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Huahui Health’s Libevitug Earns FDA Breakthrough Designation for Chronic Hepatitis Delta Virus
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Beijing-based biotech company Huahui Health, specializing in viral hepatitis, hepatology, and oncology, has announced that it has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its libevitug (HH-003), an anti-PreS1 human monoclonal antibody (mAb), for the treatment of patients with chronic hepatitis delta virus…
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Huadong Medicine’s DR10624 Receives NMPA Approval for MAFLD and MASH Clinical Trials
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for its protein drug DR10624 in metabolic related fatty liver disease (MAFLD) and metabolic associated steatohepatitis (MASH). DR10624’s Mechanism and Pre-Clinical PerformanceDR10624 is a…
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Huadong Medicine’s HDM1005 Receives FDA Approval for MASH Clinical Study
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 chemical drug, HDM1005, in metabolic associated steatohepatitis (MASH). This development marks a significant step forward for…
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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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Beijing Wantai Receives NMPA Clearance for Nine-Valent HPV Vaccine Targeting Male Population
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a leading Chinese pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its nine-valent human papillomavirus (HPV) vaccine (Escherichia coli), specifically designed for the male population. Global Impact and Vaccine RelevanceGlobally, approximately…
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Hasten Biopharmaceutical Initiates Phase III Clinical Trial for Lerodalcibep in China
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China-based Hasten Biopharmaceutical Co., Ltd, a comprehensive biopharmaceutical company co-established by CBC Group, has announced the first subject dosing in its Phase III clinical study for lerodalcibep, a third-generation PCSK9 inhibitor. The drug was in-licensed from US firm LIB Therapeutics Inc. in September of the previous year. Study Design and…
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CanSino Biologics Initiates Phase I Clinical Trial for Freeze-Dried Hib Conjugate Vaccine
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China-based biopharmaceutical company CanSino Biologics (HKG: 6185) has announced the commencement of a Phase I clinical study for its freeze-dried Haemophilus influenzae type b (Hib) conjugate vaccine, marking a significant step in the development of this important pediatric vaccine. The study has begun with the enrollment of the first subject,…
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EMA’s CHMP Recommends Approval for MSD’s Keytruda Combo in Mesothelioma Treatment
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Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of its PD-1 inhibitor, Keytruda (pembrolizumab), in combination with pemetrexed plus…
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EMA’s CHMP Recommends Approval for BMS’s Opdivo/Yervoy Combo in mCRC
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Bristol-Myers Squibb’s (BMS, NYSE: BMY) anti-PD-1 drug Opdivo (nivolumab) in combination with the anti-CTLA-4 biologic Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch…
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Sandoz Receives EC Approval for Biosimilar to Eylea for Retinal Diseases
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Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced that it has received marketing approval from the European Commission (EC) for its biosimilar of Bayer/Regeneron’s (ETR: BAYN / NASDAQ: REGN) Eylea (aflibercept). The product is now available in the form of a 2 mg vial kit and pre-filled syringe for intravitreal…
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Sanofi’s Dupixent sBLA for Chronic Spontaneous Urticaria Accepted by FDA for Review
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French pharmaceutical giant Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental biologics license application (sBLA) for Dupixent (dupilumab). The application seeks to expand the monoclonal antibody’s (mAb) indication to treat adults and pediatric patients aged 12 years and older with chronic…
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Novo Nordisk Launches Semaglutide for Weight Management in China
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Denmark-based healthcare giant Novo Nordisk A/S (NYSE: NVO) has announced the official market launch of semaglutide in China for long-term weight management. Globally, Novo Nordisk markets the glucagon-like peptide-1 receptor agonist (GLP-1RA) under the trade name Wegovy for weight loss, expanding access to this treatment for individuals seeking to manage…
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Sichuan Kelun-Biotech Secures NMPA Approval for Two Antibody Drug Conjugates
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a leading biopharmaceutical company based in China, has announced receiving separate Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SKB535 and SKB571, which target solid tumors. This development marks a significant milestone in…
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Exegenesis Bio’s Gene Therapy EXG110 Earns Orphan Drug Status for Fabry Disease
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Exegenesis Bio, a leading provider of epigenetics experimental and analytical services headquartered in Hangzhou, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary gene therapy, EXG110, which is indicated for the treatment of Fabry disease. This designation highlights…
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Janssen-Cilag’s Lazcluze-Rybrevant Combo Receives Positive EMA Opinion for NSCLC Treatment
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Janssen-Cilag International NV, a subsidiary of the US pharmaceutical giant Johnson & Johnson (J&J; NYSE: JNJ), has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding the combination of Lazcluze (lazertinib) and Rybrevant (amivantamab-vmjw). This combination therapy…
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Shanghai Junshi Biosciences’ Toripalimab Wins UK Approval for Nasopharyngeal and Oesophageal Cancers
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its PD-1 inhibitor, toripalimab, marketed as Loqtorzi. This approval allows the use of toripalimab in…
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Ascentage Pharma Submits Application for Lisaftoclax, a Novel Oral Bcl-2 Inhibitor
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Ascentage Pharma (HKG: 6855) has announced that its proprietary oral Bcl-2 selective inhibitor, Lisaftoclax (APG-2575), has submitted its market application, which has been officially accepted by regulatory authorities. The formulation is being produced in collaboration with Xuantai Pharmaceutical. This innovative treatment targets patients suffering from refractory or relapsed chronic lymphocytic…
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Bliss Bio Secures NMPA Approval for BB-1712, Pioneering ADC Therapy
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Bliss Bio announced that its Investigational New Drug (IND) application for the innovative antibody-drug conjugate (ADC) BB-1712 has been approved by the National Medical Products Administration (NMPA) of China. BB-1712, a B7-H3 targeted ADC utilizing Eribulin as its cytotoxic agent, has been developed for the treatment of multiple solid tumors,…
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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…
