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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) in China for its ophthalmology gene therapy, HG004. This gene replacement therapy drug utilizes a recombinant non-adeno-associated virus serotype 2 (non-AAV2) vector to deliver a functional human RPE65 gene…
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China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG) has published the results of the Phase I clinical study for its C-CAR031 at the American Association for Cancer Research (AACR) annual meeting 2023. The open Phase I study was designed to assess the safety and tolerability of C-CAR031, featuring a…
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Neurophth Biotechnology Ltd, a leading gene therapy specialist based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Sino-US multi-center Phase I/II study. The study will assess the safety, efficacy, and tolerability of its gene therapy NFS-02 (rAAV2-ND1) for ND1…
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a China-based pharmaceutical company, has announced that it has received marketing approval from Health Canada for its generic version of Roche’s Cytovene-IV (ganciclovir). This development marks a significant step for the company as it expands its international footprint in the generic drugs market.…
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CanSino Biologics Inc., a leading Chinese vaccines specialist, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative bivalent COVID-19 mRNA vaccine. This development signifies a significant step forward in the company’s efforts to combat the evolving SARS-CoV-2 virus. Preclinical Study…
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JS InnoPharm Ltd, a Shanghai-based pharmaceutical company, announced that the first patient has been dosed in a Phase Ib clinical study for its small-molecule aurora A kinase (AURKA) inhibitor, VIC-1911. This trial marks a significant step in the development of the drug, which is being investigated for its potential in…
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China-based Minghui Pharmaceutical has unveiled positive top-line data from a Phase II trial of its MH004 cream, which is being evaluated as a treatment for adolescents and adults with mild-to-moderate atopic dermatitis (AD). The cream, a pan-JAK inhibitor, successfully met its primary endpoint and all key secondary endpoints, demonstrating its…
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China-based AffaMed Therapeutics has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III regulatory study. The study will assess the efficacy and safety of Dextenza in subjects following ophthalmic surgery, marking a significant step forward for the company. Dextenza’s Development and…
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China-based Harbour Biomed (HKG: 2142) is set to release early clinical data for its CTLA-4 antibody in combination with Junshi Biosciences’ (HKG: 1877, SHA: 688180) programmed death-1 (PD-1) inhibitor toripalimab as a treatment for neuroendocrine neoplasms (NENs). The findings will be presented via a poster at the upcoming American Association…
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48). This single-arm, open, single-center study aims to evaluate the safety and maximum tolerable…
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Junshi Biosciences (HKG: 1877, SHA: 688180), a leading China-based biopharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for JS401, an injectable co-developed with Risen Pharma, for the treatment of hyperlipidemia. JS401’s Mechanism of ActionJS401 is an innovative angiopoietin-like 3 (ANGPTL3)…
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Ocumension Therapeutics (HKG: 1477), a leading Chinese ophthalmology specialist, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for Zerviate (OT-1001), a histamine H1 receptor-targeted therapy. This development marks a significant step forward for the company in bringing this innovative treatment…
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The Center for Drug Evaluation (CDE) website has announced that Shanghai Fosun Pharmaceutical (Group) Co., Ltd’s (SHA: 600196, HKG: 2196) novel small-molecule chemical drug FCN-159 has been granted breakthrough therapy designation (BTD) status for the treatment of histiocyte tumors. FCN-159’s Mechanism and ImpactFCN-159 is a highly selective MEK1/2 inhibitor with…
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical trial approval filing for ASKC200, a liniment product in-licensed from US-based Propella Therapeutics, Inc. The primary indication for the product is the treatment of osteoarthritis pain. Product Rights…
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Shanghai-based Convalife Pharmaceuticals has announced that it has received orphan drug designation (ODD) status from the US FDA for its second-generation PARP inhibitor, mefuparib (CVL218). The designation is in recognition of the drug’s potential as a treatment for cholangiocarcinoma, a rare and aggressive form of cancer. Advantages of CVL218 Over…
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Joint venture Overland ADCT BioPharma (CY) Ltd, a partnership between China’s Overland Pharmaceuticals and Swiss firm ADC Therapeutics SA (NYSE: ADCT), announced that the primary endpoint has been reached in a Phase II regulatory study. The study assessed the efficacy and safety of Zynlonta (loncastuximab tesirine), an antibody-drug conjugate (ADC)…
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received a new indication approval from the National Medical Products Administration (NMPA) for its Janus kinase (JAK) 1/2 inhibitor, Jakavi (ruxolitinib), as a treatment for patients with acute graft versus host disease (acute GVHD). This marks the first approval…
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China-based Chengdu Hyperway Pharmaceuticals has announced receiving tacit clinical trial approval from the National Medical Products Administration (NMPA) for its Nav1.8 inhibitor, HBW-004285, which is intended for the treatment of acute and chronic pain. Understanding the Role of Nav1.8 in Pain SignalingNav1.8 is a tetrodotoxin-insensitive voltage-gated sodium ion channel that…
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that a Phase II clinical study and two Phase III clinical studies for its APP13007, a modified hormone nano suspension eye drop, have successfully reached their clinical endpoints in the United States. The clinical results demonstrate that APP13007 exhibits significant efficacy…
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Sirnaomics Ltd (HKG: 2257) has announced the commencement of a single-center, randomized, double-blind, placebo-controlled, sequence grouping Phase I clinical study for its factor Xl-targeted RNAi drug, STP122G. The US-based trial is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy subjects initially, before expanding to its…