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FDA Extends Pfizer’s Comirnaty Vaccine Indication for Omicron XBB.1.5 Variant
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) an indication extension for its SARS-CoV-2 Omicron XBB.1.5 single-dose monovalent vaccine, Comirnaty. The vaccine is now approved for individuals aged 12 years and older, in addition to receiving an emergency use authorization (EUA) for children between 6 months…
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Amgen’s Lumakras Combo Shows Promising Results in KRAS-mutated NSCLC Early-Stage Trial
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Amgen (NASDAQ: AMGN) has announced positive early-stage data for its KRASG12C inhibitor Lumakras (sotorasib) when combined with carboplatin and pemetrexed in the treatment of KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) in adults. The confirmed objective response rate (ORR) and disease control rate (DCR) in treatment-naive patients were 65%…
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Gilead’s Trodelvy Combo with MSD’s Keytruda Shows Promise in NSCLC Phase II Trial
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Gilead (NASDAQ: GILD) has announced interim data from a Phase II trial assessing the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in combination with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 Keytruda (pembrolizumab) for first-line advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. The interim results…
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Sinovac Biotech Advances SA55 COVID-19 Neutralizing Antibody into Phase II Trials
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China-based vaccines firm Sinovac Biotech Ltd (NASDAQ: SVA) has announced the completion of a Phase I trial and the immediate initiation of a Phase II study for its broad-spectrum COVID-19 neutralizing antibody, SA55. The molecule, which was first approved to enter clinical trials in China on May 24 this year,…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for HRS-7450 Acute Ischemic Stroke Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its investigational drug HRS-7450 in patients with acute ischemic stroke. HRS-7450: A Next-Generation Thrombolytic DrugHRS-7450 is…
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SinoMab BioScience Receives NMPA Approval for Phase I Study of Atopic Dermatitis Drug SM17
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Hong Kong-based biotechnology company SinoMab BioScience Ltd (HKG: 3681) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study in China, assessing the safety of SM17, a first-in-class drug for atopic dermatitis (AD). The study is set to commence in the fourth quarter…
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Haisco Pharmaceutical Gets NMPA Approval for HSK21542 Chronic Pruritus Clinical Study
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug HSK21542, aimed at treating chronic pruritus. Understanding the Impact of Chronic PruritusPruritus, or itching, is an unpleasant sensation…
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ImmuneOnco’s IMM2510 and IMM27M Achieve Milestones in Phase I Clinical Trials
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the completion of patient enrollment for Phase I dosage escalation studies for both IMM2510 and IMM27M, with the recommended Phase II dosage (RP2D) determined for each. IMM2510: A PD-L1/VEGF Bispecific Antibody for Solid TumorsIMM2510, a PD-L1/VEGF bispecific antibody (BsAb) based on…
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CDE Indicates BTD Status for Visirna’s VSA001, Sperogenix’s Vamorolone, and Zai Lab’s Efgartigimod
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The Center for Drug Evaluation (CDE) website has indicated that Visirna Therapeutics’ novel siRNA therapy VSA001, Sperogenix Therapeutics’ vamorolone, and Zai Lab’s (HKG: 9688) efgartigimod are on track for breakthrough therapy designation (BTD) status awards in China. VSA001 for Familial Chylomicronemia Syndrome (FCS)VSA001 is designed to reduce triglyceride levels in…
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Sichuan Kelun Pharmaceutical Submits Biosimilar Cetuximab for NMPA Approval
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has announced a market approval filing for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (NYSE: MRK/BMS, NYSE: BMY) cetuximab, known under the trade name Erbitux. The…
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United Laboratories’ UBT251 Receives Tacit Approval for NAFLD Clinical Study in China
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Hong Kong firm United Laboratories International Holdings Ltd (HKG: 3933) has announced that its Category 1 drug candidate UBT251 has been tacitly approved in China for a clinical study focusing on non-alcoholic fatty liver disease (NAFLD). UBT251: A Triple Agonist for Metabolic ImprovementsUBT251 is a long-acting GLP-1 (glucagon-like peptide-1)/GIP (glucose-dependent…
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Abbisko Therapeutics Receives EMA Approval for Phase III Study of Pimicotinib for TGCT
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the European Medicines Agency (EMA) to conduct a Phase III clinical study for its Category 1 innovative drug ABSK021 (pimicotinib), which is being assessed as a treatment for tendon sheath giant cell tumor (TGCT).…
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AriBio Files for Phase III Clinical Trial Approval in China for Alzheimer’s Drug AR1001
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South Korean clinical-stage biotech AriBio Co. has announced the filing for Phase III clinical trial approval in China for its anti-Alzheimer’s disease (AD) drug candidate, AR1001. The filing is currently under review by the National Medical Products Administration’s Center for Drug Evaluation. Global Phase III Trial Expansion PlansAriBio aims to…
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Allist Pharmaceuticals and ArriVent Biopharma Release Promising Interim Data on Furmonertinib for NSCLC
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd and its US partner ArriVent Biopharma Inc. have jointly released interim data from a Phase Ib trial at the 2023 World Conference on Lung Cancer (WCLC) meeting. The trial assessed the efficacy of furmonertinib as a treatment for non-small cell lung cancer (NSCLC), specifically…
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BMS Announces Positive Outcomes for BMS-986278 in Progressive Pulmonary Fibrosis Study
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Bristol-Myers Squibb (BMS; NYSE: BMY) has released the final results from a Phase II trial evaluating the potential first-in-class LPA1 antagonist BMS-986278 in the treatment of progressive pulmonary fibrosis (PPF). The trial’s findings indicate that the twice-daily pill significantly reduced the rate of decline in percent predicted forced vital capacity…
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EMA Reviews Janssen’s Balversa for Advanced Urothelial Carcinoma with FGFR3 Alterations
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The European Medicines Agency (EMA) has accepted for review a filing made by the Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) for the tyrosine kinase inhibitor (TKI) Balversa (erdafitinib) as a treatment for locally advanced unresectable or metastatic urothelial carcinoma (UC) in adults with susceptible fibroblast growth factor…
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United Laboratories Receives Tacit Approval for JAK1 Inhibitor TUL01101 Clinical Trial
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Hong Kong-listed United Laboratories International Holdings Ltd (HKG: 3933) has announced tacit clinical trial approval for its Category 1 drug TUL01101, a small molecule JAK1 inhibitor. The upcoming trial will evaluate the efficacy of TUL01101 as a treatment for patients suffering from moderate to severe atopic dermatitis (AD). Filling the…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase Ib/III Study of Dalpiciclib in mHSPC
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind Phase Ib/III clinical study. The study will assess the combination of dalpiciclib (SHR6390) with abiraterone plus prednisone in patients with metastatic hormone…
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Roche and Alnylam’s Zilebesiran Achieves Primary Endpoint in Hypertension Phase II Trial
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Roche (SWX: ROG) and Alnylam (NASDAQ: ALNY) have announced that a Phase II trial for their RNAi therapeutic, zilebesiran, has successfully met its primary endpoint of significantly reducing 24-hour mean systolic blood pressure (SBP) at month three in patients with mild-to-moderate hypertension. The results also demonstrated reductions in SBP and…
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Pfizer and Valneva’s Lyme Disease Vaccine VLA15 Shows Promise as Booster in Pediatric Trials
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Partners Pfizer (NYSE: PFE) and Valneva SE (NASDAQ: VALN) have revealed that their Lyme disease vaccine candidate, VLA15, has demonstrated immunogenicity and safety as a booster shot in individuals aged between 5 and 17 years. The primary scheme resulted in seroconversion rates of 94.6% to 95.3% for all serotypes of…
