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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
Regulatory review	YABS0854	01/09/2025	Nipocalimab	JNJ-80202135, M281	(Pending)	mAb human	Naked monospecific	Full length Ab	None	FcRn	IgG1	lambda	None	None	None	M281 is a fully human aglycosylated, effectorless IgG1 monoclonal antibody that targets the IgG-binding site of FcRn. In preclinical models, M281 potently antagonizes FcRn binding of IgGs and rapidly diminishes circulating levels of IgG antibodies, the primary pathogenic agent in a number of autoimmune diseases.	None	Possible approval in US as early as Feb 2025.	Regulatory review EU, US	Active	06/01/2016	12/11/2018	08/01/2019	Rheumatoid arthritis, Hemolytic Disease of the Fetus and Newborn, Myositis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Lupus Nephritis, Lupus Erythematosus, Autoimmune Hemolytic Anemia, Generalized Myasthenia Gravis, Phase 1 in healthy volunteers	Immune-mediated / inflammatory disorders	Janssen Research & Development LLC	None	September 11, 2024 I Janssen-Cilag International NV, a Johnson & Johnson company, submitted an Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking first approval of nipocalimab for the treatment of people living with generalised myasthenia gravis. Summary of regulatory agency designations: EU EMA Orphan medicinal product designation for HDFN in October 2019; U.S. FDA Fast Track designation in haemolytic disease of the foetus and newborn (HDFN) and warm autoimmune haemolytic anaemia (wAIHA) in July 2019, gMG in December 2021 and foetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024; U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023; U.S. FDA Breakthrough Therapy designation for HDFN in February 2024. Aug 29, 2024: Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of nipocalimab globally for the treatment of people living with generalized myasthenia gravis. FDA granted Priority Review in gMG in Q4 2024 June 28, 2024– Johnson & Johnson announced positive results from the nipocalimab Phase 3 Vivacity-MG3 study in patients with generalized myasthenia gravis (gMG). Patients treated with nipocalimab plus standard of care (SOC) achieved superiority over placebo plus SOC as measured by the primary endpoint of improvement in the MG-ADL score from baseline over 24 weeks. These data are included in a presentation and are among eight abstracts that Johnson & Johnson will present at the European Academy of Neurology (EAN) 2024 Congress1 and will be included in submissions to regulatory authorities later this year. Mar 2024: U.S. Food and Drug Administration has granted Fast Track designation for nipocalimab to reduce the risk of FNAIT in alloimmunizeda pregnant adults during their current pregnancy. The Phase 3 FREESIA program is underway and nipocalimab is the only investigational therapy currently reported to be in clinical development for the treatment of FNAIT. https://www.prnewswire.com/news-releases/johnson--johnsons-nipocalimab-granted-us-fda-fast-track-designation-to-reduce-the-risk-of-fetal-neonatal-alloimmune-thrombocytopenia-fnait-in-alloimmunized-pregnant-adults-302099499.html NCT06028438 Phase 2 in RA started in Aug 2023 Phase 2/3 and 3 studies for Warm autoimmune hemolytic anemia (NCT04119050); Generalized myasthenia gravis (NCT05265273, NCT04951622) ; Polyradiculoneuropathy (NCT05327114) are recruiting as of May 2023. Although only NCT04951622 is listed as phase 3 on clinicaltrials.gov, on Janssen pipeline, studies of nipocalimab in the above indications are all phase 3. Feb. 6, 2023: The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive topline results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN Planned filing in Generalized Myasthenia Gravis 2021-25, as of July 2022 NCT05327114 Phase 2/3 started in Sep 2022. April 2021: Phase 2 data featured as part of an oral presentation at the American Academy of Neurology (AAN) Virtual Meeting taking place April 17-22, 2021. Momenta acquired by Janssen in Oct 2020. July 2020: Momenta Pharmaceuticals announced that its novel drug candidate, nipocalimab, has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the prevention of hemolytic disease of the fetus and newborn (HDFN). Additionally, FDA granted nipocalimab orphan drug designation in HDFN. Orphan drug designation in the EU. NCT04119050 Phase 2/3 study recruiting when posted on Oct 8, 2019. Aug. 01, 2019: Momenta Pharmaceuticals, Inc. announced the launch of an adaptive Phase 2/3 clinical study for its FcRn inhibitor nipocalimab (M281) in warm Autoimmune Hemolytic Anemia. July 2019: Momenta Pharmaceuticals' candidate nipocalimab, or M281, a treatment to prevent the blood disorder hemolytic disease of the fetus and newborn, has received Fast Track designation from the FDA. NCT03772587 Phase 2 study started in Dec 2018. Jan. 05, 2018: Momenta Pharmaceuticals, Inc. reported positive top-line data showing safety, tolerability and proof of mechanism for M281 in a phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study of normal human volunteers. Over the 98-day MAD study, M281 exhibited no serious adverse events, was well tolerated, and decreased circulating IgG levels up to 89% with a mean reduction of 84%. Company plans to finalize their development strategy and initiate a proof of concept clinical trial in the second half of 2018, pending regulatory feedback NCT02828046 Phase 1 completed in Aug 2017.	None	—	—	—	None	Raritan, New Jersey, United States	United States of America	North America	https://www.janssen.com/
Clinical	YABS0863	11/22/2024	Tifcemalimab	JS004, TAB004	None	mAb humanized	Naked monospecific	Full length Ab	None	BTLA	IgG4	kappa	None	None	None	Humanized IgG4κ monoclonal antibody. Target is B and T lymphocyte attenuator (BTLA; CD272) is a member of the CD28 family expressed on activated T cells, B cells, and APCs. INN was formerly icatolimab.	None	None	Phase 3	Active	04/15/2019	—	11/15/2023	Lung cancer, Head and Neck Squamous Cell Carcinoma/Nasopharyngeal Carcinoma, Recurrent/Refractory Malignant Lymphoma, Solid tumors	Cancer	Shanghai Junshi Bioscience Co Ltd	None	NCT06170489 / CTR20234002 Phase 3 in Hodgkin's lymphoma started in Dec 2023. NCT06095583 / CTR20233182 Phase 3 in small cell lung cancer started in Nov 2023. June 28, 2023: Shanghai Junshi Biosciences Co., Ltd announced that the U.S. Food and Drug Administration (“FDA”) has recently agreed a randomized, double-blind, placebo-controlled, multi-regional phase 3 clinical study of tifcemalimab (product code: TAB004/JS004), an anti-BTLA monoclonal antibody used in combination with toripalimab, an anti-PD-1 monoclonal antibody, as consolidation therapy for patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy may proceed. Junshi Biosciences will officially initiate the phase 3 clinical study in the near future. NCT05664971 Phase 1/2 in lung cancer due to start in Dec 2022. Phase 1/2 in Head and Neck Squamous Cell Carcinoma and Nasopharyngeal Carcinoma started in May 2021. NCT04477772 Phase 1 in lymphoma not yet recruiting when first posted in July 2020. NCT04137900 Phase 1 started in Oct 2019, In April 2019, the IND of JS004 for treatment of patients with advanced unresectable or metastatic solid tumors (including lymphoma) and patients refractory to prior PD-1 antibody treatment was approved by the U.S. FDA for clinical trial. In October 2019, the first patient has been successfully dosed in the Phase I clinical trial (NCT04137900) conducted in the U.S. Junshi Biosciences announce that the company has received the Clinical Trial Approval in respect of the “recombinant humanized anti-BTLA monoclonal antibody injection” (project code: TAB004/JS004) issued by the National Medical Products Administration (NMPA).	None	—	—	—	None	100, Pingjiaqiao Road, Shanghai, China	China	Asia	https://www.junshipharma.com/en/contact-us/
Clinical	YABS0864	11/14/2024	Roconkibart	JS005	None	mAb humanized	Naked monospecific	Full length Ab	None	IL-17A	IgG4	kappa	None	None	None	JS005 is a recombinant humanized anti-IL-17A monoclonal antibody for injection	None	None	Phase 3	Active	08/01/2019	07/01/2021	08/15/2023	Plaque Psoriasis, Psoriatic arthritis, spondylitis	Immune-mediated / inflammatory disorders	Shanghai Junshi Bioscience Co Ltd	None	NCT05975268 Phase 3 in Plaque Psoriasis started in Aug 2023. Listed as Phase 2 asset in Junshi pipeline accessed Mar 2023. CTR20212214 Phase 2 in axial spondyloarthritis started in Dec 2021. CTR20212392 Phase 2 in ankylosing spondylitis started in Dec 2021. Listed as Phase 2 as of Nov 2021 (https://junshi-biosciences-umb.azurewebsites.net/media/x04lnf3x/junshi-2021-q3-en-1104.pdf) JS005 (anti-IL-17A monoclonal antibody) has received the Clinical Trial Approval from NMPA in August 2019. Phase I clinical trial of JS005 is expected to complete the first patient enrollment in the first half of 2020 (http://www.globenewswire.com/news-release/2020/03/30/2008564/0/en/Junshi-Biosciences-Announces-Full-Year-2019-Financial-Results-and-Business-Updates.html)	None	—	—	—	None	100, Pingjiaqiao Road, Shanghai, China	China	Asia	https://www.junshipharma.com/en/contact-us/
Clinical	YABS0876	02/19/2025	Anbenitamab repodatecan	JSKN003, JSKN033 (combo of JSKN003 and envafolimab)	None	mAb humanized	ADC, Bispecific, Biparatopic	Full length Ab conjugate	None	HER2, HER2	IgG1	kappa	Dibenzocyclooctyne tetrapeptide linker (Cleavable)	3.8 (range 3 to 4)	Topoisomerase I inhibitor, Camptothecin derivative	JSKN003 is an antibody-drug conjugate (ADC) comprised of a recombinant, humanized anti-human epidermal growth factor receptor 2 (HER2) bispecific antibody conjugated to a topoisomerase I inhibitor via a dibenzocyclooctyne tetrapeptide linker. The anti-HER2 component, KN026, is a recombinant, humanized bispecific antibody that targets both extra-cellular domains II (pertuzumab binding site) and IV (trastuzumab binding site) of HER2. (doi: 10.1093/abt/tbad014.009) JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), developed inhouse with proprietary Glycan-specific conjugation platform; targets domain II and IV of HER2 (https://www.alphamabonc.com/en/uploads/2021/01/210003484816.pdf). See also https://www.alphamabonc.com/en/uploads/2023/08/169286574293454.pdf. JSKN003 and anti-PD-1 envafolimab combination = JSKN033	None	None	Phase 3	Active	05/15/2022	—	11/15/2023	Ovarian cancer, Breast cancer, Solid tumors	Cancer	Alphamab (Australia) Co Pty Ltd.	CSPC Pharmaceutical Group Co., Ltd.	NCT06751485 Phase 3 in ovarian cancer due to start in Jan 2025. Sep 2024: Alphamab Oncology announced that Jiangsu Alphamab Biopharmaceuticals Co., Ltd., a wholly-owned subsidiary of Alphamab Oncology, entered into a licensing agreement on anti-HER2 bispecific antibody-drug conjugate JSKN003 with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. According to the terms of the Licensing Agreement, JMT-Bio will obtain the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Phase III clinical study JSKN003-302 is NCT06079983. Dec. 4, 2023: Alphamab Oncology announced the first patient has been dosed in the phase III clinical study (JSKN003-302) of anti-HER2 bispecific antibody-drug conjugate JSKN003 for treatment of advanced HER2-low breast cancer. https://www.prnewswire.com/apac/news-releases/first-patient-dosed-in-phase--study-of-jskn003-for-the-treatment-of-advanced-her2-low-breast-cancer-302004249.html NCT05744427 and NCT06226766 are Phase 1/2 studies in solid tumors. JSKN033 is a combination drug product comprised of JSKN003 and envafolimab for subcutaneous injection. NCT05744427 Phase 1 started in March 2023; Mar 16: Alphamab Oncology announced that the first patient has been dosed with 2.1mg/kg in a Phase I clinical study (JSKN003-102) of JSKN003, an Anti-HER2 bispecific ADC. NCT05494918 Phase 1 started in Aug 2022; company announced Sep 19, 2022 that the first patient has been successfully dosed in a phase I clinical trial of JSKN003 (a KN026 (a recombinant humanized anti-human epidermal growth factor receptor 2 (“HER2”) bispecific antibody) antibody-drug conjugate (“KN026-ADC”) independently developed by the Company) in Australia, and that in August 2022, the investigational new drug (“IND”) application of JSKN003 was submitted to the National Medical Products Administration of China (the “NMPA”) and accepted for the treatment of solid tumors. The Company completed the efficacy validation and process development for JSKN-003 in June 2021 and targets to submit IND application in the second quarter of 2022. In May 2021, Jiangsu Alphamab entered into a collaboration agreement with Suzhou Alphamab Co., Ltd. for two technology development projects, namely, JSKN003 and the preparation process development project for mGalt1, a key material of conjugation process.	None	—	—	—	None	218 Xinhu St. Building #C23, Suzhou, Jiangsu	China	Asia	https://www.alphamabonc.com/en/contact/index.html
No development reported	YABS0886	11/16/2024	Lenzilumab	KB003	None	mAb human	Naked monospecific	Full length Ab	None	GM-CSF	IgG1	kappa	None	None	None	None	Humaneered™ technology	Termination	Phase 2/3	No development reported	12/15/2007	10/15/2009	04/30/2020	Chronic Myelomonocytic Leukaemia, COVID-19, CAR-T-related neurotoxicity, Leukemia, Rheumatoid Arthritis, Asthma	Immune-mediated / inflammatory disorders	Taran Therapeutics	None	Sep 2024: Humanigen sold off its biopharma business to Taran Therapeutics, including lenzilumab, ifabotuzumab and HGEN005, for $20 million. Humanigen, Inc. has been acquired by Taran Therapeutics, Inc. Humanigen, a clinical-stage biopharmaceutical company focused on preventing and treating certain inflammatory and oncological conditions filed chapter 11 on January 3, 2024, in the United States Bankruptcy Court for the District of Delaware. https://www.schgroup.com/press-release/scamph-capital-advises-humanigen-in-sale-to-taran-therapeutics/ Company refers to PREACH-M study as Phase 2/3 (https://www.humanigen.com/_files/ugd/daef6a_fa2075b14b0d4cb9a5405cf8705013d0.pdf) ACTRN12621000223831 PREACH-M study is a phase II Trial Studying the Efficacy of Lenzilumab and High Dose Ascorbate with Azacitidine Based on Molecular Profiling of participants with Chronic Myelomonocytic Leukaemia. 2022 H1 update: The company has strategically realigned its pipeline and resources with plans to accelerate the development of lenzilumab in CMML, for which the Phase 2 “PREcision Approach to Chronic Myelomonocytic Leukemia,” or “PREACH-M” study (ACTRN12621000223831), is already underway and to continue the “Risk Adapted Therapy in Acute GvHD,” or “ RATinG” study, in patients undergoing bone marrow transplant, that is expected to enroll its first patient in the third quarter of 2022. These studies are majority funded by the company’s partners. Under the realignment plan, the company will deemphasize the deployment of certain resources for the development of lenzilumab for COVID-19. July 2022: Humanigen reported initial topline results showing that its lenzilumab in combination with remdesivir failed to achieve statistical significance on the primary endpoint of the National Institute of Allergy and Infectious Diseases’ ACTIV-5/BET-B clinical trial in hospitalised Covid-19 patients. EUA for COVID-19 requested in May 2021. Sep 9, 2021: U.S. FDA has declined its request for emergency use authorization of lenzilumab to treat newly hospitalized COVID-19 patients. In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19. NCT04351152 Phase 3 study started in April 2020. April 15, 2020 – Humanigen, Inc., a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered® anti-human GM-CSF monoclonal antibody, announced that FDA has given permission to commence a Phase III study of lenzilumab in patients with COVID-19. March 20, 2020 – Humanigen, Inc., a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered® anti-human- granulocyte-macrophage colony stimulating factor(GM-CSF) monoclonal antibody, announced that the company is seeking to conduct a Phase III, randomized, controlled, clinical trial to rapidly advance the clinical development of lenzilumab for the prevention and treatment of cytokine storm which can lead to acute respiratory distress syndrome (ARDS) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in COVID-19. May 2019: Humanigen in collaboration with Kite plans a phase I/II trial for B-cell lymphoma (Second-line therapy or greater, refactory metastatic disease) in the fourth quarter of 2019 in USA. Feb 2018: Humanigen expects to start a phase Ib/II trial with lenzilumab for the prevention of CAR-T-related neurotoxicity in the second quarter of 2018. Lenzilumab is a specific, high-affinity and selective antagonist of circulating granulocyte-macrophage colony-stimulating factor (GM-CSF). August 7, 2017 – Humanigen, Inc. announced that its new name is effective. Phase 1 in CMML patients started end of July 2016. KaloBios in bankrupcy as of Nov 2015; emerged from bankrupcy in early July 2016. July 29, 2015 press release; Moffitt Cancer Center in Florida and the University of California, Davis (UC Davis) have suspended the planned clinical trial of KaloBios Pharmaceuticals Inc.’s KB003 following arrest of CEO on securities fraud charges. The FDA has cleared the company's IND application for KB003, an anti-GM-CSF monoclonal antibody (mAb), in patients with chronic myelomonocytic leukemia (CMML), and that the IND is now active. Did not meet primary endpoint in Phase 2 study of patients with severe asthma	None	—	—	—	None	New Jersey, United States	United States of America	North America	https://ir.humanigen.com/English/overview/default.aspx
Clinical	YABS0890	09/30/2024	Rocatinlimab	KHK4083, AMG451	None	mAb human	Naked monospecific	Full length Ab	None	OX40	IgG1	kappa	None	None	None	Immune checkpoint target. Potelligent KM mouse-derived; immunomodulator; enhanced effector functions	Transgenic mouse (KM mouse)	None	Phase 3	Active	12/15/2012	12/15/2015	05/31/2022	Prurigo Nodularis, Asthma, Ulcerative colitis, atopic dermatitis	Immune-mediated / inflammatory disorders	Kyowa Hakko Kirin	Amgen	Phase 3 studies for Atopic dermatitis: (NCT05398445, NCT05633355, NCT05724199, NCT05704738, NCT05899816) are active non recruiting; NCT05651711 is completed; (NCT05882877, NCT06224192) are recruiting as of September-November 2024. Phase 3 study in Prurigo Nodularis NCT06527404 is recruiting as of November 2024. Sep 2024: The HORIZON trial readout, the first of eight pivotal study readouts in atopic dermatitis, showed statistically significant improvement observed in co-primary endpoints. https://investors.amgen.com/static-files/a7119a35-06de-497e-ba75-146404c54d95 NCT06527404 Phase 3 in Prurigo Nodularis started in July 2024. Amgen 2023 financial results (April 27, 2023) "The ROCKET Phase 3 program, composed of seven studies evaluating rocatinlimab, an anti-OX40 monoclonal antibody, is enrolling adult and adolescent patients with moderate to severe atopic dermatitis." https://www.amgen.com/newsroom/press-releases/2023/04/amgen-reports-first-quarter-financial-results . Phase 3 studies for Atopic dermatitis (NCT05398445, NCT05633355, NCT05651711, NCT05724199, NCT05704738, NCT05882877) are recruiting as of June 2023 (NCT05899816) is also recruiting as of June 2023. Aug 4, 2022: Kyowa revealed the partners have paused the study. The Japanese drugmaker provided a brief explanation for the U-turn in its financial results for the second quarter. “Following additional discussions with regulators and our partner, we are amending the studies to improve patient convenience and investigate a range of doses. No safety or efficacy issues have arisen". NCT05398445 is a A Phase 3, 52-week, Treat-through, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of AMG 451 Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis due to start in June 2022. Feb 2022: Amgen is planning to conduct a comprehensive Phase 3 program in atopic dermatitis with AMG 451, a monoclonal antibody that inhibits OX-40 resulting in the partial depletion of activated T-cells and the inhibition of T-cell activation cascade; study initiation is anticipated in mid-2022. Phase 3 study planned in H1 2022: https://ir.kyowakirin.com/en/library/earnings/earnings0/main/0113/teaserItems1/00/linkList/01/link/presentation_2021_q3_en.pdf June 1, 2021: Amgen and Kyowa Kirin Co., Ltd. have announced an agreement to jointly develop and commercialize KHK4083, which is Kyowa Kirin's potential first-in-class, Phase 3-ready anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis. In August 2020, the company has discontinued the Phase II stage of development for the treatment of ulcerative colitis in the US, EU and Others and Phase I stage of development for the treatment of ulcerative colitis in Japan. NCT03703102 Phase 2 study in atopic dermatitis started Oct 2018 active not recruiting as of Aug 2020. Phase 2 study in Ulcerative Colitis active completed as of Sep 2018. Phase 1 NCT03096223 study in atopic dermatitis started in April 2017. Started Phase 1 in Canada as per pipeline dated January 24, 2014	None	—	—	—	None	Tokyo, Japan	Japan	Asia	https://www.kyowakirin.com/index.html
Clinical	YABS0891	11/16/2024	None	Kintuximab, gentuximab, cintuximab (not WHO assigned INN)	None	mAb chimeric	Naked monospecific	Full length Ab	None	VEGFR2	TBD	TBD	None	None	None	Anti-VEGFR2 Human-mouse Chimeric Monoclonal Antibody; Kintuximab Injection (Recombinant Anti-VEGFR2 Human-Mouse Chimeric Monoclonal Antibody Injection)	None	None	Phase 3	Active	10/11/2017	—	05/30/2022	Gastric cancer, Non-Small Cell Lung Cancer, Solid tumors	Cancer	GeneScience Pharmaceuticals Co. Ltd.	Changchun Jinsai Pharmaceutical Co. Ltd.	NCT05919381 / CTR20220815 Phase 3 study of cintuximab injection combined with paclitaxel injection versus placebo combined with paclitaxel injection for advanced gastric or gastroesophageal junction adenocarcinoma after failure of first-line standard therapy started in May 2022; contact email is fengshaohua@gensci-china.com; protocol number is Gensci043-GC-Ⅲ01. CTR20210189 Phase 1 in NSCLC started in April 2021 active not recruiting. NCT05223595 Phase 1 in NSCLC started in April 2021 recruiting as of last update in Feb 2022. NCT04053205 Phase 1/2 study in Advanced Gastric or Gastroesophageal Junction Cancer not yet recruiting as last update in Aug 2019; est start date is Aug 2019. Phase 1 NCT03313219 study started in Oct 2017 has unknown status; last updated in Dec 2017 CTR20171077 Phase 1 study started in Oct 2017 completed in Nov 2019.	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	YABS0895	08/22/2024	Anbenitamab	KN026	None	mAb humanized	Bispecific, Biparatopic	Full length Ab	None	HER2, HER2	IgG1	kappa	None	None	None	KN026* is an anti-HER2 Fc-based heterodimer bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2. Derived from Charge Repulsion Induced Bispecific (CRIB) technology; heterodimeric Fc with K409A in knob chain and F405K mutation in the hole chain (Wei H, Cai H, Jin Y, et al. Structural basis of a novel heterodimeric Fc for bispecific antibody production. Oncotarget, 2017, 8(31): 51037.)	None	BLA in 2025 planned	Phase 3	Active	09/17/2018	06/17/2019	04/07/2022	HER2+ breast and gastric cancers	Cancer	Jiangsu Alphamab Biopharmaceuticals Co. Ltd	Sanofi	June 30, 2024: The NDA for KN046 is expected to be determined whether to be submitted in 2024, subject to the results of its final OS analysis for first-line treatment of sq NSCLC, and the one for KN026 is expected to be submitted in 2025. (https://www.alphamabonc.com/en/uploads/2024/08/172372714522178.pdf) July 28 2023 press release: First patient has been successfully dosed in a randomized, controlled, open-label, multi-center, phase III clinical trial of KN026 in China NCT05838066 Phase 3 due to start in July 2023. NCT05427383 Phase 2/3 in Gastric/Gastroesophageal junction cancer (KN026-CSP-001) started in April 2022 recruiting as of last update in June 2022. KN026+KN046 combo in gastric cancer granted US Orphan Drug designation. NCT04521179 Phase 2 in solid tumors started in Dec 2020. NCT04165993 Phase 2 in metastatic breast cancer not yet recruiting when posted on Nov 22, 2019. NCT03925974 Phase 2 study in HER2+ Gastric/Gastroesophageal Junction cancer recruiting as of June 17, 2019. NCT03619681 Phase 1 study in HER2+ breast and gastric cancers started in Sep 2018	None	—	—	—	None	218 Xinhu St. Building #C23, Suzhou, Jiangsu	China	Asia	https://www.alphamabonc.com/en/contact/index.html
Clinical	YABS0896	08/22/2024	Erfonrilimab	KN046	None	mAb chimeric/humanized	Bispecific	Fragment-Fc	2+2 symmetric, (VHH-VHH')2-Fc, Tandem-VHH-Fc	PD-L1, CTLA-4	IgG1	None	None	None	None	Immune checkpoint targets. CRIB (Charge Repulsion Induced Bispecific). CRIB technology represents the 3rd generation of Fc-based bispecific platforms in engineering the Fc terminal of antibodies. To favor heterodimerization over homodimerization of the Fc, CRIB has introduced point mutations to induce changes in charge and H-bond interactions, in addition to steric interactions (Knob-in-Hole). The CRIB platform has been well validated by our HER2 bispecific program KN026*, which retains all the desirable features of a regular antibody, such as high yield at large-scale (3 g/L or above) standard production, full antibody function, and a stable product. https://www.alphamabonc.com/en/uploads/2023/08/169286574293454.pdf immunoglobulin G1 VH-VH-h-CH2-CH3 dimer, anti-[Homo sapiens CD274 (programmed death ligand 1, PDL1, PDL1, B7 homolog 1, B7H1)] and anti-[Homo sapiens CTLA4 (cytotoxic T-lymphocyte-associated protein 4, CD152)], chimeric and humanized monoclonal antibody, bispecific.	Camelid-derived	BLA in 2024 planned	Phase 3	Active	05/21/2018	06/21/2019	09/14/2020	Pancreatic Ductal Adenocarcinoma, Hepatocellular carcinoma, Gastro-intestinal tumors, thymic carcinoma, non-small cell lung cancer, colorectal cancer, triple-neg. breast cancer, solid tumors	Cancer	Alphamab (Australia) Co Pty Ltd.	Pfizer, Zelgen, Sunny Lake, Kintor, Sinovent, InxMed	NCT06834399 Phase 2 in colorectal cancer terminated due to Business Operation Strategy Adjustment. June 30, 2024: The NDA for KN046 is expected to be determined whether to be submitted in 2024, subject to the results of its final OS analysis for first-line treatment of sq NSCLC, and the one for KN026 is expected to be submitted in 2025. (https://www.alphamabonc.com/en/uploads/2024/08/172372714522178.pdf) Partners are Pfizer, Zelgen (泽璟)，Sunny Lake (东阳光)，Kintor (开拓)，Sinovent (信诺维)，InxMed (应世) April 4, 2023 Alphamab announces that KN046 enters the Pre-BLA phase: The Phase III clinical study of KN046 for the first-line treatment of advanced squamous non-small cell lung cancer achieved the preset endpoint of PFS, and the Phase III clinical study for the first-line treatment of advanced pancreatic cancer completed planned enrollment. We plan to submit two BLAs for KN046 in the treatment of sqNSCLC and PDAC in China in 2023. As of Sep 2022: Alphamab has initiated two pivotal clinical trials in NSCLC, a pivotal clinical trial in PDAC and a pivotal trial in thymic carcinoma. March 2022 presentation of YE2021 results: BLA planned in mid- 2022 (https://www.alphamabonc.com/en/uploads/2022/03/164856634734590.pdf) March 2021: Alphamab Oncology announced that U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application (IND) to initiate an open label, multi-center phase II pivotal clinical study (NCT04469725; clinical trial No.: KN046-205) in the United States to evaluate the efficacy, safety and tolerability of KN046 (PD-L1/CTLA-4 bispecific antibody) for the treatment of thymic carcinoma. September 26, 2020 - Alphamab Oncology announced that Jiangsu Alphamab Biopharmaceuticals Co., Ltd., a wholly-owned subsidiary of the company, has achieved the first patient dosing in ENREACH-LUNG-01, a pivotal Phase Ⅲ clinical trial of KN046, a recombinant humanized PD-L1/CTLA-4 bispecific antibody invented and developed by Alphamab (Study code: ENREACH-LUNG-01). NCT04474119 Phase 3 in NSCLC started in Sep 2020. Sep 2020: Alphamab Oncology announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to KN046, a recombinant humanized PD-L1/CTLA-4 bispecific antibody developed by Jiangsu Alphamab Biopharmaceuticals, a wholly-owned subsidiary of the company, for the treatment of thymic epithelial tumors (TET). This is the second ODD awarded to Alphamab Oncology by FDA after the first ODD awarded to the subcutaneous PD-L1 antibody KN035 by FDA for the treatment of Biliary track cancer in early 2020. July 2020: Alphamab Oncology announced that Jiangsu Alphamab Biopharmaceuticals, a wholly-owned subsidiary of the Company, has entered a partnership agreement with Kintor Pharmaceutical to jointly develop the combination therapy of PD-L1 / CTLA-4 bispecific antibody KN046 and ALK-1 monoclonal antibody GT90001 in hepatocellular carcinoma (HCC). NCT04054531 Phase 2 study in NSCLC recruiting as of Sep 2019. NCT03925870 Phase 2 study in Esophageal Squamous Cell cancer recruiting as of June 21, 2019. NCT03838848 Phase 2 study in NSCLC not yet recruiting as of March 5, 2019. NCT03872791 Phase 1/2 study in triple-neg. breast cancer not yet recruiting as of March 13. NCT03529526 Phase 1 study started in May 2018. Oct. 10, 2018: Alphamab Oncology announced that its proprietary humanized PD-L1 - CTLA-4 bispecific antibody (product code: KN046) program, the first of its class, has recently started phase I clinical trial in Australia. The antibody has also obtained the IND approval from the National Medical Products Administration (NMPA) in China and will enter clinical trials in the country as well.	None	—	—	—	None	218 Xinhu St. Building #C23, Suzhou, Jiangsu	China	Asia	https://www.alphamabonc.com/en/contact/index.html
Clinical	YABS0904	08/16/2024	Tarcocimab tedromer	KSI-301, OG1953	None	mAb humanized	Immunoconjugate	Full length Ab conjugate	ABC	VEGF	IgG1	kappa	None	None	Biopolymer	KSI-301 is a novel anti-VEGF antibody biopolymer conjugate. Site-specific conjugation (L443C). The ABC platform comprises a humanized IgG1 antibody with inert immune effector function and a biopolymer which is an optically clear, high molecular weight phosphorylcholine polymer covalently bound by single-site specific linkage. Its design optimized both size and molar dose to increase intraocular durability. The molecular weight of KSI-301 is 950 kDa and that of biopolymer is 800 kDa. https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl126.pdf?sfvrsn=a37e0953_7&download=true https://kodiak.com/our-pipeline/#modal-tarcocimab	None	None	Phase 3	Active	12/26/2018	09/30/2019	10/01/2020	Diabetic Retinopathy, Diabetic Macular Edema, Wet Macular Degeneration	Ophthalmic disorders	Kodiak Sciences Inc	None	NCT06556368 Phase 3 in wet AMD started in August 2024. NCT06270836 Phase 3 in Non-proliferative Diabetic Retinopathy due to start in March 2024 Nov 2023: Kodiak Sciences Inc. announced that its Phase 3 GLOW superiority study evaluating tarcocimab tedromer 5 mg in moderately severe to severe NPDR met its one-year primary endpoint. Based on discussions with FDA, The company believes they have a clear regulatory pathway requiring one additional positive study to support a single BLA submission for macular edema following retinal vein occlusion (RVO), wet age-related macular degeneration (wAMD) and non-proliferative diabetic retinopathy (NPDR). July 2023: GLEAM and GLIMMER studies did not meet their primary efficacy endpoints of showing non-inferior visual acuity gains for tarcocimab dosed every 8 to 24 weeks after 3 monthly loading doses compared to aflibercept given every 8 weeks after 5 monthly loading doses; the DAYLIGHT study met the primary endpoint of non-inferior visual acuity gains for tarcocimab dosed monthly compared to aflibercept dosed every 8 weeks following 3 monthly loading doses. Based on these data, and despite demonstrating great potential, Kodiak has made a business decision to discontinue further development of tarcocimab. First quarter 2023 financial results (May 15, 2023) "The BEACON study met its primary endpoint in 2022, and four Phase 3 clinical studies are expected to announce topline data in 3Q2023. If successful, Kodiak plans to file a single Biologics Licensing Applications ("BLA") for tarcocimab in the four major retinal vascular disease indications." https://ir.kodiak.com/news-releases/news-release-details/kodiak-sciences-announces-first-quarter-2023-financial-results. Phase 3 studies for Diabetic macular edema (NCT04603937, NCT04611152) are active non recruiting as of May 25, 2023; Macular edema due to retinal vein occlusion (NCT04592419) is completed as of February 9, 2023; Wet macular degeneration (NCT0964089) is completed as of May 30, 2023; Non-proliferative diabetic retinopathy (NCT05066230) is active non recruiting as of September 26, 2022. Mar 2023: Company is currently on track to release topline data from the four ongoing Phase 3 studies in the third quarter of 2023. Feb 2022: The Company's DAZZLE and DAYLIGHT pivotal studies in patients with treatment-naïve wet AMD, GLEAM and GLIMMER pivotal studies in patients with diabetic macular edema, and the BEACON pivotal study in patients with retinal vein occlusion are anticipated to form the basis of the Company's initial BLA to support potential approval and commercialization in multiple indications and with a full range of labeled and reimbursable dosing frequencies in each indication. An additional Phase 3 pivotal study, GLOW, in patients with non-proliferative diabetic retinopathy is also underway. NCT04611152 Phase 3 GLEAM study started Sep 30, 2020; NCT04603937 Phase 3 started in Sep 2020; NCT04592419 Phase 3 in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion started in Sep 2020. Oct 2020: Kodiak Sciences Inc., a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, announced that the first patients have been treated in the randomized, double-masked GLEAM, GLIMMER and BEACON studies, three pivotal Phase 3 studies of KSI-301, Kodiak's anti-VEGF antibody biopolymer conjugate, in treatment-naïve patients with diabetic macular edema (GLEAM and GLIMMER) and macular edema due to retinal vein occlusion (BEACON). Aug 2020 company presentation: Five pivotal KSI-301 studies in serious, vision-threatening diseases scheduled to run concurrently in 2020. NCT04049266 Phase 2/3 DAZZLE study in wet macular degeneration started in Sep 2019. Sept. 15, 2019: Kodiak Sciences Inc. announced emerging durability data in patients with wet age-related macular degeneration (AMD) treated in its Phase 1b clinical study of its investigational therapy KSI-301. The results were presented by David M. Brown, M.D., FACS, an investigator in the study, as a late-breaking oral presentation at The Retina Society Annual Meeting on September 15 in London, U.K. NCT03790852 Phase 1 started in Dec 2018.	None	—	—	—	None	Palo Alto, California, United States	United States of America	North America	https://kodiak.com/