A Multicenter,Open-label,Exploratory Study of QL1706 Plus Nab-paclitaxel and Gemcitabine With or Without Bevacizumab as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

This is a multicenter, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine with or without bevacizumab as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer

Start Date15 Apr 2024

Sponsor / Collaborator

Fudan University

CTR20233522 / RecruitingPhase 1/2

JS015联合用药治疗晚期实体瘤患者的安全性、耐受性、药代动力学特征和初步有效性的Ib/II期临床研究

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

主要研究目的：评价JS015联合用药在晚期实体瘤患者中的安全性和耐受性；确定JS015联合用药II期临床研究推荐剂量（RP2D）次要研究目的：评价JS015联合用药在晚期实体瘤患者体内的药代动力学（PK）特征 / 药效动力学特征 / 免疫原性 / 初步有效性；探索性研究目的：探索肿瘤组织中生物标志物(包括DKK1、PD-L1等)与临床疗效的关系

[Translation]

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

Start Date06 Dec 2023

Sponsor / Collaborator

Shanghai Junshi Biosciences Co., Ltd.

CTR20232394 / RecruitingPhase 2

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

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

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

[Translation]

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

Start Date01 Dec 2023

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

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

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

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

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

01 Nov 2023·Cancer medicine

Efficacy and safety of the proposed bevacizumab biosimilar BAT1706 compared with reference bevacizumab in patients with advanced nonsquamous non‐small cell lung cancer: A randomized, double‐blind, phase III study

Article

Author: Ozyilkan, Ozgur ; Chen, Likun ; Dong, Qingfeng ; Cil, Timucin ; Cicin, Irfan ; Chen, Jun ; Shen, Yihong ; Li, Xingya ; Chen, Zhendong ; Zhang, Li ; Fu, Ziyi ; Oleksandr, Kostiuk ; Zhang, Helong ; Igor, Bondarenko ; Liu, Zhihua ; 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 ; Xie, Jianhua ; Li, Shengfeng ; Yang, Yili ; Deng, Chunping ; Wang, Guangying

BACKGROUND:

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

METHOD:

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

RESULT:

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

CONCLUSION:

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

01 Jun 2019·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapyQ3 · MEDICINE

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

Q3 · MEDICINE

Article

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

OBJECTIVE:

BAT1706 is a proposed biosimilar of bevacizumab (BEV). The objective of this phase I clinical trial was to establish pairwise similarity between BAT1706, US-sourced BEV (US-BEV), and EU-sourced BEV (EU-BEV) after a single intravenous (IV) infusion in healthy male subjects.

METHODS:

This phase I clinical trial was a randomized, double-blinded, three-arm study in 128 healthy adult male subjects. Every subject received a single IV infusion of 1 mg/kg of study drug and was subsequently monitored for 14 weeks. Pharmacokinetic, safety, and immunogenicity data were collected from each patient. The primary pharmacokinetic endpoint of this clinical study was area under the concentration curve from time zero to infinity (AUC_0-inf). Biosimilarity of the study drugs was confirmed if the two-sided 90% confidence interval (CI) ratios of the geometric means for the three pairwise comparisons were contained within the range 80-125%. Other pharmacokinetic parameters including area under the concentration curve to time t (AUC_0-t), maximum concentration of drug in plasma (C_max), half-life (t_½), and time to C_max (t_max) were also measured.

RESULTS:

The pharmacokinetic parameters were comparable for the three drug products evaluated. The 90% CI for the AUC_0-inf was 99-112% for BAT1706 versus EU-BEV, 97-110% for BAT1706 vs US-BEV and 92-104% for EU-BEV versus US-BEV comparisons, respectively, demonstrating biosimilarity. There were no significant adverse events attributable to BAT1706, as compared to EU-BEV and US-BEV. BAT1706 demonstrated a similar safety profile to EU-BEV and US-BEV. In addition, no anti-drug antibody positive result was reported for any subject included in the study.

CONCLUSION:

In this study, BAT1706, a proposed biosimilar of BEV, was shown to be highly similar to EU-BEV and US-BEV in terms of pharmacokinetic equivalence, safety, and immunogenicity in healthy subjects after a single IV infusion.

TRIAL REGISTRATION:

NCT03030430.

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

03 Jun 2024

·www.prnewswire.com

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

CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing Avzivi® to the reference product Avastin® GUANGZHOU, China, June 3, 2024 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Avzivi® (bevacizumab), a biosimilar monoclonal antibody referencing AVASTIN®. The CHMP's positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for Avzivi®. "Bio-Thera is committed to developing high-quality biosimilars to expand patient access to important therapeutics like bevacizumab," said Shengfeng Li, CEO of Bio-Thera Solutions. "The positive CHMP recommendation for Avzivi® demonstrates that commitment to patients, healthcare providers, and healthcare systems in Europe." This positive CHMP opinion on Avzivi® was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of Avzivi® was conducted and supports biosimilarity with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of Avzivi® with both the EU and US reference product in healthy volunteers. In addition, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared Avzivi® with the reference product to confirm equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with Advanced Non-Squamous Non-Small Cell Lung Cancer. The totality of evidence demonstrated Avzivi® is a biosimilar of the reference biologic. Bio-Thera and Sandoz entered into a license and commercialization agreement for Avzivi® (BAT1706) in September 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Sandoz will have the right to commercialize the medicine upon approval and successful Marketing Authorization Holder Transfer in the US, Europe*, Canada and selected other countries. *Includes the European Economic Area (EEA), United Kingdom, Switzerland, the Balkan States and selected countries in Eastern Europe. About Avzivi® (bevacizumab) Avzivi® (bevacizumab) is a humanized monoclonal antibody that targets VEGF. It specifically binds to VEGF and blocks the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. The original product code for Avzivi® is BAT1706. In Europe, Avzivi® is under review for marketing authorization for the treatment of 1) metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment, 2) metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including three approved products: QLETLI® in China, and TOFIDENCE™/ BAT1806 and Avzivi® / Pobevcy® in the US and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera). Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to Avzivi® (BAT1706) or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. Avzivi® is a registered trademark of Sandoz AG Avastin® is a registered trademark of Genentech, Inc. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. TOFIDENCE™ is a registered trademark of Biogen MA Inc. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Contact Bio-Thera Solutions, Ltd.: Bert E. Thomas IV +1.410.627.1734 [email protected] SOURCE Bio-Thera Solutions, Ltd

Clinical ResultLicense out/inPhase 3Drug ApprovalImmunotherapy

02 Jun 2024

·www.prnewswire.com

Bio-Thera Solutions Presents Clinical Data for BAT8006 (Folate Receptor-alpha-ADC) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

GUANGZHOU, China, June 2, 2024 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, will present a poster at the 2024 ASCO Annual Meeting entitled "Phase 1 study of BAT8006, a folate receptor α antibody drug conjugate with strong bystander effect, in subjects with advanced solid tumors," that highlights clinical data for the potential best-in-class efficacy and safety of BAT8006 as a potential treatment for ovarian cancer patients and other patients with tumors that express Folate Receptor-alpha. The poster will be available on the company website after the presentation per ASCO rules As of May 8, 2024, 156 subjects with advanced solid tumor were treated in phase 1 study. In 84 and 93mg/m2 dose optimal/expansion cohorts (including all advanced solid tumor subjects), 3.5% (2/57) and 3.9% (2/51) subjects experienced dose reduction, and 5.3% (3/57) and 13.7% (7/51) subjects experienced study drug interruption, respectively. No study treatment related death, and no ILD/pneumonitis and keratitis, uveitis, decreased vision was reported in this study. The major TRAEs were hematological toxicity. The dosages of 84 and 93 mg/m2 were selected in dose optimal study, the incidences of ≥ Grade 3 thrombocytopenia and neutropenia were 9% vs 28% and 19% vs 37%, respectively. To the date of data cut-off, 54 subjects with platinum refractory or platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer were treated with BAT8006 doses of 1.8~2.4 mg/kg and 84/93mg/m2 and have received at least one tumor assessment. Among these patients, 38.9% (21/54) of them had undergone＞3 lines prior systemic treatment. Regardless of the FRα expression, the ORR including unconfirmed partial response (PR) is 37.0% (20/54). In subjects with FRα＜50%, FRα ≥50% and FRα ≥75%, the ORR is 33.3% (7/21), 39.4% (13/33) and 46.7% (7/15), respectively. With a median follow up of 6.5 months (1.3, 18.0 months), the median duration of response (mDOR) was 6.3 months (1.8-16.5months). The median progression free survival (mPFS) was 7.47 months (4.27~NA). The overall survival (OS) rate in 6 months and 1 year were 83.0%, 83.0%. The safety of BAT8006 is favorable with manageable toxicity. No ILD and notable ocular toxicity was reported. The preliminary efficacy of BAT8006 was superior even in all platinum-resistant ovarian cancer patients regardless of the FRα expression. BAT8006 may benefit broad patient population while providing a promising efficacy. Exploration study on endometrial carcinoma, breast cancer and NSCLC is ongoing, the efficacy was demonstrated in these tumor type as well. BAT8006 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. BAT8006 is currently being evaluated in a Phase 2 clinical study for the treatment of ovarian and other Folate Receptor-alpha overexpressed cancers. Clinical study of BAT8006 in combination with BAT1308, a PD-1 mAb, was recently approved by the NMPA. Presentation details are as follows: 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 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 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. TOFIDENCE™ is a registered 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 [email protected] SOURCE Bio-Thera Solutions, Ltd

Phase 1ASCOClinical ResultPhase 2

31 May 2024

·firstwordpharma.com

CHMP nods for haemophilia B gene therapy, chikungunya vaccine lead decisions from May meeting

At its May meeting, the European Medicines Agency's drug advisory body recommended 14 new medicines for approval, including one biosimilar and five generics, while it also backed extended labelling for seven treatments. In addition, the Committee for Medicinal Products for Human Use (CHMP) confirmed a negative opinion following a re-examination, and there were two marketing application withdrawals. All of the decisions can be found detailed below.Positive recommendations on new medicines: Takeda’s enzyme replacement therapy Adzynma (rADAMTS13) for the treatment of children and adult patients with congenital thrombotic thrombocytopenic purpura. SIFI’s Akantior (polyhexanide) for the treatment of acanthamoeba keratitis. CStone Pharmaceuticals’ anti-PD-L1 monoclonal antibody Cejemly (sugemalimab) for the treatment of adults with metastatic non-small-cell lung cancer (NSCLC). Pfizer’s gene therapy Durveqtix (fidanacogene elaparvovec) for the treatment of haemophilia B. AstraZeneca’s Fluenz (influenza vaccine [live attenuated, nasal]) for the prophylaxis of influenza in children and adolescents from 24 months to <18 years of age. Eckert & Ziegler’s GalliaPharm (germanium [68Ge] chloride / gallium [68Ga] chloride) for radiolabelling of various kits used for positron emission tomography (PET) imaging. Valneva’s Ixchiq (chikungunya vaccine [live]) to protect adults against disease caused by Chikungunya virus transmitted to humans by infected mosquitoes. Novo Nordisk’s Zegalogue (dasiglucagon) for the treatment of severe hypoglycaemia in adults, adolescents and children aged six years and over with diabetes mellitus. Bio-Thera Solutions’ biosimilar version of Avastin (bevacizumab), named Avzivi, for the treatment of carcinoma of the colon or rectum, breast cancer, NSCLC, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. Five generic medicines also received a positive opinion: Apexelsin (paclitaxel) for the treatment of metastatic breast cancer; Dasatinib Accord Healthcare (dasatinib) for the treatment of chronic myelogenous leukaemia; and generic versions of pomalidomide from Accord Healthcare, Krka and Zentiva for treatment of multiple myeloma.Positive recommendations on extensions of therapeutic indication: Sanofi/Regeneron’s Dupixent (dupilumab) as an add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils. Bristol Myers Squibb/Pfizer’s Eliquis (apixaban) to include the treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to <18 years of age. Calliditas Therapeutics/Stada’s Kinpeygo (budesonide) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). Mirum Pharmaceuticals’ Livmarli (maralixibat) to include progressive familial intrahepatic cholestasis in patients 3 months of age and older. AbbVie’s Skyrizi (risankizumab) for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy. AstraZeneca’s Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. BeiGene’s Tevimbra (tislelizumab) alone for the treatment of adults with locally advanced or metastatic NSCLC after prior platinum-based therapy; in combination with pemetrexed and platinum‑containing chemotherapy for the first-line treatment of certain adults with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations; and in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of certain adults with squamous NSCLC.Negative opinions on new medicines: The CHMP confirmed its initial recommendation to refuse the granting of a marketing authorisation for Neuraxpharm and Minoryx Therapeutics’ Nezglyal (leriglitazone) for the treatment of cerebral adrenoleukodystrophy.Withdrawal of applications: Cytokinetics pulled a filing seeking approval of Kinharto (omecamtiv mecarbil) for the treatment of adults with symptomatic chronic heart failure and reduced ejection fraction. The decision was based on feedback from the EMA that supporting results were not sufficient to conclude that the benefits of the cardiac myosin activator outweigh the risks. Cytokinetics recently outlined plans to conduct another study of Kinharto. Clinuvel withdrew an application to expand use of Scenesse (afamelanotide) into adolescents with erythropoietic protoporphyria. The drug has been approved in this indication in the EU since 2014 for adults. However, the company determined that it was not possible to provide the comprehensive safety and efficacy data expected by the EMA in the expanded population.

Drug ApprovalVaccineClinical Result

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

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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
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	BeiGene Ltd.	19 Nov 2021
Colorectal Cancer	CN	Bio-Thera Solutions, Ltd.	19 Nov 2021
Non-Small Cell Lung Cancer	CN	BeiGene Ltd.	19 Nov 2021
Non-Small Cell Lung Cancer	CN	Bio-Thera Solutions, Ltd.	19 Nov 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Renal Cell Carcinoma	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
EGFR positive Non-squamous non-small cell lung cancer	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
Metastatic breast cancer	NDA/BLA	EU	Bio-Thera Solutions, Ltd.	30 May 2024
Metastatic Cervical Carcinoma	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
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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04948697 (AdvanTIG-206, ESMO2023) Manual	Phase 2	Advanced Hepatocellular Carcinoma	94	Ociperlimab + Tislelizumab + BAT1706	qoejicdyst(wgxisvjgdo) = zpqxknhoxm bnubcqzciz (kpanymieja, 23.7 - 48.7) View more	Positive	21 Oct 2023
				Tislelizumab + BAT1706	qoejicdyst(wgxisvjgdo) = jhishfkqpe bnubcqzciz (kpanymieja, 21.1 - 56.3) View more
NCT03329911 (ASCO2022)	Phase 3	Non-Small Cell Lung Cancer	651	BAT1706 plus paclitaxelBAT1706 plus paclitaxel and carboplatin	qrnqltvwob(srhfgluuuz) = fbjzzmwsju pdudsszgps (aainfaombr ) View more	Positive	02 Jun 2022
				EU-bevacizumab plus paclitaxelEU-bevacizumab plus paclitaxel and carboplatin	qrnqltvwob(srhfgluuuz) = lcrxbxjopv pdudsszgps (aainfaombr ) View more
NCT03329911 (CTgov)	Phase 3	Advanced Lung Non-Squamous Non-Small Cell Carcinoma	651	Carboplatin+paclitaxel+EU Avastin® (EU Avastin®)	nuwzcpdsxo(wejpukozwg) = pepkkqqlql hpbmmaeqcw (qzxnqxqfvf, clubhoshtl - gguasebeut) View more	-	13 Sep 2021
				BAT1706+Carboplatin+paclitaxel (BAT1706)	nuwzcpdsxo(wejpukozwg) = eksuajtrps hpbmmaeqcw (qzxnqxqfvf, jvisibvjij - ybmkodxorq) View more

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