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China-based biopharmaceutical company BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML). The data highlights the potential of Brukinsa in combination with obinutuzumab for the treatment of…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the initiation of a Phase II clinical study in China for HLX26, an in-house developed lymphocyte activation gene 3 (LAG-3, aka CD233) inhibitor, in combination with its programmed-death 1 (PD-1) inhibitor HaiSiZhuang (serplulimab) for the treatment of metastatic…
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Takeda (TYO: 4502) and HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) have announced that the results of the Phase III FRESCO-2 study for Elunate (fruquintinib) in previously treated metastatic colorectal cancer (mCRC) have been published in The Lancet journal. The global Phase III study, conducted across the US, Europe, Japan,…
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the prestigious journal Nature Cancer has published the overall survival (OS) interim analysis from the registrational clinical study GEMSTONE-302. The study evaluates the programmed death-ligand 1 (PD-L1) inhibitor sugemalimab as a first-line treatment for stage IV non-small cell lung cancer (NSCLC). GEMSTONE-302…
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China-based Jiangxi Jemincare Group has announced that it has received approval from the China National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug, JYB1907, a monoclonal antibody (mAb) targeting GARP and TGF-β1, in patients with locally advanced malignant solid tumors. The drug had previously…
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China-based Cytocraft Biotech Development has announced that its cell therapy, SDT-T002, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of advanced liver cancer that has failed standard treatment. Cascade Primed Immune Cells (CAPRI) Cell Therapy OverviewCytocraft boasts its Cascade Primed Immune Cells (CAPRI)…
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that the Phase Ib REFINE study for its drug candidate STC3141 in sepsis has successfully reached the clinical endpoint in Australia and Belgium. Design and Results of the Phase Ib REFINE StudyThe open-label, multi-center, dosage escalation Phase Ib clinical study was…
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The Janssen subsidiary of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an additional indication application to the US Food and Drug Administration (FDA) for its CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel). The application seeks approval for the treatment of relapsed or refractory multiple myeloma (r/rMM) in adults who have…
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Guangdong-based antibody drug developer Dartsbio Pharmaceuticals has partnered with the Shanghai Institute of Materia Medica (SIMM) to receive tacit clinical trial approval from the National Medical Products Administration (NMPA) for their antibody drug conjugate (ADC), DS001. The molecule is set to be assessed as a potential treatment for various advanced…
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the US Food and Drug Administration (FDA) has accepted for review the market filing for its semaglutide active pharmaceutical ingredients (APIs). This development marks a significant step for the company as it seeks to enter the global market with its…
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate, 9MW3811. This molecule is an in-house developed IL-11 monoclonal antibody (mAb) intended for the treatment of idiopathic pulmonary fibrosis (IPF). Therapeutic…
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 candidate drug, HS-10516. The trial will evaluate the small-molecule hypoxia-inducible factor 2α (HIF-2α) inhibitor as a potential treatment…
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Chengdu-based adeno-associated virus (AAV) gene therapy developer, Genevector Biotechnology Co., Ltd., has announced the first patient dosing in a clinical study for its product candidate, JWK001. The molecule is under assessment as a potential treatment for neovascular age-related macular degeneration (nAMD). JWK001’s Mechanism of Action and Preclinical PerformanceJWK001 employs AAV…
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Shanghai-based Convalife Pharmaceuticals has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its generic version of Puma Biotechnology Inc’s neratinib. This study aims to explore the drug’s efficacy in treating advanced non-small cell lung cancer (NSCLC) patients with rare…
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Austria-based Croma-Pharma has revealed that the first patient is set to be enrolled in a clinical trial in China to support the approval of its hyaluronic acid dermal filler, Princess Volume Lidocaine. This randomized, multi-center, blinded, parallel Phase III study will confirm the safety and efficacy of Croma’s product, focusing…
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab). This approval encompasses all indications previously approved for Humira, which include a wide range of conditions such as rheumatoid…
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced receiving approval from China’s National Medical Products Administration (NMPA) to initiate Phase I/II clinical trials for BAT6026, an OX40 monoclonal antibody, for the treatment of atopic dermatitis (AD). The Role of OX40 in Immune Response and BAT6026’s MechanismOX40, an immune checkpoint expressed…
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving the green light from EU authorities to proceed with the global, multi-center, random-controlled Phase III WU-KONG28 study for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib (DZD9008). The study aims to assess the drug as a first-line treatment for…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its in-house developed Category 1 chemical drug, SYH2051. The molecule is set to be assessed in the treatment of general solid tumors. ATM…