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	YABS0407	05/21/2024	Nurulimab	BCD-217 in combo with prolgolimab, BCD-145	Nurdati®	mAb human	Naked monospecific	Full length Ab	None	CTLA-4	IgG1	kappa	None	None	None	Immune checkpoint target	None	None	Approved Russia	Active	10/02/2017	07/01/2019	08/02/2022	Melanoma	Cancer	Biocad	None	Dec19, 2023 press release: The Ministry of Health of the Russian Federation has registered an original drug for the treatment of unresectable or metastatic melanoma. The drug was developed by the biotechnology company BIOCAD and is a fixed combination of two monoclonal antibodies - nurulimab and prolgolimab. The drug received the trade name Nurdati®. Granted conditional registration following procedure* provided for by decision No. 78 of the EEC Council. https://biocad.ru/news/minzdrav-rossii-zaregistriroval-novyj-rossijskij-preparat-dlya-terapii-melanomy NCT05751928 Phase 3 started in Mar 2023. NCT05732805 Phase 3 started in Aug 2022. NCT03913923 Phase 2 of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma (OBERTON) NCT03472027 Phase 1 study completed in 2019.	None	2023	—	—	Nurulimab	198515, Saint Petersburg, Intracity Municipality the Settlement of Strelna, ul. Svyazi, d. 38, str. 1, pomeshch. 89	Russia	Europe	https://biocadglobal.com/contacts
Clinical	YABS0413	11/26/2024	Ociperlimab	BGB-A1217	None	mAb humanized	Naked monospecific	Full length Ab	None	TIGIT	IgG1	kappa	None	None	None	BGB-A1217 is a humanized, IgG1 monoclonal antibody against TIGIT.	None	None	Phase 3	Active	08/15/2019	01/15/2021	06/15/2021	Diffuse Large B-cell Lymphoma, Non-small cell lung cancer, Esophageal Squamous Cell Carcinoma, Solid tumors	Cancer	BeiGene Ltd.	None	Phase 3 studies for Non Small Cell Lung Cancer: NCT04866017 has been terminated, NCT04746924 is active non recruiting as of October 2024 Listed as Phase 3 in BeiGene pipeline dated Aug 2024 (https://www.beigene.com/wp-content/uploads/2023/04/2Q24-Pipeline-Slide-August2024.pdf), but no studies are recruiting patients. July 2023: On December 19, 2021, BeiGene Switzerland GmbH, a wholly-owned indirect subsidiary of BeiGene, Ltd. entered into an Option, Collaboration and License Agreement with Novartis Pharma AG, pursuant to which BeiGene Switzerland granted Novartis an exclusive time-based option to receive an exclusive license to develop, manufacture and commercialize the Company’s investigational TIGIT inhibitor ociperlimab in certain territories. On July 10, 2023, BeiGene Switzerland and Novartis entered into a Mutual Termination and Release Agreement to mutually terminate the Option Agreement, effective immediately. Pursuant to the Termination Agreement, BeiGene Switzerland regained full, global rights to develop, manufacture and commercialize ociperlimab. Phase 3 studies for Non-small cell lung cancer (NCT04746924, NCT04866017), sponsored bui BeiGene, are recruiting as of March 28, 2023. Phase 3 trial for NSCLC sponsored by Novartis is not yet recruiting as of March 30, 2023 (NCT05791097) As of June 2022 press release, company expected to Initiate additional pivotal clinical trials in 2022; and Announce data from Phase 1 trial (NCT04047862) cohorts in various solid tumor types in 2022.; no mention of submission timeline. June 17, 2021 I BeiGene, Ltd. announced that the first patient was dosed in the global Phase 3 AdvanTIG-302 trial of BeiGene’s investigational anti-TIGIT antibody ociperlimab (BGB-A1217) in combination with its anti-PD-1 antibody tislelizumab, for the first-line treatment of patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations. NCT04746924 and NCT04866017 Phase 3 studies in NSCLC not yet recruiting when first posted. NCT04732494 Phase 2 in Esophageal Squamous Cell Carcinoma recruiting when first posted on Feb 1, 2021 NCT04047862 Phase 1 /1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors started Aug 15 2019.	None	—	—	—	None	30 Science Park Road, Zhongguancun Life Science Park Changping District, Beijing 102206	China	Asia	https://www.beigene.com/
Clinical	YABS0438	02/12/2025	Litifilimab	BIIB059	None	mAb humanized	Naked monospecific	Full length Ab	None	BDCA2	IgG1	kappa	None	None	None	BIIB059 is a humanized IgG1 mAb that specifically recognizes blood DC antigen 2 (BDCA2), which is uniquely expressed on the surface of human pDCs (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6391094/)	None	None	Phase 3	Active	09/01/2014	08/15/2016	05/25/2021	Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus	Immune-mediated / inflammatory disorders	Biogen	Royalty Pharma	Feb 2025: Royalty Pharma will provide up to $250 million over six quarters to Biogen to support the development of litifilimab in exchange for regulatory milestones and mid-single digit royalties on annual worldwide sales. Phase 3 studies NCT06044337 (for Systemic lupus erythematosus) and NCT05352919 (for cutaneous lupus Erythematosus) Phase 3 studies are enrolling by invitation as of November 2024. Phase 2/3 study for Cutaneous lupus erythematosus (NCT05531565) is recruiting as of May 2023; phase 3 studies for Systemic lupus erythematosus (NCT04961567, NCT04895241) are recruiting as of August-November 2024. July 2022 Biogen presentation: Phase 3 study discussed, but no mention of regulatory filings. NCT04895241 and NCT04961567 Phase 3 studies have primary completion dates in 2025. NCT04961567 Phase 3 TOPAZ-2 study started in Aug 2021. NCT04895241 Phase 3 study in SLE started in May 2021. June 17, 2021 I Biogen Inc. (Nasdaq: BIIB) today announced that the first patient has been dosed in the global clinical study, TOPAZ-1. The Phase 3 study will evaluate the clinical efficacy and assess the safety of BIIB059, a first in-class, humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2), as compared to placebo, in participants with active systemic lupus erythematosus (SLE). Nov 2020: The LILAC study (part A) met its primary endpoint and a key secondary endpoint (SRI-4). These results, and the observed safety profile, support the continued development of BIIB059 in SLE. Dec 2019: The Phase 2 LILAC study met its primary endpoints, demonstrating statistically significant reduction of disease activity in patients with CLE and SLE who received BIIB059 compared to placebo. Listed as Phase 2 in Biogen pipeline accessed Aug 12, 2019. March 2019: Results of NCT02106897 published (Furie et al. Monoclonal antibody targeting BDCA2 ameliorates skin lesions in systemic lupus erythematosus. J Clin Invest. 2019 Mar 1;129(3):1359-1371. doi: 10.1172/JCI124466). NCT02847598 Phase 2 study in SLE still recruiting as of July 2018. NCT02106897 Phase 1 study complete. Target is blood dendritic cell antigen 2 (BDCA2). Blood dendritic cell antigen 2 (BDCA2) is a C-type lectin expressed on human plasmacytoid dendritic cells (pDCs) (Dzionek et al, J. Immunol, 165:6037-6046 (2000)), a specialized population of bone marrow-derived cells that secrete type I interferons (IFNs) in response to toll-like receptor (TLR) ligands. BDCA2 consists of a single extracellular carbohydrate recognition domain (CRD), which belongs to the type II C-type lectin group, at its C-terminus, a transmembrane region, and a short cytoplasmic tail at its N- terminus that does not harbor a signaling motif. BDCA2 transmits intracellular signals through an associated transmembrane adaptor, the FcsRIy, and induces a B cell receptor (BCR)-like signaling cascade.	None	—	—	—	None	Cambridge, MA 02142, United States	United States of America	North America	https://www.biogen.com/company/contact-us.html
Clinical	YABS0444	03/04/2025	Izalontamab brengitecan	BL-B01D1, BMS-986507	None	mAb chimeric/human	ADC, Bispecific	Appended Ig conjugate	2+2 symmetric, IgG-(scFv)2	EGFR, HER3	IgG1	kappa/lambda	Cathepsin B cleavable linker	8	Topoisomerase I inhibitor, Ed-04	BL-B01D1 is a bispecific antibody conjugate (ADC) developed by Bailey Pharmaceuticals, which can target EGFR and HER3 at the same time. It is planned to develop BL-B01D1 for the treatment of lung cancer, esophageal cancer, head and neck squamous cell carcinoma and other indications. BL-B01D1 is comprised of a bispecific antibody against EGFR/HER3 (SI-B001), a cathepsin B cleavable linker, and a novel topoisomerase I inhibitor agent (Ed-04), which is a derivative of the alkaloid camptothecin, driving cell cycle arrest at the S phase and subsequent apoptosis. BL-B01D1 achieves a high drug-to-antibody-ratio (DAR=8) with a highly stable linker. Cancer Res (2023) 83 (7_Supplement): 2642. doi.org/10.1158/1538-7445.AM2023-2642. The Fab arms and Fc domains are derived from cetuximab. https://www.bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2024/ESMO-2024-investor-presentation.pdf	None	None	Phase 3	Active	08/15/2021	04/15/2023	12/04/2023	Chordoma, Glioblastoma, Small cell lung cancer, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma, Triple-neg breast cancer, Non-small cell lung cancer (EGFR wild-type), Esophageal squamous cell carcinoma, Cervical cancer, Nasopharyngeal Carcinoma, Non-small Cell Lung Cancer With EGFR-sensitive Mutations, Gynecological Malignant Tumor, Urinary tract cancer, Breast cancer, Gastrointestinal Tumors, Solid tumors	Cancer	Sichuan Baili Pharmaceutical Co. Ltd., Systimmune	Bristol Myers Squibb	NCT06857175 Phase 3 in urothelial carcinoma due to start in March 2025. NCT06787664 Phase 2 in Chordoma started in Jan 2025. Phase 3 studies for Nasopharyngeal carcinoma (NCT06118333 / CTR20233419); Esophageal Squamous Cell Carcinoma (NCT06304974), Small Cell Lung Cancer (NCT06500026), Non-small Cell Lung Cancer (NCT06382129, NCT06382116), Triple-Negative Breast Cancer (NCT06382142), HR+HER2- Breast Cancer (NCT06343948) are recruiting as of May-September 2024 NCT06304974 Phase 3 in esophageal squamous cell carcinoma started in Mar 2024. Dec 2023: BMS gains ex-China rights to the EGFRxHER3 bispecific BL-B01D1. NCT06118333 / CTR20233419 Phase 3 in Nasopharyngeal Carcinoma started in Dec 2023. NCT05990803 Phase 2 in cervical cancer due to start in Sep 2023. NCT05880706 Phase 2 due to start in July 2023. NCT05785039 Phase 2 started in April 2023. NCT05470348 Phase 1 started in July 2022. NCT05461768 Phase 1 recruiting when first posted on July 18, 2022; NCT05393427 Phase 1 started in Feb 2022. Dec 2021: Beacon reports Phase 1 was started; CTR20212923 NCT05194982 Phase 1 started in Nov 2021. On August 10, 2021, the clinical trial application of Bailey Pharmaceuticals BL-B01D1 was accepted by NMPA	None	—	—	—	None	1#, Building 1,No.161, Baili Road, Cross-Strait Science and Technology Industrial Development Park, Wenjiang District, Chengdu City Postcode：610041	China	Asia	http://www.baili-pharm.com/
Clinical	YABS0446	02/18/2025	None	BL-M07D1	None	mAb - source TBD	ADC	Full length Ab conjugate	None	HER2	IgG1	kappa	Undisclosed	___	Topoisomerase I inhibitor, Ed-04	ADC BL-M07D1 is a HER2 specific antibody based on the drug Trastuzumab. Due to its HER2 binding, BL-M07D1 has anti-proliferative effects in a variety of HER2 driven solid tumors and secondarily, through a wt FC receptor can mediate innate immune effector functions toward the cancer cells. Upon antibody mediated internalization, BL-M07D1 is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induced genotoxic stress activating pathways leading to cancer cell death. https://systimmune.com/bl-m07d1	None	Phase 2 and 3 pending	Phase 3	Active	07/15/2022	—	05/22/2024	Breast cancer, HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma, Non-small cell lung cancer, Urinary and Digestive Tract Tumors, Solid tumors	Cancer	Sichuan Baili Pharmaceutical Co. Ltd., Systimmune	None	NCT06830889 Phase 3 in breast cancer due to start in May 2025. NCT06423885 Phase 2 in HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma due to start in June 2024. NCT06316531 /CTR20240858 Phase 3 in breast cancer started in May 2024. NCT06131450 Phase 1/2 in gynecological malignancies due to start in Dec 2023. NCT06114511 Phase 1/2 in NSCLC due to start in Dec 2023 NCT06031584 Phase 1/2 in Her2-positive/Low-expression Urinary and Digestive Tract Tumors due to start in Nov 2023 NCT05631964 /CTR20222950 Phase 1 in digestive tract and other solid tumors started in Jan 2023. NCT05461768 / CTR20221789 is A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-M07D1injection in Patients With Locally Advanced or Metastatic HER2-positive/Low-expression Breast Cancer and Other Solid Tumors started in Aug 2022	None	—	—	—	None	1#, Building 1,No.161, Baili Road, Cross-Strait Science and Technology Industrial Development Park, Wenjiang District, Chengdu City Postcode：610041	China	Asia	http://www.baili-pharm.com/
Clinical	YABS0464	11/22/2024	Gotistobart	BNT316, ONC-392	None	mAb humanized	Naked monospecific	Full length Ab	None	CTLA-4	IgG1	kappa	None	None	None	Immune checkpoint target. ONC-392 is the first known acid pH-sensitive anti-CTLA-4 mAb that interacts strongly with CTLA-4 at a pH typical of normal tissues/organs and the tumor microenvironment. When the pH drops below 6.0, ONC-392 rapidly disassociates from its target, thus allowing CTLA-4 to preserve its normal life cycle and avoid antibody-induced lysosomal degradation	None	None	Phase 3	Active	11/30/2019	12/15/2022	05/26/2023	Metastatic Castration-Resistant Prostate Cancer, Ovarian cancer, Solid tumors	Cancer	OncoC4 Inc.	BioNTech SE	NCT05671510 Phase 3 in NSCLC started in May 2023 still recruiting as of last update in Nov 2024. June 2023: Initiation of a pivotal Phase 3 trial with BNT316/ONC-392 as monotherapy in immunotherapy-resistant NSCLC patients is planned in Q3 2023, following FDA’s Fast Track designation in 2022 March 20, 2023 – BioNTech SE and OncoC4, Inc. announced that they have entered into an exclusive worldwide license and collaboration agreement to develop and commercialize OncoC4’s next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications. NCT05671510 Phase 3 in NSCLC started in May 2023. NCT05446298 Phase 2 in ovarian cancer started in Dec 2022. Sep 2020: OncoImmune, Inc. announced that it has dosed the first patient in the first-in-human clinical trial of ONC-392, its novel, next generation anti-CTLA-4 antibody, at the University of California (UC) Davis Comprehensive Cancer Center on September 16, 2020. This is a Phase 1A/1B clinical trial designed to assess the safety, pharmacokinetics, and clinical activity of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care therapy in Non-Small Cell Lung Cancer. NCT04140526 Phase 1 in solid tumors not yet recruiting; due to start in Feb 2020. Pfizer has option to exclusively license ONC-392--as well as any other OncoImmune anti-CTLA4 antibodies. Dec 30 2019: OncoImmune, Inc. announced today that its Investigational New Drug (“IND”) application for ONC-392, its novel, next generation anti-CTLA-4 antibody, has been approved by the U.S. Food and Drug Administration (“FDA”). The IND approval enables OncoImmune to begin a Phase 1A/1B clinical trial of ONC-392 that is designed to assess the safety, pharmacokinetics, and efficacy of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care in Non- Small Cell Lung Cancer. This open label trial is expected to begin in early 2020.	None	—	—	—	None	9640 Medical Center Dr, Rockville, MD 20850, United States	United States of America	North America	https://www.oncoc4.com/
Clinical	YABS0473	03/13/2025	Bosakitug	BSI-045B, BSI-04502, TQC2731	None	mAb humanized	Naked monospecific	Full length Ab	None	TSLP	IgG1	kappa	None	None	None	BSI-045B is an anti-thymic stromal lymphopoietin (TSLP) mAb. BSI-045B is a best-in-class high-affinity humanized anti-TSLP monoclonal antibody with over 150-fold higher in vitro efficacy compared to Tezepelumab (Tezspire™).	None	None	Phase 3	Active	10/15/2021	09/15/2022	02/20/2025	Chronic Obstructive Pulmonary Disease, Asthma, Atopic dermatitis	Immune-mediated / inflammatory disorders	Biosion	Aclaris Therapeutics, CTTQ	NCT06829784 / CTR20244307 Phase 3 in asthma start Feb 20, 2025. November 18, 2024 I Biosion, Inc. announced that it has entered into an exclusive license agreement with Aclaris Therapeutics for worldwide rights (excluding Greater China) to BSI-045B. Apr 4 2023 press release: Biosion’s collaboration partner - CTTQ, a China-based pharmaceutical company with rights to BSI-045B (TQC2731) for China development and commercialization, is currently conducting a Phase II clinical trial (CTR20221541) of BSI-045B in China for the treatment of severe uncontrolled asthma. Listed as Phase 2 asset in company pipeline accessed Feb 2023. NCT05114889 Phase 1 in Atopic Dermatitis started in Oct 2021. BSI-045B was created by Biosion under a collaboration with CTTQ in Dec 2017. CTTQ owns Greater China rights while Biosion retains all ex-China rights to develop and commercialize for all indications. Development status: CTTQ is currently conducting a Phase 2 clinical study of BSI-045B in severe asthma in China. Biosion is conducting a Phase 1b clinical study in atopic dermatitis in Australia.	None	—	—	—	None	Building D, Zhongdan Unit, Nanjing Jiangbei New Area, China 210061	China	Asia	https://www.biosion.com/
Clinical	YABS0479	11/25/2024	Anselamimab	CAEL-101, Ch mAb 11-1F4	None	mAb chimeric	Naked monospecific	Full length Ab	None	Amyloid light chain	IgG1	kappa	None	None	None	produced in a Chinese hamster ovary (CHO)-DG44 cell line	None	Marketing application possible for AL amyloidosis in 2025?	Phase 3	Active	09/01/2014	03/15/2020	11/12/2020	Amyloid light chain amyloidosis	Immune-mediated / inflammatory disorders	AstraZeneca	None	Listed as Phase 3 asset in AZ pipeline dated Nov 2024. Key Phase 3 read-out in AL amyloidosis in 2025 (NCT04504825, NCT04512235). Fast track designation as per Q3 2022 results presentation (https://www.astrazeneca.com/content/dam/az/PDF/2022/Q3/Year-to-date_and_Q3_2022_results_clinical_trials_appendix.pdf) AstraZeneca (acquired Caelum Biosciences and Alexion (formerly Syntimmune)) July 2021: Ongoing enrollment in the CAELUM CARESPhase 3 program with enrollment in both trials expected to complete by 2022. Aug 2020: Alexion Pharmaceuticals, Inc. and Caelum Biosciences today announced the initiation of the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in AL amyloidosis. The CARES clinical program includes two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease – and will collectively enroll approximately 370 patients globally. Enrollment is underway in both studies. The primary objective of the clinical program is to assess overall survival. NCT04504825 started in Feb 2021 has primary completion date in 2024 and NCT04512235 Phase 3 study started in Nov 2020 has primary completion date in March 2025. December 2, 2019 – Caelum Biosciences, Inc. (“Caelum”), a company focused on developing treatments for rare and life-threatening diseases, today announced that the European Commission (EC) has granted orphan medicinal product designation to CAEL-101 (previously known as 11-1F4), a light chain fibril-reactive monoclonal antibody (“mAb”), for the treatment of amyloid light chain (“AL”) amyloidosis. January 31, 2019: Alexion Pharmaceuticals, Inc. and Caelum Biosciences today announced a collaboration to develop CAEL-101 for light chain (AL) amyloidosis. CAEL-101 is a first-in-class amyloid fibril targeted therapy designed to improve organ function by reducing or eliminating amyloid deposits in patients with AL amyloidosis June 25, 2018 – Caelum Biosciences, Inc. today announced a complete analysis of cardiac data from Columbia University’s (“Columbia”) Phase 1b trial that supports CAEL-101’s (mAb 11-1F4) potential to improve myocardial function as assessed by global longitudinal strain (“GLS”) and generate a sustained decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in amyloid light chain (“AL”) amyloidosis patients experiencing cardiac involvement. These data were presented at the American Society of Echocardiography (ASE) 29th Annual Scientific Sessions. December 11, 2017 – Caelum Biosciences, Inc. (“Caelum”) today announced full Phase 1a/1b clinical data demonstrating CAEL-101’s (mAb 11-1F4) ability to bind to light-chain amyloid fibrils and achieve early and clinically efficacious organ responses in patients with relapsed and refractory amyloid light chain (“AL”) amyloidosis. The data were presented by Columbia University (“Columbia”) on December 10th in an oral session at the 59th American Society of Hematology (“ASH”) Annual Meeting. Caelum in-licensed CAEL-101 from Columbia and recently completed a Phase 1a/1b clinical trial at Columbia for the treatment of AL amyloidosis, a rare systemic disorder that causes misfolded amyloid proteins produced by plasma cells to cause buildup in and around tissues, nerves and organs, gradually affecting their function.The Phase 1a/1b study (ClinicalTrials.gov Identifier: NCT02245867) is examining the tolerance, safety, pharmacokinetics and possible clinical benefit of CAEL-101, a chimeric fibril‐reactive monoclonal antibody (mAb), in patients with AL amyloidosis. January 4, 2017 – Fortress Biotech, Inc. (Nasdaq: FBIO) today announced the formation of a new subsidiary company, Caelum Biosciences, Inc., to advance the development of CAEL‐101 (11‐1F4) for the treatment of amyloid light chain (“AL”) amyloidosis. Caelum has entered into an agreement with Columbia University (“Columbia”) to secure exclusive worldwide license rights to CAEL‐101, a chimeric fibril‐reactive monoclonal antibody (mAb) currently being evaluated in a Phase 1a/1b study. CAEL-101 has received Orphan Drug Designation from the U.S. Food and Drug Administration as a therapy for patients with AL amyloidosis and as a radio-imaging agent in AL amyloidosis.	None	—	—	—	None	Cambridge, United Kingdom	United Kingdom	Europe	https://www.astrazeneca.com/our-company/contact-us.html
Clinical	YABS0490	11/27/2024	Rademikibart	SIM0718, CBP-201	None	mAb human	Naked monospecific	Full length Ab	None	IL-4R alpha	IgG4	kappa	None	None	None	CBP-201 is a hinge-stabilized monoclonal antibody against IL-4Rα, a receptor found on immune cells that mediates the biological activities of both IL-4 and IL-13, two important cytokines that drive a broad range of allergic inflammation such as asthma and atopic dermatitis. Preclinical studies showed that CBP-201 is extremely potent in inhibiting IL-4Rα signaling (IC50 is approximately 40 pM). Phase 1b study in moderate-to-several atopic dermatitis has been completed and the data showed that four-week treatment of CBP-201 resulted in significant and rapid improvement in all disease metrics including skin lesion and pruritus, supporting the first-in-class potential. http://www.connectbiopharm.com/product289/detail490.html	None	None	Phase 3	Active	04/15/2018	06/23/2020	07/15/2024	Atopic dermatitis, asthma, Chronic Rhinosinusitis With Nasal Polyps	Immune-mediated / inflammatory disorders	Suzhou Connect Biopharmaceuticals Ltd.	Simcere Pharmaceutical Co. Ltd	Phase 3 studies for Atopic dermatitis (CTR20242160 / NCT06477835), Asthma (CTR20242195 / NCT06488755). CTR20242160 Phase 3 initiated in July 2024. Simcere Pharmaceutical Co., Ltd., Connect’s partner in Greater China who holds responsibility for future development and New Drug Application submission of rademikibart, has announced the initiation of Phase 3 trials in China in moderate-to-severe AD and asthma. https://investors.connectbiopharm.com/news-releases/news-release-details/connect-biopharma-reports-first-half-2024-financial-results-and Nov. 21, 2023 -- Connect Biopharma Holdings Limited announced that two of its wholly owned subsidiaries, Connect Biopharma Hong Kong Limited and Suzhou Connect Biopharma Co., Ltd., have entered into an exclusive license and collaboration agreement with Simcere Pharmaceutical Co., Ltd., a subsidiary of Simcere Pharmaceutical Group Ltd. (“Simcere”), to develop and commercialize Connect Biopharma’s rademikibart in Greater China April 2023: The Company believes it is on track to complete the 36-week stage 2 maintenance phase of the trial in patients with severe-to-moderate AD in the second half of 2023. This stage of the trial includes a once-a-month (Q4W) dosing regimen. Based on feedback received from the CDE, the Company plans to submit an NDA by the end of the first quarter of 2024 for potential approval in 2025. Global Phase 3 program: The Company is seeking strategic partnerships to advance this product candidate to the next phase of clinical development with potential global and regional partners to provide the necessary infrastructure and deliver a differentiated therapeutic program with improved efficacy and dosing convenience." (https://investors.connectbiopharm.com/news-releases/news-release-details/connect-biopharma-reports-full-year-2022-financial-results-and) Mar 2023: Data from Stage 1 of the ongoing pivotal CBP-201 China trial in moderate-to-severe atopic dermatitis (AD) showed rapid relief from symptoms, as early as week one in some cases, and no efficacy plateau at Week 16. The study met primary and secondary endpoints with mostly mild-to-moderate adverse effects reported. The data were presented as a late-breaking oral presentation today at the American Academy of Dermatology Annual Meeting, taking place in New Orleans, March 17-21, 2023. https://www.connectbiopharm.com/wp-content/uploads/AAD2023-late-breaker-11Mar2023_FINAL.pdf NCT05614817 Phase 3 in atopic dermatitis due to start in Dec 2022 was withdrawn. July 2022: Suzhou Connect Biopharmaceuticals announces the projected timeline of the Company’s global Phase 3 program in moderate-to-severe AD remains unchanged including to enroll the first patient by the end of 2022, intention to submit NDA to National Medical Products Administration (NMPA), China for Atopic dermatitis in 2024. July 2022: NCT04783389 Phase 2 in Chronic Rhinosinusitis With Nasal Polyps Terminated (Trial was discontinued in 2022 due to COVID-19 pandemic and Ukraine/Russia conflict related enrollment challenges. Discontinuation was not related to safety.) NCT05017480 Phase 2 in atopic dermatitis due to start in Sep 2021. Phase-II clinical trials in Atopic dermatitis (In adults, In the elderly) in USA (SC) (NCT04444752) started in June 2020. Jan 2020: Connect Biopharma announced positive topline data from the Phase Ib study of CBP-201, in patients with moderate-to-severe atopic dermatitis (AD). Results from the study show that CBP-201 has an efficacy profile that is superior to data from clinical studies of the current standard of care therapy for AD after four weeks of treatment, with a favorable safety profile. ACTRN12619000395134 Phase 1 study.	None	—	—	—	None	East R&D Building, 3rd floor, 6 Beijing West Road, Taicang, China, 215400	China	Asia	https://www.connectbiopharm.com/contact/
No development reported	YABS0492	11/24/2024	Geptanolimab	CBT-501, GB226, Genolimzumab (not WHO assigned INN), APT-501	Aibining 艾比寧®	mAb humanized	Naked monospecific	Full length Ab	None	PD-1	IgG4	kappa	None	None	None	Immune checkpoint inhibitor; S228P hinge stabilized. CBT-501 is a novel humanized IgG4 monoclonal antibody targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. CBT-501 has a comparable efficacy profile in in vitro and in vivo studies to marketed anti-PD-1 antibodies and has a favorable safety profile with very low undesirable antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activity.	None	Termination	Regulatory review China	No development reported	03/27/2017	07/02/2018	—	Non-small cell lung cancer, Colorectal cancer, Hepatocellular and Renal Cell Carcinoma (Phase 1/2 study), Solid tumors	Cancer	Genor BioPharma Co. Ltd	CBT Pharmaceuticals Inc., Apollomics (Australia) Pty. Ltd.	Genor Interim results 2024: Continued internal development of GB226 PD-1 and GB221, have been paused and pending further assessment of development strategy and resource allocation. (https://www.genorbio.com/media/1420/2024-interim-report-en.pdf) June 12, 2023: The board of directors of the Company (the “Board”) announces that the Company has been notified by the China National Medical Products Administration that the New Product Application approval of Geptanolimab (GB226) as a treatment for relapsed/refractory peripheral T-cell lymphoma (PTCL) was not granted. Mar 2022 update: The NDA for Geptanolimab (GB226) was officially accepted by the National Medical Products Administration (NMPA) and granted for priority review by the Center for Drug Evaluation (CDE), and successfully passed the NDA pre-approval inspection by the National Medical Products Administration. Mar 2021: GB226 (Geptanolimab) – NDA approval for r/r PTCL expected Q321. Genor Biopharma expects to launch Geptanolimab (GB226) at Q3 this year, it is the first PD-1 inhibitor worldwide for peripheral T-cell lymphoma (PTCL). August 5, 2020 -- Genor Biopharma Co. Inc announced that National Medical Products Administration (NMPA) has granted priority review status to its new drug application (NDA) for Geptanolimab, a PD-1 mAb, on July 28, 7 days after the NDA acceptance. Relapsed/refractory Peripheral T cell Lymphoma (PTCL) is the first indication that Genor targeted for its Geptanolimab. It is currently the first PD-1 mAb in China and globally being applied for this disease setting. NCT03976856 Phase 1 in NSCLC not yet recruiting as of June 6, 2019. NCT03977090 Phase 1 in colorectal cancer started in April 2019. Sep 2018: CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, today announced the initiation of the APOLLO Oncology Clinical Trials Program. The initial Phase 1/2 study, NCT03655613, is a two-arm clinical trial targeting locally advanced or metastatic disease: CBT-101 with CBT-501 (genolimzumab; anti-PD-1) in hepatocellular carcinoma (HCC), or CBT-101 and nivolumab in renal cell carcinoma (RCC). CBT-101 targets the epithelial to mesenchymal transition (EMT) pathway, and CBT-501 is CBT’s IgG4 humanized monoclonal antibody against the PD-1 membrane receptor on immune cells. Nivolumab (OPDIVO®; Bristol-Myers Squibb Company) is approved for advanced kidney cancer. April 2018: CBT Pharmaceuticals expects to initiate a Phase Ib/II study of CBT-501 in combination with CG200745 by the end of 2018. First clinical study NCT03053466 done in Australia. The antibody (CBT-501, GB226) was developed by Genor BioPharma Co. Ltd., a Walvax Company, who owns development and commercialization rights in China. CBT Pharmaceuticals, Inc. retains rest of the world (ROW) rights. An investigational new drug application has been approved by the China Food and Drug Administration (CFDA), and a Phase 1 trial will be initiated in China by Genor.	None	—	—	—	None	1690 Zhangheng Road, Building 3, Pudong New District, Shanghai	China	Asia	https://www.genorbio.com/en/contact/