Clinical & Regulatory
Harbour BioMed Announces US IND Clearance of Its First ADC Program HBM9033 in Solid Tumors
Harbour BioMed (the"Company", HKEX: 02142) announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its first antibody drug conjugate (ADC) program HBM9033.
Akeso Announced Completion of Patient Enrollment in Phase 3 Trial of Ivonescimab (PD-1/VEGF) versus Pembrolizumab in First-line PD-L1 Positive Advanced NSCLC
Akeso announced completion of patient enrollment in a head-to-head study of ivonescimab (AK112, PD-1/VEGF bispecific antibody) compared with pembrolizumab as first-line treatment for patients.
HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to savolitinib.
HUTCHMED Announces that the Sovleplenib Phase III ESLIM-01 Study Met Its Primary Endpoint in Primary Immune Thrombocytopenia in China
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the pivotal Phase III trial ESLIM-01 evaluating the investigational use of sovleplenib met its primary endpoint of durable response rate and all secondary endpoints in adult patients with primary immune thrombocytopenia.
Dizal’s Sunvozertinib Approved by China NMPA with Potential for Best-in-class Therapy in NSCLC with EGFR Exon20ins Mutations
Dizal today announced that sunvozertinib has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations, whose disease has progressed on or after platinum-based chemotherapy.
magAssist’s NyokAssist™️ granted Designation by the FDA as a Breakthrough Device
Recently, magAssist's NyokAssist™ Interventional Ventricular Assist Device (hereinafter referred to as NyokAssist™), has been granted designation as a breakthrough device by the U.S. Food and Drug Administration (FDA) in Breakthrough Device Program.
2023WCLC Oral Presentation | Molecular Analysis Validates the Effectiveness of Tumor Tissue-Based and Plasma ctDNA Testing in Identifying NSCLC Patients with EGFR Exon20ins Eligible for Treatment with Sunvozertinib
Dizal (688192.SH) will present the results of a molecular analysis on EGFR Exon20ins mutations in tumor tissue and plasma ctDNA using next-generation sequencing, and their correlation with clinical activity observed in patients treated with sunvozertinib, in a mini oral presentation at the 2023 World Conference on Lung Cancer (WCLC), taking place September 9 – 12, 2023 in Singapore.
Akeso Announced First Patient Dosed in Phase 3 Trial of Ivonescimab versus Tislelizumab for First-line Treatment of Squamous NSCLC
Akeso Inc. ("Akeso", 9926. HK) announced today that the first patient has been dosed in a head-to-head phase III trial of ivonescimab, a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso.
European Medicines Agency Accepts Iveric Bio’s Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), today announced the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol (ACP), an investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Hong Kong Department of Health has Approved the Registration Applications for the Uro-G and Uro-V Disposable Cystoscopic System
Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced that the Government of Hong Kong Special Administrative Region Department of Health has approved the registration applications for the Uro-G and Uro-V disposable cystoscopic system.
