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Clover Biopharmaceuticals Launches AdimFlu-S, the Only Imported Quadrivalent Influenza Vaccine in China
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced the launch of AdimFlu-S (QIS) in mainland China, marking it as the only imported quadrivalent seasonal influenza vaccine approved for use in individuals aged three years and older. The vaccine has been listed in 26 provinces and municipalities across the country, gearing…
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HutchMed Advances Tazverik Phase II Trial for Follicular Lymphoma in China
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in a bridging study for Tazverik (tazemetostat) in China. Tazverik, originated by US firm Epizyme Inc., was licensed to HutchMed for development in Greater China in an agreement reached in August 2021. Tazverik’s Background and Previous ApprovalsThe…
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Hybio Pharmaceutical’s Semaglutide Clinical Trial Filing Accepted by China’s NMPA
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for semaglutide, a Category 2.2 product. Category 2.2 products in China are new formulations of known drugs that aim to offer a demonstrable clinical benefit over the originator…
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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…
