024年10月30日，礼来发布三季度财报，前三季度营业收入315亿美元，同比增长27%，净利润61.8亿美元。前三季度，替尔泊肽降糖版Moujaro销售额80.10亿美元，去年同期为29.58亿美元，替尔泊肽减重版Zepbound销售额30.18亿美元。替尔泊肽合计销售额110亿美元，预计全年超过160亿美元。替尔泊肽去年11月份上市以来放量迅速，累计处方患者超过60万人。降糖版Mounjaro三季度与二季度销售额基本持平，美国处方份额约30%。总结诺和诺德司美格鲁肽今年上半年销售额为130亿美元，替尔泊肽正在快速抢占市场，与司美格鲁肽的差距快速缩小。横向对比，Keytruda今年上半年销售额142亿美元，未来新的药王争夺大概率会在司美格鲁肽、替尔泊肽中间产生。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

财报抗体药物偶联物

100 项与百奥泰生物制药股份有限公司相关的药物交易

登录后查看更多信息

100 项与百奥泰生物制药股份有限公司相关的转化医学

登录后查看更多信息

组织架构

使用我们的机构树数据加速您的研究。

或

查看完整样例数据

管线布局

2024年11月17日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

药物发现

临床前

临床申请

临床1期

临床2期

临床3期

申请上市

批准上市

其他

登录后查看更多信息

当前项目

药物(靶点)	适应症	全球最高研发状态

枸橼酸倍维巴肽 ( GP IIb/IIIa )	急性冠状动脉综合征更多	批准上市
托珠单抗生物类似药 (百奥泰生物) ( IL-6RA )	细胞因子释放综合征更多	批准上市
贝伐珠单抗生物类似药 (百奥泰生物) ( VEGF-A )	输卵管癌更多	批准上市
阿达木单抗生物类似药 (百奥泰生物) ( TNF-α )	类风湿关节炎更多	批准上市
乌司奴单抗生物类似药（百奥泰） ( IL-12 x IL-23 )	斑块状银屑病更多	申请上市