[Translation] A multicenter, open-label, Phase IB-II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BAT8008 combined with bevacizumab or combined with BAT7104 in patients with advanced solid tumors

探索BAT8008联合贝伐珠单抗/BAT7104在晚期实体肿瘤患者中的安全性、耐受性以及PK特征等，探索最大耐受剂量（MTD）并为后续临床研究提供推荐剂量及合理的给药方案，并初步评价抗肿瘤疗效。

[Translation]

Explore the safety, tolerability, and PK characteristics of BAT8008 combined with bevacizumab/BAT7104 in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), provide recommended doses and reasonable dosing regimens for subsequent clinical studies, and preliminarily evaluate the anti-tumor efficacy.

Start Date08 Aug 2024

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

NCT06313970

/ Not yet recruitingPhase 2IIT

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

Start Date15 Apr 2024

Sponsor / Collaborator

Fudan University

NCT06123884

/ RecruitingPhase 2/3

A Phase II/III Study to Evaluate the Safety and Efficacy of BAT1308 Combined with Platinum-Based Chemotherapy ± Bevacizumab As First-Line Therapy for PD-L1-Positive (CPS ≥ 1) Persistent, Recurrent or Metastatic Cervical Cancer

Phase II study: a study to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab Phase III study: a confirmatory study to evaluate the safety and efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer

Start Date13 Dec 2023

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

100 Clinical Results associated with Bevacizumab biosimilar (Bio-Thera Solutions)

100 Translational Medicine associated with Bevacizumab biosimilar (Bio-Thera Solutions)

100 Patents (Medical) associated with Bevacizumab biosimilar (Bio-Thera Solutions)

Literatures (Medical) associated with Bevacizumab biosimilar (Bio-Thera Solutions)

01 Nov 2023·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

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

AbstractBackgroundBAT1706 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).MethodsPatients 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).ResultsIn 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.ConclusionIn patients with advanced nonsquamous NSCLC, BAT1706 demonstrated clinical equivalence to EU‐bevacizumab in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

01 Sep 2023·Drugs in R&D

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

Article

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

BACKGROUNDBAT1706 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).METHODA 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.RESULTBAT1706 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.CONCLUSIONOverall, this extensive comparability exercise demonstrated BAT1706 to match EU/US-bevacizumab in terms of all physicochemical and functional attributes assessed.

01 Jun 2019·BioDrugsQ3 · MEDICINE

A Global Phase I Clinical Study Comparing the Safety and Pharmacokinetics of Proposed Biosimilar BAT1706 and Bevacizumab (Avastin®) in Healthy Male Subjects

Q3 · MEDICINE

Article

Author: Yu, Jin-Chen ; Thomas, Bert E ; Wynne, Chris ; Xu, Chenchao ; Zhang, Li ; Wu, Xiaoyun ; Li, Shengfeng ; Gan, Yiting ; Wang, Chaohe

OBJECTIVEBAT1706 is a proposed biosimilar of bevacizumab (BEV). The objective of this phase I clinical trial was to establish pairwise similarity between BAT1706, US-sourced BEV (US-BEV), and EU-sourced BEV (EU-BEV) after a single intravenous (IV) infusion in healthy male subjects.METHODSThis phase I clinical trial was a randomized, double-blinded, three-arm study in 128 healthy adult male subjects. Every subject received a single IV infusion of 1 mg/kg of study drug and was subsequently monitored for 14 weeks. Pharmacokinetic, safety, and immunogenicity data were collected from each patient. The primary pharmacokinetic endpoint of this clinical study was area under the concentration curve from time zero to infinity (AUC_0-inf). Biosimilarity of the study drugs was confirmed if the two-sided 90% confidence interval (CI) ratios of the geometric means for the three pairwise comparisons were contained within the range 80-125%. Other pharmacokinetic parameters including area under the concentration curve to time t (AUC_0-t), maximum concentration of drug in plasma (C_max), half-life (t_½), and time to C_max (t_max) were also measured.RESULTSThe pharmacokinetic parameters were comparable for the three drug products evaluated. The 90% CI for the AUC_0-inf was 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. There were no significant adverse events attributable to BAT1706, as compared to EU-BEV and US-BEV. BAT1706 demonstrated a similar safety profile to EU-BEV and US-BEV. In addition, no anti-drug antibody positive result was reported for any subject included in the study.CONCLUSIONIn this study, BAT1706, a proposed biosimilar of BEV, was shown to be highly similar to EU-BEV and US-BEV in terms of pharmacokinetic equivalence, safety, and immunogenicity in healthy subjects after a single IV infusion.TRIAL REGISTRATIONNCT03030430.

News (Medical) associated with Bevacizumab biosimilar (Bio-Thera Solutions)

11 Feb 2025

·www.pharmaceutical-technology.com

Bio-Thera signs US deal with Intas for golimumab biosimilar

Bio-Thera focuses on therapeutics for cardiovascular, cancer and autoimmune conditions. Credit: sergey kolesnikov/Shutterstock. Bio-Thera Solutions has signed an exclusive licence and commercialisation agreement with Intas Pharmaceuticals for the Simponi (golimumab) biosimilar, BAT2506 in the US. Bio-Thera will develop, manufacture and supply BAT2506. It is set to obtain an upfront payment of $21m and could earn up to $143.5m in development and commercial milestones. Intas will handle commercialisation in the US market through its US speciality division, Accord BioPharma. Accord BioPharma US president Chrys Kokino stated: “Our exclusive commercialisation agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component of our US growth strategy. “We’re investing heavily in biosimilars through external partnerships plus our own clinical efforts because we believe in their vast potential to drive patient and provider-centric solutions. Bio-Thera’s global experience makes them an excellent partner.” The human immunoglobulin G 1 (IgG1) monoclonal antibody golimumab is used to target a pro-inflammatory molecule, tumour necrosis factor alpha (TNF-α). The binding of the molecule to TNF-α can lead to a decrease in inflammatory markers. Golimumab is approved for treating ulcerative colitis, psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis in the US and Europe. Based in Guangzhou, China, Bio-Thera Solutions focuses on therapeutics for cardiovascular, cancer, autoimmune and eye conditions. It also focuses on biosimilars for existing branded biologics. The company has advanced multiple candidates into late-stage development, with four approved products: Qletli and Betagrin in China, and Tofidence/BAT1806 and Avzivi/Pobevcy in the US, European Union and China. In April 2021, Biogen and Bio-Thera entered an agreement to develop, manufacture and commercialise BAT1806, an anti-interleukin-6 (IL-6) receptor monoclonal antibody.

License out/inDrug ApprovalImmunotherapyBiosimilar

10 Feb 2025

·www.prnewswire.com

Accord BioPharma Strengthens Pipeline Through Exclusive U.S. Licensing Agreement with Bio-Thera for BAT2506, a Proposed Golimumab Biosimilar

BAT2506, a tumor necrosis factor-alpha (TNF-alpha) blocker, is a Phase 3 biosimilar candidate to Simponi® (golimumab) Agreement will provide Accord BioPharma with future U.S. commercialization rights to BAT2506, while Bio-Thera will maintain responsibility for product development, manufacturing, and supply RALEIGH, N.C., Feb. 10, 2025 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and critical care therapies, announced today that it has reached an exclusive commercialization and license agreement with Bio-Thera Solutions ("Bio-Thera") for BAT2506, a biosimilar candidate to Simponi® (golimumab). BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab, a human monoclonal antibody, inhibits the biological activity of tumor necrosis factor alpha (TNF-alpha). Originator product Simponi® is approved in the U.S. for moderate to severe rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis and moderate to severely active UC, and carries a Boxed Warning for Serious Infection and Malignancy. In 2023 worldwide sales of Simponi® (for subcutaneous injection) and Simponi Aria® (for intravenous infusion) totaled approximately $3.2 billion, representing a compelling opportunity for Accord BioPharma to broaden patient access to biologics and build scale in immunology, a high-demand therapeutic area. "Our U.S. portfolio of biosimilars continues to rapidly expand at multiple levels across the drug development and commercialization cycle," said Chrys Kokino, U.S. President of Accord. "In addition to developing and marketing our own biosimilar products, we're strategically collaborating with select partners around the world to bring more biosimilars to the U.S. market as swiftly as possible." "The U.S. biologics market is predicted to grow rapidly in the coming years. Biosimilars can play a transformative role in creating unique opportunities for stakeholders across the healthcare value chain," said Binish Chudgar, Executive Chairman and Managing Director of Intas Pharmaceuticals. "This agreement reaffirms our commitment to improving the patient experience." "Accord is a leading biosimilar company in the United States, and we are pleased to establish this commercial partnership with Accord for BAT2506," said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership will expand Bio-Thera's efforts to bring more immunology biosimilars to patients in the USA." Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506, while Accord will have exclusive rights to commercialize the product in the U.S. About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com. About BAT2506 BAT2506 is a biosimilar candidate to Simponi® (golimumab). Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. 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 . References: Simponi® (golimumab) Full Prescribing Information. Accessed January 2025. All trademarks, logos and brand names are the property of their respective owners. Contact: [email protected] SOURCE Accord BioPharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inDrug ApprovalImmunotherapy

10 Feb 2025

·www.prnewswire.com

Bio-Thera Solutions Announces Exclusive Commercialization and License Agreement with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), in the United States of America

GUANGZHOU, China, Feb. 10, 2025 /PRNewswire/ -- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced the company has reached an exclusive commercialization and license agreement with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, for the United States of America. Continue Reading Bio-Thera Solutions Announces Exclusive Commercialization and License Agreement with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), in the United States of America BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-a), a pro-inflammatory molecule. Binding of golimumab to TNF-a results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. The reference medicine golimumab has been approved in the United States and Europe for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506. Intas Pharmaceuticals, through its US-specialty division Accord BioPharma, will be responsible for commercializing the product in the United States of America. Bio-Thera will receive an upfront payment of $21 million USD, as well as further development and commercial milestones of up to $143.5 million USD. "Accord BioPharma is a leading biosimilar company in the United States, and we are pleased to establish this commercial partnership with Accord for BAT2506," said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership will expand Bio-Thera's efforts to bring more immunology biosimilars to patients in USA." "Our exclusive commercialization agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component of our U.S. growth strategy," said Chrys Kokino, U.S. President of Accord. "We're investing heavily in biosimilars through external partnerships plus our own clinical efforts, because we believe in their vast potential to drive patient- and provider-centric solutions. Bio-Thera's global experience makes them an excellent partner." 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). About Intas Pharmaceuticals Intas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. Intas Pharmaceuticals has a rich history of making quality biosimilars accessible to the masses. Being the most affordable treatment option, Intas' products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management of their respective therapies. Eleftha is the latest testament to Intas' Biosimilar for Billions philosophy, fulfilling its commitment to provide quality cancer care to the masses. Intas' biosimilars are manufactured at Intas Pharmaceuticals' state of the art European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat. For more information, visit us at . About Accord BioPharma, Inc. Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com. Bio-Thera Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT2506, or the product pipelines 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. Simponi® is a registered trademark of Johnson & Johnson 2. QLETLI® 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. 6. BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd. Contact Bert E. Thomas IV Phone: +1.410.627.1734 Email: [email protected] 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

License out/inDrug Approval

100 Deals associated with Bevacizumab biosimilar (Bio-Thera Solutions)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
EGFR positive Non-squamous non-small cell lung cancer	European Union	FGK Representative Service GmbH	26 Jul 2024
Platinum-sensitive epithelial ovarian cancer	Norway	FGK Representative Service GmbH	26 Jul 2024
Platinum-sensitive epithelial ovarian cancer	European Union	FGK Representative Service GmbH	26 Jul 2024
Platinum-sensitive epithelial ovarian cancer	Iceland	FGK Representative Service GmbH	26 Jul 2024
Platinum-sensitive epithelial ovarian cancer	Liechtenstein	FGK Representative Service GmbH	26 Jul 2024
Platinum-Sensitive Primary Peritoneal Carcinoma	European Union	FGK Representative Service GmbH	26 Jul 2024
Platinum-Sensitive Primary Peritoneal Carcinoma	Liechtenstein	FGK Representative Service GmbH	26 Jul 2024
Platinum-Sensitive Primary Peritoneal Carcinoma	Norway	FGK Representative Service GmbH	26 Jul 2024
Platinum-Sensitive Primary Peritoneal Carcinoma	Iceland	FGK Representative Service GmbH	26 Jul 2024
Metastatic Renal Cell Carcinoma	United States	Bio-Thera Solutions, Ltd.	06 Dec 2023
Non-squamous non-small cell lung cancer	United States	Bio-Thera Solutions, Ltd.	06 Dec 2023
Recurrent Glioblastoma	United States	Bio-Thera Solutions, Ltd.	06 Dec 2023
Fallopian Tube Carcinoma	China	Bio-Thera Solutions, Ltd.	21 Apr 2022
Glioblastoma	China	Bio-Thera Solutions, Ltd.	21 Apr 2022
Ovarian Cancer	China	Bio-Thera Solutions, Ltd.	21 Apr 2022
Ovarian Epithelial Carcinoma	China	Bio-Thera Solutions, Ltd.	21 Apr 2022
Primary peritoneal carcinoma	China	Bio-Thera Solutions, Ltd.	21 Apr 2022
Uterine Cervical Cancer	China	Bio-Thera Solutions, Ltd.	21 Apr 2022
Metastatic Colorectal Carcinoma	China	Bio-Thera Solutions, Ltd.	17 Nov 2021
Non-Small Cell Lung Cancer	China	Bio-Thera Solutions, Ltd.	17 Nov 2021

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Renal Cell Carcinoma	NDA/BLA	European Union	Bio-Thera Solutions, Ltd.	30 May 2024
Metastatic Cervical Carcinoma	NDA/BLA	European Union	Bio-Thera Solutions, Ltd.	30 May 2024
Metastatic Colorectal Carcinoma	NDA/BLA	European Union	Bio-Thera Solutions, Ltd.	30 May 2024
metastatic non-small cell lung cancer	NDA/BLA	European Union	Bio-Thera Solutions, Ltd.	30 May 2024
Ovarian Epithelial Carcinoma	NDA/BLA	European Union	Bio-Thera Solutions, Ltd.	30 May 2024
Platinum-sensitive epithelial ovarian cancer	NDA/BLA	European Union	Bio-Thera Solutions, Ltd.	30 May 2024
Platinum-Sensitive Primary Peritoneal Carcinoma	NDA/BLA	European Union	Bio-Thera Solutions, Ltd.	30 May 2024
Recurrent Cervical Cancer	NDA/BLA	European Union	Bio-Thera Solutions, Ltd.	30 May 2024
Recurrent Non-Small Cell Lung Cancer	NDA/BLA	European Union	Bio-Thera Solutions, Ltd.	30 May 2024
Recurrent Platinum-Resistant Primary Peritoneal Carcinoma	NDA/BLA	European Union	Bio-Thera Solutions, Ltd.	30 May 2024

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04948697 (AdvanTIG-206, CTgov)	Phase 2	Advanced Hepatocellular Carcinoma	94	Tislelizumab+BAT1706+Ociperlimab (Arm A: Ociperlimab + Tislelizumab + BAT1706)	mpwmfryfdj(vminwcukpz) = yizuvmgbev zmdsyvecfj (ktxmkvrpnn, xkzstyyimh - lzoikjjegz) View more	-	24 Feb 2025
				Tislelizumab+BAT1706 (Arm B: Tislelizumab + BAT1706)	mpwmfryfdj(vminwcukpz) = ibexghkvgd zmdsyvecfj (ktxmkvrpnn, damvdzoedt - mqhpqgfnyg) View more
NCT03329911 (Pubmed) Manual	Phase 3	Advanced Lung Non-Squamous Non-Small Cell Carcinoma First line	649	BAT1706	(hmfmyydpty) = swmxcjwbog dlreelkcok (tqxdtiufzg )	Similar	01 Nov 2023
				EU-bevacizumab	(hmfmyydpty) = xqxlcvvhgv dlreelkcok (tqxdtiufzg )
NCT04948697 (AdvanTIG-206, ESMO 12023 \| ESMO 22023) Manual	Phase 2	Advanced Hepatocellular Carcinoma	94	Ociperlimab + Tislelizumab + BAT1706	(qgiagwyrws) = zmtrzgeqrp qectsswnyc (qvfyjpxfyw, 23.7 - 48.7) View more	Positive	21 Oct 2023
				Tislelizumab + BAT1706	(qgiagwyrws) = awyklvoxbi qectsswnyc (qvfyjpxfyw, 21.1 - 56.3) View more
NCT03329911 (CTgov)	Phase 3	Advanced Lung Non-Squamous Non-Small Cell Carcinoma	651	Carboplatin+paclitaxel+EU Avastin® (EU Avastin®)	(zkizhzhzhx) = htvytmeiat trlgihafio (lwumxhgbyi, ncqgrgkwou - jfqccvyjqg) View more	-	13 Sep 2021
				BAT1706+Carboplatin+paclitaxel (BAT1706)	(zkizhzhzhx) = rhqaykhmbo trlgihafio (lwumxhgbyi, nmznfrnmmg - dwbwziygdt) View more
NCT03030430 (Pubmed 1 \| Pubmed 2 \| BioDrugs) Manual	Phase 1	-	128	BAT1706	(umsqjoplom) = 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. tsykgeqlyg (uyabcbpjei ) View more	Positive	01 Jun 2019
				US-sourced BEV
Pubmed Manual	Phase 1	-	-	MIL60	(mjuajsczwy) = 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%. htelqwczqq (etctxqkrzj ) View more	Positive	01 Oct 2018
				BAT1706

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