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Huadong Medicine’s ROR1-Targeting ADC HDM2005 Cleared for Clinical Trials by China’s NMPA
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Huadong Medicine Co., Ltd (SHE: 000963), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for HDM2005, an antibody-drug conjugate (ADC) that targets the recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1). The molecule…
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Gilead and Arcus Biosciences Report Positive Combination Therapy Results in mCRC Trial
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Biopharmaceutical companies Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced safety and efficacy data from a Phase Ib/II clinical trial for a combination therapy in third-line metastatic colorectal cancer (mCRC). The trial evaluated the combination of adenosine receptor antagonist etrumadenant, anti-PD-1 drug zimberelimab, VEGF inhibitor bevacizumab, and chemotherapy…
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AstraZeneca’s Tagrisso Achieves Milestone Progression-Free Survival in Late-Stage Lung Cancer Study
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has announced preliminary results from a late-stage study for its EGFR inhibitor, Tagrisso (osimertinib), in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) characterized by exon 19 deletions or exon 21 mutations. The trial successfully met its…
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Varian Medical Gets China Approval for Fourth-Generation Halcyon Radiotherapy System
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Varian Medical Systems (NYSE: VAR), a US-based leader in cancer treatment technology, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its fourth-generation Halcyon radiotherapy platform. The Halcyon system is a circular rack radiotherapy platform designed to deliver efficient image-guided automated radiation therapy.-…
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CSPC Pharmaceutical Secures NMPA Nod for Generic Version of AstraZeneca’s Lynparza
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of AstraZeneca’s PARP inhibitor Lynparza (olaparib). This marks CSPC Pharmaceutical’s entry into the segment with the third generic…
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Akeso Biopharma’s Ivonescimab Outshines Keytruda in NSCLC Trial, Raises FDA Concerns
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FiercePharma.com has reported on the reactions of multinational corporation executives to the recent news that Akeso Biopharma (HKG: 9926) and partner Summit Therapeutics’ ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), has become the first molecule to outperform Merck Sharp & Dohme’s (MSD) leading PD-1 therapy Keytruda (pembrolizumab) in a head-to-head trial…
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Eli Lilly’s KRAS Inhibitor Olomorasib Shows Promise in Phase I/II Trial for Advanced Solid Tumors
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Eli Lilly and Company (NYSE: LLY) has presented an update on a Phase I/II clinical trial for its KRAS inhibitor, olomorasib, in patients with KRAS G12C-mutant advanced solid tumors. The trial also explores the combination of olomorasib with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) top-selling checkpoint inhibitor, Keytruda (pembrolizumab),…
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Bristol Myers Squibb’s Krazati Meets Primary Endpoint in Late-Stage Lung Cancer Study
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage study for its KRAS inhibitor, Krazati (adagrasib), has successfully met its primary endpoint in patients with previously treated locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC). The study demonstrated that Krazati increased median progression-free survival (PFS) from…
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Pfizer’s Lorbrena Outperforms Xalkori in 5-Year ALK-Positive NSCLC Follow-Up
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Pfizer Inc. (NYSE: PFE) has announced the release of five-year follow-up data for its kinase inhibitor Lorbrena/Lorviqua (lorlatinib) in untreated ALK-positive advanced non-small cell lung cancer (NSCLC). The data revealed that Lorbrena demonstrated an 81% reduction in the rate of disease progression or death compared to Xalkori (crizotinib), and increased…
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Innovent Biologics Presents Clinical Data for Pipeline Candidates at ASCO 2024
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, presented updates on several pipeline candidates at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. IBI343 Phase I Study:The study of IBI343, a CLDN18.2 antibody-drug conjugate (ADC), for advanced pancreatic ductal adenocarcinoma or biliary tract cancer (BTC),…
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Gilead’s Trodelvy Misses Overall Survival Endpoint in Late-Stage Urothelial Cancer Study
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Gilead (NASDAQ: GILD) has announced that a late-stage study for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) did not meet the primary endpoint of overall survival (OS) in patients with previously treated locally advanced or metastatic urothelial cancer (mUC). This result casts uncertainty over the drug’s accelerated approval indication in…
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Chipscreen’s Chidamide in Sight of Breakthrough Therapy Designation in China for MSS/pMMR Colorectal Cancer
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that its drug Epidaza (chidamide) is on track to receive a breakthrough therapy designation (BTD) in China. The potential designation is for the use of chidamide in combination with PD-1 inhibitor sintilimab and bevacizumab for…
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CStone Pharmaceuticals’ Sugemalimab Receives Positive CHMP Opinion for NSCLC Treatment in Europe
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of sugemalimab in combination with chemotherapy as a first-line…
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FDA Extends Indication for BMS’ CAR-T Therapy Breyanzi to Include Relapsed MCL in Adults
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its CAR-T therapy Breyanzi (lisocabtagene maraleucel). The therapy is now approved as a treatment for relapsed or refractory mantle cell lymphoma (MCL) in adults who have received at least two…
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Novartis Halts Development of KRAS Inhibitor Opnurasib Due to Competitive Market
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Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has reportedly halted the development of its Phase III KRAS inhibitor candidate, opnurasib, citing an increasingly competitive landscape in the sector. The drug was under development for the treatment of solid tumors, including non-small cell lung cancer (NSCLC). This decision comes in the…
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Burning Rock Expands Companion Diagnostics Partnership with Bayer for Precision Oncology in China
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Burning Rock Ltd (NASDAQ: BNR), a China-based medical technology company, has announced another partnership in the field of tumor companion diagnostics (CDx), this time with the German multinational corporation, Bayer. Previously Burning Rock had collaborated with Germany-based Merck KGaA in late 2021 for the development of CDx to support Merck’s…
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Laekna Therapeutics Initiates Phase III Trial for Breast Cancer Candidate LAE002 in Combination with Fulvestrant
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its pipeline candidate LAE002 (afuresertib) in combination with fulvestrant. This new treatment regimen targets HR+/HER2- locally advanced or metastatic breast cancer. The multi-center, randomized,…
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Gilead Partners with Cartography Biosciences to Develop Therapies for Triple-Negative Breast Cancer
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Gilead Sciences (NASDAQ: GILD) has entered into a collaboration agreement with Cartography Biosciences, a US-based biotechnology company, to discover and develop novel therapies for triple-negative breast cancer (TNBC) and adenocarcinoma. Cartography will leverage its computational and genomics platform to identify and validate target antigens and pairs of antigens in cancer,…
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Alphamab Oncology’s KN046 Misses Primary Endpoint in Phase III Pancreatic Cancer Study
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has announced disappointing results from the Phase III KN046-303 study for its bispecific antibody (BsAb) KN046. The drug, which targets both programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), failed to meet its primary endpoint when used in…
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Yantai Dongcheng Pharmaceutical Receives NMPA Approval for SSTR2 Targeted Radioactive Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate, 177LuLNC1010. This investigational therapy is a somatostatin receptor 2 (SSTR2) targeted radioactive drug designed for the…
