[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)

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

Abstract:

Background:

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

Methods:

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

Results:

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

Conclusion:

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

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 ; Deng, Chunping ; Yang, Yili ; Wang, Guangying

BACKGROUND:

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

METHOD:

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

RESULT:

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

CONCLUSION:

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

01 Oct 2018·Cancer chemotherapy and pharmacologyQ4 · MEDICINE

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

Q4 · MEDICINE

Article

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

OBJECTIVE:

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

METHODS:

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

RESULTS:

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

CONCLUSIONS:

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

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

24 Dec 2024

·www.prnewswire.com

Bio-Thera Solutions Partners with Tabuk Pharmaceuticals to Commercialize BAT2206, a Stelara® (Ustekinumab) Biosimilar in Saudi Arabia

GUANGZHOU, China, Dec. 24, 2024 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced the company has partnered with Tabuk Pharmaceutical Manufacturing Company (a fully-owned subsidiary of Astra Industrial Group), a leading pharmaceutical company in the Middle East and North Africa (MENA) region, for BAT2206, its ustekinumab biosimilar, under which Tabuk will have exclusive rights to manufacture, distribute and market the drug in Saudi Arabia. Continue Reading Bio-Thera Solutions Partners with Tabuk Pharmaceuticals to Commercialize BAT2206, a Stelara® (Ustekinumab) Biosimilar in Saudi Arabia BAT2206 is a proposed biosimilar to Jansen's Stelara®. Bio-Thera has filed for regulatory approval of BAT2206 with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). This partnership will leverage Tabuk's strong local presence, sales and marketing capabilities in Saudi Arabia. Under this agreement Tabuk Pharmaceuticals will hold the marketing authorization and will be responsible to manufacture, register, import, and promote BAT2206 in Saudi Arabia. Bio-Thera will be responsible for full development, and commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China. "Bio-Thera is pleased to establish a partnership with Tabuk to commercialize our ustekinumab biosimilar program in Saudi Arabia", said Dr. Shengfeng Li, CEO of Bio-Thera. "Tabuk is a leading pharmaceutical company in the MENA region and is a great partner to ensure patients in Saudi Arabia have the best access to BAT2206." Ismail Shehada, CEO of Tabuk Pharmaceuticals "We are excited to announce our partnership with Bio-Thera that will enable us to deliver unique and specialized health solutions aimed at enhancing the well-being of people in Saudi Arabia. We are confident that this partnership supports our efforts to manufacture and localize biosimilar products in the region and strengthen our market leading position in line with our strategy. This also stands as a commitment from our side to support the 2030 vision of Saudi Arabia through localizing biopharmaceutical products in the Kingdom." About BAT2206 (ustekinumab) BAT2206 is a proposed biosimilar to Jansen's 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 EU, Stelara® is currently approved for the treatment of 1) moderate to severe plaque psoriasis in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, 2) active psoriatic arthritis, alone or combined with methotrexate, in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs), 3) moderately to severely active Crohn's disease in adults whose condition has not improved enough with other treatments for Crohn's disease or who cannot receive such treatments, 4) moderately to severely active ulcerative colitis in adults whose condition has not improved enough with other treatments for ulcerative colitis or who cannot receive such treatments. 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 Tabuk Pharmaceutical Manufacturing Company Tabuk Pharmaceutical Manufacturing Company is a leading Saudi pharmaceutical company with a regional presence in the Middle East and North Africa. Tabuk Pharmaceuticals develops, manufactures, markets and distributes various branded generics, in addition to manufacturing pharmaceutical products for renowned international partners at its manufacturing sites in Saudi Arabia, as part of its continuous efforts to cover the needs of patients by providing high quality medicines. Tabuk Pharmaceuticals is a major player in the pharmaceutical sector not only in the Kingdom of Saudi Arabia, but also in the Middle East and North Africa, thanks to its four state-of-the-art manufacturing sites located in Tabuk and Dammam in the Kingdom, as well as in Sudan and Algeria, and orchestrated by a team of more than 2,400 employees. Tabuk pharmaceuticals reaches patients in 18 countries in the Middle East and Africa, in addition to futuristic plans to expand its presence in the region. 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. 1. Stelara® is a registered trademark of Johnson & Johnson Corporation 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] Tabuk Pharmaceutical Manufacturing Company Wisam Al Khatib [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

Drug ApprovalLicense out/in

16 Dec 2024

·www.prnewswire.com

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

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

License out/in

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

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

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Indication	Country/Location	Organization	Date
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
EGFR positive Non-squamous non-small cell lung cancer	EU	FGK Representative Service GmbH	26 Jul 2024
EGFR positive Non-squamous non-small cell lung cancer	IS	FGK Representative Service GmbH	26 Jul 2024
EGFR positive Non-squamous non-small cell lung cancer	LI	FGK Representative Service GmbH	26 Jul 2024
EGFR positive Non-squamous non-small cell lung cancer	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 Cervical Carcinoma	EU	FGK Representative Service GmbH	26 Jul 2024
Metastatic Cervical Carcinoma	IS	FGK Representative Service GmbH	26 Jul 2024
Metastatic Cervical Carcinoma	LI	FGK Representative Service GmbH	26 Jul 2024
Metastatic Cervical Carcinoma	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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 3	US	BeiGene Ltd.	19 Dec 2019
Advanced cancer	Phase 3	CN	BeiGene Ltd.	19 Dec 2019
Advanced cancer	Phase 3	JP	BeiGene Ltd.	19 Dec 2019
Advanced cancer	Phase 3	AU	BeiGene Ltd.	19 Dec 2019
Advanced cancer	Phase 3	FR	BeiGene Ltd.	19 Dec 2019
Advanced cancer	Phase 3	IT	BeiGene Ltd.	19 Dec 2019
Advanced cancer	Phase 3	MY	BeiGene Ltd.	19 Dec 2019
Advanced cancer	Phase 3	NZ	BeiGene Ltd.	19 Dec 2019
Advanced cancer	Phase 3	PL	BeiGene Ltd.	19 Dec 2019
Advanced cancer	Phase 3	KR	BeiGene Ltd.	19 Dec 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

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	ohyjvinslo(mouwtampoo) = fdgmmmdudc ertyfhwlhq (yijpswxzxc )	Similar	01 Nov 2023
				EU-bevacizumab	ohyjvinslo(mouwtampoo) = eggfacgtwu ertyfhwlhq (yijpswxzxc )
NCT04948697 (AdvanTIG-206, ESMO 12023 \| ESMO 22023) Manual	Phase 2	Advanced Hepatocellular Carcinoma	94	Ociperlimab + Tislelizumab + BAT1706	ppnlgilanc(jemyucvphs) = pniorwlarn ljxhemqqrw (pgomjxxuma, 23.7 - 48.7) View more	Positive	21 Oct 2023
				Tislelizumab + BAT1706	ppnlgilanc(jemyucvphs) = xrsefaenjt ljxhemqqrw (pgomjxxuma, 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®)	vfucmwppne(jiromoyqmc) = jkgvntaejh jdcketdtjl (kjrjfttmww, otvnnjuuau - khwdphnodb) View more	-	13 Sep 2021
				BAT1706+Carboplatin+paclitaxel (BAT1706)	vfucmwppne(jiromoyqmc) = erybfbokba jdcketdtjl (kjrjfttmww, legayrtuoa - bbnfivvvqr) View more
NCT03030430 (Pubmed 1 \| Pubmed 2 \| BioDrugs) Manual	Phase 1	-	128	BAT1706	vzjwupfvkd(seyblboqtk) = 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. vdoljpeqwi (rxseesskls ) View more	Positive	01 Jun 2019
				US-sourced BEV
Pubmed Manual	Phase 1	-	-	MIL60	elwugdlott(pyqsbfhogl) = 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%. xsuyxehcjw (psiwjpgejs ) View more	Positive	01 Oct 2018
				BAT1706

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