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Sanofi’s VaxigripTetra Expands Influenza Vaccine Access to All Ages in China
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its tetravalent influenza virus split vaccine, VaxigripTetra, has been granted market approval by the National Medical Products Administration (NMPA) in China. This approval extends the vaccine’s usage to include individuals aged three years and above, building on the earlier approval for…
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AstraZeneca’s Nirsevimab on Track for Priority Review for RSV Prevention in Infants
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The Center for Drug Evaluation (CDE) website in China indicates that AstraZeneca’s (AZ, NASDAQ: AZN) Beyfortus (nirsevimab) is on course to be awarded priority review status for its use in preventing lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants who are about to enter…
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Antengene Submits Market Approval Filing for Xpovio in Indonesia for Multiple Myeloma and Lymphoma
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Antengene Corp., Ltd (HKG: 6996) has announced a market approval filing in Indonesia for its drug Xpovio (selinexor). The company is seeking approval for the treatment of relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). Background on Xpovio and Its ApprovalsDiscovered…
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TYK Medicines Receives CDE Approval for CDK7 Inhibitor TY-2699a Clinical Study
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Shanghai-based TYK Medicines has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its small molecule drug candidate, TY-2699a. This oral, selective CDK7 inhibitor is under development for the treatment of various cancers, including breast, ovarian, prostate, pancreatic, and small…
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Transcenta Holdings’ TST002 Shows Positive Phase I Results for Bone Density in China
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China-based biotech Transcenta Holdings Ltd (HKG: 6628) has announced encouraging Phase I clinical study results for TST002, a drug designed to address decreased bone density in Chinese patients. Phase I Study Design and FindingsThe randomized, double-blind, placebo-controlled, dosage escalation Phase I study assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity…
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BeiGene’s Tislelizumab Secures First Approvals Outside China Mainland in Macau
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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in Macau for 9 indications. This marks the first time tislelizumab has received approvals outside of the China mainland market, with the Macau drug regulator’s decisions based on those issued by…
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Yizun Biomedicine’s CNK-UT Cell Therapy Initiates Patient Enrollment for Solid Tumor Trial
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Hangzhou-based cell therapy specialist Yizun Biomedicine Co., Ltd has announced the completion of first patient enrollment and reinfusion in an investigator-initiated trial (ITT) for its CNK-UT cell therapy, targeting advanced solid tumors at Shulan Hangzhou Hospital. CNK-UT Cell Therapy: A Universal Cell Technology for Tumor TreatmentCNK-UT is a groundbreaking universal…
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Zelgen Biopharmaceuticals’ Jacktinib Studies Selected for EHA Annual Meeting
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that the results of three clinical studies for its Category 1 drug jacktinib in myelofibrosis have been shortlisted for the European Hematology Association (EHA) annual meeting this year. Phase III Study: Jacktinib vs. Hydroxyurea in MyelofibrosisA randomized, double-blind Phase III study…
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Zelgen Biopharmaceuticals’ ZG0895 Receives FDA Approval for Clinical Trials in Advanced Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate ZG0895, which targets advanced solid tumors. ZG0895 is a highly selective toll-like receptor (TLR8) agonist developed in-house, designed to offer a new…
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Coherent Biopharma Secures $100 Million in Series B and B+ Financings for Clinical Pipeline
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Coherent Biopharma Ltd, a specialist in bispecific-ligand drug conjugates (Bi-XDC) headquartered in Suzhou, has declared the successful completion of Series B and Series B+ financing rounds, totaling $100 million. The initial Series B round was led by HM with support from Yuanfeng Capital, V Capital, 6 Dimensions Capital, Agricultural Bank…
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Philips Agrees to $62 Million Settlement with SEC Over China Marketing Practices
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The US Securities and Exchange Commission (SEC) has announced that Dutch device company Philips (BVMF: PHGN34) has agreed to a $62 million resolution to settle charges related to improper employee practices during the marketing of products in China between 2014 and 2019. In the settlement, which Philips accepted without admitting…
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Peijia Medical Achieves Milestone with First Commercial Implants of Trilogy TAVR System in Hong Kong
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Peijia Medical Limited (HKG: 9996), a leading China-based medical device company, has announced the successful completion of the first two commercial implants using its transcatheter aortic valve replacement (TAVR) product, the Trilogy heart valve system, in Hong Kong. This marks a significant milestone as the Trilogy system is the first…
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BiOneCure Therapeutics and Nanjing Leads Biolabs Collaborate on Innovative ADCs for Solid Tumors
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US-based biotech company BiOneCure Therapeutics Inc. has entered into a strategic collaboration with China-based Nanjing Leads Biolabs. The partnership aims to develop a range of innovative antibody drug conjugates (ADCs) that target solid tumors, marking a significant step in the advancement of cancer treatments. Combining Expertise to Target Solid TumorsBiOneCure…
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Lynk Pharmaceuticals’ LNK01001 Demonstrates Efficacy in Phase II Rheumatoid Arthritis Study
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China-based Lynk Pharmaceuticals Co., Ltd announced positive results from the Phase II clinical study of its drug candidate LNK01001 in treating rheumatoid arthritis (RA). The study demonstrated a statistically significant efficacy difference in terms of primary and key secondary endpoints, along with a favorable safety and tolerability profile. LNK01001: A…
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Skyline Therapeutics Initiates Clinical Study with First Patient Dosing of SKG0106 for wAMD
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Skyline Therapeutics has reached a significant milestone with the completion of the first patient dosing in its clinical study for SKG0106 intraocular injection solution. This in-house developed ophthalmology gene therapy was approved for clinical trials in China in December 2022. The open, dosage escalation study is designed to evaluate the…
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Gracell Biotechnologies Initiates Trial for GC012F in Refractory SLE with Dual-Target FasTCAR Therapy
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Gracell Biotechnologies Inc., (Nasdaq: GRCL), a China-based biopharmaceutical company, has announced the start of an investigator-initiated trial (IIT) in China for its therapeutic candidate GC012F. This candidate is an autologous FasTCAR therapy aimed at treating refractory systemic lupus erythematosus (SLE). The therapy is distinctive as a dual B cell maturation…
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Aligos Therapeutics Partners with Amoytop Biotech for Oligonucleotide Compound R&D
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Liver and viral disease specialist Aligos Therapeutics (NASDAQ: ALGS) announced last week a significant partnership with biopharmaceutical company Xiamen Amoytop Biotech (SHA: 688278) for the research and development (R&D) of live disease-targeting oligonucleotide compounds. These compounds are discovered using Aligos’s proprietary platform, marking a step forward in the treatment of…
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CIM’s Cancer Vaccine CIMAvax Confirmed Immunogenic in US Study, Cuba Announces
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The Cuba-based Molecular Immunology Center (CIM), part of the state-run conglomerate BioCubaFarma, has shared updates on the status of clinical trials (CTs) for two of its drug candidates being conducted abroad. CIM Director Tania Crombet revealed that a US study, in collaboration with the Roswell Park Cancer Institute, has confirmed…
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COVID-19 Disruptions Lead to Soaring Lab Monkey Prices, Impacting US Drug Development
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The COVID-19 pandemic has led to a significant reduction in the export of laboratory monkeys from China, causing a dramatic increase in the costs associated with drug development in the United States. According to a Nikkei report citing research from Evercore ISI, the price for lab-tested monkey species has escalated…
