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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…
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Abbisko Therapeutics’ Pimicotinib Earns PRIME Status for TGCT from EMA
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that its Category 1 drug ABSK021 (pimicotinib) has received Priority Medicine (PRIME) status from the European Medicines Agency (EMA) for the treatment of inoperable tenosynovial giant cell tumor (TGCT). This decision comes on the heels of positive results from an…
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CStone Pharmaceuticals and Servier Report Positive AGILE Study Results for Tibsovo at ASCO
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CStone Pharmaceuticals’ (HKG: 2616) French partner, Servier, has published the latest results of the global Phase III AGILE study for Tibsovo (ivosidenib) combined with azacitidine in newly diagnosed acute myeloid leukemia (AML) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Phase III AGILE Study Design and FindingsThe…
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BioNTech’s DB-1303 ADC Shows Promising Results in Solid Tumor Phase I/IIa Trial
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Germany’s BioNTech (NASDAQ: BNTX) has released preliminary data from a Phase I/IIa trial for DB-1303, a DNA topoisomerase I-inhibiting antibody-drug conjugate (ADC) licensed from China-based Duality Biologics. The trial focused on patients with solid tumors, and the results indicated that 44.2% of patients exhibited an objective partial tumor response. Notably,…
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Gilead’s Kite Announces Breakthrough Phase III Results for Yescarta in r/r LBCL
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Gilead’s (NASDAQ: GILD) subsidiary Kite has published groundbreaking Phase III results for Yescarta (axicabtagene ciloleucel), a CAR-T therapy, in the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL). The study applauds Yescarta as the first treatment in 30 years to significantly improve survival in this indication. Compared to…
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ITabMed Ltd Receives NMPA IND Approval for A-337, a CD3-Activating BsAb Targeting EpCAM
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Shanghai-based biotech firm ITabMed Ltd has announced the receipt of Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) for its pipeline candidate, A-337. A-337 is a CD3-activating bispecific antibody (BsAb) targeting EpCAM, a tumor-associated antigen (TAA) that is up-regulated and over-expressed in many solid tumor types,…
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Luye Pharma’s Lurbinectedin for Metastatic SCLC Accepted for Review by China’s NMPA
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China-based Luye Pharma Group (HKG: 2186) has announced that its market filing for lurbinectedin (LY01017) in metastatic small cell lung cancer (SCLC) has been accepted for review by China’s National Medical Products Administration (NMPA). The filing pertains to patients with tumor progression during or after platinum-based chemotherapy, and the RNA…
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Legend Biotech Submits sBLA to Expand Carvykti Label for Relapsed Multiple Myeloma
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Legend Biotech Corporation (NASDAQ: LEGN) has announced the submission of a supplemental Biologics License Application (sBLA) to the US FDA. The sBLA aims to expand the label for Carvykti (ciltacabtagene autoleucel; cilta-cel) to include the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least…
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Zai Lab and Novocure’s TTFields Show Survival Benefit in NSCLC, Despite Stock Plunge
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China-based Zai Lab Ltd (ZLAB) (NASDAQ: ZLAB; HKG: 9688) and its partner Novocure Ltd (NASDAQ: NVCR) have presented positive results from the Phase III LUNAR clinical trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The trial evaluated the use of Tumor Treating Fields (TTFields) therapy in…
