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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.…
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Zhaoke Ophthalmology’s US Partner Visus Therapeutics Reports Positive Phase III Results
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), announced that its US partner Visus Therapeutics Inc., has published positive topline results from the pivotal Phase III BRIO-I trial. BRIO-I Trial Success and Regulatory MilestonesThe BRIO-I trial successfully met the pre-specified primary study endpoints that were agreed…
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Gan & Lee Pharmaceuticals Receives Marketing Approval for Insulin Glargine in Bolivia
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Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced that it has received marketing approval from Bolivia’s State Agency of Drugs and Health Technologies (AGEMED) for its insulin glargine product, which comes in a pre-filled format. Insulin Glargine: A Long-Acting Insulin AnalogueInsulin glargine is a long-acting insulin…
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GSK’s Cervarix Receives Approval for Two-Dose Schedule in China for Ages 9 to 14
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The UK-based pharmaceutical giant GSK plc (NYSE: GSK) has announced the official market launch of a two-dose schedule for its bivalent recombinant human papillomavirus (HPV) vaccine, Cervarix (types 16 and 18), targeting girls aged 9 to 14 in China. Cervarix’s Approval History and Expansion in ChinaCervarix was first approved in…
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Everest Medicines’ Nefecon for IgAN Approved for Clinical Use in Hainan
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China-based Everest Medicines (HKG: 1952) has announced that Nefecon (delayed-release budesonide), the first-in-disease treatment for primary immunoglobulin A nephropathy (IgAN), has been approved by the Hainan Medical Products Administration for clinical use in Shanghai Ruijin Hospital’s Hainan subsidiary. This marks the beginning of a new treatment era for IgA nephropathy…
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Zelgen Biopharmaceuticals’ ZG2001 Receives US FDA Clinical Trial Approval for Pan-KRAS Inhibitor
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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 Category 1 product candidate, ZG2001. ZG2001 is an in-house discovered oral pan-KRAS mutation inhibitor under development for the treatment of KRAS mutant tumors. Prevalence…
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Sichuan Biokin Pharmaceutical Gets NMPA Approval for Two Clinical Studies on Cancer Therapies
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct two clinical studies. One study will investigate the combination of its drug candidate BL-B01D1 with osimertinib (Tagrisso) for the treatment of locally advanced or metastatic non-small…
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Jiangsu Hengrui Pharmaceuticals’ Pyrotinib Gains NMPA Approval for HER2+ Breast Cancer Treatment
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading China-based pharmaceutical company, has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its small-molecule HER2 inhibitor, pyrotinib. The drug is now approved for use in combination with Herceptin (trastuzumab) plus chemotherapy to treat recurrent or metastatic breast cancer…
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Evopoint Biosciences Gets CDE Approval for Phase I/II Study of XNW27011 ADC
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Suzhou Evopoint Biosciences Co., Ltd., a China-based pharmaceutical company, has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase I/II clinical study for its antibody-drug conjugate (ADC), XNW27011. The study will focus on locally advanced unresectable or metastatic malignant solid tumors expressing Claudin 18.2 (CLDN18.2).…
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ChengDu ShengNuo Biotech Secures NMPA Approval for Generic Firazyr Equivalent
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ChengDu ShengNuo Biotech Co., Ltd (SHA: 688117), a China-based polypeptide specialist, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Shire’s Firazyr (icatibant). This marks a significant milestone as the company becomes the first manufacturer to file for Drug…
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Reistone Biopharma’s RSS0343 Receives NMPA Approval for Non-Cystic Fibrosis Bronchiectasis
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Reistone Biopharma Co., Ltd, a company incubated by Hengrui Pharmaceuticals (SHA: 600276) with an investment of USD 100 million in 2018, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug, RSS0343, intended to treat non-cystic fibrosis bronchiectasis (NCFB). Understanding Non-Cystic Fibrosis Bronchiectasis…
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Neurodawn Pharmaceutical’s Y-1 Receives NMPA Approval for Primary Intracranial Tumor Treatment
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Nanjing-based Neurodawn Pharmaceutical Co., Ltd has announced that its Category 1 drug, injectable Y-1, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of primary intracranial malignant tumors. TRPML1 Inhibitor’s Non-Clinical Study ResultsNon-clinical studies have demonstrated that the TRPML1 inhibitor, Y-1, can effectively inhibit…
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GenScript Biotech’s Subsidiary Legend Biotech Announces Positive CAR-T Therapy Results
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has filed a 6-K with the US Securities and Exchange Commission and published clinical studies with the European Hematology Association (EHA) regarding its chimeric antigen receptor (CAR)-T therapies. The release…
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AACR 2023 Highlights: CAR-T Therapies and Monoclonal Antibody Combinations in Cancer Research
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The 2023 edition of the American Association for Cancer Research (AACR) annual meeting has concluded, highlighting the latest trends in clinical cancer research. The event featured a range of CAR-T cell therapies under development, including Allogene Therapeutics’ (NASDAQ: ALLO) CD70-targeting allogeneic treatment ALLO-316, as well as anti-CD19/CD20 and anti-TACI/BCMA bispecific…
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Pfizer’s Prevenar 13 Receives Expanded Age Range Approval in China
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U.S.-based pharmaceutical giant Pfizer (NYSE: PFE) has reported receiving an additional indication approval from the National Medical Products Administration (NMPA) for its globally successful vaccine, Prevenar 13. The approval extends the vaccine’s use to infants and children aged between 6 weeks to 5 years (before the 6th birthday), expanding the…
