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Phase 1 Clinical Equipment Supplied In China
14 equipment items found
Manufactured by:Shanghai Henlius Biotech, Inc based inShanghai, CHINA
HLX07, recombinant anti-epidermal growth factor receptor (EGFR) humanised monoclonal antibody injection independently researched and developed as biobetter. It was granted IND approvals to be evaluated in clinical trials in China and the United States. It demonstrated favorable safety and tolerability profile in a prospective, open-label, dose-escalation Phase ...
Manufactured by:Frontier Biotechnologies Inc. based inNanjing, CHINA
Licensed with exclusive rights for greater China from AFFiRiS AG, a clinical-stage biotechnology company in Austria, FB6001 is an investigational therapeutic peptide vaccine targeting PCSK9 to treat hypercholesterolemia. PCSK9 is a clinically validated target and FB6001 is a potential first-in-class immunotherapy for hypercholesteremia. FB6001 is expected to be ...
Manufactured by:Shanghai Henlius Biotech, Inc based inShanghai, CHINA
HLX14, recombinant anti-RANKL human monoclonal antibody injection, a denosumab biosimilar. It is potentially indicated for the treatment of postmenopausal women with OP at high risk for fracture. First subject has been doesd in the international multi-centre phase 3 clinical trial in China for the treatment of postmenopausal osteoporosis in women with high fracture ...
Manufactured by:Shanghai Henlius Biotech, Inc based inShanghai, CHINA
HLX04-O, recombinant anti-VEGF humanised monoclonal antibody injection. It is indicated for wet age-related macular degeneration (wAMD). HLX04-O was granted Phase 3 clinical study approvals in Australia, the United States, Singapore and the EU countries such as Latvia, Hungary and Spanish. In April 2022, the first patient in Australia and Latvia was dosed in the global multicentre phase 3 ...
Manufactured by:Shanghai Henlius Biotech, Inc based inShanghai, CHINA
HLX11, recombinant anti-HER2 domain II humanised monoclonal antibody injection, a pertuzumab biosimilar. It can be used in combination with trastuzumab and chemotherapy for adjuvant treatment and neoadjuvant treatment for patients with HER2-positive BC and HER2-positive mBC. The first subject has been dosed in multi-centre phase 3 clinical trial of HLX11 for the neoadjuvant therapy in patients ...
Manufactured by:Shanghai Henlius Biotech, Inc based inShanghai, CHINA
The Company's first product indicated for the treatment of autoimmune diseases. (adalimumab injection) was approved by the NMPA in December 2020. It is indicated for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. It is the first China-developed adalimumab biosimilar that is manufactured in a China and Europe GMP certificated manufacturing site, as well as the only ...
Manufactured by:Shanghai Henlius Biotech, Inc based inShanghai, CHINA
HLX22, humanised IgG1 monoclonal antibody injection targeting human epidermal growth factor receptor-2 (HER2). First patient has been dosed in Phase 2 clinical trial to compare HLX22 in combination with trastuzumab and chemotherapy as first-line therapy for HER2-positive locally advanced or metastatic gastric cancer patients in Chinese ...
Manufactured by:Frontier Biotechnologies Inc. based inNanjing, CHINA
FB2001 (generic name: Bofutrelvir) is a SARS-CoV-2 3CL protease inhibitor under clinical development for hospitalized patients as well as for post-exposure prophylaxis of Covid-19. It is a peptidomimetic compound targeting 3CL-protease based on three-dimensional crystal structure of the protease. Preclinical data has shown it has potent activities in vitro and in vivo against ...
Manufactured by:Elpiscience based inShanghai, CHINA
ES101 is a first-in-class tetravalent bispecific antibody targeting 4-1BB and PD-L1. It has a unique mechanism of action as 4-1BB activation is dependent on PD-L1 binding. 4-1BB is a T cell co-stimulatory receptor and is a compelling immune checkpoint target. 4-1BB targeting antibodies being developed by multinational companies have exhibited dose-dependent liver toxicity in clinical trials, ...
Manufactured by:Shanghai Henlius Biotech, Inc based inShanghai, CHINA
It is indicated for metastatic colorectal cancer (mCRC), advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), recurrent glioblastoma, cervical cancer, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. It is the only bevacizumab with metastatic colorectal cancer Phase III clinical data in China and proposed to be ...
Manufactured by:Frontier Biotechnologies Inc. based inNanjing, CHINA
FB3001, a new transdermal topical patch, is a musculoskeletal joint pain treatment, currently under clinical development. Through collaboration with ABsize, FB3001's Phase II clinical trial for treating lower back pain has been completed in the United States. The clinical data demonstrates that FB3001 provides superior pain relief for patients with chronic lower back pain compared to placebo. ...
Manufactured by:Elpiscience based inShanghai, CHINA
ES002’s dual ATP-adenosine mechanism is a potentially powerful TME regulator and transformative cancer immunotherapy. In preclinical studies ES002 demonstrated significant single agent anti-tumor activity as well as an excellent tolerability profile. ES002 has also shown superior enzymatic inhibition and binding ...
Manufactured by:Elpiscience based inShanghai, CHINA
ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. VEGF also plays an important role in creating an immune suppressive TME. Pre-clinical and early clinical data of ES104 show that blocking both pathways provides robust ...
Manufactured by:Ionicon Analytik Ges.m.b.H. based inInnsbruck, AUSTRIA
Inlet system optimized for real-time breath analysis with PTR-MS. Based on our patented BET sampling technique and certified for clinical ...