A Randomized, Double-Blind, Parallel-Group, Phase I Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 s.c. Compared to Actemra® in Healthy Male Participants

The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra.

Start Date02 Jan 2024

Sponsor / Collaborator

Biogen, Inc.

NCT05968508 / Active, not recruitingPhase 1

A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects

This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects.

Start Date29 Aug 2023

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

CTR20232409 / Active, not recruitingPhase 1

一项随机、双盲、单次给药、平行两组BAT1806皮下注射液与雅美罗®在中国健康男性受试者的药代动力学和安全性比对研究

[Translation] A randomized, double-blind, single-dose, parallel two-group comparative study on the pharmacokinetics and safety of BAT1806 subcutaneous injection and Yamiluo® in Chinese healthy male subjects

主要研究目的：比较在中国健康男性受试者中单次皮下注射BAT1806皮下注射液或雅美罗®（欧盟），两药之间药代动力学的相似性。次要研究目的：评价BAT1806皮下注射液、雅美罗®（欧盟）在中国健康男性受试者的临床安全性、耐受性及免疫原性。

[Translation]

The main purpose of the study: To compare the similarity of pharmacokinetics between the two drugs after a single subcutaneous injection of BAT1806 subcutaneous injection or Yamiluo® (EU) in Chinese healthy male subjects. Secondary research purpose: To evaluate the clinical safety, tolerability and immunogenicity of BAT1806 subcutaneous injection and Yamiluo® (EU) in Chinese healthy male subjects.

Start Date29 Aug 2023

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

100 Clinical Results associated with Tocilizumab-bavi

100 Translational Medicine associated with Tocilizumab-bavi

100 Patents (Medical) associated with Tocilizumab-bavi

Literatures (Medical) associated with Tocilizumab-bavi

01 Jan 2024·The Lancet Rheumatology

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

Article

Author: Dong, Qingfeng ; Jeka, Slawomir ; Yang, Xiaolei ; Mitroiu, Marian ; Leng, Xiaomei ; Liu, Huaxiang ; Rezk, Mourad ; Addison, Janet ; Zhou, Yinbo ; Leszczynski, Piotr ; Zeng, Xiaofeng ; Stanislavchuk, Mykola ; Liu, Sheng-Yun ; Gu, Jieruo ; Kilasonia, Lali ; Miakisz, Malgorzata

BACKGROUNDBiosimilars provide an opportunity to address unmet medical need by expanding access to biological treatments. This study aimed to show equivalent efficacy, and comparable safety, immunogenicity, and pharmacokinetic profiles of a proposed tocilizumab biosimilar BAT1806/BIIB800, to reference tocilizumab, in participants with rheumatoid arthritis with an inadequate response to methotrexate.METHODSThis phase 3, multicentre, randomised, double-blind, active-controlled, equivalence study comprised a 24-week initial treatment period (results reported here) and a 24-week secondary treatment period. Participants were recruited at 54 centres across five countries (China, Ukraine, Poland, Georgia, and Bulgaria). Patients with active rheumatoid arthritis with an inadequate response to methotrexate were randomly assigned (1:1:2) to receive reference tocilizumab up to week 48, or reference tocilizumab up to week 24 followed by BAT1806/BIIB800 up to week 48 (the two reference tocilizumab groups were analysed as a single group in this analysis), or BAT1806/BIIB800 up to week 48 (the BAT1806/BIIB800 group), administered by intravenous infusion once every 4 weeks at a starting dose of 8 mg/kg. The primary endpoint was the proportion of participants who had a 20% improvement in American College of Rheumatology criteria (ACR20) at week 12 (for the European Medicines Agency [EMA]) or week 24 (for the US Food and Drug Administration [FDA] and China National Medical Products Administration [NMPA]) using prespecified equivalence margins (95% CI -14·5 to +14·5 [EMA], 90% CI -12·0 to +15·0 [FDA], and 95% CI -13·6 to +13·6 [NMPA]). The International Council for Harmonisation E9(R1) estimand framework, with strategies for addressing intercurrent events, was implemented for the efficacy evaluations with expected differences as per the predefined equivalence margins. This trial is registered at ClinicalTrials.gov (NCT03830203) and EudraCT (2018-002202-31), and is closed to new participants.FINDINGSBetween Dec 19, 2018, and Jan 5, 2021, we randomly assigned 621 participants: 309 to the reference tocilizumab group and 312 to the BAT1806/BIIB800 group. The mean age was 50·5 years (SD 12·0), 534 (86%) were women, 87 (14%) were men, and 368 (59%) were White. For the primary estimands, estimated ACR20 response rates were 64·8% in the reference tocilizumab group and 69·0% in the BAT1806/BIIB800 group (treatment difference 4·1% [95% CI -3·6 to 11·9]) at week 12, and 67·9% in the reference tocilizumab group and 69·9% in the BAT1806/BIIB800 group (treatment difference 1·9% [90% CI -4·0 to 7·9; 95% CI -5·2 to 9·1]) at week 24. All confidence intervals were contained within the predefined equivalence margins. Comparable pharmacokinetic and immunogenicity profiles were observed for the reference tocilizumab and BAT1806/BIIB800 groups. Adverse events were reported by 201 (65%) participants in the reference tocilizumab group and 206 (66%) in the BAT1806/BIIB800 group; 196 (63%) participants in the reference tocilizumab group and 201 (64%) participants in the BAT1806/BIIB800 group reported a treatment-emergent adverse event. Five participants had a fatal event (reference tocilizumab n=1; BAT1806/BIIB800 n=4).INTERPRETATIONBAT1806/BIIB800 showed equivalent efficacy, and comparable safety, immunogenicity, and pharmacokinetic profiles as reference tocilizumab.FUNDINGBio-Thera Solutions and Biogen.

01 Jan 2021·Annals of MedicineQ3 · MEDICINE

A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra ^® ) in Chinese healthy subjects

Q3 · MEDICINE

Article

Author: Zhang, Hong ; Ding, Yanhua ; Fang, Min ; Liu, Jingrui ; Wu, Min ; Li, Cuiyun ; Zhu, Xiaoxue ; Li, Xiaojiao ; Sun, Jixuan

PURPOSEQX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated the tolerance, variability, and pharmacokinetics (PK) of QX003S biosimilar in healthy Chinese male subjects.DESIGNA randomised, double-blind, two-arm, parallel study was performed to examine the bioequivalence of QX003S (8 mg/kg) with that of Actemra® as a reference drug.RESULTSQX003S (N = 40) and Actemra® (N = 40) groups exhibited similar PK properties. The inter-subject variability ranged from 14.95% to 18.78%. The 90% confidence intervals of the ratios for C_max, AUC_0-t andAUC_0-∞ in both groups were within the range of 80-125%. After administration, the number of subjects who tested positive for anti-drug antibodies (ADA) in the QX003S group and Actemra® groups was 6 (14.3%) and 14 (34.1%), respectively. Adverse reactions occurred in 100% and 97.6% subjects in the QX003S and Actemra® groups, respectively. The most common adverse reactions were decrease in fibrinogen level and neutrophil and leukocyte counts.CONCLUSIONThe PK characteristics and immunogenicity exhibited by QX003S were similar to that of the reference product, Actemra®. The safety profile was similar in the two treatment groups with mild-moderate adverse effects.Trial RegistrationThe trial is registered at Chinese Clinical Trial website (http://www.chinadrugtrials.org.cn/index.html#CTR20190002)Key pointsThis was the first clinical report of a new proposed tocilizumab biosimilar, QX003S.This phase-I randomized, controlled study compared pharmacokinetics, variability,immunogenicity, and safety of QX003S vs. the approved tocilizumab product (Actemra@).The results demonstrate bioequivalence between BAT1806 and the reference products (Actemra@), as well as comparable immunogenicity, safety and tolerability profiles.

Frontiers in PharmacologyQ2 · MEDICINE

A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men

Q2 · MEDICINE

ArticleOA

Author: Zhang, Hong ; Zhu, Xiaoxue ; Wei, Haijing ; Yu, Jinchen ; Wang, Hong ; Zhou, Yinbo ; Chen, Hong ; Li, Cuiyun ; Wu, Min ; Ding, Yanhua ; Li, Xiaojiao ; Liu, Jingrui ; Wang, Zhaohe ; Yang, Xiaolei

Objective: The study aimed to explore the bioequivalence of a proposed biosimilar BAT1806 to its reference products marketed in the EU and US (RoActemra-EU and Actemra-US) among healthy Chinese men. The tolerance, immunogenicity, and pharmacokinetics (PK) of the three drugs were also investigated.Methods: In this randomized, double-blind, single-dose, three-arm, parallel study, a single-dose of 4 mg/kg of the reference products, or the biosimilar was administered to the participants. The participants were followed up for 57 days, and PK, immunogenicity, and tolerance evaluations were completed during this period.Results: The PK parameters were similar in all three groups: BAT1806 (n = 45), RoActemra-EU (n = 42), and Actemra-US (n = 42). The 90% confidence intervals (CIs) for the ratios of Cmax, AUC0–t and AUC0–∞ were 86.90–104.41% for BAT1806 vs. RoActemra-EU, 91.70–106.15% for BAT1806 vs Actemra-US, and 90.04–105.53% for Actemra-US vs RoActemra-EU. For all comparisons, the 90% CIs for the Cmax, AUC0–t, and AUC0–∞ were within the predefined bioequivalence limit of 80.00–125.00%. The intersubject variability ranged from 14.5% to 21.5%, which was considerably low. Among the participants, 19 (42.2%), 10 (23.8%), and 12 (28.6%) from the BAT1806, RoActemra-EU, and Actemra-US groups were, respectively, found to be positive for anti-drug antibodies, while 14 (31.1%), nine (21.4%), and 12 (28.6%) were positive for neutralizing antibodies. Nevertheless, these antibodies did not affect the drug concentrations, and the outcomes in the bioequivalence tests were similar after sensitivity analysis. Treatment-related and treatment-emergent adverse events (TEAEs) were recorded in 27, 34, and 32 participants in the BAT1806, RoActemra-EU, and Actemra-US groups, respectively. The most common treatment-related adverse events observed were a decrease in neutrophil, and white blood cell counts.Conclusion: The PK characteristics of BAT1806 were similar to those of the reference products, RoActemra-EU and Actemra-US. Both BAT1806 and the reference products exhibited low intersubject variability and similar safety profiles.Clinical trial registration number:http://www.chinadrugtrials.org.cn/index.html, CTR20180039; https://clinicaltrials.gov/NCT03606876

News (Medical) associated with Tocilizumab-bavi

26 Apr 2024

·www.globenewswire.com

Biogen Receives Positive CHMP Opinion for TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA®

CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA® April 25, 2024 -- Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE™ (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA®1. The intravenous formulation of TOFIDENCE has been recommended for approval for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for TOFIDENCE. If a marketing authorization is granted by the EC, TOFIDENCE will be an addition to the existing biosimilars portfolio of three widely prescribed anti-TNF biosimilars commercialized by Biogen in Europe: BENEPALI (etanercept), IMRALDI (adalimumab) and FLIXABI (infliximab), offering an extension to the cost-effective treatment options with an additional mechanism of action. “The positive CHMP recommendation for TOFIDENCE marks another positive step toward helping more people with inflammatory and immune mediated conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “Positive CHMP recommendation for TOFIDENCE is testament to our continuing efforts to develop and deliver high-quality and proven biologic medicines to more patients, healthcare providers and healthcare systems in Europe.” This positive CHMP opinion on TOFIDENCE 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 TOFIDENCE was conducted and supports equivalence 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 TOFIDENCE with both the EU and US reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared TOFIDENCE with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate. The totality of evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic. Biogen and Bio-Thera entered into a commercialization and licensing agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Under the agreement, TOFIDENCE, developed by Bio-Thera, is to be commercialized by Biogen in the European Union. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan). TOFIDENCE (tocilizumab), an inteleukin-6 receptor antagonist, is a treatment developed as a biosimilar to the reference product ROACTEMRA. TOFIDENCE is indicated for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. References: RoActemra® is a registered trademark of Genentech, Inc. The content above comes from the network. if any infringement, please contact us to modify.

License out/inDrug Approval

25 Mar 2024

·www.biospace.com

Bio-Thera Solutions Receives IND Clearance From US FDA to Initiate a Phase II Study for BAT8006, an Innovative Antibody Drug Conjugate Targeting Folate Receptor α

GUANGZHOU, China, March 25, 2024 /PRNewswire/ -- Bio-Thera Solutions, Ltd. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced receiving IND clearance from the US FDA for a phase II Study for BAT8006, an innovative Antibody Drug Conjugate (ADC) targeting Folate Receptor α (FRα). The phase II study will investigate the use of BAT8006 for the treatment of subjects with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. FRα is a folic acid-binding protein located on cell membranes that is overexpressed in a variety of solid tumors such as ovarian, lung, breast cancer, etc., but has a limited distribution and a lower level of expression in normal tissues. This differential expression makes FRα an attractive target for cancer drug development. BAT8006 is developed using Bio-Thera's proprietary anti-FRα antibody and proprietary ADC linker-payload combination that includes a systemically stable and cleavable linker and a small molecule topoisomerase I inhibitor. Preclinical studies have shown that BAT8006 demonstrates good stability and safety along with strong anti-tumor activity. The small molecule topoisomerase I inhibitor payload carried by BAT8006 has a strong cell membrane penetration ability, which enables the payload to kill nearby cancer cells after the cancer cells initially targeted by the ADC are killed. This bystander effect gives BAT8006 the potential to effectively overcome the heterogeneity of the tumor. Currently, a phase I study of BAT8006 is ongoing in China. In that trial, the dose escalation study has completed and the dose expansion and dose optimization study in a series of tumors are ongoing. The preliminary data indicated that BAT8006 could potentially be a best-in-class drug. Updated clinical data will be presented at future academic conference. 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 of 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 BAT8006 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, for example, the development processes could be lengthy and high in vitro activity may not translate to desired results in vivo or successful 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. TOFIDENCETM is a trademark of Biogen MA, Inc. 3. AVZIVI® is a registered trademark of Sandoz AG 4. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Contact Bio-Thera Solutions, Ltd.: Bert E. Thomas IV +1.410.627.1734 bethomas@bio-thera.com

Phase 1INDPhase 2ADC

18 Mar 2024

·www.prnewswire.com

Bio-Thera Solutions Partners with SteinCares to Market Two Biosimilars in LATAM

GUANGZHOU, China and SAN JOSÉ, Costa Rica, March 18, 2024 /PRNewswire/ -- Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars, and SteinCares, one of Latin America's leading specialty healthcare companies, announced today a new licensing agreement for two biosimilars under which SteinCares will have exclusive rights to distribute and market Bio-Thera's pharmaceuticals in Brazil and the rest of the 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. "Partnering with Bio-Thera represents a step forward in our mission to create healthcare opportunities for patients in Latin America. This alliance strengthens our position as regional leaders in biosimilars, with seven products already launched in this market, making us the preferred partner for global biotech and pharmaceutical companies entering the Latin American market. Together, we are committed to helping patients access safe, innovative, and affordable treatments, while upholding the highest ethical standards," said Mitchell Waserstein, CEO of SteinCares. "Bio-Thera is pleased to partner with SteinCares to commercialize the two biosimilars in Brazil and LATAM," said Dr. Shengfeng Li, CEO of Bio-Thera. "We look forward to bringing these important products to patients in Central and South America in collaboration with SteinCares." 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 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 products and businesses 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, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful 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. TOFIDENCETM is a trademark of Biogen MA, Inc. 3. AVZIVI® is a registered trademark of Sandoz AG 4. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. For more information, please contact: Victoria Carrillo Marketing and Corporate Communications Manager, SteinCares [email protected], +54 911 6367 1612 Bert E. Thomas IV Senior Vice President Business Development, Bio-Thera Solutions [email protected], +1.410.627.1734 SOURCE Bio-Thera Solutions, Ltd

License out/in

100 Deals associated with Tocilizumab-bavi

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Polyarticular Juvenile Idiopathic Arthritis	US	Biogen MA, Inc.	29 Sep 2023
Cytokine Release Syndrome	CN	Bio-Thera Solutions, Ltd.	16 Jan 2023
Rheumatoid Arthritis	CN	Bio-Thera Solutions, Ltd.	16 Jan 2023
Systemic onset juvenile chronic arthritis	CN	Bio-Thera Solutions, Ltd.	16 Jan 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	NDA/BLA	EU	Biogen Netherlands BV	25 Apr 2024
Polyarticular Juvenile Idiopathic Arthritis	NDA/BLA	EU	Biogen Netherlands BV	25 Apr 2024
Systemic onset juvenile chronic arthritis	NDA/BLA	EU	Biogen Netherlands BV	25 Apr 2024
Juvenile Arthritis	NDA/BLA	US	Bio-Thera Solutions, Ltd.	09 Dec 2022
Rheumatoid Arthritis	NDA/BLA	US	Bio-Thera Solutions, Ltd.	09 Dec 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03830203 (ACR2022) Manual	Phase 3	Rheumatoid Arthritis	621	BAT1806 (BAT1806 up to Week 48)	(dssaceegmg) = jidhcwmusn axsuuiuyfg (nudecatyvy ) View more	Similar	12 Sep 2022
				BAT1806 (TCZ up to Week 24 followed by BAT1806 from Week 24 to Week 48)	(dssaceegmg) = fjewynzctw axsuuiuyfg (nudecatyvy ) View more

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