فرگمنت فاب - شرکت یائوهای بیوفارما

Modality

Fab Fragment

Antibody fragments, exemplified by fragment antigen-binding (Fab), represent an alternative to conventional immunoglobulins (IgGs) in the realms of diagnostics and therapeutics across various diseases. Their notable advantages include heightened tissue penetration due to a lower molecular weight relative to IgG, reduced inflammatory potential attributed to the absence of the Fc domain, and efficient production facilitated by low structural complexity. Clinically, numerous Fab fragments, including Abciximab, Ranibizumab, Certolizumab Pegol, and Idarucizumab, have garnered therapeutic approval, underscoring their efficacy and relevance in medical applications.

Fig 1 . Structure of Fab and (Fab)²

Fab Fragment for Therapeutic Use

Abciximab

Abciximab (Reopro) is a chimeric monoclonal antibody Fab fragment, combining human and murine elements. The mechanism of abciximab involves the inhibition of platelet aggregation by antagonizing the GP IIb/IIIa receptor.

Ranibizumab

The second FDA-approved anti-VEGF drug, ranibizumab (Lucentis, developed by Genentech/Novartis), is an antibody fragment with affinity for all VEGF isoforms. Pivotal Phase III trials of ranibizumab, ANCHOR and MARINA, demonstrated not only visual stabilization but also marked visual improvements, marking a significant milestone in clinical outcomes.

Certolizumab Pegol

Certolizumab pegol, administered through subcutaneous injection, functions as a tumor necrosis factor-alpha (TNFα) activity suppressor. It effectively mitigates ongoing inflammation in individuals diagnosed with Crohn's disease.

Idarucizumab

Idarucizumab, a humanized monoclonal antibody fragment, is meticulously designed to target dabigatran, exhibiting a binding affinity to the thrombin site that surpasses thrombin itself by 350-fold. This exceptional affinity leads to nearly irreversible binding until renal excretion occurs. Idarucizumab has gained approval for its efficacy in reversing the anticoagulant effect of dabigatran.

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for Antibody Fragments

Fab Fragment Pipelines

Generic Name	Brand Name/ Alternative Name	Expression System	Indications	Manufacturer	R&D Stage
Ranibizumab	ACCENTRIX, AMD Fab, RFB-002, Y-0317, RG-3645, RG-6321, Lucentis, 诺适得, ルセンティス	Escherichia coli (E. coli)	Neovascular (wet) age-related macular degeneration	Genentech	Approval
Idarucizumab	Prizbind, aDabi-Fab, BI-655075, 97RWB5S1U6, Taibian, Praxbind	CHO cell	Coagulopathy, bleeding	Boehringer Ingelheim	Approval
Certolizumab Pegol	CZP, CIMZIA, Simziya, PHA-738144, CDP-870, Cimziat, Cimzia	E. coli	psoriasis	UCB, Otsuka Holdings	Approval
Abciximab	Reopro, ClearWayRX, Centrex, CentoRx, c7E3-Fab	Myeloma cells	Thrombotic complications	Johnson & Johnson, Centocor, Janssen Biotech	Approval
Abciximab biosimilar	AbcixiRel, R-TPR-019	Pending update	Thrombotic complications	Reliance Life Sciences Pvt Ltd.	Approval
Abciximab biosimilar	Clotinab, ISU-301, Faximab	mammalian cell	Thrombotic complications	ISU Abxis Co., Ltd.	Approval
Crotalidae	Antivenin Polyvalent immune Fab (ovine), Antivenom CroTAb	NA, extraction	snake venom	BTG International Ltd.,Boston Scientific holding	Approval
Anti-digoxin polyclonal antibody	Anti-digoxin-polyclonal-antibody-DigiTAb (Ovine), AMAG-423	NA, extraction	poisoning, preeclampsia	BTG International Ltd.、AMAG Pharmaceuticals, Inc.	Approval
Bentracimab	MEDI-2452、PB2452、PB-2452、PB 2452	E. coli	bleeding	PhaseBio Pharmaceuticals, Inc.、SFJ Pharmaceuticals, Inc.	Phase III
Dapirolizumab pegol	DZP, Immunoglobulin fab' g1-kappa pegylated, Anti-CD40L Fab, BIIB-133, CDP-7657	Pending update	systemic lupus erythematosus, multiple sclerosis	UCB、Biogen, Inc.	Phase III
Glenzocimab	Immunoglobulin g1, anti-(human platetet glycoprotein vi) fab fragment, ACT-017	CHO cell	Acute ischemic stroke, novel coronavirus infection, adult respiratory distress syndrome, SARS-CoV-2 acute respiratory disease, Stroke	R&D by Acticor Biotech, commercialized by CMS in China and parts of Asia	Phase II/III
FR-104	Anti CD28 monoclonal antibody, JNJ-3133, FR104, VEL-101	Pending update	Organ transplant rejection, Rheumatoid Arthritis, kidney transplant rejection, Encephalomyelitis, uveitis, psoriasis, multiple sclerosis	OSE's Effimune SA, Asahi Kasei's Veloxis Pharmaceuticals, Johnson & Johnson's Janssen	Phase II
Clervonafusp alfa	4s3-004, 3E10Fab-GAA fusion protein	Pending update	Lafora Disease	Valerion Therapeutics LLC	Phase II
Naptumomab estafenatox	Anyara, TTS-CD3, ABR-217620 fusion protein	Pending update	cancer	NeoTX Therapeutics Ltd	Phase II
LMB-100	anti-MSLN-PE24-cFP fusion protein, RO-6927005, RG-7787, LMB100	Pending update	cancer	F. Hoffmann-La Roche Ltd.、Selecta Biosciences	Phase II
Certolizumab	Lactococcus lactis secreting certolizumab, AG-014	Lactococcus lactis	inflammatory bowel disease	Precigen, Inc.	Phase I
IMB071703	Pending update	Pending update	cancer	Beijing Immunity Ark	Phase I
A ß Antibody Fab	Pending update	Pending update	Alzheimer's disease	lilly	Phase I
LuCaFab	ITM-31	Pending update	glioblastoma	Itm Isotope	Phase I

Reference:

[1] Arbabi-Ghahroudi M. Camelid Single-Domain Antibodies: Promises and Challenges as Lifesaving Treatments. Int J Mol Sci. 2022 Apr 30;23(9):5009. doi: 10.3390/ijms23095009.

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Fab Fragment

Modality

Fab Fragment

Fab Fragment for Therapeutic Use

Abciximab

Ranibizumab

Certolizumab Pegol

Idarucizumab

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for Antibody Fragments

Fab Fragment Pipelines

Reference:

MICROBIAL CDMO

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