A Multicenter,Open-label,Exploratory Study of QL1706 Plus Nab-paclitaxel and Gemcitabine With or Without Bevacizumab as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

This is a multicenter, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine with or without bevacizumab as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer

开始日期2024-04-15

申办/合作机构

复旦大学

CTR20233522 / Recruiting临床1/2期

JS015联合用药治疗晚期实体瘤患者的安全性、耐受性、药代动力学特征和初步有效性的Ib/II期临床研究

主要研究目的：评价JS015联合用药在晚期实体瘤患者中的安全性和耐受性；确定JS015联合用药II期临床研究推荐剂量（RP2D）次要研究目的：评价JS015联合用药在晚期实体瘤患者体内的药代动力学（PK）特征 / 药效动力学特征 / 免疫原性 / 初步有效性；探索性研究目的：探索肿瘤组织中生物标志物(包括DKK1、PD-L1等)与临床疗效的关系

开始日期2023-12-06

申办/合作机构

上海君实生物医药科技股份有限公司

100 项与贝伐珠单抗生物类似药 (百奥泰生物) 相关的临床结果

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100 项与贝伐珠单抗生物类似药 (百奥泰生物) 相关的转化医学

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100 项与贝伐珠单抗生物类似药 (百奥泰生物) 相关的专利（医药）

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项与贝伐珠单抗生物类似药 (百奥泰生物) 相关的文献（医药）

2023-11-01·Cancer medicine

Efficacy and safety of the proposed bevacizumab biosimilar BAT1706 compared with reference bevacizumab in patients with advanced nonsquamous non‐small cell lung cancer: A randomized, double‐blind, phase III study

Article

作者: Ozyilkan, Ozgur ; Chen, Likun ; Dong, Qingfeng ; Cil, Timucin ; Cicin, Irfan ; Chen, Jun ; Shen, Yihong ; Li, Xingya ; Chen, Zhendong ; Fu, Ziyi ; Zhang, Li ; Oleksandr, Kostiuk ; Zhang, Helong ; Liu, Zhihua ; Igor, Bondarenko ; Yu, Jin-Chen ; Song, Shuqiang ; Rangel, Jose David Gomez

Abstract:

Background:

BAT1706 is a proposed biosimilar of bevacizumab (Avastin®). We aimed to compare the efficacy and safety of BAT1706 with that of EU‐sourced reference bevacizumab (EU‐bevacizumab) in patients with advanced nonsquamous non‐small cell lung cancer (NSCLC).

Methods:

Patients were randomized 1:1 to BAT1706 plus paclitaxel and carboplatin (BAT1706 arm) or EU‐bevacizumab plus paclitaxel and carboplatin (EU‐bevacizumab arm) given every 3 weeks for six cycles, followed by maintenance therapy with BAT1706 or EU‐bevacizumab. The primary endpoint was overall response rate at week 18 (ORR18). Clinical equivalence was demonstrated if the 90% confidence interval (CI) of the BAT1706:EU‐bevacizumab ORR18 risk ratio was contained within the predefined equivalence margins of 0.75–1.33 (China National Medical Products Administration requirements), or 0.73–1.36 (US Food and Drug Administration), or if the 95% CI of the ORR18 risk difference between treatments was contained within the predefined equivalence margin of −0.12 to 0.15 (EMA requirements).

Results:

In total, 649 randomized patients (BAT1706, n = 325; EU‐bevacizumab, n = 324) received at least one cycle of combination treatment. The ORR18 was comparable between the BAT1706 and EU‐bevacizumab arms (48.0% and 44.5%, respectively). The ORR18 risk ratio of 1.08 (90% CI: 0.94–1.24) and the ORR18 risk difference of 0.03 (95% CI: −0.04 to 0.11) were within the predefined equivalence margins, demonstrating the biosimilarity of BAT1706 and EU‐bevacizumab. The safety profile of BAT1706 was consistent with that of EU‐bevacizumab and no new safety signals were observed.

Conclusion:

In patients with advanced nonsquamous NSCLC, BAT1706 demonstrated clinical equivalence to EU‐bevacizumab in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

2023-09-01·Drugs in R&D

Physicochemical and Functional Similarity Assessment Between Proposed Bevacizumab Biosimilar BAT1706 and Reference Bevacizumab.

Article

作者: Liu, Yujie ; Liu, Cuihua ; Liu, Yuanmei ; Mei, Xiong ; Cao, Di ; Li, Shengfeng ; Xie, Jianhua ; Deng, Chunping ; Yang, Yili ; Wang, Guangying

BACKGROUND:

BAT1706 is a proposed biosimilar of bevacizumab, a vascular endothelial growth factor A (VEGF-A)-targeting biologic used to treat several different cancers, including metastatic colorectal cancer. A comprehensive physicochemical and functional similarity assessment is a key component of demonstrating biosimilarity between a reference biologic and a proposed biosimilar. Here we report the physicochemical and functional similarity of BAT1706 and reference bevacizumab sourced from both the United States (US-bevacizumab) and the European Union (EU-bevacizumab).

METHOD:

A large range of product attributes, including primary and higher order structure, post-translational modifications, purity, stability, and potency, were characterized for BAT1706 and EU/US-bevacizumab using sensitive state-of-the-art analytical techniques. Up to 18 lots of US- and 29 lots of EU-bevacizumab, and 10 unique drug substance lots of BAT1706, were assessed.

RESULT:

BAT1706 was shown to have an identical amino acid sequence and an indistinguishable higher-order structure compared with EU/US-bevacizumab. BAT1706 and EU/US-bevacizumab also exhibited similar post-translational modifications, glycan profiles, and charge variants. Potency, assessed using a wide range of bioassays, was also shown to be comparable between BAT1706 and EU/US-bevacizumab, with statistical equivalence demonstrated for VEGF-A binding and neutralizing activity.

CONCLUSION:

Overall, this extensive comparability exercise demonstrated BAT1706 to match EU/US-bevacizumab in terms of all physicochemical and functional attributes assessed.

2018-10-01·Cancer chemotherapy and pharmacology4区 · 医学

Tolerance, variability, and pharmacokinetics of bevacizumab biosimilars in Chinese healthy male subjects

4区 · 医学

Article

作者: Shen, Zhenwei ; Chen, Guiling ; Liu, Chengjiao ; Wang, Jing ; Ding, Yanhua ; Li, Xiaojiao ; Zhang, Hong ; Zhu, Xiaoxue ; Li, Qingmei ; Wei, Haijing ; Li, Cuiyun ; Hu, Yue

OBJECTIVE:

The aim of this study was to explore the tolerance, variability, and pharmacokinetics (PK) of bevacizumab biosimilars (MIL60, BAT1706, IBI305) in Chinese healthy male subjects.

METHODS:

This randomized, double-blind, two-arm, parallel studies included three separate investigations, which were conducted by three sponsors to investigate the bioequivalence of bevacizumab biosimilars (MIL60, BAT1706, IBI305) with that of bevacizumab-EU as a reference drug. Subjects received a single-dose of 1 or 3 mg/kg of the bevacizumab biosimilars or bevacizumab-EU and were followed up for 70-99 days. Serum concentrations of bevacizumab, antidrug antibody (ADA), and neutralizing antibody (NAb) were measured using electrochemiluminescence. In addition, the PK parameters were determined using non-compartmental methods. The safety assessments included adverse events, hematology tests, and biochemistry tests.

RESULTS:

The three bevacizumab biosimilars exhibited similar PK properties to that of bevacizumab-EU. Bevacizumab demonstrated linear PK properties and a concentration-dependent disposition. When comparing the three biosimilars with bevacizumab-EU, the 90% CIs of the ratios for C_max, AUC_0-t, and AUC_0-∞ were within 80-125%. The inter-CV ranged from 12.6 to 23.3%. Three subjects in the biosimilar groups and bevacizumab-EU were positive for the ADA and negative for the NAb. Treatment-related mild or moderate adverse events were reported in 56-80 and 36-80% of subjects in the biosimilar and bevacizumab treatment arms, respectively.

CONCLUSIONS:

The bevacizumab biosimilars exhibit similar PK characteristics to that of the reference product bevacizumab-EU. The inter-CV is moderate and less than 25% in all cases. The safety profile was similar among bevacizumab biosimilars and bevacizumab-EU with significant adverse events.

162

项与贝伐珠单抗生物类似药 (百奥泰生物) 相关的新闻（医药）

2024-12-16

·PRNewswire

Bio-Thera Solutions Expands Partnership with SteinCares in LATAM with Addition of a Third Biosimilar to Partnership

GUANGZHOU, China, Dec. 16, 2024 /PRNewswire/ -- Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars today announced an expansion of their partnership with SteinCares today with the addition of a third biosimilar to the partnership. Under the agreement, SteinCares will have exclusive rights to distribute and market an additional Bio-Thera biosimilar in Brazil and the rest of the LATAM region. Bio-Thera is responsible for completing the development of each biosimilar and for regulatory filing with FDA and EMA that will support regulatory filings in the LATAM region. The company will also be liable for the commercial supply of the biosimilars out of its manufacturing facilities in Guangzhou, China. SteinCares' extensive experience and understanding of the Latin American healthcare system will ensure an optimal go-to-market strategy and maximize product access in the region. This partnership will leverage SteinCares' strong local presence, and sales and marketing capabilities in the region. "Bio-Thera is pleased to expand our partnership with SteinCares to commercialize a third biosimilar in Brazil and LATAM," said Dr. Shengfeng Li, CEO of Bio-Thera. "We look forward to working with Steincares to bring another important biosimilar to patients in Central and South America." About SteinCares SteinCares is a leader in commercializing and distributing specialty healthcare products in Latin America, including innovative pharmaceuticals, biosimilars and complex generics. With over 40 years of progressive healthcare experience and presence in more than 30 countries in Latin America and the Caribbean, SteinCares serves as a bridge between global pharmaceutical companies and the region's healthcare providers. The company is deeply committed to creating healthcare opportunities that positively impact the lives of patients and their families in Latin America, with a vision of increasing access to innovative and cost-effective healthcare for patients in the region. For more information, please visit and follow the company on LinkedIn. About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including four approved products: QLETLI® and BETAGRIN® (Bevifibatide Citrate Injection) in China, and TOFIDENCE™ / BAT1806 and Avzivi® / Pobevcy® in the US, EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera). Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to the products in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. 1. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. 2. BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd. 3. TOFIDENCE™ is a trademark of Biogen MA, Inc. 4. AVZIVI® is a registered trademark of Sandoz AG 5. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. For more information, please contact: Bert E. Thomas IV Senior Vice President Business Development, Bio-Thera Solutions [email protected], +1.410.627.1734 SOURCE Bio-Thera Solutions, Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出

2024-12-01

·百奥泰

百奥泰BAT4406F注射液I期临床研究结果发表

百奥泰生物制药股份有限公司（上交所代码： 688177 ）是一家位于中国广州，基于科学而创新的全球性生物制药企业（以下简称 “ 百奥泰 ” 或 “ 公司 ” ）。公司致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人类生命或健康的重大疾病。 BAT4406F 注射液是公司自主研发的 1 类创新药，为 ADCC 增强的全人源抗 CD20 单克隆抗体。近日， BAT4406F 注射液在中国视神经脊髓炎谱系疾病（ NMOSD ）患者中的 I 期临床研究结果已于 CNS Neuroscience & Therapeutics 期刊上发表，题为 First-in-Human Study of BAT4406F, an ADCC-Enhanced Fully Humanized Anti-CD20 Monoclonal Antibody in Patients with Neuromyelitis Optica Spectrum Disorders (NMOSD) 。华山医院神经内科陈向军教授和华山医院 I 期临床研究室张菁教授为此项临床研究的主要研究者。视神经脊髓炎谱系疾病 (Neuromyelitis optica spectrum disorders, NMOSD) 为高复发、高致残性罕见疾病。视神经炎可导致高度视力下降、视野缺损、甚至失明，脊髓炎导致的截瘫和膀胱直肠损害也较多。 NMOSD 已被列入我国罕见病目录，临床急需开发治疗 NMOSD 的新型药物。 B 细胞清除疗法已被证明在降低 NMOSD 复发风险方面有效。 BAT4406F 注射液为 ADCC 增强的全人源抗 CD20 单克隆抗体，可靶向结合 B 细胞及前体细胞表面的 CD20 ，在补体、 NK 自然杀伤性细胞、吞噬细胞等存在的情况下，通过 ADCC 、 CDC 等作用机制达到清除患者体内 B 细胞从而治疗和缓解疾病的目的。 BAT4406F 注射液已在临床前药效学研究中显示出更强的 B 细胞清除能力。本项 I 期临床研究目的是评价 BAT4406F 剂量递增在 NMOSD 患者中的安全性、耐受性和药代动力学、药效学特征，以及研究 BAT4406F 注射液的免疫原性和初步探索其在 NMOSD 患者中的有效性。研究共设 5 个固定剂量组，共静脉给药一次，观察期为 6 个月。本研究共入组 15 例符合入排标准的 NMOSD 患者（图 1 ）。图 1 研究概览在研究的剂量范围内，所有受试者均未出现剂量限制性毒性（ DLT ）。安全性方面，除了一例与研究药物可能无关的严重不良事件（ SAE ）以外，未出现 3 级或以上的不良事件（ AE ）。药代动力学方面，随给药剂量增加， C max 、 AUC 0‑t 和 AUC 0‑inf 增加而 CL 和 V d 降低， T 1/2 范围为 9.0-16.4 天， BAT4406F 的 PK 特征总体为非线性（图 2 ）。药效学结果表明， BAT4406F 给药后所有剂量组均可显著清除 B 细胞、并使其在一定时期内维持在较低水平。随着给药剂量的增加， B 细胞清除状态维持的时间呈剂量依赖性（图 3 ）。在观察期内， 13 例（ 86.7% ）受试者完成试验， 2 例受试者出现复发。至第 180 天时， 100mg 组、 500mg 组、 750mg 组的扩展的残疾状况量表（ EDSS ）均值较基线有所降低。本研究中共 3 例受试者发生 ADA 阳性，其 NAb 均为阴性，且未观察到 ADA 阳性对 PK 、安全性、药效学和疗效的明显影响。总体而言， BAT4406F 注射液剂量递增在 NMOSD 患者中的安全性、耐受性良好，且已在大多数接受给药的 NMOSD 受试者中实现了控制疾病复发，初步显示了治疗作用。目前 BAT4406F 在中国 NMOSD 患者中的 II/III 期多中心、随机、双盲、对照研究正在进行中。 BAT4406F 注射液有望为 NMOSD 患者提供一种新的治疗选择。图 2 静脉滴注不同剂量 BAT4406F 的血药浓度时间曲线（ A ：线性坐标； B ：半对数坐标）图 3 受试者平均 CD19+B 淋巴细胞比例 - 时间半对数曲线（对数刻度纵坐标， Mean ± SD ）关于百奥泰百奥泰是一家位于中国广州，基于科学而创新的全球性生物制药企业。公司致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人类生命或健康的疾病。作为新一代抗体药物研发的领导者，百奥泰已推动多款候选药物进入后期临床试验，其中格乐立 ® （阿达木单抗）、普贝希 ® （贝伐珠单抗）、施瑞立 ® （托珠单抗）、贝塔宁 ® （枸橼酸倍维巴肽）已在中国获批上市。 TOFIDENCE™ （托珠单抗）和 Avzivi® （贝伐珠单抗）已实现中美欧三地获批上市。公司现有 20 多款在研产品处于不同临床研究阶段，其中肿瘤领域主要聚焦后 PD-1 时代的肿瘤免疫治疗和抗体药物偶联体（ ADC ）靶向药物开发。百奥泰始终以患者的福祉作为首要核心价值，通过创新研发，为患者提供安全、有效、可负担的优质药物，以满足亟待解决的治疗需求。欲了解更多信息，请访问 www.bio-thera.com ，或关注我们的推特（ @bio_thera_sol ）和微信公众号（百奥泰）。 1. 格乐立 ® 是百奥泰的注册商标 2. 普贝希 ® 是百奥泰的注册商标 3. 施瑞立 ® 是百奥泰的注册商标 4. 贝塔宁 ® 是百奥泰的注册商标 5. TOFIDENCE TM 是渤健的注册商标 6. Avzivi® 是山德士的注册商标百奥泰前瞻性声明本新闻稿包含了 BAT4406F 或百奥泰及产品线相关的前瞻性声明。由于某些重要因素可能会影响公司的实际结果，特此提醒读者注意不要过分依赖该前瞻性声明。这些前瞻性语句包括但不限于包含意愿、将要、可能、潜在性、预测、计划、估计、预期等类似陈述。它们都应被视为百奥泰基于截至本新闻稿发布之日可获得的信息的合理假设，并不保证未来的表现或发展。由于多种因素，实际结果和事件可能与前瞻性声明中包含的信息存在重大差异，这些因素包括但不限于本产品可能不会获得受理或批准，以及药物研究、开发和商业化中固有的风险和不确定性，例如临床前和临床研究的风险和不确定性以及能否获得药政部门的批准。其他风险因素包括生产、分销、营销、竞争、知识产权、药物功效和安全性方面的风险和不确定性，国家及全球财务与医疗状况的变化，公司财务状况的变化以及适用法律法规的变化等。本新闻稿中包含的任何前瞻性声明仅针对截止于作出声明之日的情况。除非法律要求，否则百奥泰没有义务更新本新闻稿中包含的任何前瞻性声明，以反映本新闻稿发布之日以后的新信息和事件，公司观点的改变或其他情况。

临床1期生物类似药抗体药物偶联物

2024-10-21

·百奥泰

百奥泰四款产品被列入首批《广州市创新药械产品目录》

百奥泰生物制药股份有限公司（上交所代码：688177）是一家位于中国广州，基于科学而创新的全球性生物制药企业（以下简称“百奥泰”或“公司”）。公司致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人类生命或健康的重大疾病。 2024年10月21日，广州市工业和信息化局发布的首批《广州市创新药械产品目录》产品清单中，7款为药品，而百奥泰有4款产品被列入在内，分别是：贝伐珠单抗注射液（普贝希®）、托珠单抗注射液（施瑞立®）、阿达木单抗注射液（格乐立®）以及枸橼酸倍维巴肽注射液（贝塔宁®）。普贝希®是公司自主开发的贝伐珠单抗生物类似药，美国、欧洲商品名：Avzivi®，已实现中美欧三地获批上市。普贝希®是目前唯一进行全球多中心注册临床研究的国产贝伐珠单抗生物类似药；是首个且目前唯一获得FDA、EMA批准上市的国产贝伐珠单抗生物类似药；是目前唯一具有400mg/16mL规格的国产贝伐珠单抗生物类似药。施瑞立®是公司自主开发的托珠单抗生物类似药，美国、欧洲商品名：TOFIDENCE™，是全球首款获批上市的托珠单抗生物类似药，已实现中美欧三地获批上市；是首个且目前唯一获得FDA、EMA批准上市的国产托珠单抗生物类似药。格乐立®是公司自主开发的阿达木单抗生物类似药，是国内首个获批上市、国内唯一获批2个规格及8个适应症的的阿达木单抗生物类似药。格乐立®上市以前，阿达木单抗原研药的费用高昂；格乐立®上市以后，原研药价格大幅降低。格乐立®目前也已纳入医保，患者可用上优质的生物制剂。贝塔宁®（枸橼酸倍维巴肽注射液）为百奥泰自主开发且拥有自主知识产权的1类化学药品，是一种肽类的β3整合素受体抑制剂。用于进行经皮冠状动脉介入术（包括进行冠状动脉内支架置入术）的急性冠脉综合征患者，以降低急性闭塞、支架内血栓、无复流和慢血流发生的风险。随着社会老龄化程度加深，急性冠状动脉综合征（ACS）患者以及需要行PCI术治疗的患者逐年增加，而围术期和术后血栓性并发症是最常见的影响PCI成功与否的主要因素之一。关于百奥泰百奥泰是一家位于中国广州，基于科学而创新的全球性生物制药企业。公司致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人类生命或健康的疾病。作为新一代抗体药物研发的领导者，百奥泰已推动多款候选药物进入后期临床试验，其中格乐立®（阿达木单抗）、普贝希®（贝伐珠单抗）、施瑞立®（托珠单抗）、贝塔宁®（枸橼酸倍维巴肽）已在中国获批上市。TOFIDENCE™（托珠单抗）和Avzivi®（贝伐珠单抗）已实现中美欧三地获批上市。公司现有20多款在研产品处于不同临床研究阶段，其中肿瘤领域主要聚焦后PD-1时代的肿瘤免疫治疗和抗体药物偶联体（ADC）靶向药物开发。百奥泰始终以患者的福祉作为首要核心价值，通过创新研发，为患者提供安全、有效、可负担的优质药物，以满足亟待解决的治疗需求。欲了解更多信息，请访问www.bio-thera.com，或关注我们的推特（@bio_thera_sol）和微信公众号（百奥泰）。 1. 格乐立®是百奥泰的注册商标 2. 普贝希®是百奥泰的注册商标 3. 施瑞立®是百奥泰的注册商标 4. 贝塔宁®是百奥泰的注册商标 5. TOFIDENCETM是渤健的注册商标 6. Avzivi®是山德士的注册商标百奥泰前瞻性声明本新闻稿包含了格乐立®、普贝希®、施瑞立®、贝塔宁®或百奥泰及其产品线相关的前瞻性声明。由于某些重要因素可能会影响公司的实际结果，特此提醒读者注意不要过分依赖该前瞻性声明。这些前瞻性语句包括但不限于包含意愿、将要、可能、潜在性、预测、计划、估计、预期等类似陈述。它们都应被视为百奥泰基于截至本新闻稿发布之日可获得的信息的合理假设，并不保证未来的表现或发展。由于多种因素，实际结果和事件可能与前瞻性声明中包含的信息存在重大差异，这些因素包括但不限于本产品可能不会获得受理或批准，以及药物研究、开发和商业化中固有的风险和不确定性，例如临床前和临床研究的风险和不确定性以及能否获得药政部门的批准。其他风险因素包括生产、分销、营销、竞争、知识产权、药物功效和安全性方面的风险和不确定性，国家及全球财务与医疗状况的变化，公司财务状况的变化以及适用法律法规的变化等。本新闻稿中包含的任何前瞻性声明仅针对截止于作出声明之日的情况。除非法律要求，否则百奥泰没有义务更新本新闻稿中包含的任何前瞻性声明，以反映本新闻稿发布之日以后的新信息和事件，公司观点的改变或其他情况。

上市批准生物类似药

100 项与贝伐珠单抗生物类似药 (百奥泰生物) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC07	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
晚期肾细胞癌	欧盟	FGK Representative Service GmbH	2024-07-26
晚期肾细胞癌	冰岛	FGK Representative Service GmbH	2024-07-26
晚期肾细胞癌	列支敦士登	FGK Representative Service GmbH	2024-07-26
晚期肾细胞癌	挪威	FGK Representative Service GmbH	2024-07-26
EGFR阳性非鳞状非小细胞肺癌	欧盟	FGK Representative Service GmbH	2024-07-26
EGFR阳性非鳞状非小细胞肺癌	冰岛	FGK Representative Service GmbH	2024-07-26
EGFR阳性非鳞状非小细胞肺癌	列支敦士登	FGK Representative Service GmbH	2024-07-26
EGFR阳性非鳞状非小细胞肺癌	挪威	FGK Representative Service GmbH	2024-07-26
转移性乳腺癌	欧盟	FGK Representative Service GmbH	2024-07-26
转移性乳腺癌	冰岛	FGK Representative Service GmbH	2024-07-26
转移性乳腺癌	列支敦士登	FGK Representative Service GmbH	2024-07-26
转移性乳腺癌	挪威	FGK Representative Service GmbH	2024-07-26
转移性宫颈癌	欧盟	FGK Representative Service GmbH	2024-07-26
转移性宫颈癌	冰岛	FGK Representative Service GmbH	2024-07-26
转移性宫颈癌	列支敦士登	FGK Representative Service GmbH	2024-07-26
转移性宫颈癌	挪威	FGK Representative Service GmbH	2024-07-26
转移性非小细胞肺癌	欧盟	FGK Representative Service GmbH	2024-07-26
转移性非小细胞肺癌	冰岛	FGK Representative Service GmbH	2024-07-26
转移性非小细胞肺癌	列支敦士登	FGK Representative Service GmbH	2024-07-26
转移性非小细胞肺癌	挪威	FGK Representative Service GmbH	2024-07-26

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
晚期癌症	临床3期	美国	BeiGene Ltd.	2019-12-19
晚期癌症	临床3期	中国	BeiGene Ltd.	2019-12-19
晚期癌症	临床3期	日本	BeiGene Ltd.	2019-12-19
晚期癌症	临床3期	澳大利亚	BeiGene Ltd.	2019-12-19
晚期癌症	临床3期	法国	BeiGene Ltd.	2019-12-19
晚期癌症	临床3期	意大利	BeiGene Ltd.	2019-12-19
晚期癌症	临床3期	马来西亚	BeiGene Ltd.	2019-12-19
晚期癌症	临床3期	新西兰	BeiGene Ltd.	2019-12-19
晚期癌症	临床3期	波兰	BeiGene Ltd.	2019-12-19
晚期癌症	临床3期	韩国	BeiGene Ltd.	2019-12-19

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03329911 (Pubmed) 人工标引	临床3期	晚期肺非鳞状非小细胞癌一线	649	BAT1706	憲襯蓋鬱範襯淵憲夢糧(遞窪繭壓鏇築繭觸窪鹹) = 醖窪鬱築築鏇鬱淵鹽鬱繭夢淵蓋衊鏇鬱遞選窪 (鹽壓網遞鹽願膚廠鬱淵 )	相似	2023-11-01
				EU-bevacizumab	憲襯蓋鬱範襯淵憲夢糧(遞窪繭壓鏇築繭觸窪鹹) = 淵鹽窪醖製夢鏇襯觸築繭夢淵蓋衊鏇鬱遞選窪 (鹽壓網遞鹽願膚廠鬱淵 )
NCT04948697 (AdvanTIG-206, ESMO 12023 \| ESMO 22023) 人工标引	临床2期	晚期肝细胞癌	94	Ociperlimab + Tislelizumab + BAT1706	膚築築築廠餘糧襯繭築(蓋網廠構選夢夢襯鹹膚) = 蓋遞憲築鏇遞鏇選艱鬱製積窪夢醖願觸簾膚繭 (醖憲窪積鏇蓋鬱齋壓窪, 23.7 ~ 48.7) 更多	积极	2023-10-21
				Tislelizumab + BAT1706	膚築築築廠餘糧襯繭築(蓋網廠構選夢夢襯鹹膚) = 鹹齋淵願顧鹽願築齋簾製積窪夢醖願觸簾膚繭 (醖憲窪積鏇蓋鬱齋壓窪, 21.1 ~ 56.3) 更多
NCT03329911 (CTgov)	临床3期	晚期肺非鳞状非小细胞癌	651	Carboplatin+paclitaxel+EU Avastin® (EU Avastin®)	鏇獵鏇繭繭夢窪蓋選選(壓艱獵觸顧網選鹽憲夢) = 顧襯齋鑰範鑰簾糧廠夢膚餘餘觸齋構膚簾繭蓋 (壓膚遞構壓衊製淵願構, 鏇窪糧廠鏇鑰糧艱積鬱 ~ 願構簾醖淵餘遞製廠製) 更多	-	2021-09-13
				BAT1706+Carboplatin+paclitaxel (BAT1706)	鏇獵鏇繭繭夢窪蓋選選(壓艱獵觸顧網選鹽憲夢) = 鏇製鏇簾夢窪網鑰窪憲膚餘餘觸齋構膚簾繭蓋 (壓膚遞構壓衊製淵願構, 獵網鏇選遞膚築選夢衊 ~ 積遞齋夢窪襯餘顧鬱襯) 更多
NCT03030430 (Pubmed 1 \| Pubmed 2 \| BioDrugs) 人工标引	临床1期	-	128	BAT1706	簾鏇鏇鏇顧製構蓋範糧(餘選網築膚網網窪窪鏇) = 99-112% for BAT1706 versus EU-BEV, 97-110% for BAT1706 vs US-BEV and 92-104% for EU-BEV versus US-BEV comparisons, respectively, demonstrating biosimilarity. 餘襯壓獵鏇齋選顧構艱 (淵鹽窪範範簾壓夢構顧 ) 更多	积极	2019-06-01
				US-sourced BEV
Pubmed 人工标引	临床1期	-	-	MIL60	襯構廠鬱憲壓選鏇壓鬱(艱窪壓構窪艱鬱餘醖衊) = Bevacizumab demonstrated linear PK properties and a concentration-dependent disposition. When comparing the three biosimilars with bevacizumab-EU, the 90% CIs of the ratios for Cmax, AUC0-t, and AUC0-∞ were within 80-125%. The inter-CV ranged from 12.6 to 23.3%. 壓壓構觸糧積糧齋齋鹽 (網鏇範構窪鬱鹽遞鬱蓋 ) 更多	积极	2018-10-01
				BAT1706