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	YABS0141	07/04/2021	Satralizumab	SA237, RG6168	Enspryng	mAb humanized	Naked monospecific	Full length Ab	None	IL-6R	IgG2	kappa	None	None	None	Recycling antibody: Designed to have pH-dependent binding to soluble IL-6R. mAb will release bound IL-6R in lysosome, then mAb will recycle via FcRn-mediated pathway. INN was formerly Sapelizumab	None	None	Approved EU, US, Japan, Australia, Canada	Active	03/15/2012	—	02/15/2014	Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD), Rheumatoid arthritis	Immune-mediated / inflammatory disorders	Chugai Pharmaceuticals	None	Approved in the EU on June 24, 2021. Approved in Canada and Japan in or about June 2020. Oct 30, 2019 EMA and FDA accept marketing applications. Marketing application submitted to EMA and validated as of October 3, 2019; application is being reviewed under EMA’s accelerated assessment program. Sep 13, 2019: Orphan drug designation in Japan announced by Chugai. April 2019: Results published - Efficacy of satralizumab (SA237) in subgroups of patients in SAkuraSky: a Phase III double-blind, placebo-controlled, add-on study in patients with neuromyelitis optica spectrum disorder (NMOSD) (S43.008) (https://n.neurology.org/content/92/15_Supplement/S43.008). Dec 2018: FDA has granted Breakthrough Therapy Designation for Chugai’s anti-interleukin-6 (IL-6) receptor humanized recycling antibody satralizumab, an investigational medicine for neuromyelitis optica and neuromyelitis optica spectrum disorders (NMO/NMOSD). October 15, 2018 – Chugai Pharmaceutical Co., Ltd. announced that positive results from the phase III study of satralizumab (development code: SA237), SAkuraSky Study (NCT02028884), were presented at the Congress of European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2018 held in Berlin, Germany from October 10 to 12 Phase 1 listed on clinicaltrials.jp as JapicCTI-121786; Two Phase 3 studies of SA237 for neuromyelitis optica and NMO Spectrum Disorder started in Feb 2014. No info on any Phase 2 study. orphan designation (EU/3/16/1680) from the European Commission for SA-237 for the treatment of neuromyelitis optica spectrum disorders. In June 2014, Chugai Pharmaceutical Co., Ltd. received orphan drug designation in US for neuromyelitis optica.	None	2020	08/15/2019	08/13/2020	Satralizumab, satralizumab-mwge	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	YABS0142	04/02/2021	Isatuximab	SAR650984	Sarclisa	mAb chimeric	Naked monospecific	Full length Ab	None	CD38	IgG1	kappa	None	None	None	Preclinical data published in Leukemia. 2016 Feb;30(2):399-408. doi: 10.1038/leu.2015.240	None	None	Approved EU, US, Japan, China, Australia	Active	12/07/2009	—	12/15/2016	Plasma cell myeloma, multiple myeloma, T-cell Type Acute Leukemia-Precursor T-lymphoblastic Lymphoma/Leukaemia, Hematological cancers	Cancer	AbbVie	Sanofi	Feb. 12, 2024: AbbVie announced that it has completed its acquisition of ImmunoGen. FDA approved March 2, 2020. July 2019: FDA accepts the BLA and sets a PDUFA date of April 30, 2020. In the second quarter of 2019, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application and Sanofi filed a Biologics License Application with the U.S. Food and Drug Administration (FDA), both for use of isatuximab in combination with pom-dex for the treatment of certain patients with RRMM. Start of Phase 3 in 1st line Multiple Myeloma in SCT eligible patients expected in H1 2018. Sanofi signed a clinical collaboration agreement with Roche to explore the role of atezolizumab in combination with isatuximab in certain solid tumors, reflecting scientific evidence that checkpoint inhibition by CD38 may reverse resistance to PD-L1. May 2017: Sanofi granted a fully paid exclusive license to develop, manufacture, and commercialize this cancer candidate. NCT02990338 Phase 3 in MM started in Dec 2016. Listed in Sanofi pipeline dated Feb 2014; EU and US orphan designations for myeloma. NCT02283775 Phase 1 started in May 2015. December 7, 2009: IND 103217 for SAR650984 was submitted to FDA for the treatment of hematological malignancies expressing the CD38 antigen. FDA issued a Safe to Proceed letter on December 29, 2009 for study TED10893, titled "A Phase I dose escalation safety and pharmacokinetic study of multiple intravenous administrations of a humanized monoclonal antibody (SAR650984) against CD38 in patients with selected CD38+ hematological malignancies."	None	2020	04/30/2019	03/02/2020	Isatuximab, isatuximab-irfc	Waltham, Massachusetts, United States	United States of America	North America	https://www.immunogen.com/
Approved	YABS0143	01/16/2024	Mepolizumab	SB-240563	Nucala	mAb humanized	Naked monospecific	Full length Ab	None	IL-5	IgG1	kappa	None	None	None	None	None	None	Approved EU, US, Japan, China, Australia	Active	07/02/1996	10/15/1997	10/15/2003	Atopic dermatitis, Chronic obstructive pulmonary disease, Hypereosinophilic Syndrome, Asthma, Eosinophilic Oesophagitis, Eosinophilic Granulomatosis with Polyangiitis (aka Churg Strauss Syndrome), Nasal Polyps	Immune-mediated / inflammatory disorders	GlaxoSmithKline	PDL	Approved in US Nov 4, 2015 and in the EU in early Dec 2015	None	2015	11/04/2014	11/04/2015	Mepolizumab	980 Great West Road Brentford Middlesex, TW8 9GS, United Kingdom	United Kingdom	Europe	https://www.gsk.com/en-gb/contact-us/
Approved	YABS0144	09/19/2018	Tildrakizumab	SCH 900222, MK-3222	ILUMYA, Ilumetri	mAb humanized	Naked monospecific	Full length Ab	None	IL-23p19	IgG1	kappa	None	None	None	None	None	None	Approved EU, US, Japan, Australia	Active	07/01/2008	10/15/2010	12/15/2012	Psoriasis, Ankylosing spondylitis and Non-Radiographic Axial Spondyloarthritis, Psoriatic Arthritis	Immune-mediated / inflammatory disorders	Merck	Sun, Almirall	BLA submitted for moderate-to-severe plaque psoriasis. Phase 3 study NCT01722331 started in December 2012; Phase 3 study NCT01729754 started in Feb 2013. July 27, 2016: Sun Pharma and Almirall today announced a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe.	None	2018	03/23/2017	03/20/2018	Tildrakizumab, Tildrakizumab-asmn	Rahway, NJ 07065 USA	United States of America	North America	https://www.merck.com/contact-us/
Approved	YABS0145	09/20/2022	Ripertamab	SCT400	Anpingxi®	mAb chimeric	Naked monospecific	Full length Ab	None	CD20	IgG1	kappa	None	None	None	immunoglobulin G1-kappa, anti-[Homo sapiens MS4A1 (membrane-spanning 4-domains subfamily A member 1, CD20)], chimeric monoclonal antibody	None	None	Approved China	Active	05/15/2012	05/15/2015	06/15/2016	Non-Hodgkin's lymphoma	Cancer	Sinocelltech Ltd	CSPC Pharmaceutical Group Ltd	Approved by NMPA for newly diagnosed CD20-positive diffuse large B-cell non-Hodgkin's lymphoma in August 2022. July 2021: Sinocelltech website indicates that State Drug Administration has accepted the listing application. Mar 2019: CSPC Pharmaceutical in-licenses SCT 400 from Sinocelltech Oct 2018: Phase-III clinical trials in Non-Hodgkin's lymphoma (Combination therapy, Second-line therapy or greater) in China (IV) NCT02772822 Phase 3 study Comparing the Efficiency and Safety of S-CHOP(Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone) Versus R-CHOP in Untreated CD20(Cluster of Differentiation Antigen 20)-Positive DLBCL Patients has not been updated since first posted in May 2016.	None	2022	—	—	Ripertamab	No. 31, Kechuang 7th Street, Beijing Economic and Technological Development Zone	China	Asia	http://www.sinocelltech.com/
Approved	YABS0146	02/22/2024	Crizanlizumab	SEG101, SelG1	Adakveo	mAb humanized	Naked monospecific	Full length Ab	None	P-selectin	IgG2	kappa	None	None	None	None	None	None	Approved US, Australia	Active	05/01/2011	08/15/2013	12/15/2016	COVID-19, Phase 1 in healthy subjects, vasoocclusion in sickle cell disease	Cardiovascular / hemostasis disorders	Novartis Pharmaceuticals	None	Feb 2024: Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA. Aug 2023: EC withdraws marketing authorization. The decision was based on a review of crizanlizumab initiated by the EC following the results of the phase III study, STAND (NCT03814746). The STAND study did not demonstrate a statistically significant difference between crizanlizumab 5mg/kg or crizanlizumab 7.5mg/kg and placebo in annualized rates of vaso-occlusive crises leading to a healthcare visit over the first-year post randomization. May 2023: EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo. EMA’s human medicines committee (CHMP) has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises) in patients aged 16 years and older with sickle cell disease. This follows a review by the CHMP, which concluded that the benefits of the medicine did not outweigh its risks. Approved by EU on Oct 28, 2020; Orphan market exclusivity for "Treatment of sickle cell disease" (based on designation EU/3/12/1034) started on 29 Oct 2020 July 16 2019 announcement: BLA has priority review. Jan 2019: The FDA granted breakthrough therapy status to Novartis' SEG101, or crizanlizumab, a monthly infusion being developed as a treatment for patients with vaso-occlusive crises in sickle cell disease. NCT03474965 Phase 2 study started in Oct 2018. July 2018: Regulatory filing planned for 2019. Listed as Phase 3 in Novartis pipeline (accessed online July 2018). Listed as Phase 3 in Novartis 2016 annual report. Dec 2016: Results from the Phase II SUSTAIN study show that SEG101 (crizanlizumab, formerly SelG1), an anti-P-selectin antibody, reduced the median annual rate of sickle cell-related pain crises (SCPC) by 45.3% compared to placebo (1.63 vs 2.98, p=0.010) in patients with or without hydroxyurea therapy. Novartis acquired Selexys Pharmaceuticals Corporation in Nov 2016, NCT01895361 Phase 2 in sickle cell disease with pain crisis. Selexys has been granted Orphan Drug Designation in both the U.S. and Europe for SelG1 in the treatment of sickle cell-related pain crises.	None	2019	05/16/2019	11/15/2019	Crizanlizumab, crizanlizumab-tmca	Basel, Switzerland	Switzerland	Europe	https://www.novartis.com/contacts
Approved	YABS0147	02/13/2025	Brentuximab vedotin	SGN-35	Adcetris	mAb chimeric	ADC	Full length Ab conjugate	None	CD30	IgG1	kappa	Valine-Citrulline, Cleavable linker	4	Tubulin inhibitor, Monomethyl auristatin E (MMAE)	Cysteine conjugated ADC	None	None	Approved EU, US, Japan, Australia	Active	11/15/2006	02/15/2009	04/15/2010	Hodgkin's lymphoma, anaplastic large cell lymphoma, germ cell tumors, mesothelioma, lymphatic diseases, systemic lupus erythematosus	Cancer	Seattle Genetics	None	US orphan; Fast track	None	2011	02/28/2011	08/19/2011	Brentuximab vedotin	21823 30Th Dr Se Bothell, WA 98021, United States	United States of America	North America	https://www.sbir.gov/node/302736
Approved	YABS0148	03/29/2022	Lanadelumab	SHP643, DX-2930	Takhzyro	mAb human	Naked monospecific	Full length Ab	None	Plasma kallikrein	IgG1	kappa	None	None	None	None	Phage display-derived	None	Approved EU, US, Japan, Australia	Active	06/15/2013	—	11/15/2015	COVID-19, Hereditary angioedema attacks	Cardiovascular / hemostasis disorders	Shire	None	Feb 23, 2018 press release: Biologics License Application (BLA) submitted to the U.S. FDA regarding SHP643 for the treatment of hereditary angioedema (HAE), and granted priority review. PDUFA date is August 26, 2018. Feb 2018: Shire announced Health Canada has accepted the company's request for priority review for the New Drug Submission (NDS) for lanadelumab (SHP643); the priority designation may be given up to 60 days before submission itself. Health Canada’s review of the NDS under Priority Review is expected to be completed in the second half of 2018. Feb 2018: Shire expects to start a Phase III pediatric trial with SHP643 for the treatment of HAE in the fourth quarter of 2018. May 2017: Phase 3 results for the HELP™ study, a global, multi-center, randomized, double-blind placebo-controlled parallel group trial that evaluated the efficacy and safety of subcutaneously administered lanadelumab versus placebo over 26 weeks in patients 12 years of age or older with Hereditary Angioedema (HAE) met primary endpoint. IND application for DX-2930 was filed in June 2013; Phase 1 studies NCT01923207 completed and NCT02093923 recruiting as of June 2014; good results reported in March 2015. DX-2930 is a human mAb inhibitor of plasma kallikrein for chronic prevention of hereditary angioedema attacks. EU and US orphan drug designations. Drug has Breakthrough therapy and Fast Track designations from the U.S. Food and Drug Administration for HAE.	None	2018	12/26/2017	08/23/2018	Lanadelumab, lanadelumab-flyo	300 Shire Way Lexington, MA 02421 USA	United States of America	North America	https://sc8-cms-shire-com.shirecontent.com/contact-us
Approved	YABS0149	08/22/2023	Adebrelimab	SHR-1316, HTI-1088	Arelili®	mAb humanized	Naked monospecific	Full length Ab	None	PD-L1	IgG4	kappa	None	None	None	Immune checkpoint target	None	None	Approved China	Active	06/26/2017	—	01/22/2021	Gastric cancer, Breast cancer, Non-small cell lung cancer, Small cell lung cancer, Solid tumors	Cancer	Jiangsu HengRui Medicine Co. Ltd	Atridia Pty Ltd.	March 7, 2023 notice: Recently Shanghai Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, received the "Drug Registration Certificate" issued by the National Medical Products Administration (NMPA), approving the company's self-developed PD-L1 inhibitor adelbelimab (Arebelimab) ®) in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). https://www.hengrui.com/media/detail-309.html Jiangsu Hengrui Medicine website accessed Aug 10, 2022: The NDA of SHR-1316 in combination with chemotherapy for SCLC has been filed to NMPA Atridia is a Sydney based company that serves as the local Sponsor for Jiangsu Hengrui Medicine Co.,Ltd for clinical trials in Australia. NCT04691063 Phase 3 study in SCLC started enrolling by invitation in Jan 2021. NCT04316364 Phase 3 in NSCLC not yet recruiting when first posted on March 20, 2020. NCT04041011 Phase 1 in small cell lung cancer not yet recruting as of Aug 1, 2019. NCT03474289 Phase 1 study started in March 2018 recruiting as of Aug 2018. NCT03133247 Phase 1 started in June 2017.	None	2023	—	—	Adebrelimab	No.7 Kunlunshan Road, Lianyungang Eco & Tech Development Zone, Jiangsu, 222000	China	Asia	https://www.globaldata.com/company-profile/jiangsu-hengrui-medicine-co-ltd/#:~:text=Jiangsu%20Hengrui%20is%20headquartered%20in%20Lianyungang%2C%20Jiangsu%20Province%2C%20China.
Approved	YABS0150	06/20/2024	Crovalimab	SKY59, RG6107, RO7112689	派圣凯®, PiaSky	mAb humanized	Naked monospecific	Full length Ab	None	Complement C5	IgG1	kappa	None	None	None	Recycling antibody: Designed to have pH-dependent binding to target. mAb will release bound target in lysosome, then mAb will recycle via FcRn-mediated pathway. A series of rabbit anti-C5 antibodies were generated by immunizing rabbits with human C5 protein. The screening process was designed to identify antibodies with pH-dependent antigen-binding capabilities. To accomplish this, we screened for antibodies with different binding affinities at pH 7.4 compared to pH 5.8 using ELISA and Biacore analysis. As a result, several antibodies which preferentially bind to C5 at pH7.4, but weakly at pH 5.8 were obtained. Among them, CFA0305 was chosen as a lead antibody to be further optimized based on its pH-dependent C5-binding property. After humanization of CFA0305, comprehensive mutagenesis on the antibody variable region was performed to identify mutations that improve the antigen-binding property, and combination of effective mutations gave the antibody high affinity with pH-dependent binding property (Fig. 1b). Some of histidine residues present in SKY59 were found to be important for the pH-dependent interaction.Various mutations were further applied to the variable regions of the antibody to improve pharmacokinetics (PK) and physicochemical properties, and to minimize the likelihood of immunogenicity in human. The constant region of the antibody was converted to a modified human IgG1/κ without effector functions, and engineered (M428L/N434A) to have enhanced affinity to FcRn at an acidic pH to extend the plasma half-life of the antibody. This final humanized and optimized antibody was named SKY59. ACT-Fc is applied to crovalimab	Rabbit B cell derived	None	Approved EU, US, Japan, China	Active	09/15/2016	—	09/30/2020	Sickle cell disease, Atypical Hemolytic Uremic Syndrome, Paroxysmal Nocturnal Hemoglobinuria	Cardiovascular / hemostasis disorders	Chugai Pharmaceuticals	None	July 1 2024: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting approval in the European Union (EU) for Roche's PiaSky (crovalimab) to treat paroxysmal nocturnal haemoglobinuria (PNH), a rare, life-threatening blood condition. March 2024: Approved in Japan. February 8, 2024 -- Chugai Pharmaceutical Co., Ltd. announced that crovalimab (Chinese product name : 派圣凯®), a humanized complement inhibitor C5 monoclonal antibody discovered by Chugai, was approved by the National Medical Products Administration (NMPA) of People’s Republic of China for treatment of adults and adolescents (12 years of age and above) with PNH not been previously treated with complement inhibitors. EU review started July 13, 2023. BLA receives standard review designation from FDA. June 2023: Chugai Pharmaceutical Co., Ltd. applied for manufacturing and marketing approval to the Ministry of Labor, and submitted marketing applications in the US and EU (https://www.chugai-pharm.co.jp/english/news/detail/20230727160000_1000.html?year=2023&category=) Aug 11, 2022: Chugai Pharmaceutical Co., Ltd. announced that the National Medical Products Administration (NMPA) of People’s Republic of China accepted an application for regulatory approval of crovalimab (development code: SKY59/RG6107) for paroxysmal nocturnal hemoglobinuria (PNH) and granted priority review. Crovalimab is a humanized complement inhibitor C5 monoclonal antibody discovered by Chugai. As F. Hoffmann-La Roche Ltd. is responsible for the development of crovalimab outside Japan and Taiwan, the regulatory application was filed by a China affiliate of Roche. In China, crovalimab was designated as a Breakthrough Therapy for PNH in July 2021. NCT04861259 Phase 3 in atypical hemolytic uremic syndrome due to start in May 2021. NCT04434092 and NCT04432584 Phase 3 studies recruiting as of Sep 30, 2020. NCT03157635 Phase 1/2 study started in Nov 2016 still recruiting as of Aug 2019. Phase 1/2 EudraCT Number: 2016-002128-10. The SMART-IgG Anti-hC5 Antibody (SKY59/RO7112689) Has Favorable PK, PD, Subcutaneous Bioavailability, and Safety Profile in Phase I HV Study. (Roeth et al Blood 2017 130:4750). Nonclinical data published in Scientific Reports 2017 Apr; 7(1):1080.	None	2024	06/20/2023	06/20/2024	Crovalimab, crovalimab-akkz	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