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BDgene Technology’s BD111 Receives Tacit Approval for HSV-1 Keratitis Trial
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Shanghai BDgene Technology Co., Ltd has announced that it has received tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its innovative therapy, BD111. This CRISPR-Cas9 in vivo-based therapy is designed for the treatment of recurrent type 1 herpes simplex virus (HSV-1)-related keratitis (HSK) and is being…
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SanReno Therapeutics Completes Dosing in Kidney Disease Trial for BION-1301
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SanReno Therapeutics, a China-based joint venture (JV) specializing in nephropathy treatments, has announced the completion of dosing in 36 patients for its new kidney disease drug, BION-1301, in a trial conducted in Shanghai. The JV is a collaboration between Chinook Therapeutics Inc., a US-based biopharmaceutical company listed on Nasdaq (KDNY),…
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Qilu Pharmaceutical Launches First Generic Iressa in the US Market
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China-based Qilu Pharmaceutical has announced the market launch of its generic version of AstraZeneca’s (AZ, NASDAQ: AZN) first-generation epidermal growth factor receptor (EGFR) inhibitor, Iressa (gefitinib), in the United States. This marks the debut of the first generic version of Iressa in the country, expanding access to this crucial medication…
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Transcenta’s Osemitamab Achieves Full Enrollment in Phase II Gastric Cancer Study
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Transcenta Holding Limited (HKG: 6628), a China-based biopharmaceutical company, has announced the completion of enrollment in two patient cohorts for its Phase II study of osemitamab (TST001), a CLDN18.2-targeted monoclonal antibody. The study, known as Transtar-102 (NCT04495296), focuses on patients with CLDN18.2 expressing gastric/gastro-esophageal junction (G/GEJ) adenocarcinoma in China. A…
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TYK Medicines’ TY-9591 Gains CDE Green Light for Pivotal Phase II Study in NSCLC with Brain Metastases
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Shanghai-based TYK Medicines has announced that it has received the green light from the Center for Drug Evaluation (CDE) to proceed with a pivotal Phase II clinical study for its drug candidate TY-9591, a novel therapy targeting lung cancer with brain metastases. This trial is strategically designed to support a…
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Skyline Therapeutics Reports Positive Preclinical Results for SKG0106 and SKG0201 Gene Therapies
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Skyline Therapeutics, a Shanghai-based cell and gene therapy (CGT) developer, has announced encouraging preclinical study results for its AAV gene therapies, SKG0106 and SKG0201, targeting neovascular age-related macular degeneration (nAMD) and spinal muscular atrophy (SMA), respectively. SKG0106: A Novel AAV Therapy for nAMDSKG0106 is a self-developed novel AAV vector carrying…
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Q1 2023 financial report: AstraZeneca leads innovation in China, Sanofi’s sales in China decline
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Several multinational companies (MNCs) have released their Q1 2023 financials, showing a varied performance over the quarter. AstraZeneca’s China Innovation BoomAstraZeneca (AZ, NASDAQ: AZN) CEO Pascal Soriot warned that Europe is lagging behind China in fostering innovation and access to medicines. This statement came during the company’s Q1 2023 earnings…
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CMS Receives NMPA Approval for Clinical Study of Tetravalent BsAb for nAMD
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its tetravalent bispecific antibody (BsAb) targeting vascular endothelial growth factor A (VEGFA) and angiopoietin 2 (ANG2) for intravitreal injection in the treatment…
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Sirnaomics’ RV-1730 Receives FDA Clearance for Phase I COVID-19 Vaccine Booster Trial
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Sirnaomics Ltd (HKG: 2257) has announced that it has received clearance from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for a Phase I clinical trial of RV-1730, a SARS-CoV-2 vaccine booster candidate. Design of the Phase I Study for RV-1730The Phase I…
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Jiangsu Hengrui’s Vunakizumab for Plaque Psoriasis Accepted for Review by NMPA
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Jiangsu Hengrui Pharmaceutials Co., Ltd (SHA: 600276), a leading China-based pharmaceutical company, announced that the National Medical Products Administration (NMPA) has accepted its market filing for vunakizumab, an IL-17A monoclonal antibody (mAb), for the treatment of moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy. Global IL-17A Products…
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SynerK Achieves Milestone with First Patient Dosing in Phase I siRNA Clinical Trial
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SynerK, a developer of RNA-targeted therapies with operations in Boston, US, and Beijing and Suzhou, China, has announced the completion of first patient dosing in its Phase I clinical study for an investigational small interfering RNA (siRNA). This marks the first time such a therapy has entered the clinical phase…
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Roche’s Q1 2023 Report: 3% Dip in Revenues with Strong Growth in Pharmaceuticals
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Roche (SWX: ROG), the Swiss pharmaceutical and diagnostics giant, reported a 3% year-on-year (YOY) decrease in turnover at constant exchange rates (CER) to CHF 15.3 billion (USD 17.2 billion) in its Q1 2023 report. The decline was attributed to the appreciation of the Swiss franc and a predicted drop in…
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SinoMab’s SM03 Meets Primary Endpoint in Phase III Rheumatoid Arthritis Trial
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Hong Kong-based biopharmaceutical company SinoMab BioScience Ltd (HKG: 3681) has announced that its Phase III clinical study for the CD22 monoclonal antibody (mAb) SM03, also known as suciraslimab, has successfully reached the primary endpoint in patients with rheumatoid arthritis (RA). Study Design and Efficacy of SuciraslimabThe randomized, double-blind, multi-center, placebo-controlled…
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Junshi Biosciences’ RENOTORCH Study Meets Endpoints for RCC Treatment
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Junshi Biosciences (HKG: 1877, SHA: 688180), a China-based biopharmaceutical company, has announced that its multi-center, randomized, open, positive-controlled Phase III RENOTORCH study has reached pre-set endpoints at the interim analysis stage. The study evaluates the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with axitinib for the treatment of moderate to…
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Sihuan Pharmaceutical’s Birociclib Meets Primary Endpoint in Phase III Breast Cancer Study
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its Phase III clinical study for birociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, has successfully reached the primary endpoint in patients with HR+/HER2- advanced breast cancer that has progressed after previous endocrine therapy combined with fulvestrant. Positive Mid-Term Analysis…
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CSPC Pharmaceutical’s Prusogliptin for Type 2 Diabetes Accepted for NMPA Review
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading China-based pharmaceutical company, announced that its market filing for the Category 1 drug prusogliptin, intended for the treatment of type 2 diabetes, has been accepted for review by the National Medical Products Administration (NMPA). Clinical Study Results and Efficacy of PrusogliptinA clinical…
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Ocumension Therapeutics’ Zerviate Receives NMPA Priority Review for Ophthalmology Treatment
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Ocumension Therapeutics (HKG: 1477), a leading Chinese ophthalmology specialist, has announced that its histamine H1 receptor-targeted drug, Zerviate (OT-1001), has been granted priority review status by the National Medical Products Administration (NMPA). Zerviate’s Origins and Market PresenceZerviate, originally developed by France-based pharmaceutical firm Nicox SA, is an innovative formulation of…
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NMPA Mandates Label Updates for 11 Drug Varieties Including Black Box Warnings
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The National Medical Products Administration (NMPA) has released 10 notifications regarding revisions to package inserts for 11 drug varieties, impacting 47 products in total. The updates include changes to sections on adverse reactions, contraindications, and precautions. Marketing Authorization Holders (MAHs) are mandated to update the package inserts and labels within…
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Junshi Biosciences Submits Market Filings for PCSK9 mAb Ongericimab to NMPA
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has announced the submission of two market filings for its PCSK9 monoclonal antibody (mAb) ongericimab (JS002) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia to the National Medical Products Administration (NMPA). Phase III and II Clinical Studies Support FilingsOngericimab is currently in…
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Belief BioMed Completes Patient Dosing in Phase III Hemophilia B Gene Therapy Trial
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Shanghai-based gene therapy specialist Belief BioMed Group (BBM) has announced the completion of patient dosing in its Phase III registrational clinical trial (CTR20212816) for BBM-H901, a gene therapy for hemophilia B. The therapy is developed and manufactured in-house by Shanghai Belief-Delivery Biomed Co., Ltd., a wholly owned subsidiary of BBM.…
