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	YABS1433	09/11/2024	None	VRDN-003	None	mAb humanized	Naked monospecific	Full length Ab	None	IGF-1R	IgG1	kappa	None	None	None	Shares the same binding domain as veligrotug. VRDN-003 is engineered to have an extended half-life, shown to be 40-50 days, or 4-5x that of veligrotug. VRDN-003 is a monoclonal antibody that incorporates half-life extension technology (YTE) into the sequence of VRDN-001, preserving the unique pharmacological attributes of VRDN-001 while adding the enhanced pharmacokinetics of VRDN-002. VRDN-001 and VRDN-003 are full agonists. VRDN-003 is designed to support administration as a convenient, low volume, infrequent, subcutaneous injection for the treatment of TED. https://investors.viridiantherapeutics.com/files/doc_events/2023/12/VRDN-SC-Slides-12-18-2023-AM-final.pdf	None	BLA planned in 2026	Phase 3	Active	07/01/2023	—	08/15/2024	Thyroid eye disease	Immune-mediated / inflammatory disorders	Viridian Therapeutics Inc.	None	Sep 2024: Viridian initiated two global phase 3 clinical trials for VRDN-003 in August as planned: REVEAL-1 and REVEAL-2 in active and chronic TED, respectively. Both trials will evaluate VRDN-003 subcutaneously administered every Q4W or Q8W and will assess outcomes versus placebo. Viridian anticipates topline data from both trials in the first half of 2026, with a BLA submission for VRDN-003 for the treatment of TED by year-end 2026. (https://investors.viridiantherapeutics.com/news/news-details/2024/Viridian-Therapeutics-Announces-Positive-Topline-Results-from-Veligrotug-VRDN-001-Phase-3-THRIVE-Clinical-Trial-in-Patients-with-Active-Thyroid-Eye-Disease/default.aspx) June 2024: Viridian Therapeutics, Inc., a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today reported details of its plans to initiate a phase 3 clinical trial program for its SC VRDN-003 product candidate for patients with moderate-to-severe TED. https://investors.viridiantherapeutics.com/news/news-details/2024/Viridian-Therapeutics-Announces-Details-of-Subcutaneous-VRDN-003-Phase-3-Clinical-Program-for-Patients-with-Active-and-Chronic-Moderate-to-Severe-Thyroid-Eye-Disease/default.aspx Nov 2023 Viridian report states that VRDN-003 Phase 1 trial is fully enrolled (https://investors.viridiantherapeutics.com/static-files/e3e8d85e-2799-485d-9f5b-269ea5d74e41)	None	—	—	—	None	Waltham, MA 02453	United States of America	North America	https://www.viridiantherapeutics.com/about/contact/
Clinical	YABS1453	11/22/2024	None	XKH004, LZM-012, LZM012	None	mAb humanized	Naked monospecific	Full length Ab	None	IL-17A, IL-17F	IgG1	kappa	None	None	None	XKH004 is a recombinant anti-human IL-17A/F humanized IgG1 monoclonal antibody (http://www.kanovabiopharma.com/news/52.html) https://patents.google.com/patent/EP4070817A1/en	None	None	Phase 3	Active	01/01/2021	12/15/2021	08/21/2023	Psoriasis, Ankylosing spondylitis	Immune-mediated / inflammatory disorders	Xinkanghe Biomedicine	Livzon Pharmaceutical Group Inc.	NCT06110676 / CTR20231931 Phase 3 in psoriasis started in Aug 2023 has status In progress (recruitment completed) when checked in Nov 2024. January 06, 2023, XKH004, the first IL-17A/F antibody drug pioneered by Xinkanghe Biomedicine in China, completed the first phase II clinical study analysis for the treatment of ankylosing spondylitis (AS), and successfully achieved The main clinical research endpoint of the trial. AS is a chronic progressive inflammatory disease with the spine as the main lesion, often involving the sacrohip joint, causing spinal rigidity and fibrosis. AS primarily affects young adults, resulting in impaired quality of life and disability. There are about 4 million patients in China alone, and there is currently a lack of effective treatments. The just completed phase II study (CTR20212135) is a multi-center, randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the preliminary efficacy and dosage of XKH004 in the treatment of active ankylosing spondylitis (AS) 140 cases of AS subjects were enrolled in the study. IND approved in China by late Feb 2020. Jointly developed by Xinkanghe Biomedicine and Livzon Mab.	None	—	—	—	None	Haidian, China	China	Asia	https://tracxn.com/d/companies/xinkanghe-biomedicine/__bgtN1e6tGot7XsKABCo2Ve40GBriVGJH9WhDo5HsJgI
Clinical	YABS1480	02/11/2025	None	YL201	None	mAb human	ADC	TBD	TBD	B7-H3	TBD	TBD	Tumor Microenviroment Activable Linker	___	Topoisomerase I inhibitor, YL0010014	YL201 uses a novel "TMALIN" (Tumor Microenviroment Activable Linker) ADC technology developed at MediLink Therapeutics to resolve potential ADC resistance and stability issues. Drug is topoisomerase I inhibitor YL0010014	None	None	Phase 3	Active	03/15/2022	09/15/2023	12/17/2024	Nasopharyngeal Carcinoma, Small cell lung cancer, Solid tumors	Cancer	MediLink Therapeutics (Suzhou) Co. Ltd.	None	NCT06629597 Phase 3 in Nasopharyngeal Carcinoma due to start in Dec 2024. NCT06612151 Phase 3 in small cell lung cancer due to start in Dec 2024. NCT06241846 Phase 2 in prostate cancer started in Feb 2024. NCT06057922 Phase 1/2 started in Sep 2023. September 23, 2023: oncologists and experts from more than 60 clinical research centers across the country gathered in Guangzhou to participate in the YL201 Phase I/II Investigators Meeting hosted by Suzhou MediLink Therapeutics Co., Ltd. NCT05434234 Phase 1 study started on June 9 2022. April 12, 2022: MediLink Therapeutics announced that YL201, the first compound based on MediLink's proprietary antibody-drug conjugate (ADC) technology platform, has been cleared on its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for its Phase I first-in-human study. Preclinical data demonstrated great efficacy of YL201 in various in vivo tumor models, such as non-small cell lung cancer, prostate cancer and esophageal squamous cell carcinoma.	None	—	—	—	None	Room 2201, Tai Chao, Block A, Honghui International Plaza, No. 1600-1602, West Zhongshan Road, Xuhui District, Shanghai	China	Asia	https://www.medilinkthera.com/contact#ny-nav
Clinical	YABS1482	09/11/2024	Veligrotug	ZL-1108, ZB001, VRDN-001, IMGN164, AVE1642	None	mAb humanized	Naked monospecific	Full length Ab	None	IGF-1R	IgG1	kappa	None	None	None	Humanized IgG1kappa mAb targeting IGF-1R extracellular domain. Full agonist. Described as chimeric in Proposed INN: List 128.	None	2025 H2 BLA planned	Phase 3	Active	09/15/2006	10/15/2008	12/15/2022	Thyroid eye disease, breast cancer, liver cancer, multiple myeloma	Immune-mediated / inflammatory disorders	Sanofi	Zenas Biopharma, miRagen	Sep 2024: Viridian Therapeutics, Inc. is On-Track to Submit Biologics License Application (BLA) in Second Half of 2025 NCT06021054 Phase 3 in TED due to start in Sep 2023. https://investors.viridiantherapeutics.com/news/news-details/2024/Viridian-Therapeutics-Announces-Positive-Topline-Results-from-Veligrotug-VRDN-001-Phase-3-THRIVE-Clinical-Trial-in-Patients-with-Active-Thyroid-Eye-Disease/default.aspx. Phase 2/3 study for Thyroid Eye Disease (NCT05176639) is recruiting as of June 15, 2023. Dec 2022: Viridian Therapeutics, Inc. announced that the first patient has been enrolled in its THRIVE Phase 3 trial evaluating the efficacy and safety of the investigational agent VRDN-001 in patients with active thyroid eye disease (TED). The global THRIVE Phase 3 trial will be conducted in approximately 50 centers across North America and Europe. NCT05542303 Phase 1 in healthy Chinese subjects due to start in Sep 2022. December 20, 2021 I Viridian Therapeutics, Inc. announced the first subject was dosed in a Phase 1/2 proof-of-concept clinical trial (NCT05176639) for VRDN-001, a monoclonal antibody that blocks the IGF-1 receptor with sub-nanomolar potency. October 14, 2021 I Viridian Therapeutics, Inc. announced today the submission of an investigational new drug (IND) application to the United States Food and Drug Administration (FDA). The Company is seeking authorization to initiate a Phase 1/2 clinical trial of VRDN-001, an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody in development for the treatment of thyroid eye disease. Oct. 28, 2020 -- miRagen Therapeutics, Inc. announced it has completed the acquisition of Viridian Therapeutics, Inc. (“Viridian”), a privately held biotechnology company focused on advancing new treatments for patients with diseases that are underserved by today’s therapies. The proceeds from a private placement are intended to be used primarily to advance clinical studies of VRDN-001, a clinical-stage insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody (mAb) in development for thyroid eye disease (TED), a debilitating condition that can cause bulging eyes, or proptosis, as well as double vision and potential blindness. miRagen’s lead candidate, VRDN-001 will be studied as a potential treatment for patients with TED. More than 100 oncology patients have previously been treated with the antibody in US and EU studies, under the name AVE-1642, enabling some understanding of its pharmacokinetic and pharmacodynamic profile, as well as its safety and tolerability. Pending feedback from regulatory authorities, miRagen expects to initiate a Phase 2 clinical trial of VRDN-001 in TED in 2021. Worldwide rights to develop and commercialize VRDN-001 for all non-oncology indications that do not use radiopharmaceuticals, including the treatment of TED, were exclusively licensed by Viridian from ImmunoGen, Inc. Under the terms of the agreement, ImmunoGen received an upfront payment, and is eligible for additional developmental milestones and mid-single-digit royalty payments. Development terminated by Sanofi in 2010; Company decision to discontinue the AVE1642 development program, not due to any safety or efficacy concerns	None	—	—	—	None	Paris	France	Europe	https://www.sanofi.us/en/contact-us
Clinical	YABS1484	09/06/2024	Obexelimab	ZB012, XMAB5871	None	mAb humanized	Naked monospecific	Full length Ab	None	CD19	IgG1	kappa	None	None	None	Not identical to XMAB-5574; XmAb5871 is a humanized and Fc engineered monoclonal antibody that uses a uniquely selective dual-targeting mechanism for B cell inhibition by co-engaging CD19 and CD32b (via Fc). Obexelimab (XmAb5871) uses the XmAb Immune Inhibitor Fc Domain and targets CD19 with its variable domain. Obexelimab is designed to inhibit the function of B cells. https://www.sciencedirect.com/science/article/abs/pii/S2665991323001571 and also https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl119.pdf?sfvrsn=63c30f39_7&download=true	None	Expected data readout for INDIGO P3 study in Oct 2025	Phase 3	Active	07/15/2011	02/15/2016	09/15/2022	Warm Autoimmune Hemolytic Anemia, IgG4-related disease, Systemic Lupus Erythematosus, rheumatoid arthritis	Immune-mediated / inflammatory disorders	Xencor	Bristol Myers Squibb, Zenas BioPharma Ltd, Amgen	Sept. 05, 2023 Zenas BioPharma announced that it has entered into a license and collaboration agreement with Bristol Myers Squibb Company to develop and commercialize obexelimab for autoimmune diseases in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia. NCT05786573 Phase 3 in Warm Autoimmune Hemolytic Anemia started in June 2023 recruiting as of last update in Sep 2024. NCT05662241 Phase 3 in IgG4 Related Disease started in Sep 2022 recruiting as of last update in Aug 2024. Nov 2022: Zenas BioPharma Secures $118 Million to Advance Its Broad Pipeline of Autoimmune Disease Therapeutics; Proceeds to fund global Phase 3 registration program for the company’s lead product candidate, Obexelimab, and support the clinical development of other pipeline programs In November 2021, Xencor entered into a second product license agreement with Zenas and granted Zenas the exclusive worldwide rights to develop and commercialize obexelimab, which uses the XmAb Immune Inhibitor Fc Domain and targets CD19 with its variable domains. May 2021: Still listed in Xencor pipeline, but no clinical studies are ongoing. (https://investors.xencor.com/static-files/243d3a74-a45c-4796-a9c8-a2d0b44b9181) Available for licensing as of Feb 2019. NCT02725476 Phase 2 study completed in Dec 2018 is identified as Phase 3 EudraCT2017-002214-31. NCT02725515 Phase 2 study in SLE completed in July 2018. Aug 2018: Company expects to initiate Phase 3 trial in the second half of 2018. Following a Type B End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA), Xencor expects this randomized, placebo-controlled, double-blinded trial to evaluate the addition of XmAb5871 to standard-of-care in approximately 250 to 350 patients with IgG4-RD. June 2017: Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, today announced interim data from an ongoing, open-label, pilot Phase 2 study of XmAb®5871 in patients with active IgG4-Related Disease (IgG4-RD). Data show that 93% of patients achieved a response to therapy, 12 of them within two weeks of their first dose. May 2017: An orphan drug designation was granted by the FDA for Xencor's lead drug candidate, XmAB5871, as a treatment for patients with IgG4-related disease. March 7, 2016: Company announced dosing the first patient in a Phase 2 trial of XmAb®5871 in patients with IgG4-Related Disease (IgG4-RD). The Company also announced dosing the first patient in a Phase 2 trial of XmAb5871 in patients with Systemic Lupus Erythematosus (SLE). Phase 1/2 started in Feb 2013. In October 2014, Xencor announced that it has regained all development and commercial rights to XmAb5871 by seeking and obtaining a termination of the prior option and collaboration agreement and executing a new right-of-first-negotiation agreement with Amgen. Xencor approached Amgen to end the original collaboration to allow the Company the freedom to pursue alternative clinical and commercial paths. Amgen agreed, provided Xencor grant them a right of first negotiation for a license to XmAb5871. Xencor has been leading all clinical development of XmAb5871 to date. The new agreement announced requires Xencor to first discuss with Amgen any proposed license prior to seeking other partners. This right expires upon the earlier of the initiation of Phase III clinical testing of XmAb5871, a change of control of Xencor, or October 2019.	None	—	—	—	None	Pasadena, California, United States	United States of America	North America	https://xencor.com/
Regulatory review	YABS1712	08/20/2024	Trastuzumab botidotin	A166, 博度曲妥珠单抗	舒泰萊®	mAb humanized	ADC	Full length Ab conjugate	None	HER2	IgG1	kappa	Valine-Citrulline, Cleavable linker	2, Site-specific	Tubulin inhibitor, Duostatin-5	2021: A166 (ASCO Abstract #1024) is a third generation antibody drug conjugate (ADC) against HER2-positive breast cancer with Levena’s proprietary tubulin inhibitor Duo-5 toxin, cleavable linker and site-specific K-Lock™ conjugation chemistry.	None	Regulatory review China - anticipate approval second half of 2024 or the first half of 2025 - https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0819/2024081901322.pdf	Regulatory review China	Active	07/16/2018	10/15/2021	07/15/2023	Solid tumors	Cancer	Kelun-Biotech, subsidiary Klus Pharma	Sorrento Therapeutics, Inc.	June 2024: Stil in review (https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0819/2024081901322.pdf) China marketing application acceptance date is May 11, 2023, sponsor is Sichuan Kelun-Biotech Biopharmaceutical Co Ltd according to NMPA's CDE database. Phase 3 study for HER2-positive unresectable or metastatic breast cancer (CTR20231740) started in July 2023. Pivotal phase 2 CTR20212088 for breast cancer status is "In progress Recruitment completed". CTR20212088 Phase 2 pivotal study is ongoing in China as per company website accessed Feb 2023 (https://www.kluspharma.com/pipeline) NCT03602079 Phase 1/2 study active not recruiting as of last update in Feb 2022; NCT05346328 Phase 2 study sponsored by Fudan University due to start in June 2022. June 04, 2021 Sorrento Therapeutics, Inc. announced that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun”), a license and development partner, will present posters at this year’s American Society of Clinical Oncology (ASCO) meeting to be held June 5-6, 2021, releasing Phase 1 data for its HER2-ADC, A166. To generate this site-specific third generation antibody drug conjugate (ADC), Kelun partnered with Levena Biopharma, a wholly owned subsidiary of Sorrento, which provided the patent-protected technologies for the generation and production of A166, including (1) a proprietary small molecule toxin, Duostatin-5, a tubulin inhibitor, (2) K-Lock, a site-specific conjugation technology and (3) an enzymatically cleavable linker. Compared to its commercial competitors, A166 demonstrated a better safety profile in the initial study and potentially better efficacy, as shown in the overall response rate (ORR) of 71.4% (A166) at 6.0 mg/kg vs DS-8201, which has an ORR of 60.9% (DS-8201) at 5.4 mg/kg. J Clin Oncol 39, 2021 (suppl 15; abstr 1024) DOI:10.1200/JCO.2021.39.15_suppl.1024 Clinical Trial Registry Number: CTR20181301 NCT03602079 is a Phase I-II, FIH Study of A166 in Locally Advanced/Metastatic Solid Tumors Expressing Human Epidermal Growth Factor Receptor 2 (HER2) or Are HER2 Amplified That Did Not Respond or Stopped Responding to Approved Therapies; started in July 2018, this study is still recruiting patients as of Aug 2019. Klus Pharma is a US subsidiary of Kelun Pharmaceuticals, which is based in China.	None	—	—	—	None	101 College Rd East, 2F, Princeton Forrestal Center, Princeton, NJ 08540	United States of America	North America	https://www.kluspharma.com/contact
Approved	YABS1713	01/21/2025	Tagitanlimab	A167, KL-A167, KLA-167, HBM9167	科泰萊®	mAb humanized	Naked monospecific	Full length Ab	None	PD-L1	IgG1	kappa	None	None	None	Immune checkpoint target	None	None	Approved China	Active	09/01/2017	07/01/2018	06/01/2022	Breast cancer, non-small cell lung cancer, nasopharyngeal cancer, Lymphoma, solid tumors	Cancer	Sichuan Kelun Pharmaceutical Research Institute Co. Ltd.	Harbour BioMed	January 23, 2025 press release: National Medical Products Administration approved tagitanlimab (formerly KL-A167) used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer. Dec. 31, 2024 Chengdu: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) has received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand1(PD-L1)-directed innovative humanized monoclonal antibody (“mAb”) tagitanlimab (formerly KL-A167) (科泰莱®) for the treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC) who have failed after prior 2L+ chemotherapy. This is the world's first PD-L1 monoclonal antibody approved for the treatment of NPC. (https://en.kelun-biotech.com/newsCenter.aspx?mid=18) As of June 2024, the Sichuan Kelun-Biotech Biopharmaceutical expected to launch trastuzumab botidotin, as well as sacituzumab tirumotecan (SKB264/MK-2870, 佳泰萊®) and tagitanlimab (A167, 科泰萊®), in the China market in the second half of 2024 or the first half of 2025. https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0819/2024081901322.pdf As per company website accessed Aug 28, 2022, HBM9167 is not listed in Harbour Biomed's pipeline. Klus Pharma website pipeline, accessed Aug 10, 2022: Currently, the BLA has been filed to NMPA in China for two solid tumor indications. Sep 10, 2021 Klus Pharma press release: Listed as A167 (anti-PD-L1 mAb, BLA filing); NMPA Acceptance number: CXSS2101052 NCT05294172 is a Phase 3 of KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma; due to start in June 2022. NCT05351788 is a Phase 2 study of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. Feb 27, 2020: Harbour BioMed announced U.S. Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application for a Phase 2 clinical trial of HBM9167, its humanized IgG1 monoclonal antibody targeting programmed death-ligand 1 (PD-L1), for the treatment of nasopharyngeal cancer (NPC). Separately, the Agency’s Office of Orphan Products Development granted HBM9167 Orphan Drug Designation (ODD) for the use in treating NPC. NCT03848286 Phase 2 study in Recurrent or Metastatic Nasopharyngeal Carcinoma patients Who Have Received Previous At Least Two Lines of Chemotherapy and NCT03580564 Phase 2 study in lymphoma not yet recruiting as of May 17, 2019. Aug 2018: KL A167 licensed to Harbour BioMed worldwide (excluding China, Hong Kong, Macau and Taiwan). A167 (formerly KL-A167) is an anti-programmed death-ligand 1 (PD-L1) antibody currently in multiple Phase I and Phase II trials in China targeting lymphoma and solid tumors, as of Aug 2018 (www.genengnews.com/topics/drug-discovery/harbour-biomed-to-develop-kelun-biotechs-cancer-immunotherapy-candidate-a167/). Founded in 2014, KLUS Pharma is a subsidiary of Kelun-Biotech, which is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd.	None	2024	—	—	Tagitanlimab	No.36 West Baihua Road, Qingyang District, Chengdu, Sichuan, P. R. China	China	Asia	https://en.kelun.com/intro/6.html
Regulatory review	YABS1714	08/25/2022	Ebdarokimab	AK101	(Pending)	mAb human	Naked monospecific	Full length Ab	None	IL-12/23 p40	IgG1	kappa	None	None	None	AK101 is an anti-IL-12/23p40 monoclonal antibody.	None	Regulatory review China - anticipate approval	Regulatory review China	Active	01/18/2018	07/01/2019	07/01/2021	Plaque psoriasis, ulcerative colitis	Immune-mediated / inflammatory disorders	Akesobio Australia Pty Ltd	None	Aug 2023: Akeso Inc., a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, announced that the New Drug Application (NDA) for its fully human IgG1 monoclonal antibody, ebdarokimab (IL-12/lL-23, AK101) has been accepted by the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE) for the treatment of adult patients with moderate-to-severe plaque-type psoriasis. NCT05120297 Phase 3 posted as active not recruiting on Nov 15, 2021, but start date is listed as Nov 1 2021; primary completion date is Feb 2022. As of Jan 2020, the company indicated that they completed a Phase I and a Phase II clinical trials, and are currently conducting Phase IIb clinical trial, of AK101 in moderate to severe psoriasis patients in China. We have also received IND approval from the FDA for evaluating AK101 for the treatment of ulcerative colitis (UC) in the U.S. in October 2019. NCT04173637 Phase 2 in psoriasis due to start Nov 30 not yet recruiting as of Nov 22, 2019.	None	—	—	—	None	Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia	Australia	Australia	https://www.akesobio.com/en/about-us/contact-us/
Approved	YABS1715	10/19/2024	Ebronucimab	AK102	伊喜宁	mAb human	Naked monospecific	Full length Ab	None	PCSK9	IgG1	lambda	None	None	None	IgG1 lambda2	None	None	Approved China	Active	05/09/2018	05/13/2019	12/01/2020	Hyperlipidemia, Homozygous Familial Hypercholesterolemia	Metabolic disorders	Akesobio Australia Pty Ltd	DAWNRAYS PHARMACEUTICAL (HOLDINGS) LIMITED	Sep 2024: Approved in China for treatment of primary hypercholesterolemia and mixed hyperlipidemia and heterozygous familial hypercholesterolemia https://www.akesobio.com/en/media/akeso-news/akeso-s-ebronucimab-pcsk9-approved-for-two-indications-for-the-treatment-of-hypercholesterolemia-in-china/ June 1, 2023: Akeso Inc. announced today that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for its fully human anti-PCSK9 monoclonal antibody ebronucimab (AK102) for 2 indications 1) primary hypercholesterolemia and mixed hyperlipidemia, and 2) heterozygous familial hypercholesterolemia (HeFH). Ebronucimab is jointly developed by Akeso and AD Pharmaceuticals (a joint venture with Akeso). Dec 2021: Ebronucimab (AK102) completed patient enrollment early in a pivotal registrational phase III clinical trial in the People’s Republic of China (‘‘China’’) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia. NCT03933293 Phase 2 study started recruiting on May 13, 2019. NCT04169386 Phase 1 started in May 2018. Agreement with Dawnrays confirms monoclonal antibody composition of matter (http://en.dawnrays.com/UploadFiles/AnnmentFile/a168305-e_announcementdiscloseabletransation161214.pdf); On 14 December 2016 (after trading hours), Dawnrays Biotech, a wholly-owned subsidiary of the Company, and Zhongshan KF entered into the JV Agreement, for the purpose of, amongst other things, establishing the JV Co and regulating the funding and management arrangements with respect to the JV Co and the respective rights and obligations of Dawnrays Biotech and Zhongshan KF.	None	2024	—	—	Ebronucimab	Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia	Australia	Australia	https://www.akesobio.com/en/about-us/contact-us/
Approved	YABS1716	05/31/2024	Ivonescimab	AK112, SMT112	依達方®	mAb humanized	Bispecific	Appended Ig	IgG-(scFv)2	PD-1, VEGF	IgG1	kappa	None	None	None	AK112 is a PD-1/VEGF bispecific antibody; tetravalent; L234A, L235A mutations impair Fc effector functions	None	None	Approved China	Active	06/01/2019	02/01/2021	01/15/2022	Head and neck cancer, Cutaneous squamous cell carcinoma, Colorectal cancer, Hepatocellular Carcinoma, Small cell lung cancer, Triple-negative breast cancer, Ovarian cancer, Gynecological Tumors, Non-small cell lung cancer, Solid tumors	Cancer	Akesobio Australia Pty Ltd	Summit Therapeutics	May 24, 2024: Akeso, Inc. announced that ivonescimab, a first-in-class PD-1/VEGF bi-specific antibody independently developed by the Company, combined with chemotherapy for the treatment of epidermal growth factor receptor (EGFR) mutated locally advanced or metastatic non-squamous non-small cell lung cancer patients who have progressed after EGFR tyrosine kinase inhibitors (TKI) treatment, has been granted marketing approval by the National Medical Products Administration of the People's Republic of China . The approval of by the NMPA is based on AK112-301/HARMONi-A (CTR20213079), a randomized, double-blinded, multi-center Phase III clinical trial with primary endpoint of progression-free survival (PFS) and secondary endpoint of overall survival (OS) in China. https://www.marketscreener.com/quote/stock/AKESO-INC-111325370/news/Akeso-Inc-Receives-NMPA-s-Marketing-Approval-in-China-for-Ivonescimab-Injection-46817650/ Aug. 25, 2023: Akeso Inc. announced that the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE) has granted priority review of New Drug Application (NDA) for ivonescimab, a potential first-in-class investigational PD-1/VEGF bi-specific antibody. CDE has granted Breakthrough Therapy Designation (BTD) for ivonescimab for three lung cancer indications. On August 1, 2023, the first NDA for ivonescimab was accepted by the CDE. NCT05840016 Phase 3 due to start in June 2023. Phase 3 studies for Non-small cell lung cancer: NCT05184712 is recruiting as of May 25, 2023, NCT05499390 is recruiting as of November 10, 2022, NCT05840016 not yet recruiting as of May 3, 2023) CTR20230869 Phase 1/2 in colorectal cancer. Nov 2022: NMPA has granted Breakthrough Therapy Designation for ivonescimab combined with docetaxel for the treatment of I-O resistance non-small cell lung cancer patients who failed to respond to prior PD-L1 inhibitor combined with platinum-based doublet chemotherapy. This is the third breakthrough therapy designation for Akeso's ivonescimab for the treatment of non-small cell lung cancer. January 30, 2022 I Akeso, Inc. announces that the first patient was dosed in a Phase III registrational clinical trial of the Company's novel immuno-oncology drug, Ivonescimab (PD-1/VEGF bi-specific antibody, AK112), combined with chemotherapy versus placebo combined with chemotherapy for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) with EGFR mutation failed after EGFR-TKI treatment. NCT05184712 Phase 3 in NSCLC due to start in Jan 2022. NCT04999605 Phase 1/2 in ovarian cancer started in July 2021; NCT04736823 in NSCLC started in Feb 2021. Started Phase I trial for the treatment of advanced solid tumors in Australia in October 2019 (Slide 28, https://www.akesobio.com/media/1306/akeso-2020-interim-results-presentation.pdf) NCT04047290 Phase 1 in solid tumors. IND approval granted in June 2019.	None	2024	—	—	Ivonescimab	Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia	Australia	Australia	https://www.akesobio.com/en/about-us/contact-us/