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Cytocraft Biotech’s SDT-T002 Cell Therapy Approved for Advanced Liver Cancer by NMPA
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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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AbbVie Inc. Files Lawsuit Against BeiGene Over BTK Inhibitor Brukinsa
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US-based AbbVie Inc., (NYSE: ABBV), the company behind the first-in-class Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib), has taken legal action against BeiGene’s (NASDAQ: BGNE) BTK inhibitor Brukinsa (zanubrutinib). The lawsuit was filed by AbbVie subsidiary Pharmacyclics in the Delaware District Court on the day it was awarded a new…
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Dartsbio Pharmaceuticals and SIMM Receive NMPA Approval for ADC DS001 Clinical Trial
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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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Hansoh Pharmaceutical Gets NMPA Approval for HIF-2α Inhibitor HS-10516 Clinical Study
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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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Convalife Pharmaceuticals Gets NMPA Approval for Generic Neratinib Clinical Study
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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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Mass General Brigham Partners with Simcere Pharmaceutical for Cancer and Autoimmune Disease Research
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Top-tier US medical institution Mass General Brigham Incorporated (MGB) has signed a sponsored research agreement with Chinese firm Simcere Pharmaceutical Group (HKG: 2096). The collaboration will see up to eight research groups at MGB receive funding for select projects over a two-year period, with a focus on developing new treatment…
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Dizal Pharmaceutical’s Sunvozertinib Gets EU Approval for Global Phase III Study
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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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CSPC Pharmaceutical Gets NMPA Approval for ATM Inhibitor SYH2051 Clinical Study
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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…
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Dizal Pharmaceutical Presents Updates on DZD8586 and Golidocitinib at ICML
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented updates on the clinical development of its JAK1 inhibitor golidocitinib (DZD4205) and DZD8586 at the 17th International Conference on Malignant Lymphoma (ICML) annual meeting. Golidocitinib: A Promising Treatment for PTCLGolidocitinib, the world’s first and only JAK1 inhibitor in regulatory trial stages, received…
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CSPC Pharmaceutical’s CPO301 Earns Fast-Track Status for EGFR Mutant NSCLC Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC), CPO301, has received fast-track status for the treatment of recurrent/refractory (R/R) or EGFR targeted therapy ineffective metastatic EGFR mutant non-small cell lung cancer (NSCLC). Preclinical Efficacy and Safety of CPO301Preclinical studies have demonstrated that…
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Keymed Biosciences’ CM313 Monoclonal Antibody Shows Promise in Phase I Study for Multiple Myeloma
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China-based Keymed Biosciences Inc., (HKG: 2162) has announced that the latest results from a Phase I clinical study for its Category 1 drug CM313, a monoclonal antibody (mAb) targeting CD38, have been presented at the 28th European Hematology Association (EHA) annual meeting. The trial focuses on the molecule’s potential use…
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HutchMed Presents Updated Data on Hematological Malignancy Therapies at EHA and ICML
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that new and updated clinical data related to two novel investigational therapies for hematological malignancies, HMPL-306 and amdizalisib, will be presented at the European Hematology Association (EHA) Annual Meeting and the 17th International Conference on Malignant Lymphoma (ICML). HMPL-306: A Dual…
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CDE Indicates Priority Review for Overland ADCT’s Zynlonta and BeiGene’s Brukinsa
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The Center for Drug Evaluation (CDE) in China has indicated that Overland ADCT BioPharma (CY) Ltd’s Zynlonta (loncastuximab tesirine), an antibody-drug conjugate (ADC) targeting CD19, and BeiGene Ltd’s (NASDAQ: BGNE, HKG: 6160, SHA: 688235) Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) are on track to receive priority review statuses. Both…
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Kexing Pharmaceutical Secures Commercial Rights for Convalife’s Neratinib Generic Outside China
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China-based Kexing Pharmaceutical (SHA: 688136) has announced a licensing agreement with compatriot firm Convalife, securing commercial rights to the latter’s generic version of Puma Biotechnology Inc’s neratinib in six countries outside China. This move expands access to the oral irreversible small molecule pan-HER tyrosine kinase inhibitor (TKI) for patients in…
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NMPA Approves Betta Pharmaceuticals’ Vorolanib for Second-Line RCC Treatment in Combination with Everolimus
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The National Medical Products Administration (NMPA) has granted approval for Betta Pharmaceuticals Co., Ltd’s (SHE: 300558) Category 1 drug vorolanib to be used in combination with everolimus for the second-line treatment of advanced renal cell carcinoma (RCC). This approval follows the market filing submitted in January last year and marks…
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Zelgen Biopharmaceuticals’ ZGGS15 Earns FDA Approval for Advanced Solid Tumor Clinical Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the US FDA for its bispecific antibody (BsAb), ZGGS15, which targets LAG-3 and TIGIT in advanced solid tumors. This marks ZGGS15 as the world’s first BsAb of its kind to reach the clinical…
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CSPC Pharmaceutical’s CPO301 Receives Health Canada Approval for Phase I Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green light from Health Canada to initiate a Phase I clinical study. The study will assess the safety, pharmacokinetics, and preliminary efficacy of its in-house developed antibody-drug conjugate (ADC), CPO301, in patients with advanced solid tumors,…
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Jacobio Pharma Gets Green Light for Phase I/IIa Study of PARP7 Inhibitor JAB-26766
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China-based Jacobio Pharma (HKG: 1167) has announced receiving approval in China to initiate a Phase I/IIa clinical study for its in-house developed PARP7 inhibitor, JAB-26766, targeting advanced solid tumors. JAB-26766: A Potential Treatment for Squamous CancersThe oral small molecule PARP7 inhibitor is under development for the treatment of squamous non-small…
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Dizal Pharmaceutical Presents Updates on Sunvozertinib and Golidocitinib at ASCO 2023
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented updates on the clinical development of its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) and JAK1 inhibitor golidocitinib (DZD4205) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Sunvozertinib: A Promising EGFR Inhibitor for NSCLCSunvozertinib, under development for…
