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

CTR20233522 / RecruitingPhase 1/2

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

[Translation] Phase Ib/II clinical study on the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of JS015 combined with other drugs in the treatment of patients with advanced solid tumors

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

[Translation]

Main research objectives: To evaluate the safety and tolerability of JS015 combination therapy in patients with advanced solid tumors; To determine the recommended dose (RP2D) for Phase II clinical study of JS015 combination therapy Secondary research objectives: To evaluate the pharmacokinetic (PK) characteristics/pharmacodynamic characteristics/immunogenicity/preliminary effectiveness of JS015 combination therapy in patients with advanced solid tumors; Exploratory research objectives: To explore the relationship between biomarkers (including DKK1, PD-L1, etc.) in tumor tissues and clinical efficacy

Start Date06 Dec 2023

Sponsor / Collaborator

Shanghai Junshi Biosciences Co., Ltd.

CTR20232394 / RecruitingPhase 2

BAT1308联合含铂化疗±贝伐珠单抗用于一线治疗PD-L1阳性（CPS≥1）的持续、复发或转移性宫颈癌安全性和有效性的II/III期研究

[Translation] A Phase II/III study of the safety and efficacy of BAT1308 combined with platinum-based chemotherapy ± bevacizumab as a first-line treatment for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer

II期研究： BAT1308联合含铂化疗 ±贝伐珠单抗安全性和初步疗效研究主要目的：评价BAT1308联合含铂化疗±贝伐珠单抗一线治疗PD-L1阳性（CPS≥1）的持续、复发或转移性宫颈癌患者的安全性 III期研究： BAT1308联合含铂化疗 ±贝伐珠单抗用于一线治疗 PD-L1阳性（ CPS≥1）的持续、复发或转移性宫颈癌的安全性和有效性确证性研究主要目的：评价BAT1308联合含铂化疗±贝伐珠单抗对比含铂化疗±贝伐珠单抗一线治疗PD-L1阳性（CPS≥1）的持续、复发或转移性宫颈癌的有效性。

[Translation]

Phase II study: Safety and preliminary efficacy study of BAT1308 combined with platinum-containing chemotherapy ± bevacizumab Main purpose: To evaluate the safety of BAT1308 combined with platinum-containing chemotherapy ± bevacizumab as first-line treatment for patients with persistent, recurrent or metastatic cervical cancer with PD-L1 positive (CPS≥1) Phase III study: Safety and efficacy confirmation study of BAT1308 combined with platinum-containing chemotherapy ± bevacizumab as first-line treatment for persistent, recurrent or metastatic cervical cancer with PD-L1 positive (CPS≥1) Main purpose: To evaluate the efficacy of BAT1308 combined with platinum-containing chemotherapy ± bevacizumab versus platinum-containing chemotherapy ± bevacizumab as first-line treatment for persistent, recurrent or metastatic cervical cancer with PD-L1 positive (CPS≥1)

Start Date01 Dec 2023

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

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

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

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

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

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: Ozyilkan, Ozgur ; Chen, Likun ; Dong, Qingfeng ; Cil, Timucin ; Cicin, Irfan ; Chen, Jun ; Shen, Yihong ; Li, Xingya ; Chen, Zhendong ; Zhang, Li ; Fu, Ziyi ; 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.

01 Sep 2023·Drugs in R&D

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

Article

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

01 Jun 2019·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapyQ3 · 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: Zhang, Li ; Gan, Yiting ; Wynne, Chris ; Wu, Xiaoyun ; Xu, Chenchao ; Wang, Chaohe ; Li, Shengfeng ; Yu, Jin-Chen ; Thomas, Bert E

OBJECTIVE:

BAT1706 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.

METHODS:

This 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.

RESULTS:

The 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.

CONCLUSION:

In 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 REGISTRATION:

NCT03030430.

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

25 Jul 2024

·www.prnewswire.com

Bio-Thera Solutions Initiates Integrated Phase I / Phase III Clinical Trial for BAT3306, a Proposed Biosimilar of Keytruda® (Pembrolizumab)

GUANGZHOU, China, July 25, 2024 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177: SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that dosing has recently begun in an integrated Phase I / Phase III clinical study for BAT3306, a proposed biosimilar of Keytruda® (pembrolizumab). The clinical study is a randomized, double-blind, parallel group, active control study to compare the pharmacokinetics, efficacy and safety of BAT3306 to Keytruda® in non-squamous non-small cell lung cancer (nsNSCLC) patients. The study is expected to enroll approximately 676 patients. "Keytruda is the most important innovative cancer therapy currently in use," said Shengfeng Li, CEO at Bio-Thera. "Bio-Thera is committed to expanding access to this important cancer therapy with the development of BAT3306." Bio-Thera Solutions is developing a large pipeline of biosimilars that include BAT1806, a tocilizumab has been approved by FDA, EMA and NMPA, BAT1706, a bevacizumab has been approved by FDA and NMPA. BAT2206, a ustekinumab has been filed with FDA, EMA and NMPA. Bio-Thera Solutions is also pursuing biosimilar versions of golimumab, secukinumab, and mepolizumab. 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 three approved products: QLETLI® (BAT1406) in China, TOFIDENCE™/ BAT1806 in the US, EU and China and Avzivi® / Pobevcy® (BAT1706) in the US 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 BAT3306 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. Keytruda® is a registered trademark of Merck Sharp & Dohme 2. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. 3. TOFIDENCE™ is a trademark of Biogen 4. Avzivi® is a registered trademark of Sandoz AG 5. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Contact Bio-Thera Solutions, Ltd.: Bert E. Thomas IV +1.410.627.1734 [email protected] SOURCE Bio-Thera Solutions, Ltd

Drug ApprovalPhase 3IND

24 Jul 2024

·www.prnewswire.com

Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2206, a Proposed Biosimilar to Stelara® in the US and EU

The U.S. Food and Drug Administration (FDA) has accepted Bio-Thera's Biologics License Applications (BLA) for BAT2206 as an interchangeable biosimilar to reference product Stelara® The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BAT2206 as a biosimilar to reference product Stelara® The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package comparing BAT2206 to the reference product Stelara® GUANGZHOU, China, July 24, 2024 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the FDA has accepted the BLA for BAT2206, a proposed interchangeable biosimilar to Stelara® (ustekinumab) seeking a commercial license in the United States of America. In addition, Bio-Thera also announced that the EMA has accepted the MAA for BAT2206 seeking a commercial license in the European Union (EU). A Biologics License Application seeking approval for BAT2206 is also currently under review by the China National Medicinal Product Administration (NMPA). "The acceptance of both the FDA BLA and the EMA MAA for BAT2206 marks a milestone for Bio-Thera as it is the first ustekinumab biosimilar developed by a Chinese company to be submitted to the FDA or EMA for approval," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. "Bio-Thera is committed to helping patients around the world in need of affordable therapeutics like ustekinumab by developing BAT2206 for the global markets." This BLA/MAA for BAT2206 is based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of BAT2206 was conducted and supports biosimilarity with the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of BAT2206 with both the EU and US reference ustekinumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared BAT2206 with ustekinumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with Moderate to Severe Plaque Psoriasis. About BAT2206 (ustekinumab) BAT2206 is a proposed biosimilar to Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease and ulcerative colitis, among many other autoimmune diseases. In the United States, Stelara® is a currently approved treatment for adult patients with 1) moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy, 2) active psoriatic arthritis (PsA), 3) moderately to severely active Crohn's disease (CD), 4) moderately to severely active ulcerative colitis. In pediatric patients 6 years and older Stelara® is currently approved for the treatment of 1) moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy and 2) active psoriatic arthritis (PsA). 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 three approved products: QLETLI® in China, and TOFIDENCE™/ BAT1806 in the US, EU and China, and Avzivi® / Pobevcy® in the US 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 antibody-drug conjugates (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 BAT2206 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. Stelara® is a registered trademark of Johnson & Johnson Corporation QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. TOFIDENCE™ is a trademark of Biogen Avzivi® is a registered trademark of Sandoz AG POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Contact Bio-Thera Solutions, Ltd.: Bert E. Thomas IV +1.410.627.1734 [email protected] SOURCE Bio-Thera Solutions, Ltd

Drug ApprovalClinical ResultPhase 1Phase 3

03 Jun 2024

·www.prnewswire.com

Bio-Thera Solutions Receives Positive CHMP Opinion for Avzivi® (bevacizumab), a Biosimilar Referencing Avastin®

CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing Avzivi® to the reference product Avastin® GUANGZHOU, China, June 3, 2024 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Avzivi® (bevacizumab), a biosimilar monoclonal antibody referencing AVASTIN®. The CHMP's positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for Avzivi®. "Bio-Thera is committed to developing high-quality biosimilars to expand patient access to important therapeutics like bevacizumab," said Shengfeng Li, CEO of Bio-Thera Solutions. "The positive CHMP recommendation for Avzivi® demonstrates that commitment to patients, healthcare providers, and healthcare systems in Europe." This positive CHMP opinion on Avzivi® was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of Avzivi® was conducted and supports biosimilarity with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of Avzivi® with both the EU and US reference product in healthy volunteers. In addition, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared Avzivi® with the reference product to confirm equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with Advanced Non-Squamous Non-Small Cell Lung Cancer. The totality of evidence demonstrated Avzivi® is a biosimilar of the reference biologic. Bio-Thera and Sandoz entered into a license and commercialization agreement for Avzivi® (BAT1706) in September 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Sandoz will have the right to commercialize the medicine upon approval and successful Marketing Authorization Holder Transfer in the US, Europe*, Canada and selected other countries. *Includes the European Economic Area (EEA), United Kingdom, Switzerland, the Balkan States and selected countries in Eastern Europe. About Avzivi® (bevacizumab) Avzivi® (bevacizumab) is a humanized monoclonal antibody that targets VEGF. It specifically binds to VEGF and blocks the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. The original product code for Avzivi® is BAT1706. In Europe, Avzivi® is under review for marketing authorization for the treatment of 1) metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment, 2) metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. 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 three approved products: QLETLI® in China, and TOFIDENCE™/ BAT1806 and Avzivi® / Pobevcy® in the US 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 Avzivi® (BAT1706) 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. 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. Avzivi® is a registered trademark of Sandoz AG Avastin® is a registered trademark of Genentech, Inc. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. TOFIDENCE™ is a registered trademark of Biogen MA Inc. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Contact Bio-Thera Solutions, Ltd.: Bert E. Thomas IV +1.410.627.1734 [email protected] SOURCE Bio-Thera Solutions, Ltd

Clinical ResultLicense out/inPhase 3Drug ApprovalImmunotherapy

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

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	EU	FGK Representative Service GmbH	26 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	IS	FGK Representative Service GmbH	26 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	LI	FGK Representative Service GmbH	26 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	NO	FGK Representative Service GmbH	26 Jul 2024
Advanced Renal Cell Carcinoma	EU	FGK Representative Service GmbH	26 Jul 2024
Advanced Renal Cell Carcinoma	IS	FGK Representative Service GmbH	26 Jul 2024
Advanced Renal Cell Carcinoma	LI	FGK Representative Service GmbH	26 Jul 2024
Advanced Renal Cell Carcinoma	NO	FGK Representative Service GmbH	26 Jul 2024
Metastatic breast cancer	EU	FGK Representative Service GmbH	26 Jul 2024
Metastatic breast cancer	IS	FGK Representative Service GmbH	26 Jul 2024
Metastatic breast cancer	LI	FGK Representative Service GmbH	26 Jul 2024
Metastatic breast cancer	NO	FGK Representative Service GmbH	26 Jul 2024
metastatic non-small cell lung cancer	EU	FGK Representative Service GmbH	26 Jul 2024
metastatic non-small cell lung cancer	IS	FGK Representative Service GmbH	26 Jul 2024
metastatic non-small cell lung cancer	LI	FGK Representative Service GmbH	26 Jul 2024
metastatic non-small cell lung cancer	NO	FGK Representative Service GmbH	26 Jul 2024
Platinum-sensitive epithelial ovarian cancer	EU	FGK Representative Service GmbH	26 Jul 2024
Platinum-sensitive epithelial ovarian cancer	IS	FGK Representative Service GmbH	26 Jul 2024
Platinum-sensitive epithelial ovarian cancer	LI	FGK Representative Service GmbH	26 Jul 2024
Platinum-sensitive epithelial ovarian cancer	NO	FGK Representative Service GmbH	26 Jul 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR positive Non-squamous non-small cell lung cancer	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
Metastatic Cervical Carcinoma	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
Recurrent Cervical Cancer	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
Recurrent Platinum-Resistant Fallopian Tube Carcinoma	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
Recurrent Platinum-Resistant Ovarian Carcinoma	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
Recurrent Platinum-Resistant Primary Peritoneal Carcinoma	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
Unresectable Lung Non-Small Cell Carcinoma	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
Neoplasms	Phase 3	CN	BeiGene Ltd.	19 Dec 2019
Neoplasms	Phase 3	PL	BeiGene Ltd.	19 Dec 2019
Neoplasms	Phase 3	KR	BeiGene Ltd.	19 Dec 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03329911 (Pubmed) Manual	Phase 3	Advanced Lung Non-Squamous Non-Small Cell Carcinoma First line	649	BAT1706	lucuicaskz(ltrdduvxiw) = wpacfrnlxd mzaslhftfh (kyfjgtyixo )	Similar	01 Nov 2023
				EU-bevacizumab	lucuicaskz(ltrdduvxiw) = rjiklrnuvp mzaslhftfh (kyfjgtyixo )
NCT04948697 (AdvanTIG-206, ESMO2023) Manual	Phase 2	Advanced Hepatocellular Carcinoma	94	Ociperlimab + Tislelizumab + BAT1706	ewbuortlcy(dxgitwwhht) = hzjrkciznm gnwvrapprx (qonpxwygty, 23.7 - 48.7) View more	Positive	21 Oct 2023
				Tislelizumab + BAT1706	ewbuortlcy(dxgitwwhht) = dbxevlvvdg gnwvrapprx (qonpxwygty, 21.1 - 56.3) View more
NCT03329911 (ASCO2022)	Phase 3	Non-Small Cell Lung Cancer	651	BAT1706 plus paclitaxelBAT1706 plus paclitaxel and carboplatin	tshjxddazc(istgdxkvqr) = zasmyborha zgyzfbmpmr (cbwhonegkb ) View more	Positive	02 Jun 2022
				EU-bevacizumab plus paclitaxelEU-bevacizumab plus paclitaxel and carboplatin	tshjxddazc(istgdxkvqr) = wmqnxsjqhr zgyzfbmpmr (cbwhonegkb ) View more
NCT03329911 (CTgov)	Phase 3	Advanced Lung Non-Squamous Non-Small Cell Carcinoma	651	Carboplatin+paclitaxel+EU Avastin® (EU Avastin®)	byghmzxeem(myoxxznekj) = lrlfennllx ltvhhzncnl (tohymjlyjg, pqoziubrro - edzdrtlwxx) View more	-	13 Sep 2021
				BAT1706+Carboplatin+paclitaxel (BAT1706)	byghmzxeem(myoxxznekj) = yqcavteqxl ltvhhzncnl (tohymjlyjg, ympjpnadeb - sgugmvfviv) View more
NCT03030430 (Pubmed) Manual	Phase 1	-	128	BAT1706	xetbjpmgal(kwihacvjvl) = 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. untygbwgal (umbzrxgmtb ) View more	Positive	01 Jun 2019
				US-sourced BEV
Pubmed Manual	Phase 1	-	-	MIL60	nozepmojod(oogttmcvij) = 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%. tpzzqpyysb (eogfuovrqc ) View more	Positive	01 Oct 2018
				BAT1706

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