[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

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.

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: 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 ; Ozyilkan, Ozgur ; Chen, Likun ; 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 ; Li, Shengfeng ; Cao, Di ; Xie, Jianhua ; Liu, Yujie ; 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, Ltd.)

11 Sep 2024

·www.prnewswire.com

Bio-Thera Solutions and Biogen Publish Phase 3 Clinical Trial Data for TOFIDENCE™ (BAT1806/BIIB800), an approved Biosimilar referencing tocilizumab in Arthritis Research & Therapy

Comparable clinical efficacy and safety in Treatment Period 2 (TP2, Week 24-48) is maintained after switch from reference tocilizumab to TOFIDENCE (BAT1806/BIIB800) Phase 3 clinical data in totality demonstrates biosimilarity between TOFIDENCE (BAT1806/BIIB800) and reference tocilizumab before and after switching.1,2 GUANGZHOU, China, Sept. 11, 2024 /PRNewswire/ -- Bio-Thera Solutions, Ltd. today announced, in collaboration with Biogen, the publication in the journal Arthritis Research & Therapy of results from Treatment Period 2 (TP2; study weeks 24-48) of a Phase 3 clinical study evaluating BAT1806/BIIB800, an approved biosimilar to Actemra®/RoActemra®3 (tocilizumab). BAT1806/BIIB800 is currently commercialized under the brand name TOFIDENCE™4. In the Phase 3, multicenter, multiregional, double-blind, active-controlled, clinical equivalence study, participants with active rheumatoid arthritis (RA) despite treatment with methotrexate were randomized (1:1:2) to intravenous (iv) administration of 8 mg/kg reference tocilizumab (TCZ) every 4 weeks to week 48 (TCZ group), or TCZ to week 24 followed by BAT1806/BIIB800 to week 48 (TCZ to BAT1806/BIIB800 group), or BAT1806/BIIB800 to week 48 (BAT1806/BIIB800 group)1,2. Efficacy in TP2 of the study was evaluated using American College of Rheumatology (ACR) response criteria (ACR20/50/70) and change from baseline in Disease Activity Score on 28 joints (DAS28)2. Pharmacokinetics, safety, and immunogenicity were also evaluated. TP2 analysis also assessed the possible impact of a single treatment switch from TCZ to BAT1806/BIIB800 after week 24, reflecting clinical practice where multiple treatment switches occur. Results from TP2 of the Phase 3 study demonstrated maintenance of comparable clinical efficacy, safety, immunogenicity and PK following switch to BAT1806/BIIB800 from TCZ, in patients with Rheumatoid Arthritis and an inadequate response to methotrexate. "We are pleased to publish the switching data of TOFIDENCE (BAT1806/BIIB800) from reference tocilizumab that strongly supports its biosimilarity to tocilizumab for a long-term period in treating patients with active rheumatoid arthritis and an inadequate response to MTX," said Dr Xiaolei Yang, Executive Medical Director for Rheumatology and Immunology at Bio-Thera. "We hope the study results help allay any concerns over safety and efficacy of TOFIDENCE (BAT1806/BIIB800) for use in patients who were previously treated with reference product." Bio-Thera Solutions, Ltd. and Biogen entered into a commercialization and license agreement to develop, manufacture and commercialize TOFIDENCE (BAT1806/BIIB800) on April 8th, 2021. Biogen has exclusive regulatory, manufacturing and commercial rights to TOFIDENCE (BAT1806/BIIB800) in all countries excluding China (including Hong Kong, Macau and Taiwan). BAT1806/BIIB800 TP2 Analysis Of 621 randomized participants, 577 (92.9%) completed Treatment Period 1 (TP1, Week 0-24) and entered TP2 (TCZ: N = 145 [93.5%]; TCZ to BAT1806/BIIB800: N = 142 [92.2%]; BAT1806/BIIB800: N = 290 [92.9%])1,2. Proportions of ACR20 responders were similar between treatment groups throughout TP2 (87.8%, 90.3%, and 90.4%, respectively, at week 48), as were proportions of ACR50 and ACR70 responders, and reduction in DAS28. Drug trough levels and antidrug antibody incidences were comparable between the treatment groups. Adverse events were balanced across the treatment groups and no fatal events were reported. In TP2, efficacy, safety, immunogenicity, and pharmacokinetic profiles were comparable between the TCZ, TCZ to BAT1806/BIIB800, and BAT1806/BIIB800 groups. These longer-term findings reinforce the results reported for TP1 and further support biosimilarity. 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®5 and BETAGRIN®(Bevifibatide Citrate Injection) in China, and TOFIDENCE/ BAT1806 and Avzivi®6 / Pobevcy®7 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). Bio-Thera Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT1806 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, 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. Leng X, Leszczynski P, Jeka S, et al. Comparing tocilizumab biosimilar BAT1806/ BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial. Lancet Rheumatol. 2024;6(1):e40-50 2. Leng X, Leszczynski P, Jeka S, et al. A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a proposed tocilizumab biosimilar, with a tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 and week 48). Manuscript in review 3. Actemra® / RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp, a member of the Roche Group 4. TOFIDENCE™ is a trademark of Biogen 5. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. 6. Avzivi® is a registered trademark of Sandoz AG 7. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. MEDIA CONTACT – BIO-THERA SOLUTIONS, LTD. Bert E. Thomas IV +1.410.627.1734 [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

Phase 3Clinical ResultLicense out/inDrug Approval

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

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
Metastatic breast cancer	NO	FGK Representative Service GmbH	26 Jul 2024
Metastatic breast cancer	LI	FGK Representative Service GmbH	26 Jul 2024
Platinum-sensitive epithelial ovarian 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
Metastatic Colorectal Carcinoma	US	Bio-Thera Solutions, Ltd.	06 Dec 2023
Metastatic Renal Cell Carcinoma	US	Bio-Thera Solutions, Ltd.	06 Dec 2023
Non-squamous non-small cell lung cancer	US	Bio-Thera Solutions, Ltd.	06 Dec 2023
Ovarian Epithelial Carcinoma	US	Bio-Thera Solutions, Ltd.	06 Dec 2023
Recurrent Glioblastoma	US	Bio-Thera Solutions, Ltd.	06 Dec 2023
Fallopian Tube Carcinoma	CN	Bio-Thera Solutions, Ltd.	21 Apr 2022
Glioblastoma	CN	Bio-Thera Solutions, Ltd.	21 Apr 2022
Ovarian Cancer	CN	Bio-Thera Solutions, Ltd.	21 Apr 2022
Primary peritoneal carcinoma	CN	Bio-Thera Solutions, Ltd.	21 Apr 2022
Uterine Cervical Cancer	CN	Bio-Thera Solutions, Ltd.	21 Apr 2022
Colorectal Cancer	CN	Bio-Thera Solutions, Ltd.	19 Nov 2021
Colorectal Cancer	CN	BeiGene Ltd.	19 Nov 2021
Non-Small Cell Lung Cancer	CN	Bio-Thera Solutions, Ltd.	19 Nov 2021
Non-Small Cell Lung Cancer	CN	BeiGene Ltd.	19 Nov 2021

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
Fallopian Tube Carcinoma	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
Metastatic breast cancer	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
metastatic non-small cell lung cancer	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
Ovarian Epithelial 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 Non-Small Cell Lung 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

Clinical Result

Indication

Phase

Evaluation

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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	(zmlhjrblcc) = iwuzrxsaqm purptgfhzk (lnsavkrlli )	Similar	01 Nov 2023
				EU-bevacizumab	(zmlhjrblcc) = lvywsubcnp purptgfhzk (lnsavkrlli )
NCT04948697 (AdvanTIG-206, ESMO2023) Manual	Phase 2	Advanced Hepatocellular Carcinoma	94	Ociperlimab + Tislelizumab + BAT1706	(mlvxdujyhf) = wlchktlovw aszqseyoie (iuqvcsppyv, 23.7 - 48.7) View more	Positive	21 Oct 2023
				Tislelizumab + BAT1706	(mlvxdujyhf) = wzsngdciix aszqseyoie (iuqvcsppyv, 21.1 - 56.3) View more
NCT03329911 (ASCO2022)	Phase 3	Non-Small Cell Lung Cancer	651	BAT1706 plus paclitaxelBAT1706 plus paclitaxel and carboplatin	(blznhztkhr) = sgqsyxoznd afevamuans (npnnkuivlw ) View more	Positive	02 Jun 2022
				EU-bevacizumab plus paclitaxelEU-bevacizumab plus paclitaxel and carboplatin	(blznhztkhr) = eqcqvsereh afevamuans (npnnkuivlw ) View more
NCT03329911 (CTgov)	Phase 3	Advanced Lung Non-Squamous Non-Small Cell Carcinoma	651	Carboplatin+paclitaxel+EU Avastin® (EU Avastin®)	(lsvzdykmtc) = rrwwmqsxsn pgkfdfslov (bafqksdshh, tloxyipnaj - bteeoxgodj) View more	-	13 Sep 2021
				BAT1706+Carboplatin+paclitaxel (BAT1706)	(lsvzdykmtc) = ktmgexjxyw pgkfdfslov (bafqksdshh, folgpjlhks - zrprxfizdv) View more
NCT03030430 (Pubmed) Manual	Phase 1	-	128	BAT1706	(xazabiwwng) = 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. fsrwiqkelt (emnbbetcdq ) View more	Positive	01 Jun 2019
				US-sourced BEV
Pubmed Manual	Phase 1	-	-	MIL60	(yuoozzbuck) = 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%. libbncuyhh (nwkhzkxpvi ) View more	Positive	01 Oct 2018
				BAT1706

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