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	YABS1727	10/24/2024	Ongericimab	JS002	君适达®	mAb humanized	Naked monospecific	Full length Ab	None	PCSK9	IgG4	kappa	None	None	None	JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. S228P (hinge-stabilization)	None	None	Approved China	Active	12/11/2017	01/15/2019	12/23/2020	Hypercholesterolemia	Metabolic disorders	Shanghai Junshi Bioscience Co Ltd	None	October 12, 2024: Junshi Biosciences Announces Ongericimab’s NDA Approval in China. [accessed 2024 Oct 15] https://www.junshipharma.com/en/君实生物宣布昂戈瑞西单抗（君适达）在中国获/ April 25, 2023 Shanghai Junshi Biosciences announced the acceptance of the new drug application for the company’s recombinant humanized anti-PCSK9 monoclonal antibody (product code: JS002) by the National Medical Products Administration Feb. 27, 2023: Shanghai Junshi Biosciences Co., Ltd announced the successful completion of two randomized, double-blind, placebo-controlled, multi-center phase III clinical studies (Study nos.: JS002-003 and JS002-006) evaluating the company’s product ongericimab (a recombinant humanized anti-PCSK9 monoclonal antibody, product code: JS002) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, and both studies have met their primary endpoints. YE 2021 report lists asset as in Phase 3; no mention of plans for regulatory submission NCT04781114 Phase 3 started in Dec 2020. NCT04469673 Phase 1/2 study started in May 2019. Jan 2019: Shanghai Junshi Bioscience Co Ltd registered a Phase II, randomized, double-blind, controlled trial evaluating the safety, tolerability, efficacy, and pharmacokinetic and pharmacodynamic characteristics of multiple doses of JS002 in patients with hyperlipidemia. The trial was registered with the China clinical trial registry. NCT04197817 Phase 1 started in Dec 2017.	None	2024	—	—	Ongericimab	100, Pingjiaqiao Road, Shanghai, China	China	Asia	https://www.junshipharma.com/en/contact-us/
Approved	YABS1728	02/13/2025	Catumaxomab	LP000	Korjuny, REMOVAB	mAb murine/rat	Bispecific	Full length Ab	None	EPCAM, CD3	IgG2a/b	TBD	None	None	None	IgG2a (mouse), IgG2b (rat)	Quadroma/hybrid hybridoma (rat/mouse)	None	Approved EU	Active	07/02/2001	—	07/02/2004	Malignant Ascites Due to Epithelial Carcinoma, ovarian cancer, gastric cancer	Cancer	Trion	LintonPharm, Lindis Biotech GmbH, Fresenius	Feb 2025: Lindis Biotech GmbH and Pharmanovia announced that catumaxomab has received marketing authorisation from the European Commission, making the drug the only approved drug therapy for malignant ascites for patients living with this debilitating condition across Europe. Under a licensing agreement, LINDIS has granted Pharmanovia the exclusive rights to bring catumaxomab to market and spearhead its launch across Europe. Catumaxomab is a T cell engaging bispecific antibody targeting epithelial cellular adhesion molecule (EpCAM) on tumor cells and CD3 on T cells. Catumaxomab was originally granted marketing authorisation under the brand name Removab in the EU on 20 April 2009 for treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. The product has not been marketed since 2014 and on 2 June 2017 the product was withdrawn from the EU due to commercial reasons. Dec 2022: CHMP meeting: catumaxomab - EMEA/H/C/005697; indicated for the treatment of malignant ascites; Scope: List of questions; Letter by the applicant requesting an extension to the clock stop to respond to the list of questions to be adopted in December 2022. The Committee adopted the CHMP recommendation and scientific discussion together with the list of questions. The CHMP agreed to the request by the applicant for an extension to the clock stop to respond to the list of questions with a specific timetable. EMA started evaluating a marketing application in Aug 2022. NCT04819399 Phase 1 in Urinary Bladder Neoplasms sponsored by Lindis Biotech GmbH started recruiting patients in July 2020. NCT04799847 Phase 1/2 in bladder cancer due to start in July 2021. July 2020: LintonPharm announced the China National Medical Products Administration (NMPA) authorized the company to proceed with a Phase III trial for catumaxomab in patients with peritoneal carcinomatosis, a form of advanced gastric cancer that has spread to the tissue that lines the abdominal cavity. LintonPharm also recently received Clinical Trial Application (CTA) authorization for the same indication from the Taiwan Ministry of Health and Welfare (MOHW) and the Korea Ministry of Food and Drug Safety (MFDS). Withdrawn from EU market in June 2017 Marketing authorization granted on April 20, 2009; withdrawn June 2, 2017 at the request of authorization holder Neovil Biotech GmbH. Decision to permanently discontinue marketing was due to commercial reasons. The product had not been marketed in the EU since 2014.	None	2009	—	—	Catumaxomab	Trion Research GmbH, Zeppelinstraße 4, 82178 Puchheim	Germany	Europe	https://www.trionresearch.com/contact/
Approved	YABS1729	09/25/2024	Donanemab	LY3002813, N3pG-AB mAb	Kisunla, 记能达	mAb humanized	Naked monospecific	Full length Ab	None	Amyloid beta (N3pG)	IgG1	kappa	None	None	None	None	None	Regulatory review EU	Approved US, Japan, China, UK	Active	05/15/2013	12/18/2017	03/15/2021	Alzheimer disease	Neurological disorders	Eli Lilly and Company	None	July 2, 2024: The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt) March 8, 2024: Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer's disease. Date of meeting has not been set. EMA evaluation started Aug 17, 2023. Jan 19, 2023: The U.S. Food and Drug Administration has issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. No other deficiencies in the application were noted. The confirmatory Phase 3 TRAILBLAZER-ALZ 2 trial remains ongoing, with topline data read-out expected in Q2 2023, and will form the basis of donanemab's application for traditional approval shortly thereafter. October 2021: Eli Lilly has announced that they have initiated rolling submission of a biologics license application (BLA) for donanemab, an investigational antibody therapy, to the FDA for accelerated approval in early Alzheimer disease (AD). July 15, 2021: Eli Lilly and Company and Banner Alzheimer's Institute today announced a strategic research collaboration as part of the planned Phase 3, randomized, placebo-controlled study evaluating donanemab in participants at risk for cognitive and functional decline related to Alzheimer's disease (TRAILBLAZER-ALZ 3). TRAILBLAZER-ALZ 3 will evaluate whether treatment with donanemab can slow the clinical progression of Alzheimer's disease in trial participants. Listed as Phase 3 in Lilly pipeline dated April 23, 2021. NCT04437511 converted into a Phase 3 study in March 2021. March 13, 2021: Phase 2 TRAILBLAZER-ALZ results presented by Eli Lilly and Company at the 15th International Conference on Alzheimer's & Parkinson Diseases™ 2021 held virtually March 9-14, 2021 and published simultaneously in the New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2100708) expand on previously reported top-line data that found donanemab met its primary endpoint and showed significant slowing of decline on the integrated Alzheimer's Disease Rating Scale (iADRS), a composite measure of cognition and daily function, in patients with early symptomatic Alzheimer's disease compared to placebo NCT04640077 Phase 2 in AD not yet recruiting when first posted on Nov 23, 2020. NCT04437511 Phase 2 study in AD not yet recruiting when first posted on June 18, 2020. Still listed in Lilly pipeline dated July 29, 2019. NCT03367403 Phase 2 study started in Dec 2017. Listed as Phase 1 in pipeline dated April 19, 2016. NCT01837641 Phase 1 study started in May 2013	None	2024	06/12/2023	07/02/2024	Donanemab, donanemab-azbt	Indianapolis, Indiana, United States	United States of America	North America	https://www.lilly.com
Regulatory review	YABS1730	08/17/2023	Narsoplimab	OMS721	(Pending)	mAb human	Naked monospecific	Full length Ab	None	MASP-2	IgG4	lambda	None	None	None	Target is mannan-binding lectin-associated serine protease-2. https://www.bbmt.org/article/S1083-8791(16)30736-4/pdf. S228P hinge mutation.	None	Sponsor response to FDA CRL	Regulatory review US	Active	05/15/2013	08/15/2014	02/23/2017	Steroid-dependent IgA nephropathy, Thrombotic Microangiopathies, Atypical hemolytic uremic syndrome (Phase 1 in healthy volunteers)	Cardiovascular / hemostasis disorders	Omeros Corporation	None	Oct 2023: Omeros has stopped a phase 3 trial of narsoplimab in immunoglobulin A (IgA) nephropathy patients after an interim analysis found it was destined to fail, adding another plot line to its epic, ongoing attempt to get the candidate to market. Aug 2023 press release: In May 2023 we had a Type B meeting with the review division at FDA to discuss the planned resubmission of our Biologics License Application (“BLA”) for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”). Based on the agency’s feedback we expect to submit to FDA early next month a detailed plan for analysis of survival data from already-identified external sources. Nov 2022: FDA's decision proposes the resubmission of the narsoplimab BLA including a comparison of the existing response data from the completed pivotal trial to a threshold derived from an independent literature analysis and evidence of increased survival from patients in the pivotal trial compared to an appropriate historical control group. It also notes that persuasive evidence of superior survival versus a well-matched historical control group could be sufficient even in the absence of the independent literature analysis. The specific approach to resubmission and its details would be determined through discussion with the review division. June 2022, Omeros submitted to the United States Food and Drug Administration (FDA) a request for Formal Dispute Resolution regarding the Complete Response Letter (CRL) issued by FDA last year regarding the Company’s biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Formal dispute resolution is an official pathway that enables a sponsor to appeal a decision by an FDA division to a higher authority within FDA, in this case the Office of New Drugs (OND). Last month, in accordance with the standard dispute resolution procedure, Omeros had a formal meeting with the OND official assigned to decide the dispute. A decision is expected in August 2022. November 18, 2020 I Omeros Corporation announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designation and orphan drug designation from FDA for HSCT-TMA. March 2020: In recent meetings with FDA focused on clinical as well as chemistry, manufacturing and controls (CMC) data, FDA confirmed important aspects of Omeros’ rolling Biologics License Application (BLA) for narsoplimab in HSCT-TMA. The BLA continues on its clear path to completion. Rolling BLA started in Oct 2019. Feb 2019: FDA will consider not only accelerated approval but also regular (full) approval for OMS721 in HSCT-TMA, with the determination based on the submitted data. A rolling BLA submission is appropriate for OMS721 in this indication. Omeros plans to submit first the nonclinical sections. Oct 2018: OMS721 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Aug. 28, 2018-- Omeros Corporation today announced that the European Commission (EC) has adopted a decision designating OMS721 as an Orphan Medicinal Product in the European Union (EU) for treatment in hematopoietic stem cell transplantation (HSCT). The adoption by the EC follows a positive opinion for orphan designation of OMS721 in this indication by the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP). April 2018: FDA granted Breakthrough therapy designation. Feb. 15, 2018-- Omeros Corporation today announced new results from the company’s ongoing Phase 2 study of OMS721 evaluating patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA). The data demonstrate an increase in median overall survival in HCT-TMA patients treated with OMS721 compared to a matched historical control. Omeros is scheduled and expects to meet with the U.S. Food and Drug Administration and with the European Medicines Agency to discuss the most expeditious path to approval for OMS721 in HCT-TM. Aug. 4, 2017-- Omeros Corporation today announced that OMS721 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of Immunoglobulin A (IgA) nephropathy June 2017: The FDA has granted breakthrough therapy designation to Omeros' OMS721 as a treatment for IgA nephropathy. March 2017: Omeros met with FDA recently to discuss these data and Phase 3 development. Following review of the data, FDA suggested that Omeros apply for breakthrough therapy designation in IgAN. The discussion included accelerated approval and an expedited approach to full approval based on an endpoint of proteinuria, which could be faster than accelerated approval. Omeros is preparing its breakthrough application and a Phase 3 protocol for discussion with FDA. The Phase 3 trial in IgAN is expected to begin this year. Fast track designation granted in March 2016. Start of Phase 3 program announced on March 8, 2016; Phase 3 enrollment is expected to begin later this year and patients currently being treated in the Phase 2 trial are likely to be included in the Phase 3 program. The OMS721 Phase 3 program will consist of one clinical trial – a single-arm (i.e., no control arm), open-label trial in patients with newly diagnosed or ongoing aHUS.The FDA has awarded OMS721 both orphan drug designation for the treatment of TMAs and fast-track status for the treatment of aHUS. Omeros' breakthrough therapy OMS721, indicated to treat patients with the kidney disorder Berger's disease, has been granted orphan drug status by the FDA	None	—	—	—	Narsoplimab	201 Elliott Avenue West, Seattle, WA 98119	United States of America	North America	https://www.omeros.com/contact-us/
Approved	YABS1731	01/03/2025	Marstacimab	PF-06741086	Hympavzi*	mAb human	Naked monospecific	Full length Ab	None	Tissue factor pathway inhibitor	IgG1	lambda	None	None	None	Tissue factor pathway inhibitor (or TFPI) is a single-chain polypeptide which can reversibly inhibit Factor Xa (Xa). Fc mutations L234A, L235A, G237A (impair Fc effector functions)	None	None	Approved EU, US, Australia	Active	09/15/2015	03/08/2017	10/30/2019	Severe hemophilia, Phase 1 in healthy subjects	Cardiovascular / hemostasis disorders	Pfizer	None	EC close date is Nov 19, 2024. Oct 11, 2024: Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) without factor VIII (FVIII) inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX (FIX) inhibitors. Sep 20, 2024: Hympavzi* (marstacimab), received a positive opinion for the treatment of bleeding episodes in patients aged 12 years and older with severe haemophilia A or B, two types of a rare inherited bleeding disorder. The FDA has set a PDUFA action date in the fourth quarter of 2024, and a decision from the EC is anticipated by the first quarter of 2025. Mid-Dec 2023: Pfizer announces BLA submitted to FDA. Marstacimab appears on EMA list of applications under evaluation by the CHMP (Data extracted 30 October 2023) May 2023: Pfizer Inc. announced that the pivotal Phase 3 BASIS clinical trial (NCT03938792) evaluating marstacimab has met its primary endpoints. Analyses of the full Phase 3 dataset are ongoing, and results will be presented at an upcoming scientific conference. Pfizer will discuss these data with regulatory authorities, with the goal of initiating regulatory filings in the coming months. NCT05145127 is a Phase 3 with primary completion date in July 2030. NCT04878731 is a Phase 1 of subcutaneous formulation. NCT03938792 (EudraCT2018-003660-31) Phase 3 study in severe hemophilia A or B started in Oct 2019; primary completion date is in Sep 2024. NCT03363321 multicenter, open-label Phase II study to evaluate the long-term safety, tolerability and efficacy of subcutaneous or intravenous PF-06741086 in subjects with severe hemophilia started in May 2018. NCT02531815 Phase 1 study in health subjects completed in July 2016. US and EU orphan designations. Fast track designation in US.	None	2024	10/11/2023	10/11/2024	Marstacimab, marstacimab-hncq	66 Hudson Boulevard East, New York, NY 10001-2192 USA	United States of America	North America	https://www.pfizer.com
Approved	YABS1732	10/15/2024	Iparomlimab, Tuvonralimab	PSB-103, PSB205, QL1706, QL1706H, 艾帕洛利单抗托沃瑞利单抗注射液	齐倍安	mAb - source TBD	Mixture of 2	Full length Ab	None	PD-1, CTLA-4	IgG4	kappa	None	None	None	Immune checkpoint targets PSB205 is a novel bifunctional product that contains a mixture of unique anti-PD-1 and anti-CTLA4 monoclonal antibodies produced by a single cell line via the company's proprietary MabPair technology. MabPair products offer many advantages over bispecific antibodies. The relative ratio of the two antibodies in the MabPair can be well-controlled and each antibody is individually engineered for optimal target coverage, effector function, pharmacokinetics and exposure. PSB205 represents a potentially best-in-class immuno-oncology product that promises to exhibit robust combination activity while being significantly more tolerable to patients than currently approved anti-PD-1/anti-CTLA-4 combinations. Iparomlimab is humanized heavy chain and chimeric light chain; tuvonralimab is humanized https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.5535. Iparomlimab (anti-PD-1), Tuvonralimab (anti-CTLA-4) QL1706H is the subcutaneously administered formulation of QL1706. (anti-PD-1; hinge-stabilized (S228P)); IgG1 kappa (anti-CTLA4; K147D F170C V173C C220G R255K D399R K409E mutations for heterodimerization)	None	None	Approved China	Active	03/10/2019	03/11/2022	05/01/2022	Hepatocellular carcinoma, Nasopharyngeal Carcinoma, Non-small cell lung cancer, small cell lung cancer, renal cell carcinoma, cervical cancer, solid tumors	Cancer	Qilu Puget Sound Biotherapeutics Corp.	None	Conditional marketing approval for cervical cancer in China 25 Sep 2024. https://www.einpresswire.com/article/751512407/sound-biologics-announces-breakthrough-approval-of-psb205-by-the-national-medical-products-administration-in-china?n=2 China marketing application acceptance date is Aug 12, 2023 according to NMPA's CDE database. NCT05976568 Phase 2/3 in hepatocellular carcinoma due to start in Sep 2023. As of Aug 2023, Phase 3 study for PD-L1 negative, locally advanced or metastatic non-small cell lung cancer (CTR20223309) status is "In progress, Recruiting" (this study has the same protocol id as NCT05690945 study); Phase 3 study for non-small cell lung cancer (CTR20222281) status is "In progress, recruiting" (this study has the same protocol id as the NCT05487391 study). Phase 2/3 study for Nasopharyngeal carcinoma (NCT05576272) is recruiting as of Octover 24, 2022; phase 3 studies: for Non-small cell lung cancer (NCT05487391 is not yet recruiting as of August 4, 2022, NCT05690945 is not yet recruiting as of January 19, 2023), Cervical cancer (NCT05446883) is recruiting as of November 30, 2022. NCT05690945 Phase 3 in lung cancer due to start in Feb 2023 NCT05446883 Phase 3 in cervical cancer started in Nov 2022. NCT05576272 Phase 2/3 in Nasopharyngeal Carcinoma started in May 2022. NCT05179317 is a Phase 2 in cervical cancer. April 13, 2021: Qilu Puget Sound Biotherapeutic Corp. (Sound Biologics), an emerging biotechnology company focused on developing a novel MabPair™ platform for antibody-based combination therapies for the treatment of cancer, inflammation and autoimmune disease, announced a clinical update on its first MabPair product PSB205 at the American Association for Cancer Research (AACR) Annual Meeting. Dr Li Zhang of Sun Yat-Sen University Cancer Centre (SYSUCC), Guangzhou, China presented a poster on Phase 1 Clinical Trial results of PSB205, a combination of anti-PD1 and anti-CTLA-4 antibodies that are manufactured together as a single product, in patients with advanced malignant tumors. The study is sponsored by Qilu Pharma in China. NCT04296994 in solid tumors not yet recruiting when first posted on March 5, 2020. NCT03986606 Phase 1 in solid tumors not yet recruiting as of last update in June 2019. April 10, 2019: Qilu Puget Sound Biotherapeutic Corp. (Sound Biologics), an emerging biotechnology company dedicated to developing next generation antibody combination therapies, today announced that U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application and issued authorization to commence a Phase I First-in-Human Clinical Trial of PSB205 for the treatment of patients with relapsed/refractory solid tumors. PSB205 is an immuno-oncology biotherapeutic that represents the first of a new class of therapeutic modality.	None	2024	—	—	Iparomlimab, Tuvonralimab	21720 23rd Dr SE Bothell, WA 98021	United States of America	North America	https://www.soundbiologics.com/news/
Regulatory review	YABS1733	10/15/2023	Iparomlimab	QL1604, 艾帕洛利单抗注射液	(Pending)	mAb chimeric/humanized	Naked monospecific	Full length Ab	None	PD-1	IgG4	kappa	None	None	None	Immune checkpoint modulator. QL1604 is the anti-PD1 component of QL1706 [iparomlimab (anti-PD1) + tuvonralimab (anti-CTLA-4)].	None	Regulatory review China - anticipate approval	Regulatory review China	Active	05/15/2019	—	09/23/2020	Cervical Cancer	Cancer	Qilu Pharmaceutical Co., Ltd.	None	China marketing application acceptance date is Sep 17, 2023 according to NMPA's CDE database. May 31, 2023: “A Phase Ib/II Clinical Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of QL1706 or QL1604 in Patients with Advanced HCC” results suggest that QL1706, in combination with bevacizumab, resulted in a higher ORR and longer PFS compared to QL1604 when used as first-line treatment for advanced HCC. These findings support further investigation of QL1706 plus bevacizumab for first-line treatment of advanced HCC in a phase III clinical trial.” December 4, 2022: “Qilu Pharmaceutical Releases Latest Results of QL1604 plus Chemotherapy as First-Line Treatment for Patients with Advanced Cervical Cancer in the Phase II Study at ESMO Asia Congress 2022”"We are pleased to release the latest study results of QL1604 plus chemotherapy as first-line treatment for patients with advanced cervical cancer. QL1604 plus chemotherapy showed promising antitumor activity and manageable safety profile as first-line treatment for women with R/M cervical cancer. Further investigations in this setting are ongoing." https://pipelinereview.com/index.php/2022120482172/Antibodies/Qilu-Pharmaceutical-Releases-Latest-Results-of-QL1604-plus-Chemotherapy-as-First-Line-Treatment-for-Patients-with-Advanced-Cervical-Cancer-in-the-Phase-II-Study-at-ESMO-Asia-C.html CTR20211777 Phase 2/3 in cervical cancer started in Sep 2020 recruiting as of first public information in May 2022. NCT04864782 Phase 2/3 in cervical cancer started in Sep 2020 terminated in Nov 2023 due to sponsor decision. NCT04435652 Phase 2/3 in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma was not updated after first posting in June 2020. NCT05649761 Phase 1 started in May 2019; NCT05801094 Phase 1 started in July 2020.	None	—	—	—	None	8888 Lvyou Road , High-tech Zone , Jinan , 250104 , China	China	Asia	https://en.qilu-pharma.com/contactdetails.html
Approved	YABS1734	03/05/2025	Odronextamab	REGN1979	Ordspono	mAb human	Bispecific	Full length Ab	None	CD20, CD3	IgG4	kappa	None	None	None	common light chain, hetero-H-chain IgG; REGN1979 is a hinge-stabilized human bispecific antibody based on an IgG4 isotype modified to reduce Fc binding. REGN1979 described in Sci Rep. 2015; 5: 17943. Published online 2015 Dec 11. doi: 10.1038/srep17943	Transgenic mouse (VelocImmune)	PDUFA date is July 30, 2025	Approved EU	Active	11/15/2014	07/24/2019	—	Follicular Lymphoma, DLBCL, CD20+ B-cell malignancies	Cancer	Regeneron Pharmaceuticals	Zai Lab	Feb. 26, 2025: Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The target action date for the FDA decision is July 30, 2025 . On August 26, 2024, Regeneron announced that the European Commission approved Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. June 28, 2024: Regeneron Pharmaceuticals, Inc., announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. March 25, 2024: Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has issued Complete Response Letters for the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. The only approvability issue is related to the enrollment status of the confirmatory trials. The CRLs – one for R/R FL and one for R/R DLBCL – did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing. Aug. 17, 2023: Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. The EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL. May 2023: Regeneron to submit a Biologics License Application (BLA) to the FDA for relapsed/refractory (R/R) DLBCL and R/R FL in the second half of 2023. FDA grants Fast Track designation for R/R FL and DLBCL. In December 2022, Regeneron announced positive first interim data from the ELM-2 Phase II trial in patients with heavily pre-treated, R/R FL and DLBCL. Potentially registrational trial in NHL started by Zai Lab in Oct 2021. December 14, 2020 I Regeneron is pausing new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in its trials for odronextamab, a CD20xCD3 bispecific antibody, in compliance with a U.S. Food and Drug Administration (FDA) partial clinical hold. The FDA requested that the company amend the trial protocols in order to further reduce the incidence of ≥Grade 3 cytokine release syndrome (CRS) during step-up dosing. Currently enrolled patients who are deriving clinical benefit from odronextamab may continue treatment following re-consent. April 2020: Regeneron Pharmaceuticals and Zai Lab announced a strategic collaboration for the development and commercialization of REGN1979 (CD20xCD3 bispecific antibody) in mainland China, Hong Kong, Taiwan and Macau. The collaboration will support global clinical development for REGN1979, starting with the ongoing potentially registrational Phase II program in B-cell non-Hodgkin lymphoma (B-NHL). Additionally, if REGN1979 is approved, Zai Lab will leverage its capabilities to commercialize REGN1979 in this region. Feb 2020: Regeneron plans regulatory submission in B cell NHL in 2020. Aug 6, 2019 press release: Phase 2 study in relapsed or refractory follicular lymphoma (FL) is recruiting patients. NCT03888105 Phase 2 study in Follicular Lymphoma started recruiting Jul 24 2019. In June 2019, the Company presented updated positive results from a study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma at the European Hematology Association meeting. May 2019: Regeneron Discloses Two Deaths from its Bispecific Antibody RGN1979, thought to be due to dosing (researchers discovered enhanced cytokine release syndrome that may be associated with increased tumor response. That increased toxicity was the possible cause of the two deaths). NCT02651662 and NCT02290951 Phase 1 studies recruiting as of Aug 2018. Jan 2018: The FDA designates Regeneron Pharmaceuticals' Phase 1-stage REGN1979 an Orphan Drug for the treatment of follicular lymphoma. NCT02290951 Phase 1 recruiting as of Nov 2014. US orphan designation for lymphoma, B-cell, diffuse large.	None	2024	—	—	Odronextamab	Tarrytown, New York, United States	United States of America	North America	https://www.regeneron.com/
Regulatory review	YABS1735	02/12/2025	Linvoseltamab	REGN5458	Lynozyfic	mAb human	Bispecific	Full length Ab	None	BCMA, CD3	IgG4	kappa	None	None	None	REGN5458 is a human bispecific antibody that binds to BCMA and CD3. REGN5458 and REGN5459 were invented using Regeneron's next generation VelocImmune® "human antibody mouse" technology, together with its VelociBi™ platform. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences. Hetero H, cL. Hetero HH: WT x H435R-Y436F (limits binding to Protein A, purification); HL-pairing: cL; both chains: E233P, F234V, L235A, G236del (Fc-silencing)	VelociBi™ platform	Approval anticipated - FDA decision expected by July 10, 2025; EC decision by end of April 2025	Regulatory review EU, US	Active	01/02/2019	08/15/2022	10/15/2023	Chronic Kidney Disease, Multiple myeloma	Cancer	Regeneron Pharmaceuticals	None	Feb 28, 2025: The CHMP recommended granting a conditional marketing authorisation for Lynozyfic (linvoseltamab) for the treatment of patients with relapsed and refractory multiple myeloma. Feb 2025: Resubmission of BLA announced; FDA decision expected by July 10, 2025 August 20, 2024 I Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. Feb. 02, 2024: Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have progressed after at least three prior therapies. NCT05730036 Phase 3 started in Sep 2023. August 2023 presentation: Linvoseltamab (BCMAxCD3) – Updated pivotal Phase 2 data presented at ASCO 2023; Phase 3 study to initiate in 3Q23; received Fast-Track designation from FDA; BLA planned in 4Q23 (https://investor.regeneron.com/static-files/a73a7d9c-591d-43e4-905f-6851ac1ff04e). May 25, 2023 press release "Updated Linvoseltamab (BCMAxCD3) Data from Pivotal Trial Demonstrates Early, Deep and Durable Responses in Patients with Heavily Pre-treated Multiple Myeloma" https://investor.regeneron.com/news-releases/news-release-details/updated-linvoseltamab-bcmaxcd3-data-pivotal-trial-demonstrates . "the LINKER-MM1 trial will form the basis of planned submissions to regulatory authorities, including to the U.S. Food and Drug Administration (FDA) later this year" 2023 FDA submission expected (https://investor.regeneron.com/static-files/dbe7aad3-8aff-483f-9366-fa1678d7b738) NCT05730036 Phase 3 due to start in May 2023. June 6 2022: FDA grants orphan drug designation for multiple myeloma Listed as Phase 2 in Regeneron pipeline dated May 2021; https://investor.regeneron.com/static-files/e90481f9-321f-4a55-804e-1d6ce4557112. NCT03761108 Phase 1/2 study in MM started in Jan 2019. REGN5458 is a human bispecific antibody that binds to BCMA and CD3. In vitro, REGN5458 efficiently activates T cells and induces polyclonal T cell killing of myeloma cell lines with a range of BCMA cell-surface densities, and also induces cytotoxicity of primary human plasma cells. 2018 ASH annual meeting (Dec), abstract 1944 REGN5458, a Bispecific BCMAxCD3 T Cell Engaging Antibody, Demonstrates Robust In Vitro and In Vivo Anti-Tumor Efficacy in Multiple Myeloma Models, Comparable to That of BCMA CAR T Cell.	None	—	—	—	None	Tarrytown, New York, United States	United States of America	North America	https://www.regeneron.com/
Approved	YABS1736	07/03/2024	Enlonstobart	SG001, SYSA1802	Enshuxing, 恩舒幸®	mAb human	Naked monospecific	Full length Ab	None	PD-1	IgG4	kappa	None	None	None	Enlonstobart for injection is a recombinant fully human anti-PD-1 monoclonal antibody developed by the Group, belonging to IgG4 monoclonal antibody drug.	None	None	Approved China	Active	05/23/2019	07/31/2021	—	Triple Negative Breast Cancer, Epithelial Ovarian Cancer, uterine cervical cancer, solid tumors	Cancer	CSPC ZhongQi Pharmaceutical Technology Co. Ltd.	None	June 28, 2024: CSPC announces Enlonstobart Injection (brand name: Enshuxing), a new Class 1 therapeutic biological product developed by the Group, has obtained conditional marketing approval granted by the National Medical Products Administration (NMPA) of the People’s Republic of China. The approved indication of the Product is for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1 (CPS≥1) expression who have previously failed to respond to platinum-based chemotherapy. https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0628/2024062802643.pdf March 10, 2023: The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited is pleased to announce that the application for marketing approval of enlonstobart for injection (brand name: Enshuxing) of CSPC Megalith Biopharmaceutical Co., Ltd* (石藥集團巨石生物製藥有限公司), a subsidiary of the Company, has been accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China with eligibility for the conditional approval pathway. It is applied as a Class 1 therapeutic biological product for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1 expression who have failed to respond to first-line platinum-based chemotherapy. NCT05715840 Phase 3 in cervical cancer due to start in Jan 2023. NCT04983550 Phase 2 due to start in Sep 2021. NCT04886700 and NCT05068141 Phase 2 studies recruiting as of March 2022. NCT03852823 Phase 1 study not yet recruiting as of last record update in Feb 2019	None	2024	—	—	Enlonstobart	No.226 Huanghe Street,, Shijiazhuang, Hebei Province,, PRC 050035	China	Asia	https://www.cspc.com.hk/en/contacts/contactus.php