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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…
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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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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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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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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 (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…
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China-based central nervous system (CNS) drug developer LanssonPharm has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its anti-depression drug, LS21031. This PDE4 inhibitor is being developed to improve symptoms of depression and cognitive-related diseases. Mechanism of ActionLS21031 works by effectively inhibiting…
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UK-based GSK plc (NYSE: GSK) has announced that a market approval filing for Nucala (mepolizumab) has been accepted by the National Medical Products Administration (NMPA) in China. The anti-interleukin-5 (IL-5) monoclonal antibody is seeking a second indication approval for use as an add-on maintenance treatment for severe eosinophilic asthma (SEA)…
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China-based Juventas Cell Therapy Ltd’s chimeric antigen receptor (CAR) T-cell therapy, CNCT19 (Inaticabtagene Autoleucel), has obtained Investigational New Drug (IND) approval from the US FDA for the treatment of recurrent or refractory B-cell acute lymphocytic leukemia (r/r B-ALL). Previous Approvals and StatusCNCT19, a CD19-targeted CAR-T therapy, has previously earned IND…
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China-based Bio-Thera Solutions, Ltd. (SHA: 688177) has announced the first patient dosing in a multi-center, open, Phase I clinical study to assess the safety, tolerability, and preliminary efficacy of BAT8007, an antibody-drug conjugate (ADC) targeting Nectin-4. The study’s primary indication is general advanced solid tumors, with the goal of determining…
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China-based Antengene Corporation Ltd (HKG: 6996) is poised to commence a Phase I clinical study to assess the safety and tolerability of ATG-022 in patients with advanced and metastatic solid tumors. The study will also determine the bioactive dose, maximum tolerable dose (MTD), and recommended Phase II dose (RP2D). ATG-022…