Top 5 Target	Count

VEGF(Vascular endothelial growth factor)	1
CSF-3R(Colony stimulating factor 3 receptor)	1
GLP-1R(Glucagon-like peptide 1 receptor)	1
RANKL(Tumor necrosis factor ligand superfamily member 11)	1
IL-2(Interleukin-2)	1

Drugs associated with Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

Albipagrastim alfa

Target

CSF-3R

Mechanism

CSF-3R agonists [+1]

Active Org.

Mabwell (Shanghai) Bioscience Co., Ltd. [+1]

Originator Org.

Mabwell (Shanghai) Bioscience Co., Ltd.

Active Indication

Neutropenia [+2]

Inactive Indication

Neoplasm Metastasis

Drug Highest PhaseNDA/BLA

First Approval Ctry. / Loc.-

First Approval Date-

Anti-VEGF humanized monoclonal antibody(Jiangsu T-Mab Biopharma Co.,Ltd)

Target

VEGF

Mechanism

VEGF inhibitors

Active Org.

Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

Originator Org.

Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

Active Indication

Wet age-related macular degeneration

Inactive Indication-

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

GW002

Target

GLP-1R

Mechanism

GLP-1R agonists

Active Org.

Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

Originator Org.

Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

CTR20212636 / Active, not recruitingPhase 3

多中心、随机、双盲、平行阳性对照评价9MW0813和阿柏西普（EYLEA®）在糖尿病性黄斑水肿（DME）患者中的有效性和安全性III期临床研究

[Translation] A multicenter, randomized, double-blind, parallel positive-controlled Phase III clinical study to evaluate the efficacy and safety of 9MW0813 and aflibercept (EYLEA®) in patients with diabetic macular edema (DME)

主要研究目的：比较在 DME 患者中玻璃体腔内注射 9MW0813 注射液和阿柏西普眼内注射溶液（EYLEA®）的临床有效性的相似性。次要研究目的：（1）比较在 DME 患者中玻璃体腔内注射 9MW0813 注射液和阿柏西普眼内注射溶液（EYLEA®）的临床安全性的相似性；（2）比较在 DME 患者中玻璃体腔内注射 9MW0813 注射液和阿柏西普眼内注射溶液（EYLEA®）的免疫原性的相似性；（3）探索在部分 DME 患者中玻璃体腔内注射 9MW0813 注射液和阿柏西普眼内注射溶液（EYLEA®）的药代动力学特征。

[Translation]

Primary study objectives: To compare the similarity of clinical efficacy of intravitreal 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in patients with DME. Secondary study objectives: (1) To compare the similarity of clinical safety of intravitreal 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in patients with DME; (2) To compare the similarity of immunogenicity of intravitreal 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in patients with DME; (3) To explore the pharmacokinetic characteristics of intravitreal 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in some patients with DME.

Start Date17 Feb 2022

Sponsor / Collaborator

Mabwell (Shanghai) Bioscience Co., Ltd.

[+2]

CTR20202561 / Active, not recruitingPhase 3

一项评价重组抗VEGF人源化单克隆抗体注射液（代号MW02）治疗新生血管性（湿性）年龄相关性黄斑变性（nAMD）受试者的有效性和安全性的多中心、随机、双盲、阳性对照的无缝设计II/III期临床研究

[Translation] A multicenter, randomized, double-blind, positive-controlled, seamlessly designed Phase II/III clinical study to evaluate the efficacy and safety of recombinant anti-VEGF humanized monoclonal antibody injection (codenamed MW02) in the treatment of neovascular (wet) age-related macular degeneration (nAMD) subjects

主要目的：？评价相较于雷珠单抗注射液，IVT MW02治疗剂量，不同给药频率[Q4W连续用药以及Q4W连续3次后每8周一次（Q8W）用药]在nAMD受试者中防止视力下降的疗效。次要目的：？评估MW02治疗nAMD受试者的安全性。？评估MW02在nAMD受试者中的免疫原性。

[Translation]

Primary objective: ? To evaluate the efficacy of IVT MW02 treatment doses and different dosing frequencies [Q4W continuous administration and Q4W for 3 consecutive times followed by once every 8 weeks (Q8W)] in preventing visual acuity loss in nAMD subjects compared with ranibizumab injection. Secondary objectives: ? To evaluate the safety of MW02 in the treatment of nAMD subjects. ? To evaluate the immunogenicity of MW02 in nAMD subjects.

Start Date31 Mar 2021

Sponsor / Collaborator

Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

CTR20202549 / CompletedPhase 1

多中心、随机、双盲、平行对照比较 9MW0813 和阿柏西普（EYLEA®）在糖尿病性黄斑水肿（DME）患者中单次给药后的安全性、药代动力学及有效性的 I 期临床研究

[Translation] A multicenter, randomized, double-blind, parallel-controlled Phase I clinical study comparing the safety, pharmacokinetics and efficacy of 9MW0813 and aflibercept (EYLEA®) after a single dose in patients with diabetic macular edema (DME)

主要目的：比较在DME患者中单次玻璃体腔内注射（IVT）9MW0813注射液和阿柏西普眼内注射溶液（EYLEA®）后的安全性。次要目的：（1）比较在DME患者中单次玻璃体腔内注射（IVT）9MW0813注射液和阿柏西普眼内注射溶液（EYLEA®）后的药代动力学特征；（2）比较在DME患者中单次玻璃体腔内注射（IVT）9MW0813注射液和阿柏西普眼内注射溶液（EYLEA®）后的免疫原性；（3）初步评价在DME患者中单次玻璃体腔内注射（IVT）9MW0813注射液和阿柏西普眼内注射溶液（EYLEA®）后的临床有效性。

[Translation]

Primary objective: To compare the safety of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) after a single intravitreal injection (IVT) in patients with DME. Secondary objectives: (1) To compare the pharmacokinetic characteristics of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) after a single intravitreal injection (IVT) in patients with DME; (2) To compare the immunogenicity of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) after a single intravitreal injection (IVT) in patients with DME; (3) To preliminarily evaluate the clinical efficacy of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) after a single intravitreal injection (IVT) in patients with DME.

Start Date26 Feb 2021

Sponsor / Collaborator

Mabwell (Shanghai) Bioscience Co., Ltd.

[+2]

100 Clinical Results associated with Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

0 Patents (Medical) associated with Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

Literatures (Medical) associated with Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

02 Jan 2020·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Development and evaluation of candidate subunit vaccine and novel antitoxin against botulinum neurotoxin serotype E

Q3 · MEDICINE

Article

Author: Yang, Zhi-Xin ; Yu, Yun-Zhou ; Cui, Rong-Tian ; Liu, Fu-Jia ; Shi, Dan-Yang ; Dong, Xiao-Jie ; Sun, Zhi-Wei ; Mao, Yun-Yun ; Lu, Jian-Sheng ; Pang, Xiao-Bin

Botulinum neurotoxins (BoNTs) are among the most toxic proteins. Vaccination is an effective strategy to prevent botulism. To generate a vaccine suitable for human use, a recombinant non-His-tagged isoform of the Hc domain of botulinum neurotoxin serotype E (rEHc) was expressed in Escherichia coli and purified by sequential chromatography. The immunogenicity of rEHc was evaluated in mice and dose- and time-dependent immune responses were observed in both antibody titers and protective potency. Then, the pilot-scale expression and purification of rEHc were performed, and its immunological activity was characterized. Our results showed rEHc has good immunogenicity and can elicit strong protective potency against botulinum neurotoxin serotype E (BoNT/E) in mice, indicating that rEHc is an effective botulism vaccine candidate. Further, we developed a novel antitoxin against BoNT/E by purifying F(ab')₂ from pepsin-digested serum IgG of rEHc-inoculated horses. The protective effect of the F(ab')₂ antitoxin was determined in vitro and in vivo. The results showed that our F(ab')₂ antitoxin can prevent botulism in BoNT/E-challenged mice and effectively alleviate the progression of paralysis caused by BoNT/E to achieve therapeutic effects. Therefore, our results provide valuable experimental data for the production of a novel antitoxin, which is a promising candidate for the treatment of BoNT/E-induced botulism.

01 Aug 2018·Toxicology LettersQ2 · MEDICINE

Preclinical pharmacokinetics of a recombinant humanized rabbit anti-VEGF monoclonal antibody in rabbits and monkeys

Q2 · MEDICINE

Article

Author: Ji, Wan-Wan ; Yan, Shou-Sheng ; You, Meng ; Liu, Bin ; Lu, You ; Yu, Dong-An

TMAB001 is a humanized rabbit monoclonal antibody (mAb) designed to bind and neutralize human vascular endothelial growth factor (VEGF)-165. The purpose of the study was to investigate the pharmacokinetics (PK) and ocular tissue distribution after a single intravitreal (IVT) dose in rabbits and monkeys. Rabbits (2.5 mg/eye; n = 40) and monkeys (2.5 mg/eye; n = 12) received TMAB001 as a bilateral IVT dose. TMAB001 concentrations were measured in ocular tissues in all rabbits and monkeys by enzyme-linked immunosorbent assay (ELISA). TMAB001 and VEGF concentrations were measured in serum of monkeys by ELISA. Following a single bilateral IVT injection of TMAB001 2.5 mg/eye, the highest concentration was in vitreous humor, followed by retina and choroid, and the lowest concentration was in lens. In rabbits, TMAB001 was still detectable in ocular tissues at day 21 after single IVT dose, with the highest level in the vitreous humor and then retina, with longest t_1/2 in aqueous humor and shortest t_1/2 in choroid. In monkeys, t_max in serum was 43 h and t_1/2 was approximately 5.5 days. C_max in serum was much lower than that in vitreous, nearly 1/200. After IVT injection of TMAB001, total VEGF concentrations in serum and ocular tissues increased over time. VEGF concentration in retina and choroid increased over time, up to 336 h after administration. This study demonstrated that TMAB001 could reach the drug target sites-retina and choroid after a single bilateral IVT administration in rabbits and monkeys, with a long t_1/2 in vitreous humor. TMAB001 also showed strong capability to neutralize VEGF. The study further confirmed that full-length antibodies can also efficiently diffuse and distribute in ocular tissues.

01 Nov 2017·European Journal of Pharmaceutical SciencesQ2 · MEDICINE

Recombinant humanized anti-vascular endothelial growth factor monoclonal antibody efficiently suppresses laser-induced choroidal neovascularization in rhesus monkeys

Q2 · MEDICINE

Article

Author: Fang, Peng ; Xie, Ning ; Yan, Shou-Sheng ; Yang, Peng ; Ji, Wan-Wan ; Yu, Dong-An ; Cao, Yu-Xia ; Li, Hu

Neovascular age-related macular degeneration, characterized by abnormal choroidal neovascularization (CNV), is a major cause of blindness worldwide. Anti-vascular endothelial growth factor (VEGF) antibodies have demonstrated significant efficacy in improving visual acuity. TMAB001 is a new recombinant humanized rabbit anti-VEGF monoclonal antibody. It presents high activities in vitro studies. In the binding affinity assay, TMAB001 exhibited a high binding capability to VEGF with an affinity constant of 10^-11M. In the receptor antagonist activity assay, IC₅₀ of TMAB001 was 0.15μg/ml. In a cell-based assay, TMAB001 inhibited VEGF₁₆₅-induced HUVEC cells proliferation in a dose-dependent manner. Furthermore, in the rhesus monkey model of laser-induced CNV, results showed the growth and leakage of experimental CNV were significantly decreased with a single bilateral intravitreal injection of TMAB001, and the grade 4 lesions were complete absence in TMAB001 groups. The efficacy of TMAB001 was maintained for at least 28days. In a mice model of oxygen-induced retinopathy, the retina fluorescence leakage was reduced and the vascular morphology in retina was normalized by TMAB001 intraperitoneal administration. In conclusion, those results indicate that TMAB001 might be a potential drug candidate for wet AMD.

100 Deals associated with Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

100 Translational Medicine associated with Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd.

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1 Clinical

Phase 3 Clinical

NDA/BLA

Approved

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Denosumab biosimilar (T-Mab Biopharma) ( RANKL )	Giant Cell Tumor of Bone More	Approved
Albipagrastim alfa ( CSF-3R )	Neutropenia More	NDA/BLA
Anti-VEGF humanized monoclonal antibody(Jiangsu T-Mab Biopharma Co.,Ltd) ( VEGF )	Wet age-related macular degeneration More	Phase 3
GW002 ( GLP-1R )	-	Phase 1
APX-002(Epitomics, Inc.) ( IL-1β )	Inflammation More	Preclinical

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