A Multicenter, Randomized, Double-blind Phase III Clinical Study Comparing the Efficacy and Safety of BAT5906 and Ranibizumab (Lucentis®) in Patients With Neovascular Age-related Macular Degeneration

A non-inferiority design was used to conduct a randomized, double-blind, parallel-controlled multi-center study. A total of 488 subjects with neovascular (wet) age-related macular degeneration (w-AMD) were planned to be enrolled. Qualified subjects were divided into experimental group and control group in a 1:1 ratio, and stratified randomized according to the letter value of baseline period and whether the eyes had received anti-VEGF drug treatment. The experimental group received BAT5906 injection. The control group received Lucentis® treatment. Only 1 eye per subject was included in this study.

Start Date28 Jul 2022

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

CTR20221092 / Active, not recruitingPhase 3

比较BAT5906和雷珠单抗（Lucentis®）在新生血管性年龄相关性黄斑变性患者中有效性和安全性的多中心、随机、双盲的III期临床研究

[Translation] A multicenter, randomized, double-blind Phase III clinical study comparing the efficacy and safety of BAT5906 and Lucentis® in patients with neovascular age-related macular degeneration

主要目的比较BAT5906 和雷珠单抗（Lucentis®）在新生血管性年龄相关性黄斑变性患者中的有效性次要目的 1. 比较BAT5906 和雷珠单抗（Lucentis®）在新生血管性年龄相关性黄斑变性患者中的安全性； 2. 研究BAT5906注射液的免疫原性。

[Translation]

Primary Objective To compare the efficacy of BAT5906 and Lucentis® in patients with neovascular age-related macular degeneration Secondary Objectives 1. To compare the safety of BAT5906 and Lucentis® in patients with neovascular age-related macular degeneration; 2. To study the immunogenicity of BAT5906 injection.

Start Date07 Jul 2022

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

CTR20200668 / CompletedPhase 1

BAT5906注射液在糖尿病性黄斑水肿患者玻璃体内两种剂量多次给药的安全性和有效性Ib/IIa期临床研究

[Translation] Phase Ib/IIa clinical study on the safety and efficacy of BAT5906 injection in the vitreous of patients with diabetic macular edema after multiple administration of two doses

主要目的：评价BAT5906不同剂量和不同固定给药方式按需给药治疗糖尿病性黄斑水肿患者的有效性和安全性。次要目的： 1. 探索BAT5906在糖尿病性黄斑水肿患者中玻璃体内首次和多次给药的药代动力学特征。 2. 研究BAT5906注射液的免疫原性。 3. 研究BAT5906玻璃体注射治疗糖尿病性黄斑水肿患者对外周VEGF影响。 4. 评价给药次数与疗效的关系。

[Translation]

Primary objectives: To evaluate the efficacy and safety of BAT5906 in different doses and different fixed dosing methods for the treatment of patients with diabetic macular edema on demand. Secondary objectives: 1. To explore the pharmacokinetic characteristics of BAT5906 in patients with diabetic macular edema after first and multiple intravitreal administration. 2. To study the immunogenicity of BAT5906 injection. 3. To study the effect of BAT5906 intravitreal injection on peripheral VEGF in patients with diabetic macular edema. 4. To evaluate the relationship between the number of dosing and efficacy.

Start Date01 Dec 2020

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

100 Clinical Results associated with Recombinant humanized anti-VEGF monoclonal antibody(Bio-Thera Solutions)

100 Translational Medicine associated with Recombinant humanized anti-VEGF monoclonal antibody(Bio-Thera Solutions)

100 Patents (Medical) associated with Recombinant humanized anti-VEGF monoclonal antibody(Bio-Thera Solutions)

Literatures (Medical) associated with Recombinant humanized anti-VEGF monoclonal antibody(Bio-Thera Solutions)

27 May 2023·BMC pharmacology & toxicology

A phase I study comparing the biosimilarity of the pharmacokinetics and safety of recombinant humanized anti-vascular endothelial growth factor monoclonal antibody injection with Avastin^® in healthy Chinese male subjects.

Article

Author: Zhao, Xiangdi ; Liu, Yuanyuan ; Ding, Jiaxiang ; Ding, Yuzhou ; Xu, Yuanyuan ; Xie, Jing ; Wang, Ying ; He, Cuixia ; Liu, Bingyan ; Shan, Rongfang ; Zhu, Minhui ; Zhou, Huan ; Zhu, Xingyu ; Li, Hongtao ; Xie, Yunqiu ; Su, Yue

BACKGROUND:

The biosimilar landscape for malignancies continues to grow, with several biosimilars for reference product bevacizumab currently available. Bevacizumab has been shown to be well tolerated; however, the safety of recombinant humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody injection remains unclear. This study aimed to compare the pharmacokinetics (PK), safety, and immunogenicity of recombinant humanized anti-VEGF monoclonal antibody injection to that of Avastin® in healthy Chinese male volunteers.

METHODS:

A randomized, double-blind, single-dose, and parallel-group study was performed on 88 healthy men who randomly (1:1) received either the test drug as an intravenous infusion of 3 mg/kg or Avastin®. The primary PK parameter was area under the serum concentration-time curve (AUC) from time zero to last quantifiable concentration (AUC_0-t). Secondary endpoints included maximum observed serum concentration (C_max), AUC from 0 extrapolated to infinity (AUC_inf), safety, and immunogenicity. Serum bevacizumab concentrations were measured using a validated enzyme-linked immunosorbent assay (ELISA).

RESULTS:

The baseline characteristics were similar among the two groups. The 90% confidence interval (CI) for the geometric mean ratio of AUC_0-t, C_max and AUC_inf between the test group and reference group were 91.71%-103.18%, 95.72%-107.49% and 91.03%-103.43%, respectively. These values were within the predefined bioequivalence margin of 80.00%-125.00%, demonstrating the biosimilarity of the test drug and Avastin®. Eighty-one treatment-emergent adverse events were reported, with a comparable incidence among the test group (90.91%) and the reference group (93.18%). No serious adverse events were reported. The incidence of ADA antibodies in the two groups was low and similar.

CONCLUSION:

In healthy Chinese men, PK similarity of recombinant humanized anti-VEGF monoclonal antibody injection to Avastin® was confirmed, with comparable safety and immunogenicity. Subsequent studies should investigate recombinant humanized anti-VEGF monoclonal antibody injection in patients setting.

TRIAL REGISTRATION:

Registered 08/10/2019, CTR20191923.

01 Feb 2023·Clinical and experimental nephrology

Comparison of outcomes after plasma therapy or eculizumab in pediatric patients with atypical hemolytic uremic syndrome

Article

Author: Matsumura, Hideki ; Shimono, Akihiko ; Yamazaki, Satoshi ; Ashida, Akira ; Fujii, Yuko

BACKGROUND:

Atypical hemolytic uremic syndrome (aHUS) is an ultra-rare and life-threatening disease. For decades, plasma therapy was used to manage patients with aHUS. Since eculizumab, a recombinant humanized anti-C5 monoclonal antibody, was approved for treatment of aHUS, it has been used to treat patients with aHUS. Here, we examined the effectiveness of eculizumab and plasma therapy, respectively in the treatment of pediatric patients with aHUS.

METHODS:

Data were collected from questionnaires sent to 75 institutions known to be treating thrombotic microangiopathy (TMA).

RESULTS:

A total of 24 patients were evaluable, in which no recurrence of TMA was reported at last observation. There were four therapy groups: two patients receiving supportive therapy, one receiving plasma therapy alone, 17 switching from plasma therapy to eculizumab (therapy switched), and four receiving eculizumab alone. Among 17 patients of therapy-switched group, only one patient achieved complete remission at the end of plasma therapy, 15 patients achieved complete remission after eculizumab initiation, and two patients reached end-stage renal disease. Adverse events were reported in nine cases; among these, meningococcal infection, anaphylaxis, and eculizumab-related infusion reaction were reported among those treated with eculizumab.

CONCLUSION:

This study provided substantial evidence from a Japanese population that the conversion from plasma therapy to eculizumab therapy should be considered in patients with aHUS who show an incomplete response to plasma therapy. In addition, although no new safety events were detected, careful attention should be paid to meningococcal infection, eculizumab-related infusion reactions and allergic reactions with administration of eculizumab.

01 Feb 2023·Anticancer research

Real-world Efficacy and Safety of Atezolizumab Plus Bevacizumab, Paclitaxel and Carboplatin for First-line Treatment of Japanese Patients With Metastatic Non-squamous Non-small Cell Lung Cancer

Article

Author: Tan, Ibun ; Igata, Fumiyasu ; Otsuka, Rikako ; Sasaki, Tomoya ; Harada, Taishi ; Ikeda, Takato ; Kinoshita, Eriko ; Inoue, Hiroyuki ; On, Rintaro ; Ebi, Noriyuki ; Hirano, Ryosuke ; Aoyama, Takashi ; Osaki, Yusuke ; Ikeuchi, Nobumitsu ; Fujita, Masaki ; Nakao, Akira ; Kawabata, Toshiaki

BACKGROUND/AIM:

Platinum-doublet chemotherapy plus either programmed cell death 1 (PD-1) or programmed death ligand 1 (PD-L1) checkpoint inhibitors has been reported to improve the survival of patients with advanced non-small cell lung cancer (NSCLC). The IMpower150 study showed significant improvements in progression-free survival and overall survival with atezolizumab in combination with bevacizumab, a humanized anti-VEGF monoclonal antibody, paclitaxel, and carboplatin (ABCP therapy) in chemotherapy-naïve patients with non-squamous NSCLC. We herein report the efficacy and safety of ABCP therapy in Japanese patients with non-squamous NSCLC in clinical practice.

PATIENTS AND METHODS:

We retrospectively evaluated the efficacy and safety of ABCP therapy in 30 patients treated at our hospital from February 2019 to December 2021.

RESULTS:

The median age of patients was 69 years, 24 (80.0%) patients were male, 29 (96.7%) patients had a performance status of 0 or 1, 28 (93.3%) patients had adenocarcinoma histology, and 7 (23.3%) patients had epidermal growth factor receptor mutations. Evaluation of the PD-L1 tumor proportion score (TPS) showed that 12 (40.0%), 8 (26.7%), and 6 (20.0%) patients had a TPS of ≥50%, 1% to 49%, and <1%, respectively. The objective response rate of the intention-to-treat wild-type population was 73.9%, and the median progression-free survival was 8.3 months. Immune checkpoint inhibitor (ICI)-induced pneumonitis occurred in one (3.3%) patient.

CONCLUSION:

ABCP therapy for Japanese non-squamous NSCLC patients in a clinical setting achieved a high response rate with low incidence of ICI-induced pneumonitis equivalent to those observed in IMpower150 study.

News (Medical) associated with Recombinant humanized anti-VEGF monoclonal antibody(Bio-Thera Solutions)

12 May 2021

·www.globenewswire.com

Diabetic Macular Edema Pipeline Sees Expansion Owing to Key

Los Angeles, USA, May 12, 2021 (GLOBE NEWSWIRE) -- Diabetic Macular Edema Pipeline Sees Expansion Owing to Key Players, Key Therapies and Research & Programmes Diabetic Macular Edema Pipeline Insight report offers deep insights into emerging Diabetic Macular Edema pipeline therapies with an analysis of 50+key players and 50+key therapies. DelveInsight’s ‘Diabetic Macular Edema (DME) Pipeline Insights’ report provides a holistic view of the DME pipeline therapies that are under development in pre-clinical as well as clinical stages of development and growth prospects across the Diabetic Macular Edema landscape. Key takeaways of the Diabetic Macular Edema Pipeline report: Got queries? Want to know more? Request for Sample @ Diabetic Macular Edema Emerging Therapies and Forecast Diabetic Macular Edema: Overview Macular edema is a condition characterized by the build-up of fluid in the macula, an area in the center of the retina. The excess build-up results in the swelling and thickening of the macula leading to distorted vision. It is referred to as Diabetic Macular Edema (DME) as it is caused by a complication of diabetes called diabetic retinopathy. For more information on emerging drugs, visit Diabetic Macular Edema Pipeline Analysis The DME pipeline report proffers a rich coverage of the therapeutics by development stage, product type, and route of administration, molecule type, and MOA type for Diabetic Macular Edema across the complete product development cycle, including all clinical and non-clinical stages. Diabetic Macular Edema Pipeline Drugs Request for Sample to know which drug is expected to outperform @ Diabetic Macular Edema Pipeline Analysis, Key Companies, and Futuristic Trends Diabetic Macular Edema Therapeutics Assessment The Diabetic Macular Edema Pipeline report proffers exhaustive insights into active pipeline assets segmented by Stage, Product Type, Route of Administration, Molecule Type, Target, and Indications of various drugs. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets By Stage and Route of AdministrationBy Stage and Product Type Get in touch with our Business executive for Rich and Deep Market Assessment and Consulting Solutions The Diabetic Macular Edema pipeline report puts on the table business opportunities, threats, prospective collaborations, strong competitors, growth strategies, and failed as well as discontinued drugs that will help the clients to keep a track of the ongoing trials, recent happenings in the DME domain. Scope of the Report Coverage: GlobalKey Players: Kodiak Sciences, Novartis Pharmaceuticals, Adverum Biotechnologies, KalVista Pharmaceuticals, Momenta Pharmaceuticals, Roche, Regeneron Pharmaceuticals, Exonate, Opthea Limited, SciFluor Life Sciences, AsclepiX Therapeutics, RemeGen, UNITY Biotechnology, Celltrion, Bio-Thera Solutions, Ripple Therapeutics, GrayBug Vision, Oxurion, Aerie Pharmaceuticals, GlaxoSmithKline, Boehringer Ingelheim, and Apexian Pharmaceuticals among others.Key Diabetic Macular Edema Pipeline Therapies: KSI 301, LKA651, ADVM-022, KVD001, MYL-1701P, Faricimab, REGN 910-3, EXN407, OPT-302, SF0166, AXT107, Brolucizumab, RC28-E, UBX1325, CT-P42, BAT5906, IBE-814, GB-102, THR-149, AR-13503, GSK2798745, BI 1026706, and APX3330 among others. Reach out how novel therapies are transforming the DME landscape @ Diabetic Macular Edema Pipeline Table of Contents Visit to know more of what’s covered @ Diabetic Macular Edema Emerging Therapies Related Reports Chronic Pain Associated With Painful Diabetic Neuropathy MarketDelveInsight's "Chronic Pain Associated with Painful Diabetic Neuropathy - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Foot Ulcers MarketDelveInsight’s ‘Diabetic Foot Ulcer (DFU) - Market Insights, Epidemiology, and Market Forecast—2030’ report. Diabetic Foot MarketDelveInsight's "Diabetic Foot - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Eye Disease MarketDelveInsight's "Diabetic Eye Disease - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Ketoacidosis MarketDelveInsight's "Diabetic Ketoacidosis (DKA) - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Gastroparesis Market SizeDelveInsight’s ‘Diabetic Gastroparesis (DGp) - Market Insights, Epidemiology and Market Forecast-2030’ report offers a detailed analysis of therapies and key pharmaceutical companies including Allergan Evoke Pharma Inc., Theravance Biopharma, Censa Pharmaceuticals, CinDome Pharma, Takeda (Millennium Pharmaceuticals, Inc.), Bird Rock Bio, and others. Diabetic Kidney Disease MarketDelveInsight's "Diabetic Kidney Disease (DKD) - Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts Understanding The Increasing Prevalence Of Diabetes And Its ComplicationsDiabetic Peripheral Neuropathy Market Landscape Diabetic Peripheral Neuropathy Medications About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

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09 Mar 2021

·www.globenewswire.com

Los Angeles, USA , March 09, 2021 (GLOBE NEWSWIRE) -- Age-related Macular Degeneration Pipeline Analysis of 70+ Key Companies and 70+ Key Therapeutic Products DelveInsight anticipates the launch of ABP 938, KSI-301, OPT-302, and RGX-314 in the Age-related Macular Degeneration Pipeline as the most promising therapies. DelveInsight’s Age-related Macular Degeneration (AMD) Pipeline Insights report provides a comprehensive outlook of the pipeline therapies that are in different clinical and preclinical stages of development, their launch, and how the market is expected to transform in the aftermath across the AMD domain. The AMD Pipeline Analysis report offers a 360° view of the therapeutics landscape by development stage, product type, route of administration, molecule type, and MOA for Age-related Macular Degeneration emerging therapies. The Age-related Macular Degeneration Pipeline report lays down the business opportunities, threats, prospective collaborations, strong competitors, and growth strategies. Some of the key takeaways from the Age-related Macular Degeneration Pipeline report: Request for Sample @ Age-related Macular Degeneration Pipeline Insights Age-related Macular Degeneration is a condition that impairs a small central area, macula, located at the center of the retina. It affects a person's central vision due to the formation of distorted, dark spots that gradually progress, thus, affecting the tasks like reading, and diving. Genetic mutations in- and around several complement gene systems, including the CFH gene, contribute to the risk of developing AMD. Further, changes on the long (q) arm of chromosome 10 in a region known as 10q26 are also associated with an increased risk of Age-related Macular Degeneration. Reach out for rich pipeline insights @ Age-related Macular Degeneration Drug Pipeline Age-related Macular Degeneration Drug Profiles KSI 301: Kodiak Sciences KSI 301 is an antibody biopolymer conjugate for the treatment of retinal vascular diseases. It is a novel anti-VEGF biologic designed to rapidly inhibit VEGF and provide extended durability of action to reduce the burden of frequent anti-VEGF injections. Kodiak Sciences is currently evaluating KSI 301 in Phase II/ III trial to evaluate its efficacy and safety versus Aflibercept in patients with Neovascular (Wet) Age-Related Macular Degeneration. Kodiak Sciences initiated a randomized, double-masked, active comparator-controlled, multi-center study (NCT04049266) to investigate the efficacy and safety of repeated intravitreal administration of KSI-301 in subjects with Neovascular (Wet) Age-related Macular Degeneration. For more information on drug profiles, visit Age-related Macular Degeneration Emerging Therapies Key Age-related Macular Degeneration Pipeline Age-related Macular Degeneration Therapeutic Assessment By Product Type By Stage By Route of Administration By Molecule Type By Mechanism of Action By Targets By Stage and Molecule TypeBy Stage and Route of AdministrationBy Stage and Product Type Dive deeper into Age-related Macular Degeneration Therapeutic Assessment Scope of the Report Coverage: GlobalKey Players: Amgen, Roche, Adverum Biotechnologies, AsclepiX Therapeutics, Bioeq/Formycon, Sinocelltech, RemeGen, Alkahest, Kyowa Kirin, EyePoint Pharmaceutical, IVERIC bio, Kodiak Sciences, Ribomic USA Inc, Sunshine Guojian Pharmaceutical (Shanghai), Lineage Cell Therapeutics, Graybug Vision, Sinocelltech, Luxa Biotechnology, CHABiotech, Shanghai Henlius Biotech, Bio-Thera Solutions, Alteogen, Samsung Bioepis, Outlook Therapeutics, Unity Biotechnology, Stealth BioTherapeutics, AiViva BioPharma, Ocular Therapeutix, AO GENERIUM, Gyroscope Therapeutics, Ionis Pharmaceuticals, Aerie Pharmaceuticals, Outlook Therapeutics, and several others. Key AMD Pipeline Therapies: Aflibercept biosimilar, Faricimab, ADVM 022, AXT 107, Ranibizumab biosimilar, SCT510A, RC 28 E, ALK4290, KHK4951, EYP-1901, Zimura, RBM-007 Injectable Solution, Drug 601, OpRegen, KSI 301, ABP 938, ADVM-022, SCT510A, GB-102, RPESC-RPE-4W, MA09-hRPE, SCD411, HLX04-O, BAT5906, LY09004, ASP7317 among others. Key Questions Answered Got queries? Reach out to us @ Age-related Macular Degeneration Drug Pipeline Table of Contents Related Reports Age-Related Macular Degeneration MarketDelveInsight's "Age-Related Macular Degeneration - Market Insights, Epidemiology, and Market Forecast-2030" report. Dry Age Macular Degeneration MarketDelveInsight's "Dry Age Macular Degeneration Market Insights, Epidemiology, and Market Forecast-2030" report Wet Age-Related Macular Degeneration MarketDelveInsight's "Wet Age-Related Macular Degeneration (Wet AMD) Market Insights, Epidemiology, and Market Forecast-2030" report. Vernal Keratoconjunctivitis MarketDelveInsight's "Vernal keratoconjunctivitis Market Insights, Epidemiology, and Market Forecast-2030" report. Allergic Conjunctivitis MarketDelveInsight's "Allergic Conjunctivitis Market Insights, Epidemiology, and Market Forecast-2030" report Allergic Rhino-Conjunctivitis MarketDelveInsight's "Allergic Rhino-Conjunctivitis Market Insights, Epidemiology, and Market Forecast-2030" report. Anterior Uveitis MarketDelveInsight's "Anterior Uveitis Market Insights, Epidemiology, and Market Forecast-2030" report. Bacterial Conjunctivitis MarketDelveInsight's "Bacterial Conjunctivitis Market Insights, Epidemiology, and Market Forecast-2030" report. Blepharitis MarketDelveInsight's "Blepharitis Market Insights, Epidemiology, and Market Forecast-2030" report. Central Retinal Vein Occlusion MarketDelveInsight's "Central Retinal Vein Occlusion Market Insights, Epidemiology, and Market Forecast-2030" report. Central Serous Chorioretinopathy MarketDelveInsight's "Central Serous Chorioretinopathy Market Insights, Epidemiology, and Market Forecast-2030" report. Choroidal Neovascularization MarketDelveInsight's "Choroidal Neovascularization Market Insights, Epidemiology, and Market Forecast-2030" report. Corneal Endothelial Dystrophy MarketDelveInsight’s ‘Corneal Endothelial Dystrophy (CED) Market Insights, Epidemiology, and Market Forecast—2030’ report. Diabetic Retinopathy MarketDelveInsight’s ‘Diabetic Retinopathy (DR) Market Insights, Epidemiology, and Market Forecast—2030’ report. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

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100 Deals associated with Recombinant humanized anti-VEGF monoclonal antibody(Bio-Thera Solutions)

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 3	CN	Bio-Thera Solutions, Ltd.	14 Sep 2024
Wet age-related macular degeneration	Phase 3	CN	Bio-Thera Solutions, Ltd.	07 Jul 2022

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