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Abbisko Therapeutics’ CD73 Inhibitor ABSK051 Clears for Phase I Clinical Trial in China
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its next-generation CD73 inhibitor, ABSK051, in China. This first-in-human (FIH), multi-center, open-label study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD),…
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US FDA Approves HutchMed and Takeda’s Fruzaqla for Metastatic Colorectal Cancer Treatment
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The US Food and Drug Administration (FDA) has granted approval to HutchMed (NASDAQ: HCM) and its partner Takeda (NYSE: TAK, TYO: 4502) for their oral tyrosine kinase inhibitor Fruzaqla (fruquintinib), marking the second approval this year for a China-developed innovative drug. The drug is indicated for adult patients with previously…
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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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Abbisko Therapeutics Receives FDA Approval for Phase I Study of FGFR4 Inhibitor ABSK012
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Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received clearance from the US Food and Drug Administration (FDA) to commence a Phase I clinical study of its next-generation FGFR4 mutant inhibitor, ABSK012, for the treatment of advanced solid tumors. Objectives of the Phase I…
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Chengdu Kanghong Pharmaceutical’s KH629 Receives FDA Approval for NASH Clinical Trial
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, KH629, which is intended for the treatment of non-alcoholic steatohepatitis (NASH). KH629’s Profile and Previous…
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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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Clover Biopharmaceuticals Submits Market Filing for Seasonal Influenza Vaccine in Brazil
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced the submission of a market filing for its seasonal influenza vaccine in Brazil. This move marks a strategic expansion for the company as it seeks to broaden the reach of its vaccine offerings. Product Details and AdvantagesThe product in question is a…
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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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RinuaGene Receives US FDA IND Approval for HPV-Associated Tumor mRNA Vaccine RG002
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RinuaGene, a leading mRNA specialist headquartered in Suzhou, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its human papillomavirus (HPV) associated tumor therapeutic mRNA vaccine, RG002. This marks a significant step forward in the development of the vaccine,…
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Enhertu Receives Priority Review Status for HER2-Positive Gastric Cancer Treatment in China
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The Center for Drug Evaluation (CDE) website has indicated that Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), is set for priority review status in China. This priority review is specifically for the ADC’s potential use as a…
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MicuRx Pharmaceuticals Secures Clinical Trial Approvals for MRX-4 and Contezolid in Multiple Countries
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced that it has received clinical trial approvals for its novel anti-microbial agent MRX-4 in combination with contezolid (MRX-I) as a sequential treatment for diabetic foot infections. The approvals span several countries, including the United Kingdom, Turkey, Georgia, Argentina, and Chile. Both…
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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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Zhejiang Huahai Pharmaceutical’s HB0052 Receives US FDA IND Approval for Solid Tumors
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IntroductionZhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its injectable drug candidate, HB0052. The drug will initially be assessed in general advanced solid tumors, marking a significant…
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BeiGene’s ZW25 on Track for Priority Review for Cholangiocarcinoma Treatment by CDE
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The Center for Drug Evaluation (CDE) website has indicated that BeiGene’s (NASDAQ: BGNE) ZW25 (zanidatamab) is set to receive priority review status for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma in patients with high HER2 expression who have previously received systemic treatment. This priority review status is a…
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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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CSPC Pharmaceutical Group Gets NMPA Approval for SYS6011 Biologic Drug Clinical Study
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a China-based pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 biologic drug candidate, SYS6011. The study will be focused on general solid tumors, marking a significant step…
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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…
