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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…
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LanssonPharm’s Anti-Depression Drug LS21031 Receives CDE Approval for Clinical Trials
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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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GSK’s Nucala Gains NMPA Approval for Severe Eosinophilic Asthma in China
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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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Juventas Cell Therapy’s CNCT19 Receives FDA IND Approval for r/r B-ALL Treatment
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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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Bio-Thera Solutions Initiates First Patient Dosing in Phase I Study of BAT8007
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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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Antengene to Begin Phase I Clinical Study of ATG-022 for Advanced Solid Tumors
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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…
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Guangdong Zhongsheng’s RAY1225 Receives NMPA Approval for Clinical Study
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 innovative polypeptide drug, RAY1225. This long-acting glucagon-like peptide-1 (GLP-1) drug features dual activation of the GLP-1 receptor and glucose-dependent…
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Vcanbio’s VUM02 Gains CDE Review for Liver Failure and ARDS Clinical Trials
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Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that two additional clinical trial filings for its VUM02 (human umbilical cord-derived mesenchymal stem cells) have been accepted for review by the Center for Drug Evaluation (CDE). The Chinese firm is seeking clinical approval for this Category 1 therapeutic…
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Luye Pharma’s Biosimilar BA9101 Completes Phase III Study Enrollment with Ocumension
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd, has completed the enrollment of all subjects in a Phase III safety and efficacy comparison study for its in-house developed ophthalmology product BA9101, a biosimilar version of Bayer’s Eylea (aflibercept). The study is being jointly conducted by…
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Akeso Biopharma Enrolls First Subject in Phase III Study of Cadonilimab for Gastric Cancer
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China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first subject in a pivotal Phase III study for its innovative bispecific antibody (BsAb), cadonilimab (AK104). The study will assess cadonilimab in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJC).…
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CSPC Pharmaceutical’s PD-1 Monoclonal Antibody Enlangsubai Completes NMPA Market Approval Filing
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for its programmed-death 1 (PD-1) monoclonal antibody (mAb), Enlangsubai. The targeted indication is recurrent or metastatic cervical cancer with positive PD-L1 expression that has failed…
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Chipscreen’s Epidaza Receives TFDA Approval for Breast Cancer Treatment in Taiwan
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Shenzhen Chipscreen Pharmaceutical Co., Ltd’s partner, GNT Biotech & Medicals Corporation, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for Epidaza (chidamide, Kepida in TW). This innovative class 1-selective oral histone deacetylase inhibitor was originally discovered by Chipscreen. Indication and Target Patient…
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Haihe Pharmaceutical Initiates Global Phase I Clinical Study for BET-BD2 Inhibitor HH3806
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Shanghai Haihe Pharmaceutical Co., Ltd has announced the first patient dosing of a global multi-center Phase I clinical study for its in-house developed BET-BD2 inhibitor, HH3806, in Australia. This marks a significant milestone in the development of the drug, which targets the bromo and extra terminal (BET) binding domain 2…
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CanSino Biologics Initiates Phase Ib Study for Innovative Protein-Based Pneumococcal Vaccine
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China-based vaccines specialist CanSino Biologics Inc. has announced the initiation and first subject enrollment of a Phase Ib clinical study for its in-house developed protein-based pneumococcal vaccine (PBPV). This marks a significant step forward in the development of a globally innovative vaccine. Innovation and AdvantagesCanSino’s PBPV represents the third generation…
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CStone’s Ayvakit Shows Significant Improvements in ISM at AAAAI Meeting
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China-based CStone Pharmaceuticals (HKG: 2616) announced that its US partner, Blueprint Medicines, published detailed data from the PIONEER regulatory study for Ayvakit (avapritinib) at the American Academy of Allergy, Asthma, and Immunology (AAAAI) annual meeting this year. Ayvakit is a tyrosine kinase inhibitor used to treat gastrointestinal stromal tumors (GIST)…
