China

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I-Mab Provides Mid-Year 2023 Financial Results, Business and Corporate Updates

I-Mab (Nasdaq: IMAB) (the "Company"), is a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics for oncology, today announced its financial results for the six months ended June 30, 2023, and provided key business updates.

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Everest Medicines’ Partner Calliditas Therapeutics Announces Full Results From NefIgArd Phase 3 Trial published in The Lancet

Everest Medicines' (HKEX 1952.HK, "Everest", or the "Company") partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced the publication in The Lancet of the full data from the NeflgArd Phase 3 trial with Nefecon® in adults with primary IgA nephropathy (IgAN).

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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.

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QiLu Pharmaceutical’s Iruplinalkib Phase III INSPIRE Study Researched Primary Endpoint and was Selected for 2023 WCLC Oral Presentation

At the 2023 World Conference on Lung Cancer (WCLC), the complete list of selected abstracts was announced, among which QiLu Pharmaceutical's iruplinalkib phase III clinical trial (INSPIRE) results were chosen for oral presentation at the conference.

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Transcenta to Present Three Study Results at ESMO 2023

Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it is going to present three posters highlighting study results from ongoing trials related to Osemitamab (TST001) at the 2023 European Society of Medical Oncology (ESMO) Congress including updated efficacy and PK/PD analysis data from the phase 2 study of Osemitamab (TST001)/CAPOX in CLDN18.2 positive first line G/GEJC as well as preclinical data on the combination study of Osemitamab (TST001) with PD1 inhibitor.

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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.

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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).

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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.

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Everest Medicines’ Partner Venatorx Receives FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI)

Everest Medicines (HKEX 1952.HK)'s partner Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic for the potential treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis.

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Successful FDA inspection at Aurisco’s manufacturing site in Yangzhou, China

Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA).