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
Terminated	YABS0627	07/31/2024	Pamrevlumab	FG-3019	None	mAb human	Naked monospecific	Full length Ab	None	Connective tissue growth factor	IgG1	kappa	None	None	None	None	Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform)	None	Terminated at Phase 3	Inactive	12/15/2003	02/15/2009	05/10/2019	Pancreatic cancer, Duchenne muscular dystrophy, Idiopathic Pulmonary Fibrosis, Pancreatic Cancer, Liver Fibrosis Due to Chronic Hepatitis B Infection, Diabetes Mellitus; Diabetic Nephropathy, focal segmental glomerulosclerosis	Cancer	FibroGen	Bristol Myers Squibb	July 2024: Pamrevlumab arm of the Precision PromiseSM study in metastatic pancreatic cancer, sponsored and conducted by the Pancreatic Cancer Action Network (PanCAN), did not meet the primary endpoint of overall survival as determined by the protocol pre-specified Bayesian statistical analysis. Company will terminate pamrevlumab research and development (R&D) investment and expeditiously wind down remaining obligations. https://investor.fibrogen.com/news-releases/news-release-details/fibrogen-announces-topline-results-two-late-stage-pamrevlumab May 2024: Results from Phase 2/3 and Phase 3 studies in pancreatic cancer expected in 2024. https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-reports-first-quarter-2024-financial-results Aug 30, 2023: FibroGen, Inc. announced topline data from the Phase 3 LELANTOS-2 trial of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) on background systemic corticosteroids. The study did not meet the primary or secondary endpoints. June 07, 2023: FibroGen, Inc. announced topline data from the Phase 3 LELANTOS-1 placebo-controlled trial of pamrevlumab for the treatment of non-ambulatory patients with Duchenne Muscular Dystrophy (DMD) on background corticosteroids. The study did not meet the primary endpoint of Performance of the Upper Limb 2.0 (PUL 2.0) score at week 52 compared to baseline. June 6, 2023 FibroGen Announces Positive Topline Results from China Pivotal Phase 3 Clinical Trial of Roxadustat for the Treatment of Chemotherapy Induced Anemia, Met primary endpoint of noninferiority of roxadustat to erythropoietin alfa https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-announces-positive-topline-results-china-pivotal-phase . May 2023: FibroGen is set to receive a non-dilutive term loan facility worth up to $150m from funds managed by Morgan Stanley Tactical Value (MSTV) to advance pamrevlumab towards commercialisation. Aug 2022 company presentation update: Phase 3 topline data expected mid-2023 to H1 2024. April 2021: FibroGen, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy (DMD). August 11, 2020 I FibroGen, Inc. announced the initiation of LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy October 23, 2019 I FibroGen, Inc. announced the dosing of the first patient in the LAPIS Phase 3 clinical study of pamrevlumab in patients with unresectable locally advanced pancreatic cancer (LAPC). July 22, 2019: FibroGen announced dosing of the first patient in the ZEPHYRUS Phase III clinical study of pamrevlumab in patients with idiopathic pulmonary fibrosis NCT03941093 Phase 3 study in pancreatic cancer started recruiting in May 2019; NCT03955146 in IPF not yet recruiting as of June 10 2019. April 2019: FibroGen Receives Orphan Drug Designation from the U.S. FDA For Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy. Sep 2018: FibroGen's pamrevlumab, being developed to treat patients with idiopathic pulmonary fibrosis, was granted fast-track designation by the FDA. NCT02606136 Phase 2 in Duchenne Muscular Dystrophy is the only study recruiting patients as of April 2018. March 2018: FibroGen announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with locally advanced unresectable pancreatic cancer. June 21, 2017: FibroGen, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation status to pamrevlumab, the company’s first-in-class antibody, for the treatment of pancreatic cancer. Jan 2017: updated results from an ongoing clinical study of pamrevlumab (FG-3019) in combination with standard-of-care chemotherapy in patients with locally advanced pancreatic ductal adenocarcinoma (PDAC) were presented in a poster session during the ASCO 2017 Gastrointestinal Cancers Symposium in San Francisco. Ophan drug designation for idiopathic pulmonary fibrosis July 2012; Partnered with BMS; NCT01890265 Phase 2 study recruiting as of Feb 2014	None	—	—	—	None	San Francisco, California, United States	United States of America	North America	https://investor.fibrogen.com/
Clinical	YABS0629	03/15/2024	None	FG-M108, M108	None	mAb - source TBD	Naked monospecific	Full length Ab	None	Claudin-18.2	IgG1	TBD	None	None	None	FG-M108 is an ADCC- enhanced afucosylated IgG1 monoclonal antibody targeting CLDN18.2 (DOI: 10.1016/j.annonc.2024.08.1499) independently developed by Mingji Biopharmaceutical for high expression of gastric cancer and other digestive system cancer tumor antigens . It mainly uses high-throughput phage display library screening technology to screen specific binding monoclonal antibodies at the cellular level. Source antibodies, while making full use of the antibody’s immunological anti-tumor mechanism, fully mobilize the patient’s immune cells to kill tumor cells through the enhanced ADCC effect. Non-clinical studies of drugs have shown that antibodies have shown good efficacy in a variety of gastric cancer animal models, and can completely inhibit tumor growth in specific models.	None	None	Phase 3	Active	06/11/2021	—	12/25/2023	Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma, Solid tumors	Cancer	FutureGen Biopharmaceutical (Beijing) Co. Ltd	None	NCT06177041 Phase 3 in Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma started in Dec 2023. NCT04894825 is A Phase I, Multi-center, Open-label, Single-dose Escalation and Expansion, Dose Escalation and Expansion Combination With Chemotherapy Study Evaluating the Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China started in June 2021 recruiting as of last update in July 2022. March 3 2021: Ji Ming biopharmaceutical (Beijing) Co., Ltd. received the M108 notice of a clinical trial approved by the injection of the monoclonal antibody, display the notice " according to" Drug Administration Law "and the relevant provisions of the State Food and Drug Administration approved Mingji Biopharmaceuticals will use M108 monoclonal antibody injection in clinical trials for the treatment of advanced solid tumors " , marking that a new treatment plan will benefit the people.	None	—	—	—	None	Room 201, Floor 2, Building 1, No. 16, Baocan South Street, Daxing Biomedical Industry Base, Zhongguancun Science and Technology Park, Daxing District, Beijing	China	Asia	https://www.futuregenbiopharm.com/#/contact
Clinical	YABS0633	11/22/2024	Bemarituzumab	FPA144	None	mAb humanized	Naked monospecific	Full length Ab	None	FGFR2b	IgG1	kappa	None	None	None	POTELLIGENT-derived, ADCC enhanced; antibody is engineered to recruit NK cells into the tumor microenvironment and kill cancer cells by antibody-dependent cell-mediated cytotoxicity	None	None	Phase 3	Active	11/01/2014	—	09/28/2018	Gastric and gastroesophageal junction adenocarcinoma, Solid tumors	Cancer	Amgen	Zai Lab	Listed as in Amgen pipeline dated Oct 30 2024 as Phase 3 for gastric cancers https://www.amgenpipeline.com/-/media/Themes/Amgen/amgenpipeline-com/amgenpipeline-com/PDF/amgen-pipeline-chart.pdf Phase 3 Gastric cancer/gastroesophageal junction adenocarcinoma: NCT05052801 is active non recruiting, NCT05111626 is recruiting as of November 2024. Phase 3 Gastric cancer/gastroesophageal junction adenocarcinoma (NCT05111626, NCT05052801) studies are recruiting as of May 25, 2023. Aug 2022: Zai Lab plans to initiate a registrational study of bemarituzumab in first-line advanced gastric and GEJ cancer in Greater China in the fourth quarter of 2022. Sep 2021: Zai Lab Limited an innovative commercial-stage biopharmaceutical company, announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for investigational bemarituzumab (FPA144), for first-line treatment for patients with FGFR2b overexpressing and human epidermal growth factor receptor (HER2)-negative metastatic and locally advanced gastric and GEJ cancers in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin). Amgen acquired Five Prime Therapeutics. April 19, 2021: Amgen announced that the FDA granted Breakthrough Therapy Designation for investigational bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b. On March 4, 2021, Amgen and Five Prime Therapeutics announced an agreement under which Amgen will acquire Five Prime Therapeutics. Five Prime’s lead asset, bemarituzumab, is a first-in-class, Phase 3-ready antibody with positive data from a randomized, placebo-controlled Phase 2 study in frontline advanced gastric or gastroesophageal junction cancer. Aug 2019: Enrollment in the NCT03694522 FIGHT trial continues ahead of projections due to FGFR2b biomarker prevalence that has remained steady at more than 30%, strong clinical trial execution, and continued support and enthusiasm from clinical investigators. The company plans to conduct an early futility analysis for the FIGHT trial during the first half of 2020. The purpose of the futility analysis is to ensure the trial is adequately powered to detect an overall survival benefit at full enrollment. October 1, 2018 I Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, and Zai Lab Limited (Nasdaq: ZLAB), a Shanghai-based innovative biopharmaceutical company, today announced dosing of the first patient in the Phase 3 FIGHT pivotal trial of bemarituzumab (FPA144), an isoform-selective FGF receptor 2b (FGFR2b) antibody, in combination with chemotherapy in patients with previously untreated, advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. The first patient was dosed at a participating investigative site in China on Sept. 28. NCT02318329 Phase 1 study started in Nov 2014; two Phase 1 studies recruiting as of March 2018. In July 2016, the U.S. Food and Drug Administration (FDA) granted bemarituzumab (FPA144) Orphan Drug Designation for the treatment of gastric cancer, including cancer of the gastroesophageal junction.	None	—	—	—	None	Thousand Oaks, California, United States	United States of America	North America	https://www.amgen.com/
Clinical	YABS0639	11/27/2024	Zigakibart	FUB523, BION-1301	None	mAb humanized	Naked monospecific	Full length Ab	None	APRIL	IgG4	kappa	None	None	None	B lymphocyte stimulator (BLyS, also indicated as BAFF (B-cell activating factor) and CD257), and A Proliferation Inducing Ligand (APRIL, CD256) are two members of the TNF superfamily with a central role in B cell survival. BION-131 is a novel humanized high-affinity anti-APRIL antibody (KD 0.4 ± 0.15 nM, EC50 0.29 ± 0.05 nM). Its epitope was mapped to the BCMA and TACI binding site conferring fully blocking capacity to BION-1301. Blocking potency (IC50) was 1.61± 0.78 nM (BCMA) and 1.29 ± 0.89 nM (TACI) respectively. The mouse anti-human parental antibody hAPRIL.01A inhibited APRIL-dependent B-cell proliferation and IgA production in vitro and in vivo (Guadagnoli et al. Blood Jun 23;117, 2011). In B-cell cultures, hAPRIL.01A reduced IgM, IgA and IgG-secreting cells after CpG pulse and APRIL stimulation. Following administration of a single-dose of BION-1301 to NHP, PK parameters typical for human IgG4 antibodies were observed, and confirmed a lack of tolerability issues. In a 4-week repeat dose NHP study BION-1301 demonstrated a favorable safety profile (No Observed Adverse Event Level was 100 mg/kg). Chronic exposure to BION-1301 led to a significantly reduced IgA level vs baseline of -50±14, -52±14, -59±7 % at 10, 30 and 100 mg/kg respectively. (ASN Kidney Week 2018, Abstract: FR-PO114)	None	None	Phase 3	Active	11/15/2017	—	07/15/2023	IgA nephropathy, Multiple myeloma (terminated)	Immune-mediated / inflammatory disorders	Novartis Pharmaceuticals	None	Jan 2024: SanReno Therapeutics, a clinical-stage company specializing in the discovery, development, and commercialization of innovative therapies for kidney diseases, today announces its acquisition by Novartis, a global medicines company. Following the acquisition's closure, SanReno becomes an indirect, wholly-owned subsidiary of Novartis. Established in late 2021 as a joint venture between the investor consortium and Chinook Therapeutics (now part of Novartis), SanReno holds exclusive rights in Greater China and Singapore for two late-stage assets targeting Immunoglobulin A Nephropathy (IgAN): atrasentan and zigakibart. July 28, 2023: Chinook Therapeutics, Inc. announced that the first patient with IgA nephropathy (IgAN) has been enrolled in the NCT05852938 BEYOND study, a pivotal phase 3 clinical trial evaluating the safety and efficacy of zigakibart (BION-1301), a potentially disease-modifying anti-APRIL monoclonal antibody. June 12, 2023 — Novartis announced that it has entered into an agreement to acquire Chinook Therapeutics, Listed as Phase 2 asset in company pipeline accessed Mar 2023; Feb 2023 press release: Chinook has finalized trial design, is conducting site and country feasibility and completing global regulatory interactions to enable initiation of a phase 3 trial of BION-1301 in mid-2023. Oct. 05, 2020 - Chinook Therapeutics, Inc. announced the closing of its merger with Aduro Biotech, Inc. and $115 million private placement financing. June 24, 2020 I Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, today announced that the first patient with IgA nephropathy has been dosed in a Phase 1 clinical trial of BION-1301, an investigational humanized IgG4 monoclonal antibody that blocks APRIL binding to both the BCMA and TACI receptors. NCT03945318 Phase 1 study in IgA nephropathy started in April 2019 active not recruiting as of last update in Jan 2023. NCT03340883 Phase 1/2 study started in Nov 2017 terminated in July 2019 (No objective responses observed following completion of Phase 1 dose-escalation) BION-1301 is Aduro’s proprietary monoclonal antibody targeting APRIL, which the company intends to evaluate in patients with multiple myeloma. Preclinical studies demonstrated that BION-1301 halts tumor growth, overcomes drug resistance to standard-of-care agents such as lenalidomide and bortezomib, and relieves immunosuppression. The team at Aduro Biotech Europe, in collaboration with Jan Paul Medema, Ph.D. of the Amsterdam Medical Center, developed BION-1301, a humanized antibody that blocks APRIL from binding to its receptors, using Aduro’s B-select monoclonal antibody platform.	None	—	—	—	None	Basel, Switzerland	Switzerland	Europe	https://www.novartis.com/contacts
Clinical	YABS0649	10/11/2024	Acasunlimab	GEN1046, DuoBody-PD-L1x4, BNT311	None	mAb humanized	Bispecific	Full length Ab	Duobody	PD-L1, 4-1BB	IgG1	kappa/lambda	None	None	None	Immune checkpoint targets. DuoBody-PD-L1x4-1BB (GEN1046) is a first-in-class bispecific antibody for conditional engagement of T-cell co-stimulatory receptor 4-1BB in concert with PD-L1 checkpoint blockade. DuoBody-PD-L1x4-1BB is an Fc-silenced IgG1 bispecific antibody that was obtained by controlled Fab-arm exchange of human(ized) PD-L1 and 4-1BB monoclonal antibodies.	Transgenic rat (OmniRat), DuoBody platform	None	Phase 3	Active	05/14/2019	10/27/2022	10/01/2024	Non-Small Cell Lung Cancer, Solid tumors	Cancer	Genmab	None	NCT06635824 Phase 3 in PD-L1-positive Metastatic NSCLC started in Oct 2024. August 5, 2024 – Genmab A/S announced that it will assume sole responsibility for the continued development and potential commercialization of acasunlimab. BioNTech SE (BioNTech) has opted not to participate in the further development of the acasunlimab program under the parties’ existing collaboration agreement. Genmab plans to initiate the Phase 3 study in the second half of this year. While the emerging clinical profile of acasunlimab is encouraging, BioNTech informed the company that it has taken this decision for reasons relating to its portfolio strategy. https://ir.genmab.com/news-releases/news-release-details/genmab-takes-full-control-acasunlimab-development-program NCT05117242 Phase 2 in NSCLC start in Oct 2021 recruiting as of last update in Mar 2023. NCT04937153 Phase 1 in solid tumors started in June 2021. NCT03917381 Phase 1/2 study in solid tumors started in May 2019. DuoBody-PD-L1x4-1BB is the first product candidate from the companies’ worldwide 50% cost-sharing 50% profit-sharing collaboration to enter the clinic. The objective of the collaboration, signed in 2015 and expanded in 2016 to include additional targets and technologies, is to develop and commercialize multiple novel bispecific antibodies with superior in vivo efficacy that specifically activate the immune system against cancer cells.	None	—	—	—	None	Copenhagen, Denmark	Denmark	Europe	https://www.genmab.com/
Regulatory review	YABS0656	05/20/2024	None	Gensci-048, Ginalimb, Genakumab, Genalumab (not WHO-assigned names)	(Pending)	mAb - source TBD	TBD	TBD	TBD	IL-1 beta	TBD	TBD	None	None	None	None	None	Regulatory review China - anticipate approval	Regulatory review China	Active	04/22/2019	05/22/2021	01/15/2023	Juvenile Idiopathic Arthritis, Solid tumors, acute gout	Immune-mediated / inflammatory disorders	Changchun GeneScience Pharmaceutical Co., Ltd.	None	On April 11 2024, Changchun GeneScience Pharmaceuticals Co., Ltd. (GenSci) received the "Acceptance Notice" from the National Medical Products Administration (NMPA), signaling the acceptance of their marketing application for GenSci's Genakumab. This development is auspicious, as Genakumab's indication for acute gouty arthritis has been recognized. NCT05983445 Phase 3 study in gout started in Jan 2023. Phase 2 studies for gout: NCT05936268 is recruiting as of July 11, 2023, NCT05936281 is not yet recruiting. Phase 2 study for Active Systemic Juvenile Idiopathic Arthritis NCT05925452 is not yet recruiting as of July 7, 2023. NCT05925452 Phase 1 in juvenile RA due to start in July 2023. NCT05894148 Phase 1 in healthy subjects started in March 2023. NCT05441046 Phase 1 is solid tumors started in June 2022.	None	—	—	—	None	No. 72 Tianhe Street, Changchun High-Tech Industrial Development Zone, Changchun, Jilin Province, China, Postal code: 130012	China	Asia	https://en.gensci-china.com/contactus.html
Clinical	YABS0661	06/25/2023	Gulgafafusp alfa	GMA-102 (diabetes indication), GMA-105 (obesity indication), Glutazumab (not WHO assigned INN)	None	mAb humanized	Immunoconjugate	Full length Ab fusion	None	GLP-1R	IgG2	TBD	None	None	GLP-1 peptide	GPCR target. "About GMA102 and GMA105: the world's only Mab GLP-1R agonist for T2D/Obesity, GMA102 and GMA105 is the same humanized anti-GLP-1R Mab (IgG2) carrying a GLP-1 fragment. GMAX completed phase 1b/2a trial in 2020 and plan to start phase III trial in China in 2021. Superb clinical data in earlier stage trials show that in T2D, GMA102 is a candidate of super long acting (2QW) and solution with robust efficacy standing head-to-head with the leading competitors. In Obesity, it offers outstanding weight reduction when dosed 1QW. Both GMA102 and GMA105 exhibited excellent tolerability throughout the early clinical studies." https://www.gmaxbiopharm.com/news_detail/30.html Glucagon like peptide 1 receptor agonist. Glutazumab is a novel antibody fusion protein engineered by linking the human GLP-1 derivative to a humanized GLP-1 receptor (GLP-1R) antibody via a peptide linker. Biochem Pharmacol. 2018 Apr;150:46-53. doi: 10.1016/j.bcp.2018.01.029. The glucagon-like peptide-1 receptor (GLP1R) is a receptor protein found on beta cells of the pancreas and on neurons of the brain. It is involved in the control of blood sugar level by enhancing insulin secretion. ... It is a member of the glucagon receptor family of G protein-coupled receptors.	None	None	Phase 3	Active	07/01/2015	11/15/2017	09/15/2021	Diabetes	Metabolic disorders	Gmax Biopharm Australia Pty Ltd	None	CTR20222558 Phase 3 studY for Type 2 diabetess "in progress, recruiting" In November 2024 Phase 3 CTR20211661 study completed. Gmax announced https://www.gmaxbiopharm.com/news_detail_zh/125.html Sep 2021: On September 27th, the Phase III clinical trial (CTR20211661) of the type 2 diabetes treatment drug GMA102 injection independently developed by Hongyun Huaning completed the first subject enrollment. The trial is a randomized, double-blind, placebo-controlled, multi-center phase III clinical trial designed to evaluate the effectiveness and safety of GMA102 injection in patients with type 2 diabetes. Glutazumab - Gmax Biopharm is available for licensing for phase III development in World (excluding China) as of 20 Jan 2021. http://www.gmaxbiopharm.com/pipeline/id/7.html Aug 2019 Gmax Biopharm LLC press release indicates assett is still at Phase 2. Dec 2018: multi-center, randomized, double-blinded, placebo controlled study started in China. Gmax is planning to initiate a multi-region, multi-center phase II/III clinical trial in China, US and Australia. The trial will be the pivotal study for BLA application. Aug 2018: IND approved in China. The ongoing phase Ib/IIa clinical trial of GMA102 in Australia and New Zealand has finished dosing of the 2nd cohort and the recruitment of the 3rd cohort. From the preliminary results of the finished two dosing cohorts, GMA102 has demonstrated expected efficacy, is safe and well tolerated. The phase Ib/IIa trial is expected to finish in Q3, 2019. ACTRN12617000811303p Phase 2 study "A Randomised, Placebo-controlled, Double-blind, Semi-sequential Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Escalating Subcutaneous Doses of Glutazumab in Subjects with Type 2 Diabetes" listed on Australian New Zealand Clinical Trials Registry; recruiting as of when record was accessed on Aug 18, 2019.	None	—	—	—	None	Suite 12.03, Level 12, 50 Margaret Street, Sydney NSW 2000, Australia	Australia	Australia	https://www.gmaxbiopharm.com/contact.html
Clinical	YABS0674	11/25/2024	Silevimig	GR1801	None	mAb human	Bispecific	Fragment-Fc	scFv-Fc-Fab	Rabies virus (glycoprotein)	IgG1	TBD	None	None	None	GR1801 is a human bispecific antibody, which simultaneously recognizes antigenic sites I and III of the RABV G protein. Antigen-binding fragments targeting epitope I and III of the RABV G protein were designed as a scFv and a Fab form, respectively, to construct human IgG1 heterodimers based on the Knob-Into-Hole (KIH) technology. Specifically, the A2 antigen-binding fragment in Fab form was fused to the N-terminus of an Fc segment containing the Knob mutation, while the B353 antigen-binding fragment in scFv form was fused to the N-terminus of an Fc segment containing the Hole mutation. This process resulted in the construction of the bispecific antibody GR1801, targeting the RABV G protein. Three constructed vectors expressing B353-scFv-FcH, A2VH-IgG1K, and A2VK-VK were cotransfected into HEK293F cells using liposomes. The bispecific antibodies GR1801 present in the culture supernatant were purified using a Protein A/G affinity chromatography. https://doi.org/10.1002/jmv.29016	Phage library	None	Phase 3	Active	11/01/2020	10/17/2021	10/24/2022	Post exposure prophylaxis	Infectious diseases	Genrix (Shanghai) Biopharmaceutical Co. Ltd.	None	Listed as Phase 3 in company pipeline dated Aug 2024 (http://www.genrixbio.com/#/science?classId=class3) NCT05846568 / CTR20222502 Phase 3 started in Oct 2022. CTR20212115 Phase 2 started in Oct 2021. CTR20202023 Phase 1 started in Nov 2020.	None	—	—	—	None	Shanghai, China	China	Asia	https://synapse.patsnap.com/organization/575cf201cc223eac2f65ac65cddb2931
Clinical	YABS0675	11/22/2024	Telikibart	GR1802, GR-1802	None	mAb human	Naked monospecific	Full length Ab	None	IL-4R alpha	IgG1	kappa	None	None	None	immunoglobulin G1-kappa, anti-[Homo sapiens IL4R (interleukin 4 receptor, IL4RA, IL-4RA, interleukin 13 receptor, CD124)], Homo sapiens monoclonal antibody;	None	None	Phase 3	Active	05/21/2021	07/01/2022	01/15/2024	Allergic rhinitis, asthma, chronic urticaria, rhinosinusitis, atopic dermatitis	Immune-mediated / inflammatory disorders	Genrix (Shanghai) Biopharmaceutical Co. Ltd.	None	Phase 3 study in Chronic Rhinosinusitis With Nasal Polyps (NCT06516302) started in September 2024 NCT06216392 / CTR20233857 Phase 3 in Atopic Dermatitis started in Jan 2024. NCT05873803 Phase 2 in Chronic Rhinosinusitis With Nasal Polyps started in Feb 2023. CTR20212483 Phase 1b/II started in Nov 2021. CTR20211101 Phase 1 started in May 2021.	None	—	—	—	None	Shanghai, China	China	Asia	http://www.genrixbio.com/
Regulatory review	YABS0683	03/04/2025	Depemokimab	GSK3511294	(Pending)	mAb humanized	Naked monospecific	Full length Ab	None	IL-5	IgG1	kappa	None	None	None	GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5	None	Regulatory decision in US Dec 16, 2025	Regulatory review EU, US, Japan, China	Active	10/17/2017	—	01/26/2021	Hypereosinophilic Syndrome, Nasal Polyps, Eosinophilic Granulomatosis With Polyangiitis, Mild to Moderate Asthma	Immune-mediated / inflammatory disorders	GSK	None	The Prescription Drug User Fee Act (PDUFA) date is 16 December 2025. Jan 28, 2025: GSK plc announced that the European Medicines Agency has accepted for review the Marketing Authorisation Application for the use of depemokimab in two indications. The submitted indications are for add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on medium to high dose corticosteroids (ICS) plus another asthma controller and also as an add-on treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). GSK plc also announced that new drug applications have been accepted for review by the China National Medical Products Administration and submitted to the Japanese Ministry of Health, Labour and Welfare for use of depemokimab in two indications. In China, the submitted indications are for an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 and older with type 2 inflammation characterised by blood eosinophil count, and add-on maintenance treatment of adult patients with inadequately controlled CRSwNP. In Japan, the submitted indications are for treatment of severe or refractory bronchial asthma and CRSwNP inadequately controlled with standard treatment. EMA started evaluation on Jan 23, 2025. NDA submitted in China, most likely in Dec 2024. https://www.echemi.com/cms/2194899.html Phase 3 studies for Hypereosinophilic syndrome (NCT05334368); Eosinophilic granulomatosis with polyangiitis (NCT05263934); are recruiting as of September 2024. Phase 3 studies in Nasal polyps (NCT05274750, NCT05281523) have been completed; Phase 3 studies in severe uncontrolled asthma with an eosinophilic phenotype (NCT05243680 and NCT04718389) are active non recruiting as of Spetember-October 2024, while NCT04719832 and NCT04718103 studies have been completed. May 2024: Positive results from SWIFT 1 and 2 announced https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-phase-iii-severe-asthma-trials-of-depemokimab/ Phase 3 studies for Hypereosinophilic syndrome (NCT05334368); Eosinophilic granulomatosis with polyangiitis (NCT05263934); Nasal polyps (NCT05274750, NCT05281523); Severe uncontrolled asthma with an eosinophilic phenotype (NCT05243680, NCT04719832, NCT04718103, NCT04718389) are all recruiting as of Jan-May 2023 except NCT04719832 and NCT04718103 for asthma which are active not recruiting as of Feb-May 2023. Two Phase 3 studies in nasal polyps started in Mar 2022. Three Phase 3 studies started in Jan 2021 (NCT04718389, NCT04718103, NCT04719832). Listed as Phase 1 in GSK pipeline accessed Aug 12, 2019. FIH Phase 1 NCT03287310 study still recruiting as of Aug 2018. GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5 which is known to block binding of IL-5 to the IL-5 receptor complex, causing a reduction in the circulating population of eosinophils.	None	—	—	—	None	980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom	United Kingdom	Europe	https://www.gsk.com/en-gb/contact-us/