[Translation] A randomized, double-blind, parallel, positive-controlled phase I clinical trial comparing the pharmacokinetic characteristics, safety and tolerability of JL14002 monoclonal antibody injection and ranibizumab injection in patients with wet age-related macular degeneration (wAMD)

主要研究目的：评价 wAMD 患者玻璃体腔内注射 JL14002 单抗注射液或雷珠单抗注射液后的药代动力学（PK）特征。次要研究目的：1) 评价wAMD患者玻璃体腔内注射JL14002单抗注射液或雷珠单抗注射液后的安全性和耐受性； 2) 评价wAMD患者玻璃体腔内注射JL14002 单抗注射液或雷珠单抗注射液后的免疫原性；3) 评价wAMD患者玻璃体腔内注射JL14002单抗注射液或雷珠单抗注射液的药效学特征； 4) 评价wAMD患者玻璃体腔内注射JL14002 单抗注射液或雷珠单抗注射液后的初步有效性。

[Translation]

Primary study objectives: To evaluate the pharmacokinetic (PK) characteristics of JL14002 monoclonal antibody injection or ranibizumab injection after intravitreal injection in patients with wAMD. Secondary study objectives: 1) To evaluate the safety and tolerability of JL14002 monoclonal antibody injection or ranibizumab injection after intravitreal injection in patients with wAMD; 2) To evaluate the immunogenicity of JL14002 monoclonal antibody injection or ranibizumab injection after intravitreal injection in patients with wAMD; 3) To evaluate the pharmacodynamic characteristics of JL14002 monoclonal antibody injection or ranibizumab injection after intravitreal injection in patients with wAMD; 4) To evaluate the preliminary efficacy of JL14002 monoclonal antibody injection or ranibizumab injection after intravitreal injection in patients with wAMD.

Start Date06 Apr 2022

Sponsor / Collaborator

Jecho Biopharmaceuticals Co., Ltd.

CTR20213179 / Active, not recruitingPhase 3

比较JL14002单抗注射液和雷珠单抗注射液在湿性年龄相关性黄斑变性（wAMD）患者中的有效性和安全性的随机、双盲、多中心、阳性对照的III期临床试验

[Translation] A randomized, double-blind, multicenter, active-controlled phase III clinical trial comparing the efficacy and safety of JL14002 monoclonal antibody injection and ranibizumab injection in patients with wet age-related macular degeneration (wAMD)

主要研究目的评估 wAMD 患者接受玻璃体腔内注射 JL14002 单抗注射液或雷珠单抗注射液的临床等效性。次要研究目的 1) 比较wAMD患者接受玻璃体腔内注射JL14002单抗注射液或雷珠单抗注射液的药代动力学特征； 2) 比较wAMD患者接受玻璃体腔内注射JL14002单抗注射液或雷珠单抗注射液的安全性； 3) 评估wAMD患者在接受雷珠单抗注射液12周后交叉使用试验药物和一直使用雷珠单抗注射液的安全耐受性； 4) 评估wAMD患者在接受雷珠单抗注射液12周后交叉使用试验药物和一直使用试验药物的安全耐受性； 5) 比较 wAMD 患者接受玻璃体腔内注射 JL14002 单抗注射液或雷珠单抗注射液药效学特征； 6）比较wAMD患者接受玻璃体腔内注射JL14002单抗注射液或雷珠单抗注射液的免疫原性。

[Translation]

Main study objective To evaluate the clinical equivalence of intravitreal injection of JL14002 monoclonal antibody injection or ranibizumab injection in patients with wAMD. Secondary study objectives 1) To compare the pharmacokinetic characteristics of wAMD patients receiving intravitreal injection of JL14002 monoclonal antibody injection or ranibizumab injection; 2) To compare the safety of wAMD patients receiving intravitreal injection of JL14002 monoclonal antibody injection or ranibizumab injection; 3) To evaluate the safety and tolerability of wAMD patients who cross over to the test drug after receiving ranibizumab injection for 12 weeks and continue to use ranibizumab injection; 4) To evaluate the safety and tolerability of wAMD patients who cross over to the test drug after receiving ranibizumab injection for 12 weeks and continue to use the test drug; 5) To compare the pharmacodynamic characteristics of wAMD patients receiving intravitreal injection of JL14002 monoclonal antibody injection or ranibizumab injection; 6) To compare the immunogenicity of wAMD patients receiving intravitreal injection of JL14002 monoclonal antibody injection or ranibizumab injection.

Start Date15 Feb 2022

Sponsor / Collaborator

Jecho Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with Ranibizumab biosimilar (Jecho Biopharmaceuticals)

100 Translational Medicine associated with Ranibizumab biosimilar (Jecho Biopharmaceuticals)

100 Patents (Medical) associated with Ranibizumab biosimilar (Jecho Biopharmaceuticals)

Literatures (Medical) associated with Ranibizumab biosimilar (Jecho Biopharmaceuticals)

01 Aug 2007·Hepatobiliary & pancreatic diseases international : HBPD INT

Recombinant anti-HBsAg Fab blocks hepatitis B virus infection after orthotopic liver transplantation.

Article

Author: Pan, Tao ; Guo, Hui ; Gong, Nian-Qiao ; Wang, Da-Wei ; Chen, Dun-Xiu ; Chen, Zhi-Shui ; Yuan, Jin ; Tang, Li

BACKGROUND:

Recurrence of hepatitis B virus (HBV) after orthotopic liver transplantation is very common in the absence of adequate prophylaxis and is often associated with poor prognosis because of the development of cirrhosis, fibrosing cholestatic hepatitis, or fulminant hepatitis. Therefore it is important to study the prevention of HBV reinfection after liver transplantation.

METHODS:

Recombinant Fab (rFab) was constructed to evaluate gene therapy for post-transplantation HBV reinfection. Hepatocytes were divided into three groups: HBV-infection, rFab-blocked HBV-infection, and control. The inhibition of HBsAg adsorption test, the micro-cytotoxicity assay, and the blockade test of HBV infection were carried out. The HBsAg adsorption rate, the hepatocyte death rate and the HBV infection rate were statistically analyzed.

RESULTS:

The HBsAg adsorption rate blocked by rFab in the HBsAg adsorption test was 0.3%. The hepatocyte death rate was 98.8% induced by rFab in the micro-cytotoxicity assay, 1.3% in the rFab-blocked HBV-infected group and 77% in the HBV-infected group in the blockade test of HBV.

CONCLUSIONS:

We found that rFab effectively blocked HBV infection in human hepatocytes. This provides an attractive alternative for hepatitis B prophylaxis.

01 Aug 2005·Journal of virological methodsQ4 · MEDICINE

Production and characterization of recombinant human anti-HBs Fab antibodies

Q4 · MEDICINE

Article

Author: Y. Ono ; I. Kido ; M. Tsukahara ; F. Maeda ; A. Ohshima ; M. Takekoshi ; S. Aotsuka ; S. Ihara ; Y. Nagatsuka

Recombinant human Fab antibodies were generated with different reactivities against the hepatitis B virus surface (HBs) antigen. To isolate the antibodies, a method was used that combined transformation of human B cells by Epstein-Barr virus (EBV) infection with a primer-vector system developed for isolating DNA fragments of human Ig Fab portions. With this method, monoclonal and oligoclonal cell lines producing anti-HBs antibodies were established and three anti-HBs Fab antibodies were isolated from two of these cell lines. From analysis of affinity characteristics, immunohistochemical activity, and cytolysis activity, these three Fab antibodies were classified into three different groups. The first group had high affinity for HBs, the second had the ability to kill HBV-infected cells, and the third was applicable to immunohistochemical staining with HBV-infected cells. The combined effect of these antibodies was also investigated by complement-dependent cytotoxicity assay.

01 Sep 2004·Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology

[Purification of recombinant humanized anti-HBsAg Fab antibody by affinity chromatography].

Article

Author: Chen, Wen-yin ; Rao, Gui-rong ; Tang, Yong ; Deng, Ning ; Xiang, Jun-jian

AIM:

To establish a steady purification method for producing recombinant humanized anti-HBsAg Fab from yeast fermentation supernatant.

METHODS:

Humanized anti-HBs scFv was used to immunize BALB/c mice to obtain anti-scFv monoclonal antibody (mAb) which was used to purify recombinant humanized anti-HBsAg Fab from yeast fermentation supernatant by affinity chromatography.

RESULTS:

The purity of purified recombinant anti-HBsAg Fab was above 95% and its recovery rate was about 75%-85%.

CONCLUSION:

An efficient affinity chromatography suitable for purification of recombinant humanized anti-HBsAg Fab in large-scale was established.

100 Deals associated with Ranibizumab biosimilar (Jecho Biopharmaceuticals)

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Indication	Highest Phase	Country/Location	Organization	Date
Wet age-related macular degeneration	Phase 3	CN	Jecho Biopharmaceuticals Co., Ltd.	15 Feb 2022

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