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Guangdong Zhongsheng Pharmaceutical’s RAY1225 Shows Positive Results in Phase II Study
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Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based pharmaceutical company, has announced positive top-line results from Part A of a Phase II clinical study for its Category 1 innovative polypeptide drug candidate, RAY1225. The drug demonstrated significant superiority over placebo in achieving weight loss targets and alleviating multiple cardiovascular…
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GSK’s Linerixibat Demonstrates Efficacy in Phase III GLISTEN Study for Cholestatic Pruritus
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UK-based pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK) has announced positive headline results from the Phase III GLISTEN study, which assessed the efficacy of its ileal bile acid transporter (IBAT) inhibitor, linerixibat, in treating cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC). Study Design and Primary Endpoint AchievementThe GLISTEN…
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MSD Announces Positive Topline Results from Phase III Subcutaneous Keytruda Trial
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has released positive topline results from the pivotal Phase III MK-3475A-D77 trial. The study aimed to assess the noninferiority of subcutaneous administration of PD-1 inhibitor Keytruda (pembrolizumab) combined with berahyaluronidase alfa, a hyaluronidase variant developed by Alteogen Inc., in comparison to…
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Brii Biosciences’ Elebsiran Shows Promising Results in Phase II ENSURE Study for Chronic HBV
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China-based Brii Biosciences Ltd (HKG: 2137) has published the latest data from its ongoing Phase II ENSURE study for elebsiran (BRII-835, VIR-2218), an investigational small interfering ribonucleic acid (siRNA) therapy for chronic hepatitis B virus (HBV) infection. Phase II ENSURE Study Design and Initial FindingsThe active-controlled and randomized Phase II…
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UCB and Biogen’s Dapirolizumab Pegol Shows Promise in Phase III SLE Study
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Partners UCB (FRA: UNC) and Biogen Inc. (NASDAQ: BIIB) have announced positive results from a Phase III study of their co-developed drug candidate, dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L agent, when combined with the standard-of-care (SOC) in patients with moderate-to-severe systemic lupus erythematosus (SLE). The findings, which indicate a…
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Rona Therapeutics’ RN0191 Showcases Positive Phase I Results at AHA Scientific Sessions
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Shanghai-based nucleic acid drug developer Rona Therapeutics has announced the presentation of positive Phase I results for its investigational drug, RN0191, at the American Heart Association’s (AHA) Annual Scientific Sessions in Chicago, IL. The study’s findings highlight the potential of RN0191 in managing lipid levels and offer promising news for…
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Eli Lilly’s Tirzepatide Meets Primary Endpoints in Phase III SUMMIT Heart Failure Study
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Eli Lilly and Company (NYSE: LLY), a leading US pharmaceutical corporation, has announced positive results from the Phase III SUMMIT study assessing the effects of tirzepatide in heart failure. The study successfully met both primary endpoints, marking a significant advancement in the treatment of heart failure. Study Outcomes and EfficacyTirzepatide,…
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Eli Lilly’s Muvalaplin Demonstrates Potent Lp(a) Reduction in Phase II Study
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Eli Lilly & Co. (NYSE: LLY), a leading US pharmaceutical company, has announced positive results from a Phase II study for its investigational drug, muvalaplin, a selective lipoprotein(a) [Lp(a)] inhibitor. The study successfully met its primary endpoint, showing a significant reduction in elevated Lp(a) levels in adults, a genetic risk…
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TenNor Therapeutics’ Rifasutenizol Shows High Eradication Rate in H. pylori Phase III Study
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China-based TenNor Therapeutics has announced positive results from its Phase III clinical study for rifasutenizol (TNP-2198) in treating Helicobacter pylori (H. pylori) infection. The study successfully met its primary endpoints, showing significant advantages of the rifasutenizol regimen over the bismuth-containing quadruple therapy (BQT), which is the current standard of care.…
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GSK’s Blenrep Shows Survival Benefit in Phase III Multiple Myeloma Study
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UK-based pharmaceutical company GSK plc (NYSE: GSK) has reported positive results from a Phase III trial for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma (RRMM). The DREAMM-7 head-to-head study demonstrated that GSK’s BCMA-targeted antibody drug…
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Janssen-Cilag’s Nipocalimab Shows Promise in Phase II Study for Sjögren’s Disease
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Janssen-Cilag International NV, a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ), has unveiled the latest analysis results from the Phase II DAHLIAS study for nipocalimab, an investigational FcRn blocker, in adult patients with moderate-to-severe Sjögren’s disease (SjD). The study has shown that the drug significantly improved key measures of…
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Eli Lilly’s Tirzepatide Shows Sustained Weight Loss in 176-Week Study
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US pharmaceutical giant Eli Lilly and Company (NYSE: LLY) has released 176-week follow-up data from its Phase III SURMOUNT-1 study for tirzepatide, marking the longest completed study to date for the dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. This data provides significant insights into the drug’s…
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Gan & Lee’s GZR18 Shows Significant Weight Loss in Phase IIb Study at ObesityWeek 2024
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Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced the oral presentation of results from the Phase IIb study for its glucagon-like peptide-1 (GLP-1) receptor agonist, GZR18, at ObesityWeek 2024. The drug is administered once per week and targets the obese or overweight Chinese population. Study Design…
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BeyondSpring Presents Positive Phase II Data for Plinabulin Combination Therapy in NSCLC at SITC
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BeyondSpring Inc. (NASDAQ: BYSI), a US-based biotech company, has announced the presentation of the latest results from the Phase II KeyPelms-004 study at the 39th Society for Immunotherapy of Cancer’s (SITC) Annual Meeting. The study evaluated the efficacy and safety of plinabulin combined with pembrolizumab plus docetaxel in patients with…
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Abbisko Therapeutics’ Pimicotinib Meets Primary Endpoint in Phase III MANEUVER Study for TGCT
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hanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has revealed positive top-line results from the pivotal Phase III MANEUVER study for its drug candidate ABSK021 (pimicotinib) in tendon sheath giant cell tumor (TGCT). The study, designed to assess the efficacy and safety of pimicotinib in TGCT patients suitable for systemic…
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AstraZeneca’s Tezspire Meets Phase III Co-Primary Endpoints in CRSwNP Study
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced positive high-level results from the Phase III WAYPOINT study for Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The drug, a thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) co-developed with US firm Amgen (NASDAQ: AMGN),…
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Alphamab Oncology Presents JSKN033 Phase I/II Study Results at SITC 2024
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Alphamab Oncology (HKG: 9966), a China-based biopharmaceutical company, has announced the presentation of the latest results from the Phase I/II study of its investigational drug JSKN033 at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024). The study focuses on patients with HER2-expressing advanced or metastatic…
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Ascletis Pharma’s ASC47 Showcases Promising Weight Loss Results in Phase I Clinical Trial
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Ascletis Pharma Inc. (HKG: 1672), a China-based pharmaceutical company, has announced positive results from a Phase I clinical study for its drug candidate ASC47 in Australia. This in-house developed therapy is designed to facilitate weight loss without the loss of muscle mass, offering a potential new option for obesity management.…
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HutchMed to Present Updated Data from Solvleplenib ESLIM-01 Phase III Trial at ASH and ESMO Congress 2024
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China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced plans to present new and updated data from the sovleplenib ESLIM-01 Phase III trial, along with several investigator-initiated studies of compounds discovered by HutchMed, at the American Society of Hematology (ASH) Annual Meeting and the European Society for Medical Oncology…
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CARSgen Therapeutics Presents Latest CAR-T Data at ASH Annual Meeting
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CARSgen Therapeutics Holdings Ltd (HKG: 2171), a China-based specialist in chimeric antigen receptor (CAR)-T cell therapies, has announced the presentation of the latest data for its CAR-T therapies, CT053 (zevorcabtagene autoleucel; zevor-cel), CT071, and CT0590, at the 66th American Society of Hematology (ASH) annual meeting. CT053 Phase II Study Subgroup…
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Ascentage Pharma to Present Olverembatinib and Lisaftoclax Clinical Data at ASH Annual Meeting
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China-based Ascentage Pharma (HKG: 6855) has announced that it will present the results of multiple clinical studies for its olverembatinib (HQP1351) and three clinical studies for its lisaftoclax (APG-2575) at the 66th American Society of Hematology (ASH) annual meeting. These presentations highlight the company’s commitment to advancing treatments for various…
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CStone Pharmaceuticals Presents CS5001 Clinical Data at the ASH Annual Meeting
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China-based CStone Pharmaceuticals (HKG: 2616) has announced the presentation of the latest clinical data on CS5001, an anti-ROR1 antibody drug conjugate (ADC) for lymphoma, at the 66th American Society of Hematology (ASH) Annual Meeting. CS5001 is a leading asset in CStone’s Pipeline 2.0 and has shown significant promise in treating…
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Roche to Showcase 40+ Abstracts on Blood Disorders at ASH Annual Meeting
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced plans to present over 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The presentations will feature data on approved medicines Polivy (polatuzumab vedotin), Lunsumio (mosunetuzumab), and Columvi (glofitamab), including long-term follow-up and…
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Legend Biotech to Showcase CARTITUDE-4 Trial Data on Carvykti at ASH Annual Meeting
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China-based Legend Biotech Corporation (NASDAQ: LEGN) is set to present new data on minimal residual disease (MRD) negativity rates from the Phase III CARTITUDE-4 trial at the 66th Annual American Society of Hematology (ASH) Annual Meeting in San Diego. The data will compare Carvykti (ciltacabtagene autoleucel; cilta-cel) treatment with the…
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China Grand Pharmaceutical Completes Phase III Clinical Study for Post-Cataract Surgery Treatment
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the successful completion of a Phase III clinical study for its investigational drug, GPN00833, used for inflammation and pain management following cataract surgery in China, meeting all clinical endpoints. GPN00833: A Nanosuspension Eye Drop for Inflammation and PainGPN00833…
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J&J MedTech Completes Pilot Enrollment for OMNY-AF Study on Atrial Fibrillation Treatment
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US major Johnson & Johnson (J&J, NYSE: JNJ) MedTech has announced the completion of pilot phase enrollment for the OMNY-AF study, which is assessing the effect of its OMNY-AF platform in symptomatic paroxysmal atrial fibrillation (AFib) in the United States and Australia. The single-arm, multi-center study aims to enroll up…
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Teva Pharmaceutical Reports Positive Phase III Results for TEV-‘749 in Schizophrenia Trial
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Israel-based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has released new positive data on social functioning and quality of life from the Phase III Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial. The study assesses the efficacy of TEV-‘749 in adult patients diagnosed with schizophrenia. SOLARIS Study Design and TEV-‘749’s EfficacyThe SOLARIS…
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Novo Nordisk’s Semaglutide Meets Primary Endpoints in ESSENCE Phase III Study for MASH
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Denmark-based pharmaceutical company Novo Nordisk (NYSE: NVO; CPH: Novo-B) has announced that part 1 of the Phase III ESSENCE study, a pivotal 240-week, double-blinded trial involving 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis, has successfully reached its primary endpoints. The trial evaluated the efficacy…
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Jenscare Scientific’s LuX-Valve Plus Shows Positive One-Year Results in TRAVEL II Study
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Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced the one-year follow-up results from the multi-center TRAVEL II study for its transjugular tricuspid valve replacement product, LuX-Valve Plus, at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual meeting in Washington. The TRAVEL II study, which assesses…
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Sino Medical Reports Five-Year PIONEER Study Results for HT Supreme Stent System
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Sino Medical Sciences Technology Inc. (SHA: 688108), based in China, has announced the five-year follow-up results from the Phase III PIONEER study for its first-in-class HT Supreme drug-eluting stent system across the United States, Japan, and Europe. The HT Supreme system represents a significant milestone as the first cardiac stent…
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Zai Lab Reports Positive Phase III Results for KarXT, Showcasing Efficacy in Psychiatric Conditions
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced encouraging topline results from its Phase III multi-center trial evaluating the safety and efficacy of KarXT (xanomeline and trospium chloride) within China. In line with prior global studies, this registrational bridging trial successfully met its primary endpoint, showing a…
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Innovent Biologics’ Picankibart Shows 64.6% Skin Clearance in Phase II Psoriasis Study
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced encouraging results from the multi-center, open Phase II study of its picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection. The study focused on psoriasis patients with a poor response to prior biologic treatments, primarily IL-17 antibodies. After 16 weeks of treatment…
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Clover Biopharmaceuticals Reports Strong Phase I Results for RSV Vaccine SCB-1019
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China-based Clover Biopharmaceuticals Ltd. (HKG: 2197) has announced encouraging additional immunogenicity and safety data from its Phase I trial of SCB-1019, a non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate. The trial assessed SCB-1019 against GSK (NYSE: GSK)’s AS01E-adjuvanted RSV vaccine, Arexvy, in elderly subjects. In the ongoing Phase…
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Eli Lilly’s Ebglyss Shows Positive Results in Phase III Study for Atopic Dermatitis Patients Previously Treated with Dupilumab
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Eli Lilly & Co. (NYSE: LLY), a leading U.S. pharmaceutical company, has announced the results of the Phase III Adapt study for its interleukin-13 (IL-13) inhibitor, Ebglyss (lebrikizumab). The study demonstrated that Ebglyss improved skin conditions, including on the hands and face, and reduced itch in patients with moderate-to-severe atopic…
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Biogen’s Felzartamab Demonstrates Promising Results in Phase II Study for IgA Nephropathy
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Biogen Inc. (NASDAQ: BIIB), a prominent biopharmaceutical company based in the U.S., has announced comprehensive results from the Phase II IGNAZ study for felzartamab in the treatment of IgA nephropathy. The findings were showcased at Kidney Week 2024, the annual meeting of the American Society of Nephrology. The study demonstrated…
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MicuRx Pharmaceuticals’ Antibiotic MRX-5 Completes Successful Phase I Clinical Trial in Australia
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MicuRx Pharmaceuticals Inc. (SHA: 688373), a Sino-US pharmaceutical company, has announced the successful completion of a Phase I clinical study for its in-house developed antibiotic, MRX-5, in Australia. This new benzodiazole antibiotic is designed to treat infections caused by Mycobacterium, with a particular focus on non-tuberculosis Mycobacterium (NTM). The Phase…
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Sanofi’s Dupixent Demonstrates Positive Results in Phase III Study for Chronic Urticaria
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Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced the presentation of new data from the Phase III LIBERTY-CUPID Study C for its drug Dupixent (dupilumab) in the treatment of chronic spontaneous urticaria (CSU) at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 annual meeting. The LIBERTY-CUPID Study…
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Lee’s Pharmaceutical’s Subsidiary Reports Positive Results from Phase III Myopia Treatment Study
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive top-line results from the Phase III China CHAMP study for NVK002, an atropine external use eye solution designed to address myopia progression. The Phase III study, a randomized, double-blinded,…
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Novo Nordisk’s Semaglutide Shows 14% Reduction in Cardiovascular Events in Landmark SOUL Trial
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Copenhagen-based healthcare giant Novo Nordisk (NYSE: NVO) has declared the primary outcomes of the SOUL cardiovascular outcomes trial, showcasing that its oral glucagon-like peptide-1 (GLP-1) analogue, semaglutide, successfully reduced major adverse cardiovascular events (MACE) by 14%. The SOUL trial, a global, multi-center, randomized, double-blinded, and parallel-controlled study, enrolled 9,650 individuals…
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FDA Extends Review of Amgen’s Lumakras for KRAS G12C mCRC Treatment to January 2025
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On October 18, FirstWord reported that the U.S. FDA has extended the review period for Amgen (NASDAQ: AMGN)’s KRAS G12C inhibitor Lumakras (sotorasib) in combination with the anti-EGFR monoclonal antibody panitumumab for second-line treatment of KRAS G12C-mutated metastatic colorectal cancer (mCRC) by three months, pushing the decision date to January…
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Kintor Pharmaceutical Initiates Phase II/III Trial for KX-826 Tincture 1.0% in Treating Male Androgenetic Alopecia
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Kintor Pharmaceutical Ltd (HKG: 9939), a biopharmaceutical company based in China, has announced the commencement of patient enrollment in a pivotal Phase II/III study for its KX-826 tincture 1.0%. The study aims to evaluate the efficacy and safety of the treatment in adult males with androgenetic alopecia (AGA) in China.…
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Innovent Biologics’ Picankibart Achieves Positive Results in Phase II UC Study
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase II clinical trial for picankibart, an anti-IL-23p19 antibody injection, has successfully met its primary endpoint in Chinese patients with moderately to severely active ulcerative colitis (UC). The multi-center, randomized, double-blinded, placebo-controlled study (NCT05377580)…
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Johnson & Johnson’s Nipocalimab Shows Promise in Treating Adolescent Myasthenia Gravis in Phase II/III Trial
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Johnson & Johnson (J&J, NYSE: JNJ), a US pharmaceutical giant, has reported encouraging outcomes from its Phase II/III clinical trial, Vibrance-MG, which evaluated the efficacy of nipocalimab in treating adolescents with generalized myasthenia gravis (gMG) who tested positive for anti-AChR antibodies. The study successfully achieved its primary and secondary endpoints,…
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Eli Lilly’s Mirikizumab Shows Statistically Significant Improvement in Crohn’s Disease VIVID-1 Study
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Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company in the U.S., has published the results of the VIVID-1 study, demonstrating the efficacy of mirikizumab in patients with moderately to severely active Crohn’s disease. The study showed that mirikizumab achieved nominally statistically significant improvements across all histological and histological…
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BrightGene’s BGM0504 Shows Promise in Phase II Obesity Study Without Diabetes
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BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166), a Chinese biopharmaceutical company, has announced positive results from the Phase II clinical study (CTR20233198) for its investigational drug BGM0504. This dual agonist targets GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin stimulating polypeptide) receptors and is being studied for the treatment of…
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Pfizer’s Talzenna Combo Shows Improved Survival in mCRPC Patients, According to TALAPRO-2 Study
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Pfizer Inc. (NYSE: PFE) has announced positive topline results regarding overall survival (OS) in the Phase III TALAPRO-2 study for Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, when combined with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI). This combination is used for the treatment of patients with…
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Harbour BioMed’s Innovative Antibody Porustobart Shows Promise in Early Clinical Trials for Melanoma
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Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands, and Suzhou, China, has announced the publication of the Phase I clinical study results for its CTLA-4 antibody porustobart (HBM4003) in combination with Junshi Biosciences’ PD-1 inhibitor toripalimab. This combination is aimed at treating advanced…
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InnoCare Pharma’s ICP-488 Shows Promising Results in Phase II Psoriasis Study
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced positive results from a Phase II clinical study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, ICP-488, in patients with moderate to severe plaque psoriasis. The study demonstrated the drug’s potential in treating psoriasis and other autoimmune diseases by inhibiting…
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InnoCare Pharma Achieves Positive Phase II Results for TYK2 Inhibitor ICP-488 in Psoriasis Treatment
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced positive results from a Phase II clinical study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, ICP-488, in patients with moderate to severe plaque psoriasis. ICP-488 is a potent and selective TYK2 allosteric inhibitor that is being developed to treat…
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Merck’s Keytruda Meets Primary Endpoint in Phase III Study for Head and Neck Cancer
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US pharmaceutical giant Merck & Co., Inc. (MRK, NYSE: MRK) has announced that the Phase III KEYNOTE-689 study for its PD-1 inhibitor Keytruda (pembrolizumab) has met its primary endpoint of event-free survival (EFS) in patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell…
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J&J’s Carvykti Shows 45% Reduced Risk of Death in Multiple Myeloma Patients, Landmark Trial Data Reveals
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Johnson & Johnson (J&J, NYSE: JNJ), a U.S.-based healthcare conglomerate, has released new clinical trial data for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel). The data reveals long-term overall survival (OS) for the therapy’s use as a second-line treatment for multiple myeloma (MM). The three-year…
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Wuhan YZY Biopharma Presents M701 Interim Results at 2024 ESMO Congress for NSCLC-Related Pleural Effusion
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the presentation of interim analysis results from a Phase Ib clinical study for its investigational drug M701 at the 2024 European Society of Medical Oncology (ESMO) Congress. M701 is a recombinant anti-EpCAM and CD3 human…
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AstraZeneca’s HIMALAYA Trial Data Showcases Significant Survival Benefits for Liver Cancer Treatment at ESMO 2024
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At the European Society for Medical Oncology (ESMO) 2024 conference, AstraZeneca (NASDAQ: AZN, LON: AZN) presented updated data from the HIMALAYA Phase III trial, demonstrating sustained and clinically meaningful overall survival (OS) benefits for patients with unresectable hepatocellular carcinoma (HCC) who had not previously received systemic therapy and for whom…
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Aligos Therapeutics’ ALG-055009 Achieves Positive Topline Results in Phase 2a HERALD Study for MASH
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Aligos Therapeutics, a clinical-stage biopharmaceutical company focused on liver and viral diseases, has announced positive topline results from its Phase 2a HERALD study for ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH). The study, which is the first to demonstrate the benefits of…
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Roche’s Xofluza Receives FDA Approval for Reducing Influenza Transmission in Phase III Study
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Roche (SWX: ROG; OTCMKTS: RHHBY) has announced that its antiviral drug Xofluza (baloxavir marboxil) has received approval from the US Food and Drug Administration (FDA) based on positive results from the Phase III CENTERSTONE study. The study demonstrated that a single dose of Xofluza significantly reduced the transmission of influenza…
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AstraZeneca’s Tagrisso Achieves Milestones in Phase III LAURA Study for EGFR-mutated NSCLC at ESMO 2024
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Global pharmaceutical company AstraZeneca (NASDAQ: AZN, LON: AZN) has reported updated results from the Phase III LAURA study on its EGFR-tyrosine kinase inhibitor (EGFR-TKI), Tagrisso (osimertinib), at the 2024 European Society of Medical Oncology (ESMO) Congress. The study included data from the Chinese cohort, highlighting the drug’s efficacy in treating…
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Adagene’s ADG126 Shows Promising Results in Phase Ib/II Study for MSS CRC at ESMO 2024
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Adagene Inc. (NASDAQ: ADAG), a biopharmaceutical company dedicated to the discovery and development of innovative antibody-based therapies, has announced updated results from the Phase Ib/II study of its anti-CTLA-4 SAFEbody, ADG126 (Muzastotug), in combination with pembrolizumab for the treatment of advanced/metastatic microsatellite stable colorectal cancer (MSS CRC) at the 2024…
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Transcenta’s Osemitamab Combo Therapy Shows Promising Results in G/GEJ Cancer Treatment at ESMO 2024
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Transcenta Holdings Ltd (HKG: 6628), a leading biopharmaceutical company, has announced updated positive results from the cohort-G data of its drug candidate osemitamab (TST001) in combination with nivolumab and CAPOX for the first-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) cancer at the 2024 European Society of Medical Oncology…
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AstraZeneca’s Imfinzi-Imjudo Combo Sets New Longevity Benchmark in Liver Cancer Treatment
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has achieved a significant milestone with its drug combination of Imfinzi (durvalumab) and Imjudo (tremelimumab), used in the treatment of patients with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC). Data from the Phase III HIMALAYA trial, showcased at the 2024 European…
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Abbisko Therapeutics’ FGFR4 Inhibitor Irpagratinib Shows Positive Phase I Results at ESMO Congress
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has presented updates on its innovative cancer treatments at the 2024 European Society of Medical Oncology (ESMO) Congress. The company highlighted the Phase I study results for irpagratinib, a novel small-molecule FGFR4 inhibitor, in patients with FGF19 over-expressing advanced hepatocellular carcinoma…
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Alphamab Oncology’s JSKN003 ADC Achieves Positive Safety and Efficacy Outcomes in Phase I Studies
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Alphamab Oncology (HKG: 9966), a leading player in the oncology space, has reported encouraging results from its Phase I clinical studies of JSKN003, a HER2-targeted antibody-drug conjugate (ADC), at the 2024 European Society of Medical Oncology (ESMO) Congress. The studies, conducted in Australia and China, targeted advanced and metastatic solid…
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CStone Pharmaceuticals’ Sugemalimab Shows Promising Long-Term Survival Data at ESMO 202
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has presented long-term treatment and survival data for sugemalimab at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. The data comes from the GEMSTONE-302 study, which combines sugemalimab with platinum-based chemotherapy. The Phase III trial, a multicenter, randomized,…
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Dizal Pharmaceutical’s Sunvozertinib Shows Promising Results in WU-KONG Series Study at ESMO 2024
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has presented updates on the WU-KONG series study for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib (DZD9008), at the 2024 European Society of Medical Oncology (ESMO) Congress. Sunvozertinib received approval in China in August of the…
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iTeos Therapeutics and GSK’s Belrestotug/Dostarlimab Combo Shows Promising Results in NSCLC
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iTeos Therapeutics has announced the latest data from the Phase 2 platform study GALAXIES Lung-201, led by its development partner GSK. The study evaluates the efficacy of the combination therapy consisting of the anti-TIGIT monoclonal antibody belrestotug and the anti-PD-1 monoclonal antibody dostarlimab in patients with untreated, unresectable, locally advanced,…
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Merck and Daiichi Sankyo’s HER3-DXd ADC Patritumab Deruxtecan Passes Phase 3 Trial After FDA Rejection
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Merck (NYSE: MRK) and Daiichi Sankyo (TYO: 4568) announced that their antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) has passed Phase 3 HERTHENA-Lung 02 study, months after the drug was rejected by the U.S. FDA due to manufacturing issues following its presentation at this year’s ESMO conference. The companies will discuss…
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Kangfang Biotech Presents Groundbreaking mCRC Treatment Data at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) debuted its independently developed PD-1/VEGF bispecific antibody, Yivoxi, in combination with or without the next-generation CD47 monoclonal antibody, Laifali, plus FOLFOXIRI as a first-line treatment for microsatellite stable (MSS) or proficient mismatch repair (pMMR) advanced metastatic…
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Kangfang Biotech’s Yivoxi Shows Promising Results in First-Line TNBC Treatment at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled for the first time the results of its independently developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination with chemotherapy for the first-line treatment of locally advanced unresectable or metastatic triple-negative breast cancer (TNBC). Preliminary data…
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Kangfang Biotech’s Yivoxi Shows Promising Results in Treating R/M HNSCC at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled the impressive Phase II clinical study results of its self-developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination or alone with the next-generation CD47 monoclonal antibody, Laifali, for the first-line treatment of PD-L1 positive (CPS≥1) recurrent…
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Ascentage Pharma’s Olverembatinib Shows Promise in SDH-Deficient GIST at ESMO Congress
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced the presentation of clinical study results for its drug olverembatinib (HQP1351) at the 2024 European Society of Medical Oncology (ESMO) Congress. The study focused on patients with succinate dehydrogenase-deficient gastrointestinal stromal tumor (GIST), a rare and aggressive form…
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Innovent Biologics’ Mazdutide Outperforms Dulaglutide in Phase III T2D Study at EASD Meeting
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Innovent Biologics, Inc. (HKG: 1801), a biopharmaceutical company based in China, has presented significant findings from the Phase III DREAMS-2 study on its drug candidate mazdutide at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD). Mazdutide, a dual agonist targeting the glucagon-like peptide-1 receptor…
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Qilu Pharmaceutical’s Iruplinalkib Shows Promising Results in Phase II Study for ALK+ NSCLC
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Qilu Pharmaceutical, a leading pharmaceutical company based in China, has presented updated results from the Phase II INTELLECT study for its Category 1 drug iruplinalkib at the World Conference on Lung Cancer (WCLC). The study focuses on patients with cizotinib-resistant anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC).…
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Innovent Biologics Presents Promising Phase I Data for IBI363 in Advanced NSCLC at WCLC
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has unveiled Phase I clinical data for its innovative PD-1/IL-2α-biased bispecific antibody (BsAb) fusion protein, IBI363, at the 2024 World Conference on Lung Cancer (WCLC). The data, which pertain to the treatment of advanced non-small cell lung cancer…
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AstraZeneca and Daiichi Sankyo’s Dato-DXd Misses Overall Survival Endpoint but Shows Promise in NSCLC Subgroup
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AstraZeneca (NASDAQ: AZN) and its co-development partner, Japan’s Daiichi Sankyo, have released data from the TROPION-Lung01 Phase III study, which focuses on the TROP-2-targeted antibody drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) as a second-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The molecule did not achieve…
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Innovent Biologics’ Dupert Demonstrates Positive Results in Phase II NSCLC Trial
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase II clinical trial results for Dupert (fulzerasib) have been selected for an oral presentation at the 2024 World Conference on Lung Cancer (WCLC). The study, known as HARMONi-2 (AK112-303), focuses on the treatment…
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Zelgen Biopharma’s ZG006 Shows Promising Anti-Tumor Efficacy in Phase I/II SCLC Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced positive preliminary results from a Phase I/II clinical study assessing the tolerability, safety, efficacy, and pharmacokinetics of ZG006 in patients with advanced small-cell lung cancer (SCLC) or neuroendocrine carcinoma. The study, which included a dosage…
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Sanofi’s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials
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PARIS—French pharmaceutical giant Sanofi (Nasdaq: SNY; EURONEXT: SAN) has reported mixed outcomes from three Phase III trials for its Bruton’s tyrosine kinase (BTK) inhibitor, tolebrutinib, as a treatment for multiple sclerosis (MS). The drug candidate achieved success in the HERCULES study, where it met the primary endpoint of delaying the…
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Bayer’s Finerenone Shows Promise in Heart Failure Treatment, Outperforms Placebo in Phase III Trial
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FRANKFURT—Bayer AG (FRA: BAYN) has announced positive results from the Phase III FINEARTS-HF study for its mineralocorticoid receptor (MR) antagonist, finerenone. Originally approved for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes, finerenone is now being developed for heart failure, a condition with significant market potential.…
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Sino Biopharmaceutical’s Anlotinib-Penpulimab Combo Meets Milestone in Phase III HCC Study
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HONG KONG—Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the successful completion of a pre-set interim analysis in its Phase III clinical study. The study combines anlotinib with penpulimab as a first-line treatment for advanced hepatocellular carcinoma (HCC), achieving the optimal efficacy thresholds for…
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3SBio Subsidiary Achieves Milestone in Phase III Psoriasis Trial with SSGJ-608
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced that its Phase III clinical study for the drug candidate SSGJ-608 has successfully met all primary endpoints (PASI 75 and sPGA 0/1), key secondary efficacy endpoints (PASI 90, PASI 100, and sPGA 0), and all…
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3SBio’s Subsidiary Achieves Milestone in Phase II Study for Chronic Sinusitis Treatment SSGJ-611
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced that its Phase II clinical study for SSGJ-611, an IL-4Rα monoclonal antibody (mAb) candidate for chronic sinusitis with nasal polyps (CRSwNP), has met its primary endpoint. The study demonstrated the efficacy and safety of SSGJ-611…
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Suzhou Zelgen’s Jacktinib Tablets Achieve Positive Results in Phase II IPF Clinical Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced the successful completion of a Phase II clinical study for its Category 1 product candidate, jacktinib tablets, in the treatment of idiopathic pulmonary fibrosis (IPF). The study demonstrated that jacktinib tablets effectively delayed the decline…
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FibroGen Inc. Enters Restructuring Mode After Late-Stage Trial Failures for Pamrevlumab
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US-based biotechnology company FibroGen Inc. (NASDAQ: FGEN), which maintains significant operations in China, is initiating damage control measures following the failure of two late-stage trials for its potential first-in-class anti-connective tissue growth factor (CTGF) fully human monoclonal antibody, pamrevlumab. In response to these setbacks, FibroGen has decided to terminate all…
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Pfizer’s Hemophilia A Gene Therapy Shows Promise in Phase III AFFINE Study
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Pfizer Inc. (NYSE: PFE), a US pharmaceutical giant, has announced positive topline results from the Phase III AFFINE study for its gene therapy candidate, giroctocogene fitelparvovec, for the treatment of hemophilia A. With these results, Pfizer is now poised to prepare for regulatory submission for this one-time gene therapy, which…
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Jiangsu Hansoh’s Loxenatide Matches Dapagliflozin in Diabetes Nephropathy Clinical Trial
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Jiangsu Hansoh Pharmaceutical Co., Ltd, a leading pharmaceutical company based in China, has published the results of a clinical study for its polyethylene glycol (PEG) loxenatide—a Category 1 novel chemical drug—in the treatment of diabetes nephropathy (DKD) in the Frontiers in Endocrinology journal. The study’s data indicate that loxenatide is…
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Innovent Biologics’ Mazdutide Achieves Primary and Secondary Endpoints in Phase III T2D Trial
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Innovent Biologics Inc. (Innovent) (HKG: 1801), a leading biopharmaceutical company based in China, has announced positive results from the Phase III DREAMS-1 clinical trial for mazdutide (IBI362), a dual agonist targeting the glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) for the treatment of type 2 diabetes (T2D) in Chinese…
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Sino Biopharmaceutical’s Anlotinib Achieves Milestones in Phase III Trial for Soft-Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced positive interim data from a Phase III clinical study for its drug anlotinib. The study combines anlotinib with chemotherapy as a first-line treatment for advanced unresectable or metastatic soft-tissue sarcoma. The Independent Data Monitoring Committee (IDMC)…
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Eli Lilly’s Lupus Treatment LY3361237 Misses Mark in Phase II Trial
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Eli Lilly & Co. (NYSE: LLY) has encountered a setback in its drug development pipeline with the failure of the Phase II trial for LY3361237, an antibody agonist targeting the BTLA immune checkpoint, in the treatment of systemic lupus erythematosus (SLE). The trial, registered on clinicaltrials.gov as NCT05123586, was terminated…
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Everest Medicines’ Velsipity Shows Positive Results in Largest Asian Phase III UC Trial
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Everest Medicines (HKG: 1952), a leading biopharmaceutical company based in China, has announced positive top-line results from a multi-center Phase III clinical study for its Velsipity (etrasimod) in moderate-to-severe active ulcerative colitis (UC) during the maintenance period in Asia. This landmark trial is the largest Phase III study for moderately-to-severely…
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Sirnaomics’ STP122G Achieves Phase I Milestone with Positive Interim Data for Anticoagulation Treatment
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Sirnaomics Ltd (HKG: 2257) has announced the completion of the Phase I second sequence for its drug candidate STP122G, which is being developed as an anticoagulation treatment, along with the release of interim data. The Factor XI program, to which STP122G belongs, has broad therapeutic potential as an anticoagulant across…
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Legend Biotech’s Carvykti Shows Significant Overall Survival Improvement in Phase III CARTITUDE-4 Study
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Legend Biotech Corporation (NASDAQ: LEGN) has announced positive results from the CARTITUDE-4 study, a global, randomized, open-label Phase III trial. The study assessed the efficacy and safety of Legend Biotech’s BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy Carvykti (ciltacabtagene autoleucel) compared to standard therapies of pomalidomide, bortezomib, and dexamethasone…
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Tracon Pharmaceuticals Halts Development of Envafolimab After Clinical Trial Failure
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Tracon Pharmaceuticals (OTCMKTS: TCON), a US-based biopharmaceutical company, has decided to cease development of its programmed death-ligand 1 (PD-L1) inhibitor, envafolimab, following disappointing results from a clinical trial. The company had obtained the rights to develop this molecule for soft-tissue sarcomas in North America through a 2019 agreement with China’s…
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Innovent Biologics Presents Positive Phase I Results for IBI343 at ESMO GI Congress 2024
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the presentation of new results from a Phase I clinical study of its anti-CLDN18.2 antibody-drug conjugate (ADC), IBI343, at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024. The study focuses on advanced gastric and gastroesophageal junction…
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Ningbo-Based Jenscare Scientific Announces Successful Follow-up Data for Transjugular Tricuspid Valve Device
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading manufacturer of structural heart disease devices headquartered in Ningbo, has announced the six-month follow-up results from the multi-center TRAVEL II study for its transjugular tricuspid valve replacement product, LuX-Valve Plus. The TRAVEL II study, a prospective, multi-center, single-arm clinical trial, was designed…
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Henlius Pharmaceutical’s HLX15 Biosimilar Meets Phase I Clinical Endpoints
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the successful completion of a Phase I clinical study for HLX15, its biosimilar candidate for Johnson & Johnson’s Darzalex (daratumumab). The trial involved healthy Chinese male subjects and met all pre-set endpoints. Daratumumab is a monoclonal antibody therapy indicated for the…
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Johnson & Johnson Achieves Positive Phase III Results for Nipocalimab in Generalized Myasthenia Gravis
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Johnson & Johnson (J&J, NYSE: JNJ), a leading US-based healthcare company, has announced positive results from the Phase III trial for nipocalimab, a potential first-in-class anti-FcRn (neonatal Fc receptor) antibody, for the treatment of generalized myasthenia gravis (gMG). The company has achieved its primary endpoint and is preparing for regulatory…
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Abbisko Therapeutics Presents Positive Phase II Results for HCC Treatment at ESMO-GI
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotech company, has announced the presentation of Phase II study results for its irpagratinib in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) at the 2024 ESMO-GI annual meeting. Irpagratinib, a novel FGFR4 inhibitor discovered and developed by Abbisko,…
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Novo Nordisk’s Ocedurenone Misses Primary Endpoint in Chronic Kidney Disease Trial
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Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a Danish pharmaceutical company, has announced that its pipeline candidate ocedurenone has failed in a Phase III trial for chronic kidney disease (CKD). The drug did not meet the primary endpoint in the CLARION-CKD study, leading to the cancellation of its development for CKD.…
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Gan & Lee Pharmaceuticals’ GZR18 Outperforms Market Similars in Weight Reduction Study
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced the presentation of results from a Phase Ib/IIa study for GZR18, a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist, at the American Diabetes Association’s (ADA’s) 84th Scientific Sessions. The study evaluated GZR18’s efficacy in weight reduction for obese/overweight Chinese…
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Innovent Biologics’ Mazdutide Shows Promise in Phase III Obesity Trial
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Innovent Biologics Inc. (HKG: 1801), a biopharmaceutical company based in China, has announced the presentation of key results from the first Phase III clinical trial of mazdutide in Chinese adults with overweight or obesity at the ADA Scientific Sessions 2024. The trial, known as GLORY-1 (NCT05607680), is a multi-center, randomized,…
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Keymed Biosciences’ CM313 Shows Promise in Treating Immune Thrombocytopenia, NEJM Study Says
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Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has published results from an exploratory clinical study on its Category 1 drug CM313 in the New England Journal of Medicine. CM313 is a CD38-targeted monoclonal antibody (mAb) being investigated for the treatment of primary immune thrombocytopenia (ITP). The…
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Clover Biopharmaceuticals’ RSV Vaccine Candidate Shows Promising Results in Elderly
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Clover Biopharmaceuticals Ltd. (HKG: 2197), a biopharmaceutical company based in China, has announced positive preliminary results from the Phase I clinical study of its pipeline candidate SCB-1019 in the elderly population. The molecule is a respiratory syncytial virus (RSV) PreF trimeric subunit candidate vaccine. A total of 48 subjects were…
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Ascentage Pharma Presents Positive Clinical Results for Olverembatinib and Lisaftoclax at EHA Meeting
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has presented the results of multiple clinical trials for two of its pipeline candidates at the 29th European Hematology Association (EHA) Annual Meeting. The candidates are olverembatinib, a Category 1 drug and approved BCR-ABL inhibitor, and the investigational BCL-2 inhibitor…
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Walvax Biotechnology Halts COVID-19 Vaccine Clinical Trials Citing Low Benefits
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Walvax Biotechnology Co., Ltd (SHE: 300142), a biopharmaceutical company based in China, has announced the termination of clinical studies for its recombinant COVID-19 vaccine (CHO cell) and recombinant COVID-19 variant vaccine (CHO cell), due to the assessment of low economic and social benefits. The vaccines were approved for clinical trials…
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Takeda’s Soticlestat Misses Primary Endpoints in Phase III Epilepsy Trials
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Takeda Pharmaceutical Co., Ltd (TYO: 4502; NYSE: TAK), a leading Japanese pharmaceutical company, has announced that its drug candidate soticlestat did not meet the primary endpoints in two Phase III trials. The drug is currently under development for the treatment of two rare forms of epilepsy—Dravet syndrome and Lennox-Gastaut syndrome—and…
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CARsgen Therapeutics’ Saikaize and CT071 Show Strong Results in EHA Clinical Trials
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CARsgen Therapeutics, a biopharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 2171), has announced promising results from two pivotal clinical trials at the 29th European Hematology Association Annual Meeting. The data presented highlights the potential of two CAR-T therapies: Saikaize (zevorcabtagene autoleucel), an autologous BCMA-targeted therapy for multiple…
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RemeGen’s Disitamab Vedotin Shows Positive Results in Phase III Trial for HER2 Positive Breast Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced positive results from a Phase III clinical trial for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with HER2 positive advanced breast cancer with liver metastasis, achieving the trial’s primary endpoint. The open, parallel-controlled, multi-center Phase…
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Innovent Biologics’ IBI363 Shows Promising Results in Phase Ia/Ib Trial for Advanced Solid Tumors
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced the results of a Phase Ia/Ib clinical trial for its investigational PD-1/IL-2 bispecific antibody fusion protein, IBI363. The study’s findings were presented at the European Society for Medical Oncology (ESMO) Annual Congress 2024, highlighting the molecule’s…
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Zelgen Biopharmaceuticals’ Jacktinib Meets Primary Endpoint in Severe Alopecia Areata Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that its Phase III clinical trial for jacktinib tablets, a Category 1 product candidate for severe alopecia areata, has successfully met its primary endpoint. The multi-center, randomized, double-blinded, placebo-controlled trial was conducted to evaluate the…
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Eli Lilly’s Tirzepatide Hits Primary Endpoint in MASH Trial, Outperforming Placebo
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Eli Lilly and Company (NYSE: LLY), a global healthcare conglomerate, has announced positive outcomes from a Phase II clinical trial of tirzepatide, a novel GIP/GLP-1 receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis. The study successfully achieved its primary endpoint, demonstrating resolution of MASH without exacerbation of…
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Junshi Biosciences’ Toripalimab-Bevacizumab Combo Meets Primary Endpoints in HCC Phase III Trial
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has declared a significant milestone with its multi-center, randomized Phase III HEPATORCH study. The trial evaluated the combination of Loqtorzi (toripalimab) with bevacizumab for first-line treatment of advanced hepatocellular carcinoma (HCC) and successfully met its primary endpoints, which included progression-free survival…
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CGP’s GPN00884 Myopia Drug Enters Phase I Clinical Trial with First Patient Dosed
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the commencement of a Phase I clinical study for GPN00884, an innovative ophthalmic drug aimed at arresting the progression of childhood myopia, with the first patient now dosed. This randomized, double-blind, placebo-controlled, dose-escalation study is designed to evaluate…
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Biosion’s Bosakitug Shows Positive Results in Atopic Dermatitis Phase II POC Study
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Biosion, a clinical-stage biotechnology company with operations in Delaware, U.S., and China, has announced key findings from its Phase II proof-of-concept (POC) ADAMANT study for bosakitug, a candidate in its pipeline for the treatment of atopic dermatitis (AD). Bosakitug is a monoclonal antibody (mAb) that targets thymic stromal lymphopoietin (TSLP),…
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Ascletis Pharma’s ASC41 Shows Promise in Phase II Study for Metabolic Dysfunction-Associated Steatohepatitis
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Ascletis Pharma Inc. (HKG: 1672), a biopharmaceutical company based in China, has announced positive interim results from a 12-week Phase II clinical study of its thyroid hormone receptor β (THRβ) agonist, ASC41, in patients with metabolic dysfunction-associated steatohepatitis (MSAH). The randomized, double-blinded, placebo-controlled, and multi-center Phase II trial demonstrated significant…
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Sino Biopharmaceutical Presents FS222 Phase I Results at ASCO Annual Meeting
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Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has presented updates from a Phase I clinical trial for its tetravalent bispecific antibody (BsAb), FS222, at the American Society of Clinical Oncology (ASCO) annual meeting. The study focuses on the use of FS222 in treating advanced solid tumors…
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J&J’s Tecvayli Shows Promising Response Rates in Multiple Myeloma Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has reported updates from a Phase I/II clinical trial for its bispecific antibody (BsAb) Tecvayli (teclistamab) in patients with relapsed or refractory multiple myeloma (r/rMM) who have received three or more prior lines of treatment. With a median follow-up of 30.4 months, the trial…
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Bristol Myers Squibb’s Breyanzi Shows Promising Results in Three Lymphoma Trials
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced results from three distinct clinical trials assessing the efficacy of its CAR-T therapy Breyanzi (lisocabtagene maraleucel) in treating patients with relapsed or refractory large B-cell lymphoma (LBCL), mantle cell lymphoma (MCL), and relapsed or refractory follicular lymphoma (FL). In a placebo-controlled, late-stage…
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Gilead and Arcus Biosciences Report Positive Combination Therapy Results in mCRC Trial
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Biopharmaceutical companies Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced safety and efficacy data from a Phase Ib/II clinical trial for a combination therapy in third-line metastatic colorectal cancer (mCRC). The trial evaluated the combination of adenosine receptor antagonist etrumadenant, anti-PD-1 drug zimberelimab, VEGF inhibitor bevacizumab, and chemotherapy…
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MicuRx Pharmaceuticals’ MRX-8 Achieves Positive Results in Phase I Clinical Study
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MicuRx Pharmaceuticals (SHA: 688373), a Shanghai-based developer of antibacterial drugs, has announced the successful completion of a Phase I clinical study in China for its new drug candidate MRX-8, which targets gram-negative drug-resistant bacteria. The randomized, double-blinded, placebo-controlled Phase I study aimed to evaluate the safety, tolerability, and pharmacokinetic characteristics…
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Legend Biotech’s Carvykti Shows Durable Responses in Multiple Myeloma Patients Post ASCT
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Legend Biotech Corporation (NASDAQ: LEGN) has announced results from the Phase II CARTITUDE-2 Cohort D study of its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), in multiple myeloma (MM) patients. The data was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, along…
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Gilead and Arcus Biosciences Report Positive Interim Phase II Data for Domvanalimab Combo in GI Cancers
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Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced interim Phase II data for their anti-TIGIT biologic domvanalimab in combination with the anti-PD-1 drug zimberelimab. The treatment is being investigated for locally advanced unresectable or metastatic upper gastrointestinal cancers. The study, which has a median time on treatment of…
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Eli Lilly’s KRAS Inhibitor Olomorasib Shows Promise in Phase I/II Trial for Advanced Solid Tumors
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Eli Lilly and Company (NYSE: LLY) has presented an update on a Phase I/II clinical trial for its KRAS inhibitor, olomorasib, in patients with KRAS G12C-mutant advanced solid tumors. The trial also explores the combination of olomorasib with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) top-selling checkpoint inhibitor, Keytruda (pembrolizumab),…
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Bristol Myers Squibb’s Krazati Meets Primary Endpoint in Late-Stage Lung Cancer Study
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage study for its KRAS inhibitor, Krazati (adagrasib), has successfully met its primary endpoint in patients with previously treated locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC). The study demonstrated that Krazati increased median progression-free survival (PFS) from…
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Pfizer’s Lorbrena Outperforms Xalkori in 5-Year ALK-Positive NSCLC Follow-Up
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Pfizer Inc. (NYSE: PFE) has announced the release of five-year follow-up data for its kinase inhibitor Lorbrena/Lorviqua (lorlatinib) in untreated ALK-positive advanced non-small cell lung cancer (NSCLC). The data revealed that Lorbrena demonstrated an 81% reduction in the rate of disease progression or death compared to Xalkori (crizotinib), and increased…
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Simcere Pharma’s Suvemcitug Shows Positive Results in Platinum-Resistant Ovarian Cancer Study
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has presented updated data from the SCORES study for its drug candidate suvemcitug at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Suvemcitug, also known as sevacizumab; APX-003; BD-0801, is being studied in platinum-resistant ovarian cancer. The…
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Ascentage Pharma’s APG-2449 Shows Positive Results in ROS1 and ALK Positive NSCLC at ASCO 2024
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in Suzhou, has announced a wall poster presentation showcasing the latest data for its FAK/ALK/ROS1 inhibitor APG-2449 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study determined the recommended Phase II dosage (RP2D) of APG-2449 to be 1200…
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Jacobio Pharma’s KRAS G12C Inhibitor Combo Shows Promising Results in NSCLC at ASCO 2024
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, presented updated data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting for its KRAS G12C inhibitor glecirasib (JAB-21822) in combination with an SHP2 inhibitor (JAB-3312) as a frontline treatment for non-small cell lung cancer (NSCLC) patients with…
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Innovent Biologics Presents Clinical Data for Pipeline Candidates at ASCO 2024
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, presented updates on several pipeline candidates at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. IBI343 Phase I Study:The study of IBI343, a CLDN18.2 antibody-drug conjugate (ADC), for advanced pancreatic ductal adenocarcinoma or biliary tract cancer (BTC),…
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Gilead’s Trodelvy Misses Overall Survival Endpoint in Late-Stage Urothelial Cancer Study
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Gilead (NASDAQ: GILD) has announced that a late-stage study for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) did not meet the primary endpoint of overall survival (OS) in patients with previously treated locally advanced or metastatic urothelial cancer (mUC). This result casts uncertainty over the drug’s accelerated approval indication in…
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Simcere Pharma’s Anti-Insomnia Drug Daridorexant Meets Primary Endpoint in Phase III Clinical Trial
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced topline results from a Phase III clinical study for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd, a Swiss pharmaceutical company. The study evaluated the efficacy and safety of daridorexant in Chinese patients with insomnia and successfully met its…
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Akeso Inc.’s Ivonescimab Shows Positive Interim Analysis in Phase III NSCLC Study
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced positive interim analysis results from the regulatory Phase III HARMONi-2 (AK112-303) study. The study assessed ivonescimab as a monotherapy against pembrolizumab in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically targeting patients with…
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Alphamab Oncology’s KN046 Misses Primary Endpoint in Phase III Pancreatic Cancer Study
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has announced disappointing results from the Phase III KN046-303 study for its bispecific antibody (BsAb) KN046. The drug, which targets both programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), failed to meet its primary endpoint when used in…
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Hinova Pharmaceuticals to Present Phase I Data for PROTAC Drug HP518 at ASCO 2024
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Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, is poised to present data from the first-in-human, non-randomized, open-label, multi-center Phase I dosage escalation study of its drug candidate HP518 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. HP518 is an androgen receptor (AR)-targeted PROteolysis TArgeting…
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Innovent Biologics’ Picankibart Achieves Positive Results in Phase III Psoriasis Trial
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced the successful completion of a Phase III trial for its pipeline candidate drug, picankibart (IBI112). The drug, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, has met all primary and key secondary endpoints in the Phase III…
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Hinova Pharmaceuticals to Present HP518 Data at ASCO, Marking First-in-Human Trial Milestone
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Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, is scheduled to present data from the first-in-human Phase I clinical study of its drug candidate HP518 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study is an open-label, multi-center dose escalation trial designed to evaluate…
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Innovent Biologics’ Picankibart Achieves Positive Results in Phase III Psoriasis Trial
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced the successful conclusion of a Phase III trial for its pipeline candidate drug, picankibart (IBI112). The recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection has met all primary and key secondary endpoints in the Phase III registrational study…
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Chinese Biopharma Companies Set to Showcase Oncology Pipelines at ASCO 2024
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A cohort of Chinese biopharmaceutical companies, including Wuhan YZY Biopharma Co., Ltd (HKG: 2496), Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), JW Therapeutics (HKG: 2126), and CStone Pharmaceuticals (HKG: 2616), are preparing to present updates on their pipeline products at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting,…
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Novartis’ Fabhalta Shows Promise in Late-Stage C3 Glomerulopathy Trial
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Novartis AG (NYSE: NVS), a leading Swiss pharmaceutical company, last week announced positive preliminary data from a late-stage study for its complement inhibitor Fabhalta (iptacopan) in patients with the ultra-rare kidney disease C3 glomerulopathy (C3G). The study showed that compared to placebo, iptacopan achieved a 35.1% reduction in proteinuria and…
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Novartis’ Atrasentan Shows Significant Reduction in Proteinuria in IgA Nephropathy Trial
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Novartis AG (NYSE: NVS), a Swiss pharmaceutical company, last week presented interim results for the primary endpoint of a Phase III trial for atrasentan in patients with IgA nephropathy (IgAN). The trial indicated that the endothelin A (ETA) receptor antagonist demonstrated a 36.1% reduction in proteinuria at 36 weeks compared…
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AccurEdit Therapeutics Publishes Positive Data for Gene-Edited Drug ART001 in Amyloidosis Treatment
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AccurEdit Therapeutics (Suzhou) Co., Ltd., a leading gene editing therapy specialist based in China, has published the efficacy and safety data for its drug candidate ART001, which is being investigated as a treatment for transthyroxine protein amyloidosis. ART001, the first non-viral vector in vivo gene-edited drug in China to enter…
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Chinese Pharma Companies Set to Showcase Cancer Treatments at ASCO 2024
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The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 to June 4 in Chicago, will feature updates from Chinese pharmaceutical companies Ascentage Pharma (HKG: 6855), Lepu Biotechnology Co., Ltd (HKG: 2157), Transcenta Holding Ltd, and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) on their…
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J&J’s Tremfya Meets Primary Endpoints in Phase III Crohn’s Disease Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that a Phase III trial for its dual-acting biologic Tremfya (guselkumab) has successfully met its composite co-primary endpoints in patients with moderately to severely active Crohn’s disease (CD) when compared to placebo. The study also demonstrated that the IL-23-focused subcutaneous maintenance therapy…
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Sino Biopharmaceutical’s Benmelstobart Shows Positive Results in RCC Combination Therapy Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced positive interim analysis results from a Phase III clinical study for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) in combination with anlotinib for the treatment of advanced unresectable or metastatic renal cell carcinoma…
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Gilead’s Seladelpar Shows Interim Benefits in PBC-Related Itch Clinical Trial
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Gilead Sciences (NASDAQ: GILD) has announced interim results from a long-term study assessing the safety and efficacy of seladelpar, a PPAR-delta agonist, in treating pruritus associated with primary biliary cholangitis (PBC). The trial involved patients who had an inadequate response or were intolerant to ursodeoxycholic acid (UDCA), with 70% of…
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BMS’s Sotyktu Sustains Clinical Response in Long-Term Psoriasis Treatment
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced the release of long-term clinical data for Sotyktu (deucravacitinib), the company’s tyrosine kinase 2 (TYK2) inhibitor, used in the treatment of moderate-to-severe plaque psoriasis. The data, which spans a four-year period, indicates that the first-in-class drug has maintained a clinical response rate…
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Eli Lilly’s Weekly Insulin Efsitora Alfa Matches Daily Basal Insulins in Reducing A1C Levels
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Eli Lilly and Company (NYSE: LLY), a global healthcare company, has announced results from a comparative study on its once-weekly insulin efsitora alfa. The study demonstrated that efsitora alfa is non-inferior in reducing A1C levels compared to daily basal insulins degludec or glargine in adults with type 2 diabetes (T2D).…
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Roche’s CT-388 Shows Significant Weight Loss in Phase I Clinical Trial for Obesity
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Switzerland-based healthcare giant Roche (SWX: ROG) has announced preliminary results from a Phase I study of its investigational dual GLP-1/GIP receptor agonist, CT-388. The study is assessing the drug’s effects in obese adults, both healthy and those with type 2 diabetes (T2D). Initial data from the healthy cohort showed that…
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HutchMed’s Sovleplenib Phase III Results to be Showcased at EHA 2024
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013), a biopharmaceutical company based in China, is preparing to unveil the topline and subgroup results from the Phase III ESLIM-01 study at the European Hematology Association’s (EHA) 2024 annual conference. Additionally, the company will present updated clinical data for its hematological malignancy therapies…
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Lifetech Scientific’s IBS Stent Demonstrates Non-Inferiority in Phase II Trial
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Lifetech Scientific Corporation (HKG: 1302), a biopharmaceutical company based in China, has announced the completion of the one-year follow-up of its Phase II clinical study for the IBS absorbable drug-eluting coronary stent system. The results were initially published at the EuroPCR 2024. The prospective, multi-center, single-blinded, random-controlled Phase II study,…
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Novo Nordisk’s Wegovy Shows Durable Weight Loss and Heart Health in Extended Trials
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At the 31st European Congress on Obesity (ECO), Denmark’s pharmaceutical giant Novo Nordisk (CPH: NOVO-B) presented findings from two studies on its weight loss therapy Wegovy (semaglutide). The data indicated that Wegovy’s weight loss effects can be sustained for up to 4 years, along with cardiovascular benefits, irrespective of the…
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Novo Nordisk’s Mim8 for Haemophilia A Exceeds Endpoints in Late-Stage Trial
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Denmark-based healthcare company Novo Nordisk (CPH: NOVO-B) has announced positive results from a late-stage trial of its bispecific antibody (BsAb) Mim8, used for the treatment of haemophilia A. The trial successfully met its primary endpoints, which focused on the reduction of treated bleeding episodes. The study demonstrated that once-weekly and…
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MSD Discontinues Vibostolimab and Keytruda Combo Trial in High-Risk Melanoma
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced its decision to cease development of the anti-TIGIT antibody vibostolimab in combination with its anti-PD-1 drug Keytruda (pembrolizumab) as an adjuvant treatment for resected high-risk melanoma. This strategic move follows an interim analysis that failed to meet the primary endpoint of…
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BMS’s Opdivo/Yervoy Combo Misses PFS Endpoint in Unresectable Stage III NSCLC Trial
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage trial for its checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) in patients with unresectable stage III non-small cell lung cancer (NSCLC) did not achieve its primary endpoint of progression-free survival (PFS). The study compared the efficacy and safety of Opdivo…
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MSD’s Keytruda Adjuvant Treatment for High-Risk Endometrial Cancer Fails to Meet Primary Endpoint
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that a late-stage trial for its blockbuster drug Keytruda (pembrolizumab) as an adjuvant treatment in newly diagnosed, high-risk endometrial cancer failed to meet the primary endpoint of disease-free survival (DFS). Although the analysis of the co-primary endpoint of overall survival (OS)…
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Innovent Biologics’ Mazdutide Shows Superiority in Type 2 Diabetes Phase III Trial
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase III DREAMS-2 study for mazdutide (IBI362), a dual agonist targeting both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), has met its primary endpoint in Chinese subjects with type 2 diabetes (T2D). The…
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Boehringer Ingelheim’s Anti-Sema3A BI 764524 Shows Promise in Diabetic Macular Ischemia Trial
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Boehringer Ingelheim (BI) has announced the publication of results from a Phase I/IIa clinical trial for its anti-Sema3A antibody candidate, BI 764524, used in the treatment of diabetic macular ischemia (DMI), a serious complication of diabetic retinopathy (DR) that can result in blindness. The trial successfully met its primary safety…
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Pfizer Pauses Dosing in DMD Gene Therapy Trial Following Participant’s Sudden Death
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This week, Pfizer Inc. (NYSE: PFE) announced the unfortunate sudden death of a participant in a Phase II study for its investigational gene therapy, fordadistrogene movaparvovec, used to treat Duchenne muscular dystrophy (DMD). The patient, aged between 2 and 4 years, had received the treatment in the previous year. In…
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J&J’s Erleada Plus ADT Shows 0% Biochemical Recurrence Rate in High-Risk Prostate Cancer Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Phase II clinical trial for the androgen receptor inhibitor Erleada (apalutamide), in combination with androgen deprivation therapy (ADT), successfully met its primary endpoint of biochemical recurrence (BCR) in patients with high-risk localized prostate cancer (HRLPC) following radical prostatectomy (RP). The…
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LEO Pharma’s Enstilar Outperforms Daivobet in Phase III Psoriasis Trial in China
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Denmark-based dermatology specialist LEO Pharma A/S has announced positive outcomes for its drug candidate Enstilar (LEO 90100) in a Phase III clinical trial conducted in China. The trial focused on evaluating Enstilar as a potential treatment for Chinese patients with stable plaque psoriasis. The primary objective of the study was…
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EyePoint Pharmaceuticals’ Durvayu Fails to Meet Primary Endpoint in NPDR Trial
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EyePoint Pharmaceuticals Inc., (NASDAQ: EYPT) has announced that its drug candidate Durvayu (vorolanib intravitreal insert; EYP-1901) did not meet its primary endpoints in the Phase II PAVIA clinical trial for non-proliferative diabetic retinopathy (NPDR). Although the trial data showed some treatment effect, including a reduction in NPDR progression rates at…
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Jacobio Pharma’s Glecirasib Shows Promise in Phase II Study for NSCLC Presented at ASCO
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has announced the presentation of results from a Phase II regulatory study for its KRAS G12C inhibitor, glecirasib, at the 2024 American Society of Clinical Oncology (ASCO) Plenary Series. In terms of efficacy, the study reported a confirmed objective response…
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Keymed Biosciences’ Stapokibart Meets Primary Endpoint in Phase III Seasonal Allergic Rhinitis Study
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China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), has successfully achieved its primary endpoint in a Phase III clinical trial for seasonal allergic rhinitis (SAR). The Phase III study, which was multi-center, randomized, double-blinded, and placebo-parallel-controlled, aimed to…
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AbbVie’s Rinvoq Outperforms Sanofi’s Dupixent in Moderate-to-Severe Atopic Dermatitis Trial
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AbbVie (NYSE: ABBV) has announced positive results from a head-to-head Phase IIIb/IV clinical trial comparing its JAK inhibitor Rinvoq (upadacitinib) with Sanofi’s (NASDAQ: SNY) interleukin blocker Dupixent (dupilumab) in patients with moderate-to-severe atopic dermatitis. The trial demonstrated that Rinvoq was superior in improving eczema area and severity as well as…
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Betta Pharmaceuticals’ BPI-16350 Combo Therapy Shows Improved PFS in Breast Cancer Trial
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced an update on its Phase III clinical study for BPI-16350, a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, used in combination with fulvestrant for the treatment of locally advanced or recurrent hormone receptor positive (HR+) HER2-negative metastatic breast cancer in patients…
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Sanofi’s Rilzabrutinib Meets Primary Endpoint in Phase III ITP Trial
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its Phase III trial for rilzabrutinib, a potential best-in-class BTK inhibitor, has successfully met its primary endpoint of durable platelet response in patients with immune thrombocytopenia (ITP). The trial also produced positive results in key secondary endpoints and did not raise…
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CANbridge Pharmaceuticals’ CAN008 Fails to Meet Phase II Endpoints in Glioblastoma Multiforme
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CANbridge Pharmaceuticals (HKG: 1228) has announced that its Phase II clinical study for CAN008 (asunercept) in newly diagnosed glioblastoma multiforme (GBM) did not achieve progression-free survival (PFS) or overall survival (OS) benefits. As a result, the Sino-US biopharma company has decided to discontinue the development of CAN008 for GBM. The…
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GSK’s Gepotidacin Shows Non-Inferior Efficacy in Phase III Gonorrhoea Tria
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GlaxoSmithKline (GSK; NYSE: GSK, LON: GSK), a leading UK pharmaceutical company, last week announced positive results from a Phase III clinical trial for gepotidacin, a first-in-class triazaacenaphthylene antibiotic, in the treatment of uncomplicated urogenital gonorrhoea (GC). The study demonstrated non-inferiority to the standard azithromycin-based treatment, with a microbiological response rate…
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Kintor Pharmaceutical’s GT20029 Meets Primary Endpoint in Phase II AGA Trial
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Kintor Pharmaceutical Ltd (HKG: 9939), a clinical-stage biotechnology company, has announced that its Phase II clinical study for GT20029, a first-in-class proteolysis targeting chimera (PROTAC) compound, has met its primary endpoint in the treatment of male androgenetic alopecia (AGA) in China. The multi-center, randomized, double-blind, placebo-controlled study aimed to evaluate…
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GSK’s Shingrix Vaccine Maintains High Efficacy for Over a Decade, Phase III Data Show
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GlaxoSmithKline (LON: GSK, NYSE: GSK), the UK-based pharmaceutical giant, has this week released long-term data from a follow-up Phase III trial of its recombinant herpes zoster vaccine, Shingrix. The vaccine demonstrated robust efficacy in adults aged 50 and above, with a 79.7% efficacy rate sustained from year 6 to year…
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AbbVie’s Rinvoq Meets Main Goal in Late-Stage Giant Cell Arteritis Trial
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AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that a late-stage clinical trial for its JAK inhibitor Rinvoq (upadacitinib) in combination with corticosteroids has successfully met the primary endpoint in patients with giant cell arteritis (GCA). The study demonstrated sustained remission from week 12 through week 52. The…
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Chia Tai Tianqing’s Rovadicitinib Meets Main Goal in Myelofibrosis Trial, Eyes Market Filing
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Chia Tai Tianqing, a renowned pharmaceutical company based in China, has declared that it has successfully met the primary endpoint in a pivotal study for its Category 1 drug, rovadicitinib, for the treatment of medium-to-high-risk myelofibrosis (MF). The company is advancing towards filing for market approval in China, following consultations…
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Novartis’s Kesimpta Shows Sustained Efficacy in 6-Year Relapsing MS Study
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has this week unveiled six-year efficacy data for its anti-CD20 drug Kesimpta (ofatumumab) in the treatment of recently diagnosed relapsing multiple sclerosis (MS) in treatment-naive patients. The data shows that first-line continuous Kesimpta treatment, as compared to a teriflunomide regimen switched to Kesimpta, resulted…
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Amgen’s Tezspire Shows Promise in Phase IIa COPD Trial, Reduces Exacerbations
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Amgen (NASDAQ: AMGN), a multinational biopharmaceutical company, has this week announced results from a Phase IIa proof-of-concept trial for its anti-thymic stromal lymphopoietin (TSLP) biologic, Tezspire (tezepelumab), in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). The trial indicated that Tezspire reduced the annualized rate of moderate or severe exacerbations…
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AstraZeneca’s Imfinzi Shows Sustained Survival Benefit in Advanced Biliary Tract Cancer Trial
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has this week announced 3-year results from a Phase III clinical trial of its anti-PD-L1 therapy Imfinzi (durvalumab) in combination with chemotherapy for the treatment of advanced biliary tract cancer (BTC). The trial, after a median follow-up of 41.3 months,…
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Roche’s Columvi Meets Overall Survival Endpoint in Diffuse Large B-Cell Lymphoma Trial
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Roche (SWX: RO), a leading Swiss pharmaceutical company, has announced that a late-stage clinical trial for its bispecific antibody Columvi (glofitamab) has successfully met its primary endpoint of overall survival (OS) in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The trial involved patients who had received…
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Novartis’s Fabhalta Shows Promise in Phase III IgA Nephropathy Trial
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced positive preliminary results from a Phase III clinical trial of its complement inhibitor Fabhalta (iptacopan) for the treatment of IgA nephropathy (IgAN). The trial data showed that after a nine-month treatment period, the Factor B inhibitor Fabhalta reduced proteinuria by 38.3% when…
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AbbVie’s Aquipta/Qulipta Shows Promise in Migraine Prevention Trial
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AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, last week released interim results from a Phase III open-label trial of its CGRP receptor antagonist, Aquipta/Qulipta (atogepant), for the prevention of migraines in patients with chronic or episodic migraine. The data, collected between weeks 13 to 16, indicated that the average…
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Teva’s Ajovy Achieves Positive Results in Phase III Migraine Prevention Trial in China
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Teva Pharmaceutical Industries Ltd (NYSE: TEVA), headquartered in Israel, has announced positive results from a Phase III study for Ajovy (fremanezumab) as a preventive treatment for migraine in adult Chinese patients. The study met its primary and all secondary endpoints, demonstrating Ajovy’s efficacy in reducing the number of migraine days…
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Enhertu Shows 58.3% Response Rate in Phase II Lung Cancer Study, AstraZeneca and Daiichi Sankyo Report
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The Phase II DESTINY-Lung05 study results for Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568, OTCMKTS: DSNKY), were unveiled at the American Association for Cancer Research (AACR) 2024 annual meeting. The study reported an objective response rate (ORR) of 58.3% (95% CI:…
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Sino Biopharmaceutical to Present Phase II Data for Garsorasib at AACR 2024
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Sino Biopharmaceutical Ltd. (HKG: 1177) announced that it will present the results of a Phase II study for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd., at the American Association for Cancer Research (AACR) 2024 annual meeting. The study focuses on non-small cell lung cancer (NSCLC)…
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Pfizer Reports Positive Phase III Results for RSV Vaccine Abrysvo in Younger Adults
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Pfizer (NYSE: PFE) has announced interim results from a Phase III trial evaluating its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults aged 18 to 59 at risk of severe RSV-associated lower respiratory tract disease (LRTD). Currently, the vaccine is approved for preventing RSV-associated LRTD in older adults and for…
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Alphamab Oncology’s JSKN003 Demonstrates Promising Results in Phase I HER2-Targeted Solid Tumor Study
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Alphamab Oncology (HKG: 9966) presented compelling data from a Phase I clinical trial of its HER2-targeted antibody-drug conjugate (ADC), JSKN003, at the AACR 2024 annual meeting. Conducted in Australia, the study focused on advanced solid tumors with HER2 expression. JSKN003, which utilizes a click reaction for conjugation, showcased superior serum…
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Johnson & Johnson’s Xarelto Demonstrates Reduced Bleeding Risk in Atrial Fibrillation Patients Post-PCI
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Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has announced positive results from a Phase III trial, highlighting the efficacy of its anticoagulant Xarelto (rivaroxaban) in reducing the risk of clinically significant bleeding (CSB) and net adverse clinical events (NACE) or rehospitalization in adult patients with nonvalvular atrial fibrillation (AF)…
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Clover Bio’s SCB-1019 Vaccine Candidate Shows Promising Results in Phase I Trial
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Clover Biopharmaceuticals (HKG: 2197), a leading biotechnology company based in China, has announced robust preliminary data from the Phase I clinical trial of its bivalent RSV candidate vaccine, SCB-1019. The vaccine, which targets both RSV-A and RSV-B, demonstrated significant increases in neutralizing titers, a key indicator of immune response. Specifically,…
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Bristol Myers Squibb Reports Positive Long-Term Data for KarXT in Schizophrenia Trial
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Pharmaceutical giant Bristol Myers Squibb (BMS, NYSE: BMY) has announced preliminary long-term data from a late-stage extension trial of its muscarinic antipsychotic drug KarXT (xanomeline + trospium) in adult patients with schizophrenia. The 52-week study demonstrated significant improvements, with participants showing an average reduction of 34% in the positive and…
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Beijing Aosaikang Pharmaceuticals Achieves Clinical Milestone for c-MET Inhibitor ASKC202
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced the presentation of promising data from a Phase I dosage escalation study (ASKC202-001) for its investigational small-molecule c-MET inhibitor, ASKC202, in advanced solid tumors at the American Association for Cancer Research (AACR) 2024 annual meeting. This development underscores the company’s commitment…
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Luye Pharma’s Subsidiary Boan Biotech Completes Phase III Trial for Eylea Biosimilar BA9101
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Shandong Boan Biotechnology Co., Ltd., a subsidiary of China-based Luye Pharma Group (HKG: 2186), has achieved a significant milestone with the completion of a Phase III clinical study for its proprietary ophthalmology product BA9101. This biosimilar version of Bayer’s Eylea (aflibercept) targets the treatment of recurrent or metastatic esophageal squamous…
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AstraZeneca’s Imfinzi Achieves Positive Results in Late-Stage Trial for Small Cell Lung Cancer
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that a late-stage trial for its anti-PD-L1 drug Imfinzi (durvalumab) has successfully met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer (LS-SCLC). The trial’s success marks a significant milestone…
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Novartis’s Leqvio Showcases Real-World Efficacy in Managing Cholesterol in ASCVD Patients
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has presented compelling real-world data for its innovative small interfering RNA (siRNA) therapy, Leqvio (inclisiran), which is used for the treatment of atherosclerotic cardiovascular disease (ASCVD) in patients who have not responded well to statins. The data, unveiled last week, demonstrated that the early…
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Sichuan Kelun-Biotech Presents Positive Results for Sacituzumab Tirumotecan at AACR 2024
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced the presentation of favorable results from two clinical studies on sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC), at the American Association for Cancer Research (AACR) 2024 annual meeting. The drug is under global co-development with Merck, Sharp &…
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Ascletis Pharma Halts ASC42 Phase II Study in Primary Biliary Cholangitis
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced its decision to terminate the Phase II clinical study for ASC42 in primary biliary cholangitis (PBC) following a comprehensive data analysis. The farnesoid X receptor (FXR) agonist will also see the cancellation of studies in non-alcoholic steatohepatitis (NASH) and hepatitis B virus…
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Shanghai Henlius Reports Phase III Success for HLX14 in Osteoporosis Treatment
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Shanghai Henlius Biotech Inc. (HKG: 2696), based in China, has announced that its global, multi-center Phase III clinical trial for HLX14, a biosimilar of Amgen’s Prolia/Xgeva (denosumab), has successfully met its primary endpoints in treating postmenopausal osteoporosis in women at high risk of fracture. The Phase III study aims to…
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Walvax Biotechnology’s COVID-19 Variant Vaccine RQ3033 Shows Positive Phase III Results
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China-based Walvax Biotechnology Co., Ltd (SHE: 300142) has announced positive results from a Phase III immunogenic bridge study for its COVID-19 variant mRNA vaccine candidate, RQ3033, co-developed with Fudan University and RNACure. The vaccine is specifically targeting the Omicron XBB.1.5 variant and has demonstrated good efficacy and safety in the…
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Zai Lab Announces Positive Phase III Data for Krazati in KRASG12C-mutated NSCLC, Plans NDA Filing in China
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Zai Lab (NASDAQ: ZLAB; HKG: 9688), a China-based biotech company, has announced positive Phase III results for Krazati (adagrasib) in the treatment of KRASG12C-mutated non-small cell lung cancer (NSCLC) as a second-line therapy. The company is now preparing to submit a New Drug Application (NDA) to China’s National Medical Products…
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Bristol Myers Squibb’s Krazati Trial Yields Positive Phase III Results in NSCLC
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Last week, Bristol Myers Squibb (BMS; NYSE: BMY) unveiled preliminary results from a Phase III confirmatory trial for its KRAS inhibitor Krazati (adagrasib) in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying a KRASG12C mutation. This encouraging data reinforces BMS’s strategic 2023 acquisition of original…
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Bristol Myers Squibb’s Zeposia Fails to Meet Primary Endpoint in Crohn’s Disease Trial
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that a Phase III study for its S1P receptor modulator Zeposia (ozanimod) in patients with moderate-to-severe active Crohn’s disease (CD) did not meet its primary endpoint of clinical remission at week 12. The trial’s outcome means that Zeposia joins a number of…
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Regenxbio Reports Stable Visual Acuity Improvements with AbbVie’s Gene Therapy in Wet AMD Trial
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Regenxbio (NASDAQ: RGNX), the development partner for AbbVie’s (NYSE: ABBV) gene therapy ABBV-RGX-314, has announced results from a Phase I/IIa trial focused on wet age-related macular degeneration (wAMD). This announcement complements the preliminary results shared earlier in the year. The 2-year data from the trial indicate that a single administration…
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Guangdong Zhongsheng Reports Positive Phase I Results for Innovative Weight Loss Drug RAY1225
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Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based biopharmaceutical company, has announced promising top-line results from a Phase I clinical trial for its innovative polypeptide drug candidate, RAY1225. This long-acting glucagon-like peptide-1 (GLP-1) therapy features dual activation of both the GLP-1 and glucose-dependent insulin-promoting polypeptide (GIP) receptors. The randomized,…
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MSD’s Phase III Trial of Keytruda Plus Lynparza Misses Primary Endpoints in NSCLC
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an unfavorable outcome for a Phase III trial combining Keytruda (pembrolizumab) and Lynparza (olaparib) in the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). The study, which aimed to evaluate the efficacy of this combination therapy, was halted after…
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BMS Reports Positive Phase III Results for Opdivo and Yervoy in Advanced HCC
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Bristol Myers Squibb (BMS; NYSE: BMY) announced this week that its Phase III study evaluating the combination of anti-PD-1 drug Opdivo (nivolumab) and anti-CTLA-4 biologic Yervoy (ipilimumab) as a first-line treatment for advanced hepatocellular carcinoma (HCC) has yielded promising top-line results. According to data from a pre-specified interim analysis, the…
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Bayer’s Elinzanetant Achieves Primary Endpoint in Late-Stage Menopause Symptom Trial
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Bayer (ETR: BAYN), a leading German pharmaceutical company, has announced positive results from a placebo-controlled late-stage trial of its NK-1,3 receptor antagonist, elinzanetant. The trial successfully met its primary endpoint, demonstrating a significant reduction in the frequency of moderate-to-severe vasomotor symptoms (VMS) associated with menopause by week 12. The 52-week…
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AstraZeneca’s Lynparza-Imfinzi Combo Shows Promising Results in Endometrial Cancer Study
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical giant, has presented interim results from a late-stage study combining the PARP inhibitor Lynparza (olaparib) with the anti-PD-L1 Imfinzi (durvalumab) for the treatment of newly diagnosed advanced or recurrent endometrial cancer. The study has shown promising outcomes, with the combination therapy extending the…
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Jiangsu Yahong Meditech to Present Phase III Results for Cervical Cancer Treatment at SGO Annual Meeting
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Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, is preparing to unveil key findings from a global multicenter Phase III clinical study on its Cevira (APL-1702) at the Society of Gynecologic Oncology (SGO) annual meeting. The study focuses on the treatment of high-grade squamous…
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GSK’s Jemperli Shows Survival Benefits in Phase III Endometrial Cancer Study
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GlaxoSmithKline (GSK; NYSE: GSK), a leading UK pharmaceutical company, has presented early results from a Phase III study for its PD-1-blocking antibody Jemperli (dostarlimab) in the treatment of primary advanced or recurrent endometrial cancer. The placebo-controlled trial aims to expand the current indication for frontline mismatch repair deficient (dMMR)/microsatellite instability-high…
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Mabwell’s Nectin-4 Targeting ADC 9MW2821 Shows Promise in Cervical Cancer Clinical Study
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced positive results from a clinical study of its pipeline candidate, the antibody drug conjugate (ADC) 9MW2821, which targets Nectin-4. The data, highlighting the potential of 9MW2821 in treating cervical cancer, is set to be presented…
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Pfizer’s Adcetris Combo Shows Improved Survival in Relapsed/Refractory DLBCL Late-Stage Trial
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Pfizer (NYSE: PFE) has announced positive results from a late-stage clinical trial for its antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study successfully met its primary endpoint, demonstrating an improvement in overall survival (OS)…
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Sanofi’s Amlitelimab Shows Promising Phase IIb Results in Atopic Dermatitis, Potential for 12-Week Dosing
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Sanofi (NASDAQ: SNY) announced this week promising results from a Phase IIb study of its OX40-ligand blocker, amlitelimab, in patients with moderate to severe atopic dermatitis. The study focused on participants who demonstrated a favorable response after an initial 24-week treatment period. Following a subsequent 28-week maintenance or withdrawal phase,…
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Amgen Reports Positive Results for Otezla in Pediatric Psoriasis Trial
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Amgen (NASDAQ: AMGN) provided an update last week on a late-stage trial evaluating its PDE4 inhibitor Otezla (apremilast) for the treatment of moderate to severe plaque psoriasis in patients aged 6 to 17 years. The one-year data revealed that 56.3% of participants achieved clear or almost clear skin, while 71.4%…
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Gilead and MSD Report Positive Interim Data for Once-Weekly HIV Treatment in Phase II Trial
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Gilead Sciences Inc. (NASDAQ: GILD) and Merck & Co., Inc., known as MSD (NYSE: MRK), have this week unveiled preliminary findings from a Phase II clinical trial of their investigational antiretroviral combination therapy, islatravir plus lenacapavir, as a potential once-weekly oral treatment for HIV/AIDS. Despite the primary endpoint being influenced…
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Novo Nordisk’s Ozempic Meets Phase III Endpoints in Type 2 Diabetes and Chronic Kidney Disease Study
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Novo Nordisk (NYSE: NVO), a Denmark-based pharmaceutical company, has this week published results from a Phase III study assessing the impact of the GLP-1 receptor agonist Ozempic (semaglutide) on the progression of renal impairment in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). Following the trial’s discontinuation…
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Novartis Gene Therapy Zolgensma Shows Continued Benefits in Broader SMA Patient Group
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has presented Phase III data this week, demonstrating that the clinical benefits of its gene therapy Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy (SMA) extend beyond patients up to 2 years of age. The new study has shown similar benefits in older children, including…
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ViiV Healthcare Presents Phase I Data for Ultra-Long-Acting Cabotegravir in HIV Treatment and Prevention
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GlaxoSmithKline (GSK; NYSE: GSK) unit ViiV Healthcare has presented Phase I results for an ultra-long-acting formulation of the antiretroviral cabotegravir, which is being investigated for the treatment and prevention of HIV. The safety and pharmacokinetic data from the study support the potential to double dosing intervals to four months or…
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BMS Reports Positive Long-Term Data for Zeposia in Multiple Sclerosis Trials
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Bristol Myers Squibb (BMS; NYSE: BMY) has unveiled results from several Phase III trials for its S1P receptor modulator Zeposia (ozanimod) in the treatment of relapsing forms of multiple sclerosis (MS). In a long-term study, the oral medication demonstrated a low annualized relapse rate, with disability progression observed in only…
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BeiGene’s Brukinsa Outperforms Acalabrutinib in MAIC for Relapsed/Refractory CLL, Says BeiGene
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the results of a matching-adjusted indirect comparison (MAIC) between its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), and acalabrutinib in terms of efficacy. The comparison is based on data from the Phase III ALPINE and Phase III ASCEND studies, which…
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Merck’s Mavenclad Demonstrates Lasting Efficacy in RMS Patients, New Data Show
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Merck KGaA (ETR: MRK), a German multinational pharmaceutical, chemical, and life sciences company, has this week unveiled new clinical data for its cytotoxic drug Mavenclad (cladribine) in the treatment of highly active relapsing multiple sclerosis (RMS). The results indicate that over 95% of participants noted clinically meaningful improvements in cognitive…
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Pfizer’s RSV Vaccine Demonstrates Durable Efficacy with Abrysvo Phase III Results
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Pfizer Inc. (NYSE: PFE) last week reported the outcomes of a Phase III trial for its respiratory syncytial virus (RSV) bivalent vaccine, Abrysvo, in adults aged 60 and above following the second RSV season. The vaccine’s efficacy against RSV-associated lower respiratory tract disease (LRTD) experienced a decline from 88.9% in…
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Huadong Medicine’s MaiLi Extreme Achieves Clinical Study Milestone for Chin Retraction Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that a Chinese clinical study for MaiLi Extreme, an injectable lidocaine-containing sodium hyaluronate by its UK subsidiary Sinclair, has successfully met its primary endpoint, demonstrating good safety data. The study aimed to evaluate the efficacy and safety of MaiLi Extreme injections…
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Abbisko Therapeutics Reports Positive Phase I Results for ABSK061 in Solid Tumors at ESMO TAT 2024
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Shanghai-based Abbisko Therapeutics Co., Ltd. (HKG: 2256) has revealed promising outcomes from a global, multi-center Phase I trial evaluating the safety, tolerability, pharmacokinetics (PK), and anti-tumor efficacy of its oral FGFR2/3 inhibitor, ABSK061, in treating solid tumors. These findings were presented at the European Society for Medical Oncology (ESMO) TAT…
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Cutia Therapeutic’s CU-20401 Shows Promising Safety and Efficacy in Phase I Abdominal Fat Reduction Study
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Cutia Therapeutic (HKG: 2487), a China-based dermatology specialist, has announced the successful completion of a Phase I study for its potential Category 1 drug CU-20401, a recombinant mutant collagenase, which is being investigated for the treatment of abdominal fat accumulation. The single-center, open-label, placebo-controlled, dosage-escalation study enrolled 48 subjects in…
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AstraZeneca’s Fasenra Matches Nucala in EGPA Trial and Shows Steroid Reduction Benefits
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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has presented results from a Phase III trial that previously announced the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) against GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab), the current standard of care for relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The data revealed…
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Polpharma Biologics’ Biosimilar Candidate PB016 Shows Comparable Profiles to Takeda’s Entyvio
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Polish biotechnology firm Polpharma Biologics has announced positive results from a comparability study for its late-stage biosimilar candidate PB016, which references Takeda’s (TYO: 4502) inflammatory bowel disease (IBD) blockbuster Entyvio (vedolizumab). The study’s data indicate that PB016 demonstrates similar pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety profiles compared to the…
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AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial for Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI), has successfully met its primary endpoint of progression-free survival (PFS) in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC). The trial evaluated a once-daily…
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Innovent Biologics’ IBI311 Achieves Primary Endpoint in Phase III Study for Thyroid Eye Disease
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that its Phase III regulatory study in China for IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has successfully achieved its primary endpoint. The study targeted thyroid eye disease (TED), with a New Drug Application…
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Roche’s Faricimab Shows Sustained Vision Benefits in Phase III Study for Retinal Vein Occlusion
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Swiss pharmaceutical giant Roche (SWX: ROG) has released interim Phase III data for its bispecific antibody (BsAb) Vabysmo (faricimab) in the treatment of macular edema resulting from branch and central retinal vein occlusion (BRVO and CRVO). The biologic demonstrated significant vision improvements, with gains of 17 to 19 letters on…
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Bristol Myers Squibb’s Subcutaneous Opdivo Shows Noninferiority in Phase III ccRCC Trial
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Bristol Myers Squibb (BMS; NYSE: BMY) this week announced preliminary Phase III data demonstrating that its subcutaneous formulation of Opdivo (nivolumab), developed in partnership with Halozyme Therapeutics (NASDAQ: HALO), is noninferior to the intravenous version for patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The equivalence trial…
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Laekna Therapeutics Reports Phase II Data for Afuresertib in Platinum-Resistant Ovarian Cancer
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Laekna Therapeutics Shanghai Co., Ltd, a China-based pharmaceutical company, has announced topline data from the global multi-center Phase II PROFECTA-II study for its afuresertib combined with paclitaxel in the treatment of platinum-resistant ovarian cancer (PROC). The Sino-US study aimed to assess the efficacy and safety of the combination therapy in…
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Roche’s Tecentriq in Combination with Exelixis’s Cabometyx Meets Primary Endpoint in mCRPC Phase III Study
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced positive results from a Phase III study showcasing the efficacy of its anti-PD-L1 drug Tecentriq (atezolizumab) in combination with Exelixis’s (NASDAQ: EXEL) tyrosine kinase inhibitor (TKI) Cabometyx (cabozantinib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The study focused on…
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Eli Lilly’s Subsidiary Akouos Reports Positive Preliminary Results for Gene Therapy in Hearing Loss
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Eli Lilly (NYSE: LLY) has announced preliminary results from a Phase I/II study conducted by its subsidiary Akouos for gene therapy AK-OTOF, which is being investigated for the treatment of sensorineural hearing loss due to mutations in the otoferlin gene (OTOF). The press release reported that the first participant in…
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BMS’s Opdivo-Yervoy Combo Cuts Cancer Progression Risk by 79% in Phase III Study
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Bristol Myers Squibb (BMS; NYSE: BMY) has published late-stage and long-term data for its anti-PD-1 drug Opdivo (nivolumab) across various cancer indications. Early results from a Phase III trial in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) indicate that the combination of Opdivo with anti-CTLA-4…
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Merck’s Bavencio Shows Promising Survival Data in Real-World Urothelial Carcinoma Studies
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German pharmaceutical company Merck (NYSE: MRK) has released data from real-world studies for its anti-PD-L1 biologic Bavencio (avelumab), used as a maintenance therapy in eligible patients with locally advanced or metastatic urothelial carcinoma (UC). Preliminary results indicate that the median overall survival (OS) in patients without progression after first-line chemotherapy…
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Gilead’s Trodelvy Misses Primary Endpoint in Late-Stage NSCLC Trial
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Gilead Sciences (NASDAQ: GILD) has announced that a late-stage trial for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in metastatic or advanced non-small cell lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS) in patients who had previously received treatment for metastatic NSCLC. Despite this setback,…
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Novartis Lutathera Combo Therapy Shows Significant Progress in GEP-NETs
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced preliminary results from a Phase III study that evaluated the efficacy of radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) in combination with the symptom-control drug octreotide as a first-line therapy for SSTR+ well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The clinical…
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AstraZeneca’s Imfinzi Meets Primary Endpoint in Hepatocellular Carcinoma Trial
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced the successful completion of the primary endpoint in a Phase III trial for its anti-PD-L1 drug Imfinzi (durvalumab). The trial investigated the combination of Imfinzi with bevacizumab, originally developed by Roche (SWX: ROG) as Avastin, and transarterial chemoembolization (TACE) for embolization-eligible hepatocellular…
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CARsgen Therapeutics’ CT041 Shows Promising Results in Advanced Solid Tumors at ASCO GI 2024
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China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the presentation of interim results from the Phase Ib ELIMYN18.2 study’s dosage escalation phase for its pipeline asset, CT041. The data will be showcased at the esteemed 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI 2024). The study is…
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Eisai and Medivir’s Combo Therapy Advances in Liver Cancer with Positive Trial Results
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Japanese pharmaceutical company Eisai’s (TYO: 4523) kinase inhibitor Lenvima (Lenvatinib), combined with Swedish partner Medivir’s (STO: MVIR) chemotherapy fostroxacitabine bralpamide (fostrox), has demonstrated positive outcomes in an open-label Phase Ib/IIa trial for advanced hepatocellular carcinoma (HCC), Medivir announced. Following last year’s encouraging early data, these results are expected to pave…
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Regenxbio’s One-Time Gene Therapy for Wet AMD Shows Promise in Phase II Study
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Gene therapy specialist Regenxbio (NASDAQ: RGNX) has announced preliminary results from a Phase II study for ABBV-RGX-314, a VEGF pathway inhibitor developed in partnership with AbbVie (NYSE: ABBV) for the treatment of wet age-related macular degeneration (wet AMD). The therapy is designed to be administered as a one-time injection, aiming…
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Novo Nordisk’s IcoSema Shows Promise in Late-Stage Trial for Type 2 Diabetes Management
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Danish pharmaceutical giant Novo Nordisk (CPH: NOVO-B) has announced positive results from a late-stage trial of its antidiabetic combination therapy, IcoSema (insulin icodec + semaglutide), in patients with type 2 diabetes (T2D) inadequately controlled on daily basal insulin. In comparison to insulin glargine plus insulin aspart, once-weekly IcoSema demonstrated non-inferiority,…
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AbbVie’s Lutikizumab Advances to Phase III for Hidradenitis Suppurativa After Positive Mid-Stage Results
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AbbVie (NYSE: ABBV) has announced the progression of lutikizumab to Phase III clinical trials following the IL1α/1β antagonist’s successful performance in a mid-stage trial for patients with moderate-to-severe hidradenitis suppurativa (HS) who had failed anti-TNF therapy. The study successfully met its primary endpoint, demonstrating a 35% higher clinical response rate…
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Ascletis Pharma’s ASC41 Shows Promising Results in Phase II NASH Study
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Ascletis Pharma Inc. (HKG: 1672), a Chinese pharmaceutical company, has announced positive interim results from a 52-week Phase II study evaluating the efficacy of the thyroid hormone receptor β (THRβ) agonist ASC41 in patients with liver biopsy-proven non-alcoholic steatohepatitis (NASH). The ongoing, randomized, double-blind, placebo-controlled, and multi-center Phase II study…
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Jiangsu Recbio’s REC610 Shingles Vaccine Shows Positive Results in First-In-Human Study
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Jiangsu Recbio Technology Co., Ltd (HKG: 2179), a Chinese biotechnology company, has announced positive results from the first-in-human (FIH) study for its novel adjuvanted recombinant shingles vaccine, REC610, which is being conducted in the Philippines. The study uses GlaxoSmithKline’s Shingrix (recombinant zoster vaccine; RZV), a major UK pharmaceutical company’s shingles…
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Clover Biopharma’s SCB-219M Shows Promising Phase I Results for Chemotherapy-Induced Thrombocytopenia
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Clover Biopharmaceuticals Ltd (HKG: 2197), based in China, has announced promising preliminary results from its Phase I clinical study of SCB-219M, an innovative thrombopoietin receptor agonist (TPO-RA) developed in-house. The study, which focused on safety, efficacy, and pharmacokinetics, involved tumor patients undergoing chemotherapy. In the Phase I trial, nine chemotherapy-treated…
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AbbVie and Alpine Immune Sciences Halt Early Enrollment in Lupus Trial
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AbbVie (NYSE: ABBV) and Alpine Immune Sciences (SWX: ALPN) have made the decision to prematurely cease enrollment in a Phase II trial for the T-cell stimulatory pathways inhibitor acazicolcept in systemic lupus erythematosus (SEL). This move allows for an early assessment of the trial data and enables Alpine to redirect…
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Yifan Pharmaceutical’s F-652 Shows Promise in Phase II Clinical Trial for ACLF
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Yifan Pharmaceutical Co., Ltd (SHE: 002019), a China-based pharmaceutical company, has reported positive outcomes from a Phase II clinical trial for F-652, a product developed by its subsidiary Evive Biotech Ltd, in the treatment of acute-on-chronic liver failure (ACLF). The trial demonstrated that F-652 not only exhibits good safety and…
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Sanofi Halts Development of Tusamitamab Ravtansine After Missed Trial Endpoints
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Sanofi (NASDAQ: SNY) has announced the discontinuation of its antibody-drug conjugate (ADC) tusamitamab ravtansine following disappointing results from a Phase III trial in metastatic non-squamous (NSq) non-small cell lung cancer (NSCLC) patients with high CEACAM5 expression. The trial did not meet its dual primary endpoints, as indicated by an interim…
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Zylox-Tonbridge Completes Patient Enrollment for ZENFLEX Study in Germany
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Zylox-Tonbridge Medical Technology (HKG: 2190), a China-based developer of nerve and peripheral vascular interventional devices, has announced the completion of patient enrollment in a multi-center clinical study for its ZENFLEX peripheral vascular stent system in Germany. The study has reached its target of 100 patients. This prospective, multi-center, single-arm study…
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InnoCare’s TYK2 Inhibitor ICP-332 Shows Positive Results in Atopic Dermatitis Phase II Study
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Beijing InnoCare Pharma Tech Co., (HKG: 9969), a Chinese biotechnology company specializing in oncology and autoimmune diseases, has reported positive outcomes from a Phase II clinical trial for its tyrosine kinase 2 (TYK2) inhibitor, ICP-332. The randomized, double-blind, placebo-controlled study is investigating the efficacy of ICP-332 in patients with moderate…
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AbbVie and Genmab’s Epcoritamab Shows Promising Results in Follicular Lymphoma Study
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AbbVie (NYSE: ABBV) and Genmab (NASDAQ: GMAB) have presented Phase I/II clinical data for their T-cell engager, Tepkinly/Epkinly (epcoritamab), in patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of therapy. Interim results, with a median follow-up of 17.4 months, showed that the…
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BMS Presents Promising Golcadomide Trial Results for Non-Hodgkin Lymphomas
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Bristol Myers Squibb (BMS; NYSE: BMY) has presented results from Phase I and Phase I/II trials for combination therapies with golcadomide, a potential first-in-class drug from the company’s CELMoD line of protein degraders, in the treatment of non-Hodgkin lymphomas. The Phase I study indicated that previously untreated patients with aggressive…
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J&J’s Carvykti Demonstrates Extended Time to Symptom Worsening in Multiple Myeloma Patients
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Johnson & Johnson (J&J; NYSE: JNJ) has released data from a Phase III study showing that its CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel), extended the median time until symptom worsening to 23.7 months in patients with relapsed and lenalidomide-refractory multiple myeloma (MM) after one to three prior lines of therapy,…
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MSD Halts Phase III Trial of Keytruda Combo in NSCLC After Missing Primary Endpoints
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of a Phase III trial for its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with AstraZeneca’s (AZ; NASDAQ: AZN) co-developed PARP inhibitor Lynparza (olaparib) for metastatic squamous non-small cell lung cancer (NSCLC). The decision follows the trial’s failure to meet…
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Novartis Reports Kisqali Success in Reducing Recurrence Risk in Early Breast Cancer
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Novartis (NYSE: NVS) has announced an update on the late-stage trial for its CDK4/6 inhibitor Kisqali (ribociclib) in early breast cancer. Data from 78.3% of patients who completed treatment showed a significant reduction in the risk of recurrence, with 30% and 24.5% decreases for stage II and stage III tumors,…
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Pfizer’s Danuglipron Phase IIb Trial Achieves Weight Loss Goals Amid Tolerability Concerns
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Pfizer (NYSE: PFE) announced last week that its Phase IIb trial evaluating danuglipron, a glucagon-like peptide-1 (GLP-1) receptor agonist, in adults with obesity but without type 2 diabetes (T2D) has successfully met its primary endpoint. The study demonstrated significant reductions in body weight from baseline, with participants achieving placebo-adjusted mean…
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Sunshine Guojian’s SSGJ-608 Meets Phase III Efficacy Endpoints in Psoriasis Trial
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., a subsidiary of 3SBio Inc. (HKG: 1530), has announced that its Phase III clinical trial for the anti-IL-17A monoclonal antibody SSGJ-608 in moderate to severe plaque psoriasis has successfully met its primary efficacy endpoints, including PASI 75 and sPGA 0/1, as well as all…
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Akeso’s AK111 Achieves Key Efficacy Milestones in Phase III Trial for Plaque Psoriasis
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Akeso Biopharma (HKG: 9926), based in China, has announced that its pivotal Phase III clinical trial for the interleukin (IL)-17A monoclonal antibody (mAb) AK111 in moderate to severe plaque psoriasis has successfully met all primary efficacy endpoints, including PASI100 and sPGA0/1. This randomized, double-blind, placebo-controlled, multi-center study was designed to…
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Sichuan Kelun-Biotech to Present Promising Phase II Results for SKB264 in mTNBC at SABCS 2023
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Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), is poised to present updated results from a Phase II study expansion cohort for its antibody-drug conjugate, SKB264, targeting previously treated metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio…
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Everest Medicines Reports Positive Phase III Results for Velsipity in Ulcerative Colitis
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Everest Medicines (HKG: 1952), based in China, has announced positive topline results from a multi-center Phase III clinical trial for Velsipity (etrasimod) in patients with moderate-to-severe active ulcerative colitis (UC). Conducted across various sites in Asia, the trial demonstrated clinically meaningful and statistically significant improvements in the primary endpoint, as…
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AbbVie’s Telisotuzumab-Vedotin Shows Promising Results in NSCLC Phase 2 Trial
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AbbVie (NYSE: ABBV) has unveiled data from a Phase 2 trial of its potential first-in-class antibody-drug conjugate (ADC) telisotuzumab-vedotin, which targets c-Met protein-overexpressing, EGFR-wild-type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). The trial results showed an overall response rate (ORR) of 35% in patients with high c-Met levels and 23%…
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Merck’s V116 Pneumococcal Vaccine Shows Promising Data Against Pfizer’s Prevnar 20
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has unveiled new data from a late-stage trial of its 21-valent pneumococcal conjugate vaccine, V116, confirming earlier topline results. The data, released this week, highlights the vaccine’s immunogenicity, tolerability, and safety in comparison to Pfizer’s (NYSE: PFE) 20-valent Prevnar 20/Apexxnar in unvaccinated adults.…
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Dupixent Trial Success Reinforces Potential in Moderate-to-Severe COPD Treatment
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Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NASDAQ: SNY) have announced that a late-stage replicate trial for their interleukin blocker Dupixent (dupilumab) has successfully met its primary endpoint during an interim analysis. The trial demonstrated a significant reduction in exacerbations over 52 weeks in patients with chronic obstructive pulmonary disease (COPD)…
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Jenscare Reports Positive One-Year Outcomes for LuX-Valve in Tricuspid Valve Replacement Study
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Jenscare Scientific Co., Ltd. (HKG: 9877), a Ningbo-based manufacturer of devices for structural heart disease, has released promising one-year results from a confirmatory study of its transcatheter tricuspid valve replacement system, LuX-Valve. The prospective, multi-center, single-arm study aimed to evaluate the safety and efficacy of the LuX-Valve in patients suffering…
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Akeso Biopharma’s Cadonilimab Meets Primary Endpoint in Phase III Cervical Cancer Study
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China-based Akeso Biopharma (HKG: 9926) has announced that its Phase III AK104-303 study for cadonilimab (AK104), an innovative bispecific antibody targeting programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), has achieved its primary endpoint. The study combines the antibody with chemotherapy and optional bevacizumab for the first-line treatment of…
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Alphamab Oncology’s JSKN003 ADC: Promising Preliminary Data in Advanced Solid Tumors
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Alphamab Oncology (HKG: 9966) has released preliminary data from a Phase I clinical study on its JSKN003-KN026 antibody drug conjugate (ADC) in Australia, focusing on advanced solid tumors. This open-label, multi-center, dosage escalation study is designed to evaluate the safety, tolerability, and preliminary efficacy of the molecule in treating these…
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Yipinhong Pharmacy’s AR882 Shows Promise in Gout Treatment in Phase II Study
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China-based Yipinhong Pharmacy Co., Ltd (SHE: 300723) has announced positive data from a Phase II clinical study for its pipeline candidate drug AR882, co-developed with Arthrosi Therapeutics Inc., for the treatment of gout. The randomized, placebo-controlled global study involved 42 patients, and after 6 weeks of treatment, results indicated that…
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Visen Pharmaceuticals Reports Positive Phase II Results for TransCon CNP in Achondroplasia
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Visen Pharmaceuticals, a joint venture between Denmark-based Ascendis Pharma A/S (NASDAQ: ASND) and Chinese healthcare investment firm Vivo Capital, has announced topline results from the ACcomplisH China Phase II trial. The study assessed the safety and efficacy of once-weekly TransCon CNP (navepegritide) in children with achondroplasia (ACH) aged 2 to…
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Bayer Withdraws Aliqopa FDA Filing Following Missed Phase III Endpoint
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Germany-based pharmaceutical major Bayer (ETR: BAYN) has announced its decision to withdraw the filing for the kinase inhibitor Aliqopa (copanlisib) with the US Food and Drug Administration (FDA). Aliqopa, which received accelerated approval in 2017 for the treatment of relapsed follicular lymphoma (FL), failed to meet the primary endpoint of…
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Novo Nordisk Commits Over DKK 42 Billion to Expand Chronic Disease Production in Denmark
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Novo Nordisk (CPH: NOVO-B), a leading pharmaceutical company, last week announced a substantial plan to invest over DKK 42 billion (USD 6.0 billion) into expanding its production capacity for serious chronic diseases in Denmark. This significant investment underscores the company’s commitment to addressing the growing needs of patients with chronic…
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ImmVira’s MVR-T3011 IV Achieves Positive Outcomes in US Phase I Clinical Study
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Shenzhen-based biotechnology company ImmVira has announced the successful completion of Phase I clinical studies in the United States for its intravenous oncolytic virus product, MVR-T3011 IV. The trial, which focuses on late stage patients with various tumor types, yielded “exceptional” safety results and demonstrated initial efficacy for certain indicationsThe study…
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Novartis’ Remibrutinib Meets Milestones in Late-Stage Chronic Spontaneous Urticaria Studies
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that two late-stage studies for its Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, used in the treatment of chronic spontaneous urticaria (CSU), have successfully met all primary and secondary endpoints at the 12-week mark of a 52-week trial. After three months of treatment…
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Janssen Presents Real-World Data on Tremfya’s Efficacy in Treatment-Resistant Psoriatic Arthritis
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Johnson & Johnson’s (J&J; NYSE: JNJ) pharmaceutical unit, Janssen, has presented real-world efficacy data for Tremfya (guselkumab), an IL-23p19-subunit inhibitor, in the treatment of treatment-resistant active psoriatic arthritis (PsA). The data provides valuable insights into the drug’s performance in alleviating pain, improving physical function, and reducing fatigue in patients with…
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Janssen’s Nipocalimab Shows Promising Results in Phase II Rheumatoid Arthritis Trial
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced the results of a Phase II trial for nipocalimab, a potential best-in-class anti-neonatal Fc (FcRn) biologic, in patients with moderate-to-severe active rheumatoid arthritis (RA) who have anti-citrullinated protein antibodies (ACPAs) or rheumatoid factor (RF) and are unresponsive to…
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Gilead Sciences and Arcus Biosciences Announce Positive Phase II Data for Domvanalimab Combination Therapy
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Gilead Sciences (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have this week released preliminary data from a Phase II study combining Gilead’s anti-TIGIT biologic domvanalimab with Arcus’ anti-PD-1 drug zimberelimab plus chemotherapy for the treatment of locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The study marks…
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Boehringer Ingelheim’s Aldosterone Synthase Inhibitor BI 690517 Shows Promise in CKD Phase II Trial
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Germany-based Boehringer Ingelheim (BI) has published the results of a Phase II trial for its aldosterone synthase inhibitor (ASi) BI 690517, used alone or in combination with the antidiabetic Jardiance (empagliflozin), in patients with chronic kidney disease (CKD), with or without type 2 diabetes (T2D). The trial aimed to evaluate…
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Bayer Unveils Real-World Insights on Kerendia for CKD and T2D Management
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Germany-headquartered Bayer (ETR: BAYN) recently published interim insights from a significant real-world observational study focusing on the clinical characteristics and treatment patterns associated with its mineralocorticoid receptor antagonist (MRA), Kerendia (finerenone). This medication has received global approvals aimed at reducing cardiorenal risk in patients suffering from chronic kidney disease (CKD)…
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Seagen’s Adcetris Combo with Keytruda Shows Promising Results in Phase II Study
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has released the results of a Phase II study combining its antibody drug conjugate (ADC) Adcetris (brentuximab vedotin) with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy Keytruda (pembrolizumab). The study focused on patients with…
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AstraZeneca Announces Positive Phase IIb Results for CKD Treatment Combination
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced last week that its combination therapy of ETA receptor antagonist zibotentan and SGLT2 inhibitor dapagliflozin achieved dose-dependent reductions in urinary albumin-to-creatinine ratio (UACR) during a Phase IIb trial for chronic kidney disease (CKD). This development marks a significant step forward in the…
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Dizal Pharmaceutical Presents Updates on DZD8586 and Golidocitinib at ASH Annual Meeting
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) provided updates on the clinical development of its drug candidates, DZD8586 and the JAK1 inhibitor golidocitinib (DZD4205), at the 65th American Society of Hematology (ASH) annual meeting. The event showcased the latest findings from the company’s research and development efforts in the field…
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Innovent Biologics Presents Positive Clinical Results for Efdamrofusp Alfa and IBI324 at AAO
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Innovent Biologics, Inc. (HKG: 1801), a China-based biopharmaceutical company, has published the latest clinical results for its two drug candidates, efdamrofusp alfa (IBI302) and IBI324, at the American Association of Ophthalmology (AAO) meeting. IBI302 is a recombinant fully human anti-VEGF and anti-complement bispecific fusion protein, while IBI324 is a bispecific…
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Cutia Therapeutics Achieves Primary Endpoint in Phase I Study of CU-40101 for Androgenic Alopecia
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Cutia Therapeutics (HKG: 2487), a company specializing in dermatological therapies, has announced that its Phase I clinical study for CU-40101, a small-molecule thyroid hormone receptor agonist liniment for external use in androgenic alopecia in China, has successfully reached its primary endpoint. Study Design and ResultsThe Phase I study was a…
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Abbisko Therapeutics to Present CSF-1R Inhibitor ABSK021 Data at CTOS Annual Meeting
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it will present data from two clinical studies on its next-generation CSF-1R inhibitor, ABSK021 (pimicotinib), at the Connective Tissue Oncology Society (CTOS) annual meeting. The presentations will highlight significant findings from the Phase Ib clinical study and the ongoing…
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Ascentage Pharma’s Olverembatinib Showcases Promising Results at ASH Annual Meeting
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Suzhou-based Ascentage Pharma (HKG: 6855) has presented the latest results of multiple studies regarding its innovative drug candidate olverembatinib at the 65th American Society of Hematology (ASH) annual meeting. The data highlights the potential of olverembatinib in treating various hematological malignancies, including chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic…
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Sirnaomics’ STP705 Demonstrates Positive Results in Phase I Focal Fat Reduction Study
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Sirnaomics Ltd (HKG: 2257) has announced positive safety and efficacy results from a Phase I clinical study for its investigational product, STP705, which is focused on focal fat reduction (FFR). The study provides valuable insights into the potential of STP705 as a non-invasive treatment for reducing fat accumulation in specific…
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Shanghai Henlius Biotech’s HanSiZhuang Shows Positive Results in Phase III ASTRUM-002 Study
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company in China, has unveiled positive data from the Phase III ASTRUM-002 study. The study assessed the efficacy of its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), in combination with chemotherapy for first-line treatment of non-squamous non-small cell lung cancer (nsqNSCLC). The…
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Roche’s Gene Therapy Elevidys Misses Primary Endpoint in DMD Trial
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Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) has announced that a Phase III trial for its gene transfer therapy Elevidys (delandistrogene moxeparvovec) did not meet its primary endpoint in Duchenne muscular dystrophy (DMD) ambulatory patients aged 4 to 7 years. The trial aimed to measure the change from baseline in motor…
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Yirui Pharmaceutical’s YR001 Completes Successful Phase I Clinical Study in the US
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Hangzhou-based Yirui Pharmaceutical Technology Co., Ltd has announced the successful conclusion of a Phase I clinical study for its YR001 external preparation in the United States. The topical ointment, which is a small molecule Kv1.3 inhibitor, showed a good safety and tolerability profile in all subjects tested. YR001: Indications and…
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Novartis Announces Positive Interim Results for Atrasentan in IgA Nephropathy Phase III Study
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Novartis (NYSE: NVS), a global healthcare company, has released interim results from an ongoing Phase III study for its endothelin A receptor antagonist (ERA) atrasentan, indicating a significant milestone in the treatment of IgA nephropathy (IgAN), a rare kidney disease. The trial successfully met its primary endpoint, demonstrating a clinically…
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Innovent Biologics’ Mazdutide Shows Promising Weight Loss Results in Phase II Trial
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China-based Innovent Biologics Inc., (HKG: 1801) has revealed compelling Phase II data for its weight loss drug candidate, mazdutide (IBI362), after 48 weeks of treatment. The higher dose (9mg) of mazdutide demonstrated significant efficacy in achieving weight loss among Chinese subjects with obesity, alongside favorable safety profiles and multiple metabolic…
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Biogen’s BIIB080 Shows Promise in Phase Ib Trial for Mild Alzheimer’s Disease
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Biogen (NASDAQ: BIIB) has released preliminary findings from a Phase Ib trial for BIIB080, a microtubule-associated protein tau (MAPT)-targeting antisense oligonucleotide (ASO) co-developed with Ionis Pharmaceuticals (NASDAQ: IONS). The trial focused on patients with mild Alzheimer’s disease (AD), showing that high doses of the spinal injection led to improvements in…
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MSD Halts Phase II Trials for Glutamate Modulator MK-1942 in Alzheimer’s and Depression
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of two Phase II trials evaluating the efficacy of its glutamate modulator MK-1942 in patients with mild-to-moderate Alzheimer’s disease (AD) and treatment-resistant major depressive disorder (MDD). The decision comes after an unblinded data analysis indicated potential safety concerns. Trial…
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Novartis’ Pluvicto Demonstrates Positive Phase III Results in mCRPC Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has released encouraging data from a Phase III study for its radioligand therapy (RLT) Pluvicto (177Lu vipivotide tetraxetan). The study focused on patients with prostate-specific membrane antigen (PSMA)-positive progressive metastatic castration-resistant prostate cancer (mCRPC), a challenging form of the disease. Primary Endpoint and Risk…
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Dizal’s Sunvozertinib Shows Promising Efficacy in Advanced NSCLC at ESMO 2023
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented compelling efficacy and safety data for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, at the European Society for Medical Oncology (ESMO) Congress 2023. The drug is being evaluated for first-line treatment in advanced non-small cell lung cancer (NSCLC) with EGFR…
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Shandong Luoxin’s LX-039 Demonstrates Promise in Phase I Oncology Study at ESMO
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Shandong Luoxin Pharmaceutical Group Stock Co., Ltd (SHE: 002793), a China-based pharmaceutical innovator, has published data from a Phase I clinical study for its novel anti-tumor drug, LX-039. This oral selective estrogen receptor modulator (SERD) was in the spotlight at the European Society for Medical Oncology (ESMO) Congress 2023, where…
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Kintor’s Proxalutamide Shows Promise in Metastatic Breast Cancer Study at ESMO
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has published the latest data from a Phase Ic clinical study evaluating its proxalutamide in combination with endocrine therapies (ETs) for metastatic breast cancer. The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2023, shedding light on the drug’s potential…
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Ascentage Pharma’s Pelcitoclax Shows Promise in ESMO Study for NSCLC
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Suzhou-based pharmaceutical company Ascentage Pharma (HKG: 6855) has published the latest results from a Phase Ib study of its pelcitoclax (APG-1252), a dual inhibitor of BCL-2 and BCL-xL proteins, in combination with AstraZeneca’s Tagrisso (osimertinib) for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). The findings were presented at…
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Transcenta Holdings Unveils Updated Osemitamab Data in Advanced Gastric Cancer at ESMO
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China-based biotech Transcenta Holdings Ltd (HKG: 6628) has presented updated efficacy data from the expansion cohort of the TranStar102 trial at the ESMO Congress 2023 in Madrid, Spain. The trial assessed osemitamab (TST001), a high affinity humanized anti-CLDN18.2 monoclonal antibody (mAb) with enhanced antibody-dependent cellular cytotoxicity (ADCC), in combination with…
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Alphamab Oncology Presents Promising Data for KN046 and KN026 at ESMO 2023
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China-based Alphamab Oncology (HKG: 9966) has released data snapshots from clinical studies for two of its pipeline candidates, KN046 and KN026, at the European Society for Medical Oncology (ESMO) Congress 2023. These bispecific antibodies (BsAbs) are being evaluated for their efficacy and safety in treating various types of cancers, with…
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Janssen’s TAR-200 Shows High Complete Response Rate in Bladder Cancer Study
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has published data from a Phase IIb study demonstrating the efficacy of its intravesical gemcitabine delivery system, TAR-200, in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) carcinoma in situ-positive. The study results are a significant step forward in the…
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Novartis’ Kisqali Plus Endocrine Therapy Shows Improved Survival in Early Breast Cancer Study
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Switzerland-based pharmaceutical company Novartis (NYSE: NVS) has announced additional results from an ongoing Phase III study evaluating the CDK4/6 inhibitor Kisqali (ribociclib) in combination with endocrine therapy for stage II and III HR+/HER2- early breast cancer (EBC). The findings confirm that the combination therapy significantly improves invasive disease-free survival (iDFS)…
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Jacobio Pharma’s Glecirasib Combo Shows Promising Results in ESMO Congress 2023 Presentation
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China-based Jacobio Pharma (HKG: 1167) has presented clinical data for its KRAS G12C inhibitor glecirasib in combination with its pipeline SHP2 inhibitor JAB-3312 at the European Society for Medical Oncology (ESMO) Congress 2023. The data comes from a Phase I/II study that enrolled 144 patients with KRAS G12C mutated cancers,…
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InxMed Presents Positive Data for FAK Inhibitor Ifebemtinib at ESMO 2023
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China-based firm InxMed (Nanjing) Co., Ltd has updated two clinical studies for its first-in-class small-molecule FAK inhibitor ifebemtinib (IN10018) at the European Society for Medical Oncology (ESMO) Congress 2023. The studies evaluated the drug’s efficacy and safety in treating platinum-resistant recurrent ovarian cancer and advanced triple negative breast cancer. Phase…
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BMS’s Subcutaneous Opdivo Meets Phase III Study Endpoints in ccRCC
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from a Phase III comparative study of its anti-PD-1 drug Opdivo (nivolumab) formulated as a subcutaneous injection. The study, conducted in pre-treated advanced or metastatic clear cell renal cell carcinoma (ccRCC) patients, utilized Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) for…
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Qilu Pharmaceutical Presents Promising Data for QL1706 and QL1209 at ESMO 2023
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China-based Qilu Pharmaceutical has announced the presentation of clinical data for two of its pipeline candidates, QL1706 and QL1209, at the European Society for Medical Oncology (ESMO) Congress 2023. The data highlights the therapeutic potential of these drugs in treating various forms of cancer, showcasing Qilu’s commitment to innovation in…
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Roche’s Alecensa Shows Unprecedented 76% Improvement in Disease-Free Survival in NSCLC Trial
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Roche (SWX: ROG) subsidiary Genentech has revealed preliminary but promising results from a Phase III trial for Alecensa (alectinib) in patients with early-stage resected ALK-positive non-small cell lung cancer (NSCLC). The trial demonstrated that the ALK inhibitor significantly improved disease-free survival (DFS) by an unprecedented 76% compared to chemotherapy, meeting…
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BeiGene’s Tislelizumab Shows Promising Results in ESMO Presentations for GC/GEJC and NSCLC
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China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced two late-breaking presentations of Phase III data for its programmed death-1 (PD-1) inhibitor tislelizumab at the European Society for Medical Oncology (ESMO) Congress 2023. The presentations include an oral presentation for tislelizumab in combination with chemotherapy for advanced…
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Mabwell to Present Promising Clinical Data at 2023 ESMO Congress
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it will present the latest clinical data for its investigational drugs 9MW2821 and 8MW0511 at the upcoming 2023 European Society for Medical Oncology (ESMO) Congress. This presentation underscores the company’s commitment to advancing innovative therapies in oncology. 9MW2821: Promising…
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Eli Lilly’s Tirzepatide Shows Robust Weight Loss Results in Phase III Study
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Eli Lilly (NYSE: LLY) has released compelling efficacy results from a Phase III study evaluating its GLP-1 receptor agonist, tirzepatide, in adults with obesity or overweight accompanied by comorbidities, excluding type 2 diabetes (T2D). The study successfully met its two co-primary endpoints, demonstrating superiority over placebo in weight loss after…
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Abbisko Therapeutics to Unveil Phase I Data for ABSK011 and ABSK043 at ESMO 2023
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Shanghai-based biotech powerhouse Abbisko Therapeutics Co., Ltd (HKG: 2256) is preparing to present the results of Phase I clinical studies for two of its pipeline candidates at the 2023 European Society for Medical Oncology (ESMO) Congress. The spotlight will be on ABSK011, a small-molecule FGFR4 inhibitor, and ABSK043, an in-house…
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Kelun-Biotech to Present SKB264 Study Results for Metastatic Breast Cancer at ESMO
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China-based pharmaceutical innovator Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) and its subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) are preparing to present the results of a Phase I/II basket study for their drug SKB264 (MK-2870) at the 2023 European Society for Medical Oncology (ESMO) Congress. The study focuses…
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Roche’s Ocrevus Demonstrates Long-Term Efficacy in Multiple Sclerosis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has presented compelling long-term efficacy data for its selective immunosuppressant Ocrevus (ocrelizumab) in the treatment of multiple sclerosis (MS). The 10-year results from a Phase III extension study provide significant insights into the drug’s sustained impact on patients with relapsing and primary progressive forms…
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AbbVie’s Rinvoq Demonstrates Sustained Efficacy in Late-Stage Atopic Dermatitis Study
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AbbVie (NYSE: ABBV) has announced late-stage results for its JAK inhibitor Rinvoq (upadacitinib) in the treatment of moderate-to-severe atopic dermatitis, a skin condition characterized by inflammation and itching. The data, released this week, highlights the drug’s performance over an extended period of two years. Sustained Efficacy in Atopic DermatitisThe primary…
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Lee’s Pharmaceutical’s Subsidiary Announces Positive Results for Myopia Treatment NVK002
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive topline results from the Phase III mini CHAMP study for NVK002, an atropine external use eye solution developed to address myopia progression. Study Design and ParticipantsThe Phase III mini CHAMP study was…
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MSD’s Keytruda Achieves Primary Endpoint in Late-Stage NSCLC Trial
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that a late-stage trial for its anti-PD-1 drug Keytruda (pembrolizumab) has successfully met the primary endpoint of statistically significant and clinically meaningful improvement in overall survival (OS) in patients with resectable non-small cell lung cancer (NSCLC). The trial evaluated Keytruda as…
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Novo Nordisk Halts Phase III Ozempic Study on Renal Impairment in Diabetes Patients
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Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) has decided to discontinue a Phase III global study evaluating the impact of the GLP-1 receptor agonist Ozempic (semaglutide) on the progression of renal impairment in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). The decision was recommended by an…
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Janssen Unveils Promising Clinical Data on IL-23 Blockers for Psoriasis
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) is showcasing new clinical data this week from trials assessing the efficacy of IL-23 blockers, Tremfya (guselkumab) and JNJ-2113, in the treatment of psoriasis. The findings, derived from a late-stage study, reveal that Tremfya facilitated clear skin within 28 weeks…
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J&J’s Janssen Reports Favorable Spravato Data in Late-Stage TRD Trial
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Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, has presented tolerability and efficacy data from a late-stage trial comparing its antidepressant Spravato (esketamine nasal spray) with oral quetiapine in the treatment of treatment-resistant major depressive disorder (TRD). The trial evaluated both drugs in combination with serotonin reuptake inhibitors (SRIs). Trial…
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AstraZeneca Reports Positive Phase III Results for Forxiga in Children with Type 2 Diabetes
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UK-based AstraZeneca (AZ, NASDAQ: AZN) has announced promising results from the Phase III T2NOW study (NCT03199053) for its diabetes medication, Forxiga (dapagliflozin), in adolescents and children aged 10 to 17 with type 2 diabetes (T2D). Enrolling 256 patients, this study stands as one of the largest investigations into type 2…
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Everest Medicines and Calliditas Present New Data on Nefecon for IgA Nephropathy
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Everest Medicines (HKG: 1952), in partnership with Calliditas Therapeutics AB (Nasdaq: CALT), recently presented new biomarker and subgroup analyses for Nefecon, a targeted oral formulation of budesonide currently under clinical development for the treatment of IgA nephropathy (IgAN). The data was showcased during both poster and oral presentations at the…
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Novartis’ Lutathera Meets Primary Endpoint in Phase III Trial for GEP-NETs
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that a Phase III trial for its radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) combined with the symptom-control drug octreotide has successfully met its primary endpoint of progression-free survival (PFS) in patients with SSTR-positive, aggressive, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement…
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Shanghai Junshi’s Tuoyi Meets Primary Efficacy Endpoint in Phase III Melanoma Study
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that the Phase III MELATORCH study (NCT03430297) for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) has successfully reached the progression-free survival (PFS) primary efficacy endpoint. This study evaluates Tuoyi as a first-line…
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Abbisko Therapeutics’ Irpagratinib Receives FDA Clearance for Phase I Study in HCC
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its pipeline candidate, irpagratinib (ABSK121), a fibroblast growth…
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MSD’s Keytruda Meets Endpoints in Urothelial Carcinoma Trial but Misses in NSCLC Study
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading global pharmaceutical company, last week released clinical data from separate late-stage studies for its anti-PD-1 biologic, Keytruda (pembrolizumab), in combination with other oncology therapies from different partners. The results presented a mixed picture of success and challenges in the field of…
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Tonghua Golden-Horse’s Octohydroaminoacridine Succinate Meets Phase III Endpoints in Alzheimer’s Disease
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China-based Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd. (SHE: 000766) has announced positive results from its Phase III clinical study for the in-house developed octohydroaminoacridine succinate, an oral acetylcholinesterase inhibitor designed for the treatment of mild to moderate Alzheimer’s disease (AD). Study Design and OutcomesThe Phase III study was a double-blind,…
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AIM Vaccine’s Serum-Free Rabies Vaccine Completes Phase III Safety Observation
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the successful completion of the 7-day safety observation period in a Phase III clinical study for its investigational freeze-dried human rabies vaccine, developed using serum-free Vero cells. The study, which was conducted in a randomized, blinded, and similar vaccine parallel controlled…
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Jiangsu Yahong’s Cevira Meets Primary Endpoint in Phase III Cervical HSIL Study
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Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, has announced that its Phase III clinical study for Cevira (APL-1702) in high-grade squamous intraepithelial lesions (HSIL) of the cervix has successfully reached its primary endpoint. Study Design and ResultsThe global, multi-center Phase III study was…
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Caliway Biopharmaceuticals’ CBL-514 Achieves Milestones in Dercum’s Disease Trial
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Taiwan-based Caliway Biopharmaceuticals, a specialist in medical aesthetics and inflammatory medicine, has announced that its trial assessing the efficacy and safety of CBL-514 in subjects with Dercum’s Disease lipomas has met all primary and secondary efficacy endpoints. CBL-514 is a first-in-class small-molecule injection lipolysis drug designed to induce adipocyte apoptosis…
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Zelgen Biopharmaceuticals’ rhTSH Achieves Primary Endpoint in Phase III Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that its Phase III clinical study for the drug candidate, recombinant human thyroid stimulating hormone for injection (rhTSH), has successfully reached its pre-set primary endpoint. Following this achievement, the company will proceed with a pre-BLA (Biologics License…
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CSBIO’s Albenatide Shows Positive Results in Two Phase III Diabetes Trials
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced encouraging results from two Phase III clinical studies for its innovative drug candidate, albenatide (CJC-1134-PC). This Category 1 drug is a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), modified with Drug Affinity Complex (DAC) technology based on exenatide. CSCJC DM301…
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Gilead’s Kite CAR-T Therapy Yescarta Achieves 71% CMR in Phase II Trial for R/R LBCL Patients
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Gilead’s (NASDAQ: GILD) subsidiary Kite has announced early results from a Phase II trial of its CAR-T therapy, Yescarta (axicabtagene ciloleucel), for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT). The study achieved a primary endpoint…
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Novartis’s Kisqali Reduces Cancer Recurrence Risk in HR+/HER2- Early Breast Cancer: Phase III Results
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has published results from a Phase III study of its CDK4/6 inhibitor Kisqali (ribociclib) in combination with endocrine therapy (ET) as an adjuvant treatment for HR+/HER2- early breast cancer (EBC). The data, recorded for up to three years, indicated that Kisqali reduced the risk…
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AstraZeneca and Daiichi Sankyo Report Positive Results for Datopotamab Deruxtecan Combo in NSCLC
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced positive data from a Phase Ib study for the antibody-drug conjugate (ADC) datopotamab deruxtecan in combination with checkpoint inhibitor Imfinzi (durvalumab). The study, conducted in partnership with Daiichi Sankyo (TYO: 4568), focused on first-line advanced or metastatic non-small cell lung cancer…
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Grand Pharmaceutical’s GSP301 NS Meets Primary Endpoint in Phase III SAR Study
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Phase III study (GSP 301-308) for the Ryaltris compound nasal spray (GSP301 NS) in seasonal allergic rhinitis (SAR) has successfully reached its primary endpoint in China. Study Design and Patient EnrollmentThe randomized, double-blind, double-simulation, three-arm, multi-center, parallel-controlled Phase III…
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Asieris Pharmaceuticals’ APL-1202 Shows Positive Interim Analysis in MIBC Trial with BeiGene’s Tislelizumab
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has revealed positive results from a Phase II interim analysis of its drug candidate APL-1202, combined with BeiGene Ltd’s (NASDAQ: BGNE; HKG: 6160) programmed death-1 (PD-1) inhibitor tislelizumab, as neoadjuvant chemotherapy (NAC) in muscular invasive bladder cancer (MIBC). The trial has demonstrated…
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AstraZeneca’s Fasenra Shows Non-Inferior Efficacy to Nucala in EGPA: Phase III Results
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has unveiled the results of a Phase III study, demonstrating the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) compared to GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab) in the treatment of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The study highlights that Fasenra…
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AbbVie’s Skyrizi Outperforms Janssen’s Stelara in Phase III Crohn’s Disease Trial
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AbbVie (NYSE: ABBV) has announced early data from a Phase III trial that compared the IL-23 inhibitor Skyrizi (risankizumab) with Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen’s Stelara (ustekinumab) in patients with moderate-to-severe Crohn’s disease (CD) unresponsive to anti-TNF therapy. The blinded efficacy assessment revealed that Skyrizi achieved clinical…
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MSD’s Sotatercept Demonstrates Positive Interim Results in Phase III PAH Studies
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has presented interim data from Phase III and extension studies for its potential first-in-class biologic sotatercept, which is being investigated for the treatment of pulmonary arterial hypertension (PAH). The late-stage trial indicated that the activin signaling inhibitor led to a reduction in right…
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AstraZeneca’s Tagrisso Combination Therapy Shows Improved Efficacy in EGFR-mutated NSCLC
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UK-headquartered AstraZeneca (AZ; NASDAQ: AZN) has announced interim Phase III data demonstrating that the addition of pemetrexed plus cisplatin/carboplatin chemotherapy to tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) improves therapeutic effects in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The combination therapy reduced the risk of…
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Janssen Reports Positive Results from Phase Ib/II Study of Rybrevant Combo in EGFR-mutated NSCLC
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has provided an update on an ongoing Phase Ib/II study cohort assessing the safety and pharmacokinetics of the bispecific antibody (BsAb) Rybrevant (amivantamab) in combination with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy for the treatment of relapsed/refractory EGFR-mutated non-small cell lung…
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AstraZeneca’s Enhertu Shows Promising Results in Phase II HER2-mutant NSCLC Trial
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AstraZeneca (AZ; NASDAQ: AZN) has released early data from a Phase II trial investigating the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-mutant unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). The trial assessed the efficacy and safety of different dosages of Enhertu, revealing that while a…
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Amgen’s Lumakras Combo Shows Promising Results in KRAS-mutated NSCLC Early-Stage Trial
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Amgen (NASDAQ: AMGN) has announced positive early-stage data for its KRASG12C inhibitor Lumakras (sotorasib) when combined with carboplatin and pemetrexed in the treatment of KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) in adults. The confirmed objective response rate (ORR) and disease control rate (DCR) in treatment-naive patients were 65%…
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Gilead’s Trodelvy Combo with MSD’s Keytruda Shows Promise in NSCLC Phase II Trial
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Gilead (NASDAQ: GILD) has announced interim data from a Phase II trial assessing the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in combination with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 Keytruda (pembrolizumab) for first-line advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. The interim results…
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ImmuneOnco’s IMM2510 and IMM27M Achieve Milestones in Phase I Clinical Trials
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the completion of patient enrollment for Phase I dosage escalation studies for both IMM2510 and IMM27M, with the recommended Phase II dosage (RP2D) determined for each. IMM2510: A PD-L1/VEGF Bispecific Antibody for Solid TumorsIMM2510, a PD-L1/VEGF bispecific antibody (BsAb) based on…
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Allist Pharmaceuticals and ArriVent Biopharma Release Promising Interim Data on Furmonertinib for NSCLC
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd and its US partner ArriVent Biopharma Inc. have jointly released interim data from a Phase Ib trial at the 2023 World Conference on Lung Cancer (WCLC) meeting. The trial assessed the efficacy of furmonertinib as a treatment for non-small cell lung cancer (NSCLC), specifically…
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BMS Announces Positive Outcomes for BMS-986278 in Progressive Pulmonary Fibrosis Study
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Bristol-Myers Squibb (BMS; NYSE: BMY) has released the final results from a Phase II trial evaluating the potential first-in-class LPA1 antagonist BMS-986278 in the treatment of progressive pulmonary fibrosis (PPF). The trial’s findings indicate that the twice-daily pill significantly reduced the rate of decline in percent predicted forced vital capacity…
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Roche and Alnylam’s Zilebesiran Achieves Primary Endpoint in Hypertension Phase II Trial
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Roche (SWX: ROG) and Alnylam (NASDAQ: ALNY) have announced that a Phase II trial for their RNAi therapeutic, zilebesiran, has successfully met its primary endpoint of significantly reducing 24-hour mean systolic blood pressure (SBP) at month three in patients with mild-to-moderate hypertension. The results also demonstrated reductions in SBP and…
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Cutia Therapeutics’ CU-40102 Meets Primary Endpoint in Phase III Study for Androgenic Alopecia
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Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has announced that its Phase III clinical study for CU-40102 (external einasteride spray) in androgenic alopecia in China has successfully reached its primary endpoint. Study Design and Patient EnrollmentThe multi-center, randomized, double-blind, placebo-controlled Phase III regulatory study was designed to assess the efficacy…
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LIQUIK Study Interim Results to Showcase Lucence’s Liquid Biopsy Advancements at WCLC 2023
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Precision medicine specialist Lucence, with a presence in Suzhou, Hong Kong, and Palo Alto, California, has announced that the interim results of the LIQUIK study, a prospective international multicenter liquid biopsy study for lung cancer, will be reported at the IASLC 2023 World Conference on Lung Cancer (WCLC) held on…
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Janssen’s Rybrevant Combo Meets Primary Endpoint in Advanced NSCLC Study
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Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ), has released an update on a late-stage study for its bispecific antibody (BsAb) Rybrevant (amivantamab). The study investigated the combination of Rybrevant with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy in treating advanced or metastatic non-small cell lung cancer (NSCLC)…
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Hainan Haiyao Concludes Phase I Clinical Study for PaiEnJiaBin, a Novel KCNQ Agonist
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China-based Hainan Haiyao Co., Ltd (SHE: 000566) has announced the conclusion of Phase I clinical studies for PaiEnJiaBin, a Category 1 chemical drug co-developed with the Shanghai Institute of Materia Medica. PaiEnJiaBin is a next-generation KCNQ potassium channel agonist, with no similar products approved globally, and is being developed to…
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MSD’s Gardasil 9 HPV Vaccine Demonstrates 10-Year Efficacy in Adolescents
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has released long-term effectiveness data for its recombinant human papillomavirus (HPV) 9-valent vaccine, Gardasil 9, in minors aged between 9 and 15 years old. The results indicate that the immunogenicity generated by the vaccine persisted for 10 years after the third and final…
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Seagen and Genmab Announce Positive Phase III Results for Tivdak in Cervical Cancer
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), and its partner Genmab (NASDAQ: GMAB), have announced the achievement of the primary endpoint in a Phase III trial for their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). The trial focuses on patients with recurrent or metastatic…
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Columbia University Study Weighs Cost-Effectiveness of Weight-Loss Treatments for Adolescents
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Researchers at US Columbia University have published the results of a study estimating the cost-effectiveness of Novo Nordisk’s (NYSE: NVO) injections Wegovy (semaglutide) and Saxenda (liraglutide), as well as Vivus’s (NASDAQ: VVUS) pill Qsymia (phentermine + topiramate) for weight-loss interventions in adolescents. The study utilized a simulated cohort of 100,000…
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BDgene Technology Announces Clinical Milestone for CRISPR-Cas9 Gene Therapy in HSK
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Gene therapy specialist Shanghai BDgene Technology Co., Ltd has announced the conclusion of three clinical research treatments using its HELP technology, based on the CRISPR-Cas9 gene editing tool, for herpes simplex keratitis (HSK). Preliminary positive results have been published in the journal Molecular Therapy, in an article titled “In Vivo…
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Roche’s Alecensa Achieves Milestone in Adjuvant Therapy Trial for Early-Stage NSCLC
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Switzerland-based pharmaceutical giant Roche (SWX: ROG) has released an update from an interim analysis of a late-stage trial for its ALK inhibitor Alecensa (alectinib) as adjuvant therapy in the early setting for resected non-small cell lung cancer (NSCLC) with ALK mutations. These mutations are present in approximately 5% of NSCLC…
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Sirnaomics’ STP707 siRNA Drug Shows Promising Results in Phase I Solid Tumor Study
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has revealed that all patients have been dosed in a Phase I clinical study for its siRNA drug candidate STP707, which targets multiple solid tumors. The study is designed to assess the safety, tolerability, and anti-tumor activity of STP707 in six dose…
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Genscript’s CAR-T Therapy JNJ-4528 Demonstrates 100% Effective Rate in Long-Term Myeloma Study
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Genscript Biotech Corporation (1548.HK), a leading China-based Contract Development and Manufacturing Organization (CDMO), has announced the publication of long-term follow-up data from the Phase 1b/2 study, CARTITUDE-1. The study, conducted in partnership with Janssen Pharmaceutical, focuses on the chimeric antigen receptor (CAR)-cell therapy JNJ-4528 for the treatment of recurrent or…
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Innovent Biologics and Eli Lilly & Co.’s Tyvyt Achieves Primary Endpoints in Phase II ESCC Clinical Study
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Innovent Biologics (HKEX: 01801), a prominent biotech firm headquartered in Suzhou, China, and Eli Lilly & Co. (Nasdaq: LLY), a titan of the US pharmaceutical industry, have jointly declared a significant milestone in the Phase II clinical study known as ORIENT-2. The study focuses on the co-developed anti-programmed death-1 (PD-1)…
