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China-based Luye Pharma Group (HKG: 2186) has announced that a market approval filing for its subsidiary Shandong Boan Biotechnology Co., Ltd’s BA1102, a biosimilar version of Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), has been accepted for review by the Center for Drug Evaluation (CDE). Indications and Market ContextDenosumab is a monoclonal…
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German pharmaceutical giant Bayer AG (ETR: BAYN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its drug Nubeqa (darolutamide). The drug, which was previously approved for use in non-metastatic castration-resistant prostate cancer (nmCRPC) in February 2021, can now be used to…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) announced in a stock exchange statement that the National Medical Products Administration (NMPA) has declined to issue a market approval for plinabulin, a potential first-in-class GEF-H1-targeted small-molecule drug in-licensed from US-based BeyondSpring Inc. (NASDAQ: BYSI). Hengrui was seeking approval for the drug’s use…
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SciClone Pharmaceuticals Inc (HKG: 6600) has announced that a clinical trial filing for its Vaborem (meropenem vaborbactam), a new antibacterial drug, has been approved by the National Medical Products Administration (NMPA). This approval allows the drug to enter a Phase III clinical study in China. Study Objectives and DesignThe Phase…
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US-based Janssen Pharmaceutical reportedly decided to withdraw Carvykti (ciltacabtagene autoleucel; cilta-cel) from the UK market last week. The BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, which is under development globally by Janssen in partnership with China-based Legend Biotech (NASDAQ: LEGN), was being assessed by the UK’s National Institute of…
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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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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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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 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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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 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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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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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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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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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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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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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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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 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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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…