YAbS

YAbS

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Record category	Entry ID	Status check date	INN	Drug code(s)	Brand name	MAb sequence source	General Molecular Category	Format, general category	Format details	Target(s)	Isotype (Fc)	Light chain isotype	Linker	Ave. DAR	Conjugated moiety	Description	Discovery method	Anticipated events	Most advanced stage of development	Status	Start of clinical phase	Start of first Phase 2	Start of first Phase 3	Indications of clinical studies	Primary therapeutic area	Company	Licensee/Partner	Comments	Factors to discontinuation	Initial approval year	FDA submission date	US approval date	US product name	Company address	Company country	Company region	Company website
Approved	YABS0001	01/01/2024	Racotumomab	1 E10	Vaxira®	mAb murine	Vaccine, Anti-idiotype antibody	Full length Ab	None	NeuGcGM3 idiotype	IgG1	kappa	None	None	None	The anti-GM3 antibody racotumomab (1E10) uses a vaccine mechanism of action. It is an anti-idiotypic monoclonal antibody that induces an immune response against glycolylated gangliosides (NeuGcGM3) present in the tumor cells. Originally developed in Cuba at the Center of Molecular Immunology, Vaxira® is marketed in Argentina and Cuba for the treatment of recurrent or advanced NSCLC, or NSCLC independent of the disease stage when no other standard therapy can be administered for lung cancer.	Mouse origin (BALB/C mouse derived)	None	Approved Argentina, Cuba	Active	01/15/2000	—	09/15/2010	Neuroblastoma; Ewing's Sarcoma; Wilm's Tumor; Retinoblastoma; Glioma, Non-small Cell Lung Cancer	Cancer	Center of Molecular Immunology	Recombio, Laboratorio Elea SACIFyA	Vaxira® is marketed in Argentina and Cuba for the treatment of recurrent or advanced NSCLC, or NSCLC independent of the disease stage when no other standard therapy can be administered for lung cancer. NCT02998983 Phase 2 study in neuroblastoma recruiting as of July 2018. Status of Phase 3 NCT01460472 study unknown as of July 2018; primary completion date was Sep 2016.	None	2013	—	—	Racotumomab	15 Street and 216 Street, Siboney, Playa, La Habana, Cuba. A.P 16040, La Habana 11600, Cuba	Republic of Cuba	North America	https://www.cim.cu/SobreNosotros/QuienesSomos
Approved	YABS0002	04/06/2017	Pertuzumab	2C4, R1273	Perjeta	mAb humanized	Naked monospecific	Full length Ab	None	HER2	IgG1	kappa	None	None	None	None	None	None	Approved EU, US, Japan, Australia	Active	06/27/2003	09/15/2003	09/15/2006	Non-small cell lung cancer, pancreatic, ovarian, breast, prostate, neuroendocrine cancer	Cancer	Genentech	None	None	None	2012	12/08/2011	06/08/2012	Pertuzumab	South San Francisco, California, United States	United States of America	North America	https://www.gene.com/contact-us/visit-us
Approved	YABS0003	01/03/2018	Abciximab	7E 3	Reopro	mAb chimeric	Naked monospecific	Fragment	Fab	GP IIb/IIIa receptor	None	kappa	None	None	None	None	None	None	Approved EU, US	Active	07/02/1987	11/15/1989	11/26/1991	Prevention of blood clots	Cardiovascular / hemostasis disorders	Centocor	Tanabe Seiyaku	None	None	1994	12/16/1993	12/22/1994	Abciximab	800-850 Ridgeview Drive HORSHAM PA 19044 UNITED STATES	United States of America	North America	https://www.orpha.net/en/institutions/legal-entity/82182
Approved	YABS0004	09/06/2020	Zimberelimab	AB122, GLS-010	YuTuo®	mAb human	Naked monospecific	Full length Ab	None	PD-1	IgG4	lambda	None	None	None	Immune checkpoint target. AB122, a fully human monoclonal antibody targeting PD-1 (https://www.annalsofoncology.org/article/S0923-7534(19)32690-0/fulltext)	Transgenic rat (OmniRat)	None	Approved China	Active	11/15/2017	08/24/2018	—	Melanoma, Colorectal cancer, Metastatic Castrate Resistant Prostate Cancer, GI malignancies, Cervical cancer, non-small cell lung cancer, Hodgkin lymphoma, advanced malignancies	Cancer	Harbin Gloria Pharmaceuticals	WuXi Biologics, Arcus Biosciences, Taiho Pharma	Sep 2023: Approved in China for treatment of recurrent or metastatic cervical cancer NCT05518318 Phase 3 in Hodgkin lymphoma due to start in Sep 2022. In March 2022, Gloria Pharma filed the second NDA for GLS-010 (zimberelimab) – the sixth homegrown PD-1 antibody in China – for the treatment of cervical cancer. The drug received breakthrough therapy designation from the NMPA in March 2021. Aug 30, 2021: Ligand Pharmaceuticals Incorporated announced that its partner Gloria Biosciences (GloriaBio) has received approval from China’s National Medical Products Administration (NMPA) for zimberelimab (GLS-010), an OmniAb-derived anti-PD-1 monoclonal antibody for the treatment of recurrent or refractory classical Hodgkin’s lymphoma According to Ligand press release of Aug 3, 2020, Gloria Biosciences submitted a marketing application for OmniAb-derived zimberelimab, but no country is specified Feb 2020: Arcus Biosciences announced Taiho’s exercise of its option to exclusively license zimberelimab, an anti-PD-1 monoclonal antibody, from Arcus Biosciences for commercialization in Japan and certain other territories in Asia (excluding China). NCT04262856 in NSCLC recruiitng as of Jan 2020. NCT03972722 Phase 2 study started in May 2019. NCT03629756 Phase 1 study started in July 2018. Clinical trial information: N+W947CT03655483 (J Clin Oncol 37, 2019 (suppl; abstr e14072); https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.4_suppl.125). NCT03655483 Phase 2 study in Hodgkin lymphoma started in Aug 2018. Nov 2017: The proceeds from this financing will be used for the advancement of Arcus’s clinical programs for AB928, a first-in-class dual adenosine receptor antagonist, and AB122, a PD-1 antibody. Earlier this month, Arcus initiated a phase 1 trial of AB928 in healthy volunteers and Arcus plans to initiate a phase 1/2 trial of AB928 in combination with AB122 in cancer patients during the first half of 2018. Also in November, Arcus initiated a phase 1 trial of AB122 in cancer patients in Australia. Data from the AB122 trial will be available in 2018 and Arcus plans to evaluate AB122 in combination with its other product candidates, in addition to AB928, in the future. The proceeds raised will also allow Arcus to advance at least two additional product candidates into clinical development, including AB680, a first-in-class small molecule CD73 inhibitor, and AB154, a TIGIT antibody. Aug 18, 2017 Ligand press release: WuXi Biologics was contracted by its Chinese partner Harbin Gloria Pharmaceuticals to discover and develop GLS-010 using Ligand’s OmniAb® technology, specifically the OmniRat® transgenic rat platform. GLS-010 is currently being evaluated in cancer patients in Phase 1 clinical studies in China. WuXi Biologics subsequently licensed their exclusive rights to the anti-PD-1 antibody GLS-010 to Arcus Biosciences in North America, Europe, Japan and certain other territories.	None	2021	—	—	Zimberelimab	Hong Kong	China	Asia	https://www.forbes.com/companies/harbin-gloria-pharmaceuticals/?sh=591924c84888
Approved	YABS0005	01/24/2022	Risankizumab	ABBV066, BI 655066	SKYRIZI	mAb humanized	Naked monospecific	Full length Ab	None	IL-23p19	IgG1	kappa	None	None	None	L234A, L235A mutations reduce effector function	None	None	Approved EU, US, Japan, Australia	Active	04/15/2012	01/15/2014	02/15/2016	Atopic dermatitis, Psoriasis, Crohn's Disease, asthma, Ankylosing spondylitis, psoriatic arthritis	Immune-mediated / inflammatory disorders	Boehringer Ingelheim	AbbVie	Approved in US on April 23, 2019. First approved in Japan in March 2019 for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies. April 2018: BLA for plaque psoriasis submitted. Based on a standard 12-month original BLA filing under PDUFA V guidelines, the PDUFA decision should occur on April 25, 2019. Seven Phase 3 studies in psoriasis completed or active, one not yet recruiting as of Oct 2017; three studies in Crohn's disease not yet recruiting. In April 2016, AbbVie acquired all rights to risankizumab (BI 655066) for psoriasis, from Boehringer Ingelheim (BI) pursuant to a global collaboration agreement. AbbVie is also evaluating the potential of this biologic in Crohn’s disease, psoriatic arthritis, and asthma.	None	2019	04/23/2018	04/23/2019	Risankizumab, risankizumab-rzaa	Binger Strasse 173 , 55216 Ingelheim am Rhein, Germany	Germany	Europe	https://www.boehringer-ingelheim.com/contact-us
Approved	YABS0006	07/20/2017	Raxibacumab	Abthrax	None	mAb human	Naked monospecific	Full length Ab	None	B. anthracis (PA)	IgG1	lambda	None	None	None	None	Phage display (CAT library)	None	Approved US	Active	05/22/2003	—	03/15/2008	Anthrax infection	Infectious diseases	GlaxoSmithKline	Emergent Biosolutions	US orphan; Fast track. July 2017: GlaxoSmithKline granted Emergent BioSolutions rights to regulatory approvals and intellectual property rights for its FDA-approved anthrax monoclonal antibody raxibacumab. Under the terms of the deal, GSK will get a $76 million upfront payment and up to $20 million for sales and milestone payments 'GlaxoSmithKline acquired Human Genome Sciences in 2012. Fast track designation in Aug 2003; orphan drug designation in Nov 2003. IND filed May 22, 2003 [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125349Orig1s000MedR.pdf; p.13)	None	2012	05/14/2009	12/14/2012	Raxibacumab	980 Great West Road Brentford Middlesex, TW8 9GS, United Kingdom	United Kingdom	Europe	https://www.gsk.com/en-gb/contact-us/
Approved	YABS0007	01/10/2018	Panitumumab	ABX-EGF	Vectibix	mAb human	Naked monospecific	Full length Ab	None	EGFR	IgG2	kappa	None	None	None	None	Transgenic mouse (Xenomouse)	None	Approved EU, US, Japan, Australia	Active	07/19/1999	04/15/2001	—	Renal, prostate, lung, breast, colorectal Cancers	Cancer	Abgenix	None	None	None	2006	03/29/2006	09/27/2006	Panitumumab	6701 Kaiser Drive Fremont, CA 94555 United States	United States of America	North America	https://pitchbook.com/profiles/company/40732-21#overview
Approved	YABS0008	03/15/2019	Emicizumab	ACE910, RO5534262, RG6013	Hemlibra	mAb humanized	Bispecific	Full length Ab	None	Factor IXa, Factor X	IgG4	kappa	None	None	None	cLC-hetero-H-chain IgG. The CDRs of the anti-FIXa heavy chain (Q chain), the anti-FX heavy chain (J chain), and the light chains were derived from rats immunized with human FIXa, mice immunized with human FX, and both, respectively. Emicizumab molecule contains two different heavy chains and two identical light chains. S228P; K196Q; F296Y; E356K; K439E; L445P; G446 > del; K447 > del	None	None	Approved EU, US, Japan, Australia	Active	08/15/2012	—	11/18/2015	Hemophilia A	Cardiovascular / hemostasis disorders	Chugai Pharmaceuticals	None	Approved on November 16, 2017 in US; Approved in EU Feb 2018; approved in Japan Priority review in US and accelerated assessment in EU; PDUFA date Feb 23 2018. Chugai's submission of marketing application in Japan announced July 21, 2017. NCT02622321 Phase 3 study in patients with congenital hemophilia A. Breakthrough Therapy Designation for the prophylactic treatment of people who are 12 years or older with hemophilia A with factor VIII inhibitors. June 2015: Data from Phase I extension study presented at major medical conference on bleeding disorders showed that reduction in bleeding rates was maintained after a follow-up of 5.6 to 18.5 months; ACE910 is the first FVIIIa-mimetic bispecific antibody to have shown potential benefit in people with severe haemophilia A both with or without inhibitors to factor VIII. Orphan designations in Japan, EU and US; listed in Roche pipeline as Phase 2 as of April 2014. First-in-human study published in Blood. 2016 Mar 31;127(13):1633-41; this trial was registered at www.clinicaltrials.jp as #JapicCTI-121934, duration of study listed as 2012-8 ～ 2015-8.	None	2017	06/23/2017	11/16/2017	Emicizumab, emicizumab-kxwh	1-1 Nihonbashi-Muromachi 2-Chome Chuo-ku, Tokyo 103-8324 JAPAN	Japan	Asia	https://www.chugai-pharm.co.jp/english/rule/contact/index.html
Approved	YABS0009	04/06/2017	Canakinumab	ACZ885	Ilaris	mAb human	Naked monospecific	Full length Ab	None	IL-1 beta	IgG1	kappa	None	None	None	None	Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform Ultimab)	None	Approved EU, US, Japan, Australia	Active	08/15/2003	08/15/2005	07/15/2007	COVID-19, Cryopyrin-Associated Periodic Syndromes, Rheumatoid arthritis, wet age-related macular degeneration, Atherosclerosis and Either T2DM or IGT, Type 2 Diabetes, gout, juvenile arthritis	Immune-mediated / inflammatory disorders	Novartis Pharmaceuticals	None	US orphan	None	2009	12/17/2008	06/17/2009	Canakinumab	Basel, Switzerland	Switzerland	Europe	https://www.novartis.com/contacts
Approved	YABS0010	02/06/2025	Loncastuximab tesirine	ADCT-402	Zynlonta	mAb humanized	ADC	Full length Ab conjugate	None	CD19	IgG1	kappa	Valine-alanine, Cleavable linker	2.3	DNA binding, Pyrrolobenzodiazepine (PBD) dimer SG3199	ADCT-402 is an antibody drug conjugate (ADC) composed of a humanized antibody directed against human cluster of differentiation 19 (CD19), stochastically conjugated via a valine-alanine cleavable, maleimide linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Described as chimeric in WHO Proposed INN list 117.	None	None	Approved EU, US, Canada	Active	02/01/2016	—	08/01/2018	Non-Hodgkin lymphoma, B-ALL	Cancer	ADC Therapeutics Sarl	SOBI (Swedish Orpha Biovitrum)	Dec 20, 2022: Approved in EU FDA approved on April 23, 2021. This indication (B-cell lymphoma) is approved under accelerated approval based on overall response rate. The BLA submission was supported by data from the open-label, single-arm Phase 2 LOTIS 2 study (NCT03589469). This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.This application was granted priority review and orphan drug designation. Dec 2020: ADC Therapeutics SA and Overland Pharmaceuticals, a fully integrated biopharmaceutical company backed by Hillhouse Capital, today announced that they have jointly formed a new company, Overland ADCT BioPharma (CY) Limited, to develop and commercialize four of ADC Therapeutics’ antibody drug conjugate (ADC) product candidates for difficult-to-treat hematologic and solid tumors – loncastuximab tesirine (Lonca), ADCT-601, ADCT-602 and ADCT-901 – in greater China and Singapore. ADCT submitted the Initial BLA and a request for priority review designation on 21 Sep 2020. The Chemistry, Manufacturing, and Controls (CMC) information for the BLA was submitted as a presubmission on Aug 7, 2020. July 17, 2020: ADC Therapeutics SA announced that the first patient has been dosed in the pivotal Phase 2 portion of LOTIS 3, a Phase 1/2 clinical trial evaluating loncastuximab tesirine (Lonca, formerly ADCT-402) in combination with ibrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL). “Based on the encouraging interim data Lonca and ibrutinib demonstrated in Phase 1, the trial was amended to a Phase 1/2 protocol intended to support the submission of a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA),” said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. “We are pleased to have dosed the first patient in the pivotal Phase 2 portion of this trial as we continue advancing Lonca as both a single agent and in combination with other therapies for patients with non-Hodgkin lymphoma. We are on track to file a BLA with the FDA for Lonca as monotherapy for the treatment of relapsed or refractory DLBCL in the second half of 2020.” June 2020: Company is on track to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration for Lonca for the treatment of relapsed or refractory DLBCL in the second half of 2020 NCT04384484 Phase 3 in diffuse large B cell lymphoma not yet recruiting when posted on May 12, 2020. NCT03589469 Phase 2 LOTIS 2 study started in Aug 2018. NCT03685344 Phase 1 study in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma recruiting as of Dec 6, 2018. Aug 7, 2018: ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), today announced that the first patient has been dosed in its Phase II clinical trial intended to support the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The clinical trial is evaluating the efficacy and safety of ADCT-402 (loncastuximab tesirine) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). June 9, 2017: U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ADCT-402 for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma. June 2017: In a presentation at the 14th International Conference on Malignant Lymphoma, interim results from the Phase I, open label, dose-escalating study of ADCT-402 evaluating tolerability, safety, pharmacokinetics and efficacy in patients with relapsed or refractory non-Hodgkin’s lymphoma (r/r NHL) were reported. Data were presented from 62 evaluable patients with a median age of 67 years and a median of 3 previous therapies (range 1-10). NCT02669017 and NCT02669264 Phase 1 studies recruiting as of March 2017 NCT02669264 Phase 1 in ALL started in March 2016 terminated (The study was early terminated prior to part 2 because of slow accrual.)	None	2021	09/21/2020	04/23/2021	Loncastuximab tesirine, loncastuximab tesirine-lpyl	Biopôle, Route de la Corniche 3B, 1066 Epalinges, Switzerland	Switzerland	Europe	https://www.adctherapeutics.com/contact/