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Hainan Poly Pharm’s Generic Gadovist Receives FDA Approval for MRI Use
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that it has received marketing approval from the US FDA for its generic version of German giant Bayer’s (ETR: BAYN) Gadovist (gadobutrol injection). The drug is approved for use in contrast-enhanced magnetic resonance imaging (CE-MRI) examination of lesions in various…
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Jacobio Pharma’s JAB-24114 Receives CDE Approval for Phase I/IIa Clinical Study
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China-based Jacobio Pharma (HKG: 1167) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase I/IIa clinical study for its in-house developed JAB-24114, a glutaminase enzyme (GUE) inhibitor. This marks a significant step forward in the development of innovative cancer therapies. Mechanism…
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Hengrui Pharmaceuticals’ Dexmedetomidine Nasal Spray Approved by NMPA
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its dexmedetomidine hydrochloride nasal spray (1ml:500μg). The drug is approved for use as a preoperative sedation in adults. History and Innovation of DexmedetomidineDexmedetomidine was first applied…
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Tot Biopharmaceutical Terminates Phase III Study for HER2-Targeted ADC TAA013
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Tot Biopharmaceutical International Co., Ltd (HKG: 1875) has announced the termination of the Phase III clinical study for its HER2-targeted antibody-drug conjugate (ADC) TAA013. The decision was made due to significant changes in the market competitive landscape for the drug target and technology. Rational Resource Allocation and Strategic TransformationThe China-based…
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Shouyao Holdings Receives CDE Approval for Phase II Study of Third-Generation ALK Inhibitor
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Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) to conduct a single-arm pivotal Phase II clinical study. The study will focus on patients with ALK gene fusion-positive advanced non-small cell lung cancer (NSCLC) who…
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Likang Life Sciences’ Personalized Neoantigen Vaccine LK101 Receives IND Approval
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Likang Life Sciences has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its LK101, a personalized neoantigen-targeted vaccine. This marks the first personalized neoantigen vaccine and mRNA editing product to be approved for clinical trials by the NMPA. LK101 will…
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Walvax Biotechnology Announces Positive Results for RQ3013 mRNA Vaccine
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the safety, immunogenicity, and protective efficacy results of a Phase IIIb clinical study for its RQ3013, a bivalent mRNA vaccine based on the S protein chimera of Alpha/Beta SARS-CoV-2 variants. The vaccine was co-developed by Shanghai Llanque Biomedical Co., Ltd and…
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AIM Vaccine Initiates Phase I Clinical Study for MCV4 Meningococcal Vaccine in China
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the initiation of a single-center, open Phase I clinical study for its ACYW135 meningococcal polysaccharide conjugate vaccine, MCV4. The study is expected to enroll 120 subjects, marking a significant step in the development of this vaccine. Market Context and CompetitionCurrently, commercially…
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NMPA Accepts Market Filing for Guangdong Zhongsheng’s COVID-19 Drug RAY1216
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that the market filing for its drug candidate RAY1216, a 3CL protease (3CLpro) inhibitor, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step towards the potential commercialization of the drug for COVID-19…
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Mabwell Bioscience’s 9MW3811 Gains NMPA Approval for Clinical Trials in China
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its 9MW3811, an in-house developed IL-11 monoclonal antibody (mAb). The drug is intended for the treatment of various advanced malignant tumors and fibrotic diseases. It…
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Everest Medicines’ Xerava Receives NMPA Approval for Complicated Intra-Abdominal Infections
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China-based Everest Medicines Limited (HKG: 1952) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its antibiotic Xerava (eravacycline). The approval is for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in China, with plans to commercialize the product during the…
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Fosun Pharma’s Generic Remodulin Gains NMPA Approval for Pulmonary Arterial Hypertension
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its generic version of Remodulin (treprostinil) has been approved by the National Medical Products Administration (NMPA) for the treatment of pulmonary arterial hypertension (PAH). The drug is marketed to alleviate symptoms caused by exercise. Understanding PAH and…
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RemeGen Gains NMPA Approval for Phase I/IIa Study of RC88 with Junshi Bio’s PD-1 Inhibitor
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China-based pharmaceutical firm RemeGen (HKG: 9995) has received approval from the National Medical Products Administration (NMPA) to conduct an open, multi-center Phase I/IIa study. The study will assess the safety, tolerability, pharmacokinetics, and efficacy of RC88 combined with Junshi Bio’s (HKG: 1877, SHA: 688180) programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab),…
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ImmuneOnco Gains NMPA Approval for Phase Ib/II Study of IMM27M in Advanced Tumors
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its IMM27M. This ADCC-enhanced CTLA-4 monoclonal antibody (mAb) will be combined with the programmed death-1 (PD-1) inhibitor tislelizumab for the treatment…
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Henlius’ OX40 Monoclonal Antibody HLX51 Gains NMPA Approval for Phase I Clinical Study
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Shanghai Henlius Biotech, Inc (HKG: 2696) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study in mainland China for its OX40 monoclonal antibody (mAb), HLX51. The study will focus on patients with advanced/metastatic solid tumors and lymphoma. Mechanism…
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Haisco Pharmaceutical’s EGFR-PROTAC HSK40118 Gains NMPA Approval for Clinical Trials
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its oral small molecule EGFR-PROTAC, HSK40118. The drug is targeted for the treatment of advanced non-small cell lung cancer (NSCLC). Drug Mechanism and Pre-Clinical ResultsHSK40118…
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Astellas Pharma’s Xtandi Gains Momentum in China with Positive Phase III ARCHES Study Results
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that its prostate cancer therapy, Xtandi (enzalutamide), is poised to add a new indication for the China market following positive results from the Phase III China ARCHES study. The trial evaluated Xtandi in combination with androgen deprivation therapy (ADT) in men with…
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MabPharm Files NDA for CMAB009, Biosimilar to Erbitux, Targeting Metastatic Colorectal Cancer
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Taizhou-based monoclonal antibody (mAb) biosimilar specialist MabPharm Ltd (HKG: 2181) has announced the filing of a New Drug Application (NDA) for its CMAB009, a biosimilar of Merck KGaA (ETR: MRK)/Bristol-Myers Squibb’s (BMS, NYSE: BMY) cetuximab (trade name: Erbitux). The filing has been accepted for review by the National Medical Products…
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NMPA Releases 65th Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 65th batch of reference drugs for the Generic Quality Consistency Evaluation (GQCE) work. This update includes 67 new specifications, encompassing 8 injectables and 21 specifications with modifications. Details of the UpdateThe modifications in this batch involve changes and increases in marketing…
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Immorna Enrolls First Patient in Phase I Study of JCXH-211 for Malignant Tumors
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Immorna (Hangzhou) Biotechnology, an mRNA-based vaccine developer based in Hangzhou, has announced the enrollment of the first patient in a Phase I clinical study to assess the safety and efficacy of JCXH-211, a potential cancer therapeutic, in malignant solid tumors in China. The study will determine the recommended Phase II…
