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Akeso Biopharma Receives Development Payment for PD-L1 Monoclonal Antibody
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China-based Akeso Biopharma (HKG: 9926) has announced receiving a drug collaboration development payment from compatriot firm Kelun Pharmaceutical Research Institute, following the National Medical Products Administration’s (NMPA) approval of its programmed death ligand 1 (PD-L1) monoclonal antibody (mAb) tagitanlimab last month. Collaboration BackgroundAkeso entered into a collaboration agreement with Kelun…
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Lepu Biopharma Licenses Potential Best-in-Class ADC MRG007 to ArriVent
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Lepu Biopharma Co., Ltd (HKG: 2157) has announced an exclusive licensing agreement with ArriVent BioPharma, Inc. (NASDAQ: AVBP) for MRG007, a potential best-in-class antibody-drug conjugate (ADC) targeting gastrointestinal (GI) cancers. This partnership aims to advance the development and commercialization of MRG007 globally, excluding Greater China. Agreement DetailsUnder the terms of…
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CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
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The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include: Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular…
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Lepu Biotechnology’s MRG003 Earns FDA Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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Lepu Biotechnology Co., Ltd (HKG: 2157), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its pipeline candidate, MRG003. This designation highlights the drug’s potential in treating recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), a significant…
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Chinese Pharma Companies Set to Showcase Cancer Treatments at ASCO 2024
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The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 to June 4 in Chicago, will feature updates from Chinese pharmaceutical companies Ascentage Pharma (HKG: 6855), Lepu Biotechnology Co., Ltd (HKG: 2157), Transcenta Holding Ltd, and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) on their…
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Lepu Biotechnology Reports 1,347% YOY Revenue Increase in 2023 Financial Results
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Lepu Biotechnology Co., Ltd (HKG: 2157), a biopharmaceutical company based in China, has released its financial report for 2023, showcasing a significant increase in revenues to RMB 225 million (USD 31 million), marking a year-on-year (YOY) growth of 1,347%. This substantial revenue included RMB 124 million (USD 17.1 million) from…
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Lepu Biotechnology’s MRG004A ADC Gains Fast Track Designation for Pancreatic Cancer
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Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed antibody-drug conjugate (ADC) MRG004A has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This indication previously secured the ADC an orphan drug designation (ODD)…
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Lepu Biotechnology Completes Enrollment for Phase IIb Trial of MRG003 in Nasopharyngeal Carcinoma
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Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced the completion of subject enrollment in its Phase IIb clinical study for MRG003, its flagship product targeting recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The randomized, open-label, multi-center pivotal study aims to evaluate the efficacy and safety of this epidermal growth…
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Biocytogen and Lepu Biotechnology Develop WT1-Targeted Trispecific Antibody for Cancer Treatment
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd, (HKG: 2315) and Lepu Biotechnology Co., Ltd (HKG: 2157) have announced significant progress in the co-development of their trispecific T cell connector, having identified a WT1/HLA-A02 targeted T-cell connector, WT1×CD3×4-1BB trispecific antibody, as part of their collaboration initiated last year. Pre-clinical data for this product…
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Lepu Biotechnology’s Pancreatic Cancer Drug Earns Orphan Drug Status from FDA
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Lepu Biotechnology Co., Ltd (HKG: 2157), a Chinese pharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), MRG004A, which is being developed to treat pancreatic cancer. MRG004A is an innovative ADC that targets…
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Lepu Biotechnology’s MRG003 Gains Fast-Track Status from U.S. FDA for Nasopharyngeal Carcinoma
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Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced that its flagship product MRG003 has received fast-track status from the U.S. FDA for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The antibody-drug conjugate (ADC), which targets the epidermal growth factor receptor (EGFR), was previously granted orphan drug…
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Lepu and Keymed License CLDN18.2 ADC CMG901 to AstraZeneca
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China-based firms Lepu Biopharma Co., Ltd (HKG: 2157) and Keymed Biosciences Inc. (HKG: 2162) have jointly announced a licensing agreement with UK major AstraZeneca (AZ, NASDAQ: AZN) for CMG901, a potential first-in-class antibody-drug conjugate (ADC) targeting Claudin 18.2. AstraZeneca is taking on global development, manufacturing, and commercialization rights to the…
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Lepu Biotechnology’s MRG003 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation for its core product MRG003 in recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The epidermal growth factor receptor (EGFR) targeted antibody drug conjugate (ADC) had previously obtained Orphan Drug…
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Lepu Biotechnology’s PD-1 Inhibitor HX008 Gains New Indication Approval
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its HX008, a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug, which was first approved in China in July this year for…
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Lepu Biotechnology’s MRG003 Receives Orphan Drug Designation from FDA
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received orphan drug designation (ODD) status from the US FDA for its core product MRG003, an epidermal growth factor receptor targeted antibody drug conjugate (ADC) for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). Drug Mechanism and DevelopmentMRG003…
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Keymed and Lepu’s CMG901 Receives Breakthrough Therapy Designation for Gastric Cancer
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The Center for Drug Evaluation (CDE) website indicates that CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody drug conjugate (ADC) co-developed by Keymed Biosciences Inc. and Lepu Biopharma Co., Ltd, has obtained breakthrough therapy designation (BTD) status. The designation is specifically for the drug’s potential use in CLDN18.2-positive advanced gastric cancer in…
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Lepu Biopharma’s MRG002 Earns FDA Orphan Drug Status for Gastric Cancer
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China’s Lepu Biopharma Co., Ltd (HKG: 2157) announced that the U.S. FDA has granted orphan drug designation (ODD) to its antibody-drug conjugate (ADC) MRG002 for gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJ). The drug is in a Phase I/II trial in the U.S. targeting HER2-positive, advanced or metastatic GC/GEJ. Drug…
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Lepu Biopharma’s Pucotenlimab Receives Conditional NMPA Approval for MSI-H/dMMR Tumors
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The National Medical Products Administration (NMPA) has granted conditional market approval to Lepu Biopharma Co., Ltd’s pucotenlimab (HX008), a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug is indicated for microsatellite instability-high/deficient mismatch repair (MSI-H/dMMR) expressing tumors in two patient groups: (1) those with advanced colorectal…
