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
Clinical	YABS0580	11/24/2024	Ifinatamab deruxtecan	DS-7300a	None	mAb humanized	ADC	Full length Ab conjugate	None	B7-H3	IgG1	kappa	Glycine-Glycine-Phenylalanine-Glycine (GGFG; Tetrapeptide-based cleavable linker)	4	Topoisomerase I inhibitor, DXd/DX-8951 (MAAA-1181a)	Immune checkpoint target. DAR=4. DS-7300a is a B7-H3-targeting antibody-drug conjugate (ADC), which is composed of a humanized anti-B7-H3 monoclonal antibody (MABX-9001a), an enzymatically cleavable peptide-based linker, and a novel exatecan derivative (DXd) that is a potent DNA topoisomerase I inhibitor. https://www.ejcancer.com/article/S0959-8049(20)31102-3/fulltext	None	None	Phase 3	Active	10/17/2019	06/15/2022	05/15/2024	Esophageal Squamous Cell Carcinoma, Small cell lung cancer, Solid tumors	Cancer	Daiichi Sankyo Co. Ltd	Merck Sharp & Dohme	Listed as Phase 3 in Merck pipeline dated Nov 1 2024. Phase 3 study for Esophageal Squamous Cell Carcinoma (NCT06644781) due to start in February 2025 NCT06203210 Phase 3 study in SCLC started in May 2024. October 19, 2023 I Daiichi Sankyo and Merck have entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd antibody drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd). NCT05280470 Phase 2 in small cell lung cancer started in June 2022 recruiting as of last update in Mar 2023. NCT04145622 Phase 1/2 in solid tumors started in Oct 2019; still recruiting as of last update in Feb 2023.	None	—	—	—	None	Chuo City, Tokyo, Japan	Japan	Asia	https://www.daiichisankyo.com/
Clinical	YABS0590	10/31/2024	Etalanetug	E2814	None	mAb humanized	Naked monospecific	Full length Ab	None	Tau (MTBR)	IgG1	kappa	None	None	None	E2814 is a humanised, high affinity, IgG1 antibody recognising the tau microtubule binding region (MTBR). E2814 is being developed as a disease modifying agent for Alzheimer’s disease and other tauopathies, Phase I clinical studies are under preparation. E2814 is designed to prevent the spreading of tau seeds within the brains of affected individuals. DOI: 10.1186/s40478-020-0884-2; https://pubmed.ncbi.nlm.nih.gov/32019610/	None	None	Phase 2/3	Active	01/15/2020	—	12/22/2021	Alzheimer's disease	Neurological disorders	Eisai Inc.	University College London	In September 2024, Eisai initiated a Phase II clinical study (Study 202) for individuals with early AD in the United States Phase 2/3 studies for Dominantly inherited Alzheimer's Disease (NCT05269394, NCT01760005) are recruiting as of May 12, 2023. Jan 18, 2022: Eisai Co., Ltd. announced that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has enrolled the first subject in the phase II/III study (Tau NexGen study). The study will assess the effect of Eisai's investigational anti-microtubule binding region (MTBR) tau antibody E2814, in dominantly inherited Alzheimer's disease (DIAD). NCT05269394 Phase 2/3 study started in Dec 2021 recruiting as of last update in Dec 2022. March 2021: Eisai Co., Ltd. announced that anti-microtubule binding region (MTBR) tau antibody E2814, which was created from collaboration research between Eisai and University College London, has been selected by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) led by Washington University School of Medicine in St. Louis, as the first investigational medicine among anti-tau drugs for their on-going DIAN-TU tau study (NCT01760005). Listed in Eisai pipeline update, dated Jan 31, 2020, as Phase 1. NCT04231513 Phase 1, A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Intravenous Infusions of E2814 in Healthy Subjects, started in Dec 2019 active not recruiting as of last update in Feb 2023. The clinical candidate was discovered as part of the research collaboration between Eisai and University College London.	None	—	—	—	None	4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan	Japan	Asia	https://www.eisai.com/company/profile/group/index.html#anc-01
Clinical	YABS0591	11/16/2024	Paridiprubart	EB05, NI-0101	None	mAb humanized	Naked monospecific	Full length Ab	None	TLR4	IgG1	kappa	None	None	None	Immunoglobulin G1 (326-serine,329-phenylalanine,de-448-lysine), anti-(human toll-like receptor 4) (human-mus musculus monoclonal EB05 gamma1-chain), disulfide with human-mus musculus monoclonal EB05 kappa-chain, dimer	None	None	Phase 2/3	Active	11/15/2012	05/10/2017	11/25/2020	Acute Respiratory Distress Syndrome, COVID-19, Rheumatoid arthritis	Immune-mediated / inflammatory disorders	NovImmune SA	Edesa Biotech, Genentech	NCT04401475 Phase 2/3 study suspended in Nov 2024. Edesa has made the decision to suspend this study solely for business reasons. Aug 2024: During Q2 , the company’s anti-TLR4 drug candidate, EB05 (paridiprubart), was selected by the U.S. Department of Health and Human Services for use in a U.S. government-funded platform study investigating novel threat-agnostic host-directed therapeutics in patients with Acute Respiratory Distress Syndrome (ARDS). Edesa is providing drug product for the trial as well as technical support at its own expense. In addition, the company reported today that it plans to continue utilizing its internal resources to advance its vitiligo and pulmonary fibrosis programs, including preparations to file an Investigational New Drug application with the U.S. Food and Drug Administration for a Phase 2 study of its anti-CXCL10 technology in moderate-to-severe vitiligo patients. Fiscal 2nd quarter 2023 results, Edesa reports "Edesa is currently evaluating EB05 in a Phase 3 study as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure." https://feeds.issuerdirect.com/news-release.html?newsid=4892354568451630 Dec 2022: Edesa Biotech, Inc. has received Fast Track designation from the U.S. Food and Drug Administration for its anti-Toll-like receptor 4 monoclonal antibody candidate, EB05. Approval of the company's application follows favorable Phase 2 results from an international Phase 2/3 study of EB05 in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome, a severe form of respiratory failure characterized by widespread inflammatory injury to the lungs. August 12, 2022: Edesa Biotech, Inc. reported financial results for the three and nine months ended June 30, 2022 and provided an update on its business. During the quarter, the company expanded an international Phase 3 study of its critical care drug candidate in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS). The company is now recruiting a second cohort of subjects in parallel to its critically severe cohort. June 18, 2021: Edesa Biotech, Inc. reported that an independent Data and Safety Monitoring Board (DSMB) has completed an interim review of the company's COVID-19 drug candidate, and based on blinded comparative data, has recommended that the company's international study continue as planned. Nov 30, 2020: Edesa Biotech, Inc., a clinical-stage biopharmaceutical company, announced that the first patient has been enrolled in a Phase 2/3 clinical trial evaluating the company's investigational drug, EB05, as a therapy for hospitalized COVID-19 patients. NCT04401475 Phase 2/3 is Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With Moderate to Severe COVID-19 Pneumonia. Licensed to Edesa Biotech in April 2020 for COVID-19. Aug 2019: No ongoing clinical studies found. July 2019: NovImmune has successfully divested EmaCo AG, a newly established company owning emapalumab and related assets to Sobi on 18 July 2019. NovImmune SA will continue to operate and focus on its bispecific technology and associated programs and will rebrand as Light Chain Bioscience – A brand of Novimmune SA. Listed in NovImmune pipeline accessed online Sep 2 2018. Phase 2 NCT03241108 study in RA started in May 2017 completed in June 2018. Dec 2016: Swiss Biotech firm Novimmune has entered into an option and licence agreement with Roche company Genentech to develop and commercialise its anti-toll-like receptor 4 (TLR4) monoclonal antibody, NI-0101, to treat rheumatoid arthritis and other auto-immune diseases. NCT01808469 Phase 1 completed as of Oct 2014.	None	—	—	—	None	15B Chemin du Pré-Fleuri, CH-1228 Plan-Les-Ouates, Switzerland	Switzerland	Europe	https://www.lightchainbio.com/contact/contact-us.html
Clinical	YABS0595	03/14/2025	None	ELA026	None	mAb human	TBD	TBD	TBD	SIRP alpha	IgG1	TBD	None	None	None	ELA026 is a fully human IgG1 SIRP-directed monoclonal antibody designed to reduce the myeloid and T cells driving the inflammation.	None	None	Phase 2/3	Active	10/15/2021	05/19/2022	—	Secondary Hemophagocytic Lymphohistiocytosis	Immune-mediated / inflammatory disorders	Electra Therapeutics Inc.	None	NCT05416307 Phase 1 study started in May 2023 converted to a Phase 2/3 study in Mar 2025. NCT05556863 Phase 1 study started in Oct 2021.	None	—	—	—	None	201 Haskins Way, 5th Floor South San Francisco, CA 94080	United States of America	North America	https://electra-therapeutics.com/
Clinical	YABS0609	10/02/2024	None	ES102, INBRX-106	None	mAb humanized	Naked monospecific	Fragment-Fc	(VHH-VHH-VHH)2-Fc	OX40	IgG1	None	None	None	None	Immune check point target. Hexavalent OX40 agonist antibody. Wild type IgG1 Fc.	None	None	Phase 2/3	Active	12/12/2019	—	05/14/2024	Non-small cell lung cancer, Head and neck cancer, solid tumors	Cancer	Inhibrx Biosciences Inc.	Elpiscience Biopharma Ltd.	NCT06623136 Phase 2 in NSCLC due to start in Oct 2024. NCT06295731 Phase 2/3 in head and neck cancer started in May 2024 Jan 2024: all non-101 assets and liabilities, including INBRX-105, INBRX-106, INBRX-109, Inhibrx's non-101 discovery pipeline and its corporate infrastructure, will be spun out from the Company into a new publicly traded company, Inhibrx Biosciences, Inc. Aug 2023 Inhibrx presentation: Promising clinical activity in ongoing phase 1/2; Randomized, Phase 2 study in CPI r/r NSCLCSA and in combo with IO; update in Q4 ’23 with data expected 2H ‘24. https://inhibrx.com/wp-content/uploads/2023/08/Inhibrx-Presentation-August-2023.pdf NCT04991506 Phase 1 started in Oct 2021 still recruiting as of last update in Dec 2022. NCT04730843 Phase 1 in solid tumors started in March 2021. Elpiscience has in-licensed ES102/ INBRX-106 from Inhibrx, and possesses rights to manufacture, develop, and commercialize in greater China. ES102 has shown impressive monotherapy efficacy in pre-clinical animal models and has the potential to translate clinically. ES102 is currently being evaluated in dose escalation study in the US, while Elpiscience also received IND approval from CDE in August 2020. NCT04198766 Phase 1 started recruiting in Dec 2019; changed to Phase 1/2 as per title: An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors.	None	—	—	—	None	La Jolla, CA 92037	United States of America	North America	https://inhibrx.com/
Clinical	YABS0610	01/29/2025	Tovecimig	CTX-009, ES104, TR009, NOV1501, ABL001	None	mAb - source TBD	Bispecific	Appended Ig	scFv-scFv-Full-length antibody	DLL4, VEGF	TBD	TBD	None	None	None	IgG with 2x c-terminal scFv fusion. Paper "ABL001 [TR009], a Bispecific Antibody Targeting VEGF and DLL4, with Chemotherapy, Synergistically Inhibits Tumor Progression in Xenograft Models" reports that TR009 demonstrates more potent in vitro and in vivo biological activity compared to VEGF or DLL4 targeting monoclonal antibodies alone.	None	None	Phase 2/3	Active	09/18/2017	06/22/2020	01/15/2023	Colorectal cancer, Solid tumors	Cancer	National OncoVenture	Compass Therapeutics Inc., Elpiscience Biopharmaceuticals, ABL Bio Inc.	Nov 2024: Fully enrolled the Phase 2/3 trial of lead asset CTX-009 (DLL4 and VEGF-A bispecific antibody) in patients with biliary tract cancers (BTC); top-line data readout is on track for the end of the first quarter of 2025. NCT05506943 Phase 2/3 in Biliary Tract Cancers started in Jan 2023 active not recruiting as of last update in Aug 2024. Nov 1 2021 press release: A Phase 2a study for CTX-009 in combination with paclitaxel was initiated by Handok Pharmaceuticals, Inc. in Q1 2021 in patients with BTC and the enrollment in the first part of the study has been completed. May 2021: Compass Therapeutics, Inc. and TRIGR Therapeutics, Inc., a private biotechnology oncology company, today announced that the companies have entered into a definitive merger agreement, under which Compass, through a subsidiary, will acquire TRIGR. Jan 2021: TRIGR Therapeutics, Inc., a US based clinical stage biopharmaceutical company focused on the development of multi-targeted angiogenic and immunomodulatory bispecific antibodies for oncology and certain ischemic indications and Elpiscience Biopharmaceuticals, a leading China based clinical stage company focused on developing next generation of cancer immunotherapies announced today that they have entered into an exclusive licensing agreement for the development and commercialization of TR009 in mainland China, Hong Kong, Macau and Taiwan. NCT04492033 Phase 1/2 in advanced solid tumors started in June 2020. March 25, 2019: TRIGR Therapeutics, Inc., a newly formed privately held company focused on the clinical development and commercialization of targeted and immunomodulatory bispecific antibodies for oncology and ophthalmology indications, announced today that it has completed the second tranche of its seed financing round, with $14 million in aggregate proceeds. TRIGR's pipeline now includes one clinical stage dual angiogenesis bispecific antibody (TR009) which is currently in a dose escalation phase 1a clinical trial being conducted at the Samsung Medical Center in Seoul, South Korea and 3 dual checkpoint and T-cell engaging bispecific antibody candidates. TR009 (ABL001/NOV1501) phase 1a/phase 1b clinical trials are conducted under the auspices of National OncoVenture (NOV), a Korean government funded organization. TRIGR licensed TR009 in Dec 2018. NCT03292783 Phase 1 study started in Sep 2017 last updated in Sep 2017, but results were discussed in March 25 2019 press release: As an update to the Phase 1a dose escalation study, TR009 single agent clinical activity has been demonstrated across all dose levels in heavily pre-treated (5+ lines of prior therapy) cancer patients with solid tumors including gastric, colon, GIST, and ovarian cancers.	None	—	—	—	None	Madu, Kyonggi-do, South Korea	Republic of Korea	Asia	https://www.crunchbase.com/organization/national-oncoventure
Clinical	YABS0612	12/13/2024	None	OQY-3258, ESG401, ESG-401, STI-3258	None	mAb humanized	ADC	Full length Ab	None	TROP-2	IgG1	TBD	Undisclosed	___	Topoisomerase I inhibitor, SN38 (irinotecan active metabolite)	Recombinant Humanized Anti-Trop2 Mab-SN38 Conjugate. ESG-401 has potentially distinct differentiating advantages over its competitors in terms of safety, effectiveness and process robustness. Using an innovative, highly stable and cleavable linker, this ADC demonstrated in a series of preclinical studies that it releases very little free toxin during circulation, highly enriches in tumor tissues and rapidly endocytoses, thereby effectively killing tumor cells and inhibiting tumor growth.	None	None	Phase 3	Active	06/15/2021	07/15/2022	07/11/2024	Metastatic Breast Cancer, Solid tumors	Cancer	Sorrento Therapeutics Inc.	Escugen Biotechnology Co Ltd., Levena (Suzhou) Biopharma Co. Ltd.	Dec. 27, 2024: Vincerx Pharma, Inc. announced that it has entered into a binding term sheet for a proposed merger with Oqory, Inc., a privately-held, clinical-stage company developing ADCs for the treatment of multiple oncology indications. OQY-3258 is also known as ESG401. (https://oqory.com/wp-content/uploads/2025/01/Oqory_JPM-Slide-Deck_09JAN25.pdf) NCT06732323 Phase 3 in triple-neg breast cancer due to start in Feb 2024. NCT06383767 Phase 3 in Metastatic Breast Cancer started in July 2024. NCT04892342 Phase 1/2 started in Sep 2021 recruiting as of last update in Oct 2022. July 21, 2021: Sorrento Therapeutics, Inc. announced its partner Escugen Biotechnology Co, Ltd. (“Escugen”) and Sorrento’s subsidiary Levena (Suzhou) Biopharma Co., Ltd. (“Levena”) have received an approval letter from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Application for Clinical Trial (Acceptance No. CXSL2101069) of Recombinant Humanized Anti-Trop2 Mab-SN38 Conjugate. The TROP-2 ADC (ESG-401) was jointly developed by Shanghai-based Escugen and Levena, and the two companies jointly own the domestic and international patents for this ADC and share global rights for the product. Sorrento intends to file a US IND for this ESG-401 before the end of 2021.	None	—	—	—	None	9380 Judicial Drive San Diego, CA 92121	United States of America	North America	https://sorrentotherapeutics.com/contact/
Clinical	YABS0619	08/29/2024	None	MK-3000, EYE103, F4L5.13, ANT-39, Restoret™	None	mAb - source TBD	Multispecific, Trispecific, Biparatopic	Fragment-Fc	1+1 asymmetric, Diabody-Fc-Diabody	FZD4, LRP5, LRP5	IgG1	TBD	None	None	None	June 2023: Clinical testing of AntlerA’s first-in class Norrin/Wnt-agonist antibody initiated through a strategic collaboration and licensing agreement with EyeBio Derived from ANT-Pharm platform, EYE103 is a Norrin/Wnt-agonist clinical antibody molecule developed by EyeBio in close collaboration with AntlerA for treatment of retinopathies F4L5.13 consists of a diabody formed by two identical paratopes recognizing FZD4 fused to the N-terminus of a heterodimeric Fc, and a diabody composed of two distinct paratopes, respectively, recognizing the first two propellers (E1E2; Wnt-1 binding site) and the membrane proximal two propellers (E3E4; Wnt-3 binding site) of LRP5 fused to the C-terminus of the Fc Here, we developed F4L5.13, a tetravalent antibody designed to induce FZD4 and LRP5 proximity in such a way as to trigger βcatenin signaling. Treatment of cultured endothelial cells with F4L5.13 rescued permeability induced by VEGF in part by promoting surface expression of junction proteins. Treatment of Tspan12−/− mice with F4L5.13 restored retinal angiogenesis and barrier function. F4L5.13 treatment also significantly normalized neovascularization in an oxygen-induced retinopathy model revealing a novel therapeutic strategy for diseases characterized by abnormal angiogenesis and/or barrier dysfunction. https://www.embopress.org/doi/full/10.15252/emmm.202113977 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8261507/ "There is a significant unmet medical need in several rare pediatric retinopathies including FEVR/Norrie, Coats, and ROP, as there are no approved drugs for their treatment. Our Norrin/Wnt7-mimetic is an important drug candidate for these pediatric patients. Also, it will provide a new treatment modality for macular telangiectasia and diabetic retinopathy, which afflicts over 4 million people in the US alone. The mechanism of action of the drug is supported by strong human and mouse genetics and it acts by restoring signaling fundamental to junctional integrity of vascular blood vessels. We plan to bring this exciting drug to clinical trials rapidly," said Dr. Sekar Seshagiri, CEO of AntlerA Therapeutics.	None	None	Phase 2/3	Active	06/15/2023	—	08/14/2024	Diabetic macular edema and neovascular age-related macular degeneration	Ophthalmic disorders	AntlerA Therapeutics	Merck	NCT06571045 Phase 2/3 in diabetic macular edema started in Aug 2024. May 2024: Merck, known as MSD outside of the United States and Canada, and EyeBiotech Limited (EyeBio), a privately held ophthalmology-focused biotechnology company, today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire EyeBio. Restoret is anticipated to advance into a pivotal Phase 2b/3 trial to investigate the treatment of patients with DME in the second half of 2024. February 13, 2024 – Eyebiotech Limited announced the presentation of Week 12 data from its first-in-human Phase 1b/2a AMARONE trial of Restoret in patients with treatment-naïve diabetic macular edema and treatment-naïve neovascular age-related macular degeneration. The Phase 1b/2 AMARONE (Anti-permeability Mechanism and Age-Related Ocular Neovascularization Evaluation) clinical trial is a multi-centre two-part trial consisting of an open-label multiple ascending dose (MAD) safety study, and a dose-finding single-masked comparative safety and preliminary efficacy study of intravitreal (IVT) Restoret™ (EYE103) in participants with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD).	None	—	—	—	None	Toronto, Ontario, Canada	Canada	North America	https://pitchbook.com/profiles/company/279759-79#overview
Clinical	YABS0621	01/26/2024	Rulonilimab	F520	None	mAb chimeric	Naked monospecific	Full length Ab	None	PD-1	IgG1	kappa	None	None	None	Immune checkpoint target; described as humanized by company	None	None	Phase 2/3	Active	03/01/2019	11/01/2020	11/01/2022	Non-small cell lung cancer, cervical carcinoma, Peripheral T Cell Lymphoma, Hepatocellular Carcinoma, Urothelial Cell Carcinoma	Cancer	Shandong New Time Pharmaceutical Co. LTD	None	NCT05408221 Phase 2/3 study started in Nov 2022 is recruiting as of last update in March 2023. As of March 2022, 4 Phase 2 studies are listed as not yet recruiting, e.g., NCT05178836 Phase 2 in diffuse large B-cell lymphoma due to start in Jan 2022. NCT06226350 Phase 2 in cervical cancer started in Mar 2021. NCT04636515 Phase 2 in Urothelial Carcinoma due to start in January 2021. NCT04457830 Phase 1 in Peripheral T Cell Lymphoma. NCT03657381 Phase 1 study started in March 2019. Recombinant Programmed death-1(PD-1) humanized monoclonal antibody injection (company code: F520) jointly developed by Shandong New Time Pharmaceutical Co., LTD	None	—	—	—	None	No. 209, Hongqi Road, Linyi City, Shandong Province, China	China	Asia	http://lunanpharma.com/contact/
Clinical	YABS0625	07/25/2024	None	FDA018, FDA018-ADC	None	mAb - source TBD	ADC	TBD	TBD	TROP-2	TBD	TBD	Undisclosed	___	Topoisomerase I inhibitor, SN38 (irinotecan active metabolite)	Anti-Trop2 antibody-coupled SN38 drug for the treatment of advanced malignant solid tumors (also known as “FDA018 antibody for injection").	None	None	Phase 3	Active	03/15/2021	—	08/09/2024	Triple-negative Breast Cancer, Solid tumors	Cancer	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd	None	NCT06519370 / CTR20242630 Phase 3 in Triple-negative Breast Cancer started in Aug 2024. NCT05174637 Phase 1: First patient dosed Oct 22 2021. The clinical trial application for the Coupling Agent Project”) was accepted in April 2021, and the "Drug" approved and issued by CDE was approved in June 2021. April 2021: China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd’s clinical trial filing for FDA018, an anti-trophoblast cell-surface antigens2 (TROP2) antibody drug conjugate (ADC), has been accepted for review by the National Medical Products Administration. The drug, filed as a Category 1 therapeutic biologic product, will be assessed as a treatment for solid tumors.	None	—	—	—	None	308 Cailun Rd., Z.J.Hi-tech Park, Shanghai, P.R.China	China	Asia	http://www.fd-zj.com/desktopmodules/ht/English/ContactUs/Index.aspx?LS=1