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MicuRx Pharmaceuticals’ MRX-8 Achieves Positive Results in Phase I Clinical Study
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MicuRx Pharmaceuticals (SHA: 688373), a Shanghai-based developer of antibacterial drugs, has announced the successful completion of a Phase I clinical study in China for its new drug candidate MRX-8, which targets gram-negative drug-resistant bacteria. The randomized, double-blinded, placebo-controlled Phase I study aimed to evaluate the safety, tolerability, and pharmacokinetic characteristics…
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Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Recommended for Approval by EMA’s CHMP
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Bio-Thera Solutions (SHA: 688177), a biopharmaceutical company based in Guangzhou, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of its biosimilar product, Avzivi (bevacizumab), which is a biosimilar version of Roche’s Avastin. The CHMP’s positive…
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Akeso Expands Licensing Deal with Summit Therapeutics for Ivonescimab Bispecific Antibody
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced a supplementary licensing agreement with Summit Therapeutics Inc. (NASDAQ: SMMT) for ivonescimab, Akeso’s bispecific antibody (BsAb) that targets PD-1 and VEGF. The original agreement, valued at a potential USD 5 billion, was signed in December 2022 and granted…
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Jiangsu Aidea Pharmaceutical Gets Green Light from NMPA for AINUOVirine APIs
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Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to manufacture the active pharmaceutical ingredients (APIs) for ainuovirine. The APIs correspond to ainuovirine tablets, which are a Category 1 oral therapy for…
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Allergan Aesthetics’ Botox Secures New Indication for Masseter Muscle Protrusion in China
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Allergan Aesthetics, a division of AbbVie (NYSE: ABBV), has announced that it has received approval for a new indication from the National Medical Products Administration (NMPA) for its Botox (botulinum toxin type A) product. The drug is now approved for the temporary improvement of significant or very significant masseter muscle…
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Legend Biotech’s Carvykti Shows Durable Responses in Multiple Myeloma Patients Post ASCT
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Legend Biotech Corporation (NASDAQ: LEGN) has announced results from the Phase II CARTITUDE-2 Cohort D study of its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), in multiple myeloma (MM) patients. The data was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, along…
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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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Gilead and Arcus Biosciences Report Positive Interim Phase II Data for Domvanalimab Combo in GI Cancers
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Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced interim Phase II data for their anti-TIGIT biologic domvanalimab in combination with the anti-PD-1 drug zimberelimab. The treatment is being investigated for locally advanced unresectable or metastatic upper gastrointestinal cancers. The study, which has a median time on treatment of…
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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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Astellas Resubmits FDA Application for Vyloy as Treatment for CLDN18.2-Positive Cancer
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Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has resubmitted its first-in-class anti-CLDN18.2 biologic Vyloy (zolbetuximab) to the US Food and Drug Administration (FDA) for the treatment of locally advanced unresectable or metastatic HER2-negative CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This resubmission follows an earlier rejection and comes…
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Simcere Pharma’s Suvemcitug Shows Positive Results in Platinum-Resistant Ovarian Cancer Study
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has presented updated data from the SCORES study for its drug candidate suvemcitug at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Suvemcitug, also known as sevacizumab; APX-003; BD-0801, is being studied in platinum-resistant ovarian cancer. The…
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Ascentage Pharma’s APG-2449 Shows Positive Results in ROS1 and ALK Positive NSCLC at ASCO 2024
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in Suzhou, has announced a wall poster presentation showcasing the latest data for its FAK/ALK/ROS1 inhibitor APG-2449 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study determined the recommended Phase II dosage (RP2D) of APG-2449 to be 1200…
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Jacobio Pharma’s KRAS G12C Inhibitor Combo Shows Promising Results in NSCLC at ASCO 2024
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, presented updated data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting for its KRAS G12C inhibitor glecirasib (JAB-21822) in combination with an SHP2 inhibitor (JAB-3312) as a frontline treatment for non-small cell lung cancer (NSCLC) patients with…
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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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Simcere Pharma’s Anti-Insomnia Drug Daridorexant Meets Primary Endpoint in Phase III Clinical Trial
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced topline results from a Phase III clinical study for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd, a Swiss pharmaceutical company. The study evaluated the efficacy and safety of daridorexant in Chinese patients with insomnia and successfully met its…
