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CSPC Pharma’s rhTNK-tPA Accepted for Review by NMPA for Stroke Indication
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that a supplementary market filing for its recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA) has been accepted for review by the National Medical Products Administration (NMPA). The new indication filing is for the drug’s use as a thrombolytic therapy…
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Haisco’s HSK31858 Gains Ethical Approval for Phase II Study in NCFBE
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its drug candidate HSK31858 obtained ethical approval at the First Affiliated Hospital of Guangzhou Medical University. The in-house developed Category 1 drug will be assessed for its efficacy and safety in a multi-center, randomized, double-blind, placebo-controlled Phase II study…
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CANbridge’s CAN106 Receives Orphan Drug Designation for Myasthenia Gravis
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China-based rare disease firm CANbridge Pharmaceuticals Inc. (HKG: 1228) has announced receiving Orphan Drug Designation (ODD) status for its pipeline drug candidate CAN106, a long-acting monoclonal antibody (mAb) targeting C5 of the complement system, for use in myasthenia gravis (MG). Myasthenia gravis is a rare and chronic autoimmune disease caused…
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Ascletis Pharma’s PD-L1 Inhibitor ASC61 Gains NMPA IND Approval
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced the approval of the Investigational New Drug (IND) application by China National Medical Products Administration (NMPA) for its in-house developed oral programmed-death ligand 1 (PD-L1) small molecule inhibitor ASC61. This approval will accelerate the global development of the drug, which is currently…
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Kelun Pharma’s SKB264 Advances to Phase II Study for NSCLC
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained approval from the National Medical Products Administration (NMPA) to enter a Phase II clinical study in advanced or metastatic non-small cell lung cancer (NSCLC). The…
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Hengrui Pharmceuticals’ SHR0302 Achieves Positive Results in Phase III Atopic Dermatitis Study
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China-based Jiangsu Hengrui Pharmceuticals (SHA: 600276) has announced positive results from the randomized, double-blind, placebo-controlled, multi-center RSJ10333 (QUARTZ3) Phase III study for SHR0302 in atopic dermatitis. The study, conducted by Hengrui’s subsidiary Reistone Biopharma Co., Ltd, has reached the pre-set primary efficacy endpoint. Study DetailsThe RSJ10333 study was designed to…
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Kanghong Pharma Gains NMPA Approval for Innovative Eye Injection KH631
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for its Category 1 innovative eye injection KH631 and a generic version of Acadia Pharmaceuticals Inc’s pimavanserin. The approvals are for the treatment of neovascular (wet) age-related macular…
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Antengene’s ATG-008 Shows Promising Results in Cervical Cancer and Hepatocellular Carcinoma Studies
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Shanghai-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced positive preliminary results from the TORCH-2 study (NCT04337463) for its mTORC1/2 inhibitor ATG-008 (onatasertib) in combination with the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) for recurrent/metastatic cervical cancer. The company also released data from the TORCH study for ATG-008 monotherapy in…
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CStone Pharmaceuticals Launches AML Public Welfare Project with China Social Welfare Foundation
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The acute myeloid leukemia (AML) public welfare project, initiated by the China Social Welfare Foundation (CSWF) and sponsored by CStone Pharmaceuticals (HKG: 2616), has officially been launched. This initiative aims to raise awareness and support for AML, a disease that disproportionately affects the elderly and progresses rapidly. AML ContextAcute myeloid…
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Betta Pharmaceuticals’ BPI-D0316 Accepted for NMPA Review for NSCLC Adjuvant Therapy
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that its clinical trial filing for BPI-D0316, a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), has been accepted for review by the National Medical Products Administration (NMPA). The filing is for the drug’s use as a postoperative adjuvant therapy for…
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Kelun-Biotech’s SKB264 Receives FDA Approval for Phase II Study
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the US FDA to conduct a Phase II clinical study for its drug candidate SKB264, an antibody drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), in combination with the PD-1 inhibitor pembrolizumab. The initial development target is selected…
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Peru Approves BMS’s Reblozyl and BeiGene’s Brukinsa
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Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) has approved Bristol-Myers Squibb’s (BMS; NYSE: BMY) erythropoietic aid Reblozyl (luspatercept) and BeiGene’s (NASDAQ: BGNE; HKG: 6160; SHA: 688235) Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib), according to Fineline Info & Tech analysis. The approvals mark significant milestones for both drugs…
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LaNova Medicines Gets NMPA Approval for LM-305 Clinical Study
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Shanghai-based cancer therapy developer LaNova Medicines Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its antibody drug conjugate (ADC) LM-305, targeting GPRC5D. This marks a significant milestone for LaNova as it advances its innovative ADC into clinical…
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Everest Medicines’ Nefecon NDA Accepted for IgA Nephropathy in China
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China-based biotech Everest Medicines (HKG: 1952) announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for its Nefecon, an oral budesonide-targeted release preparation. The drug is intended for the treatment of primary IgA nephropathy (IgAN) with a risk of progression. This marks a significant…
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Innovent Biologics Initiates Phase III Trial for Mazdutide in Obesity
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first patient dosing in the randomized, double-blind, placebo-controlled Phase III GLORY-1 study for its mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. The drug is being evaluated for the treatment of overweight or obese Chinese patients, marking a…
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Guangdong Zhongsheng Starts Phase III Trial for COVID-19 Drug RAY1216
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the enrollment of the first subject in a randomized, double-blind, placebo-controlled Phase III study for its drug candidate RAY1216, which is being evaluated as a treatment for mild SARS-CoV-2 infection. The study is expected to enroll 1,070 patients with mild…
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Yabao Receives FDA Clearance for Generic Nexavar
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China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received Abbreviated New Drug Application (ANDA) clearance from the US FDA for its generic version of Nexavar (sorafenib), originally developed by German pharmaceutical giant Bayer. This approval marks a significant milestone for Yabao in expanding its presence…
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Hengrui’s Pyrotinib Granted Priority Review for HER2-Positive Breast Cancer
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The Center for Drug Evaluation (CDE) website has announced that China-based Hengrui Pharmaceuticals’ (SHA: 600276) pyrotinib has been granted priority review status. The drug is being evaluated for use in combination with trastuzumab and docetaxel for the treatment of recurrent or metastatic breast cancer that is human epidermal growth factor…
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AstraZeneca to Launch Soliris in Hangzhou After Regulatory Approval
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UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has revealed plans to sell Soliris (eculizumab) in Hangzhou for the first time. The drug, originally developed by Alexion Pharmaceuticals, received conditional approval in 2018 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adults and…
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Akeso Biopharma’s AK112 Receives Two New Breakthrough Therapy Designations
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The Center for Drug Evaluation (CDE) website indicates that China-based Akeso Biopharma (HKG: 9926) has obtained two additional Breakthrough Therapy Designations (BTDs) for its AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). These designations follow last month’s BTD for AK112 in combination with…
