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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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Lee’s Pharmaceutical Subsidiary Zhaoke Ophthalmology Announces FDA Review of NVK002 for Pediatric Myopia
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that the US FDA has accepted for review the New Drug Application (NDA) for Vyluma Inc.’s NVK002, an atropine external use eye solution for pediatric myopia. The FDA has set a Prescription Drug User Fee…
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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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CStone Pharmaceuticals Presents Ayvakit Data for Advanced GIST at ASCO 2023
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China-based CStone Pharmaceuticals (HKG: 2616) announced that new data from a post hoc analysis of the global Phase I NAVIGATOR and Phase I/II China bridging (CS3007-101) studies for Ayvakit (avapritinib) in advanced gastrointestinal stromal tumor (GIST) were presented in a poster discussion session at the 2023 American Society of Clinical…
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Hansoh Pharmaceutical Gets NMPA Approval for HS-20117 Bispecific Antibody Clinical Study
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for HS-20117, a bispecific antibody (BsAb) targeting both EGFR and cMet in advanced solid tumors. Strategic Licensing Deal with BiotheusIn a significant move to expand its…
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Chinese Pharma Companies Update Pipelines at ASCO 2023 Annual Meeting
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A number of Chinese pharmaceutical companies have shared updates on their pipeline developments at the 2023 American Society of Clinical Oncology (ASCO) annual meeting. Among them are CSPC Pharmaceutical Group Ltd (HKG: 1093), Alphamab Oncology (HKG: 9966), and Innovent Biologics Inc. (HKG: 1801). CSPC’s CLDN18.2 ADC Demonstrates Promise in Phase…
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Gracell Biotechnologies’ GC012F Showcases Positive Data at ASCO Annual Meeting
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Suzhou-based biotech firm Gracell Biotechnologies Inc., (Nasdaq: GRCL) has announced positive data for its pipeline candidate GC012F at the American Society of Clinical Oncology (ASCO) Annual Meeting. GC012F is a FasTCAR-T therapy targeting both B-cell maturation antigen (BCMA) and CD19, under development for the treatment of relapsed/refractory multiple myeloma (r/r…
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Biosyngen’s BRG01 Earns Orphan Drug Designation from US FDA for Nasopharyngeal Carcinoma
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Biosyngen, a leading cell therapy developer based in Guangzhou, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its first-in-class nasopharyngeal carcinoma (NPC) cell therapy, BRG01. BRG01: A Pioneering Cell Therapy for NPCBRG01 is a genetically modified T cell product…
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Guangdong Zhongsheng Pharma Initiates Phase IIb Study for ZSP1601 in NASH
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the first subject enrollment in a Phase IIb clinical study for its Category 1 drug ZSP1601, targeting non-alcoholic steatohepatitis (NASH). The study, set to be conducted across over 30 centers in China, will involve subjects stratified into randomized groups based…
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Novartis’s Iptacopan on Track for Priority Review Status in China for PNH Treatment
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China’s Center for Drug Evaluation (CDE) website has indicated that Swiss pharmaceutical giant Novartis’ (NYSE: NVS) iptacopan is likely to receive priority review status for the treatment of adult paroxysmal nocturnal hemoglobinuria (PNH). This potential award highlights the fact that iptacopan is a clinically urgently needed innovative drug addressing a…
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Novo Nordisk’s Semaglutide for Weight Loss Accepted for Review by China’s NMPA
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Denmark-headquartered Novo Nordisk (NYSE: NVO) has announced that its market filing for the glucagon-like peptide-1 (GLP-1) analogue semaglutide has been accepted for review by the National Medical Products Administration (NMPA) in China, with the targeted indication being weight loss. Semaglutide’s Mechanism and Existing ApprovalsSemaglutide, a subcutaneous injection version of a…
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Qilu Pharmaceutical Gains Temporary FDA Approval to Import Cisplatin Amid US Shortage
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Qilu Pharmaceutical, a China-based firm, has benefited from the effects of drug shortages in the United States. According to a notice on the US FDA website, Qilu has been temporarily authorized to import the chemotherapy drug cisplatin to the US market, despite its product not being officially approved. Timing and…
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CStone Pharmaceuticals and Blueprint Medicines’ Ayvakit Wins FDA Approval for ISM Treatment
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Partners CStone Pharmaceuticals (HKG: 2616) and Blueprint Medicines have announced that the US FDA has approved Ayvakit (avapritinib), a tyrosine kinase inhibitor, for the treatment of adults with indolent systemic mastocytosis (ISM). ISM is a rare hematologic disorder that can lead to a range of debilitating symptoms across multiple organ…
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Sirnaomics Initiates Phase I Clinical Trial for Anticoagulant Drug Candidate STP122G
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Sirnaomics Ltd (HKG: 2257) has announced the first systemic dosing of a Phase I clinical trial for its leading RNAi drug candidate, STP122G, an anticoagulation treatment. STP122G, developed using Sirnaomics’ GalNAc RNAi delivery platform technology GalAhead, targets Factor XI and has broad applicability across various disease indications, including the potential…
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CANbridge Pharmaceuticals’ Maralixibat Approved by NMPA for Alagille Syndrome
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China-based rare disease specialist CANbridge Pharmaceuticals Inc., (HKG: 1228) has announced receiving market approval from the National Medical Products Administration (NMPA) for its drug maralixibat (CAN108). The drug is approved to treat pruritus due to cholestasis in patients with Alagille Syndrome (ALGS) aged 1 year and above. Understanding Alagille Syndrome…
