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Harbour BioMed’s HBM1020 Receives FDA Approval for US Phase I Study
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Harbour BioMed (HKG: 2142), a global biotech company operating in the Netherlands, the United States, and China, has announced receiving approval from the US Food and Drug Administration (FDA) to conduct an open-label, multi-center Phase I study of its monoclonal antibody (mAb) HBM1020. The study will assess the safety, tolerability,…
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Sanofi’s iGlarLixi Approved in China for Type 2 Diabetes Management
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced that the National Medical Products Administration (NMPA) has approved its iGlarLixi (insulin glargine, lixisenatide) for use in adult patients with type 2 diabetes who have poor blood glucose control. This approval marks a significant step in expanding treatment options for patients struggling…
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Roche’s Polivy Approved by China’s NMPA for Lymphoma Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the National Medical Products Administration (NMPA) has approved its antibody-drug conjugate (ADC) Polivy (polatuzumab vedotin for injection). Polivy is the world’s first ADC targeting CD79b and is designed for use as a first-line treatment for diffuse large B-cell lymphoma…
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MSD China to Take Legal Action Against Market Infringement of Molnupiravir
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Merck Sharp & Dohme (MSD, NYSE: MRK)’s China unit has issued a WeChat notification vowing to take necessary legal actions against certain unnamed drug companies accused of market infringement related to molnupiravir, the oral COVID-19 therapy. The notice states that some manufacturers are falsely claiming authorization from MSD to distribute…
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Kexing Pharmaceutical Initiates Phase I Trial for IFN-Alpha-1b Inhalation Solution
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China-based Kexing Pharmaceutical (SHA: 688136) has announced the enrollment of the first subject and dosing in a Phase I clinical study for its interferon-alfa-1b (IFN-alpha-1b) solution for inhalation. The drug will be assessed for treating lower respiratory tract infections caused by respiratory syncytial virus (RSV) in children, including conditions such…
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CSPC’s Cleviprex Approved for Clinical Study by China’s NMPA
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its pipeline drug candidate cleviprex. The company’s first nanoemulsion, cleviprex, is a dihydropyridine calcium channel blocker being developed to treat hypertension when oral antihypertensive drugs are…
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Takeda’s Mobocertinib Approved in China for EGFR Exon20ins NSCLC
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Japan-based Takeda Pharmaceutical Co., Ltd’s (TYO: 4502) China unit has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its lung cancer therapy mobocertinib. The drug is indicated for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed during…
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Kelun-Biotech’s SKB264 Approved for Phase II Study in EGFR-Mutant NSCLC
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its drug candidate SKB264. The antibody-drug conjugate (ADC) targets trophoblast cell-surface antigen 2 (TROP2) and will be evaluated in combination with AstraZeneca’s (AZ, NASDAQ: AZN)…
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Pfizer’s Nurtec ODT Launches in China via Hainan’s Bo’Ao Lecheng Zone
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US-based Pfizer’s (NYSE: PFE) Nurtec ODT (rimegepant), the world’s first calcitonin gene-related peptide (CGRP) receptor antagonist in rapidly dissolving oral disintegrating tablet form, has become available to patients in China via the Bo’Ao Lecheng Medical Tourism Pilot Zone in Hainan from January 1. The drug is being launched in Hainan…
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Konruns Initiates Phase II Study for KC1036 in Advanced Thymic Tumors
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced the initiation of a single-arm, open, multi-center Phase II clinical study to assess the efficacy and safety of its Category 1 chemical drug KC1036 in patients with advanced thymoma and thymic carcinoma. The study focuses on patients whose disease has progressed…
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Dizal’s Sunvozertinib NDA Accepted for Review by China’s NMPA
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA) filing for sunvozertinib (DZD9008), a next-generation epidermal growth factor receptor (EGFR) inhibitor, has been accepted for review by the National Medical Products Administration (NMPA). The drug is indicated for use in locally advanced or metastatic…
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HighTide Therapeutics Doses First Patient in Phase IIb Study for HTD1801 in NASH
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Shenzhen-based HighTide Therapeutics Inc. has announced that the first patient has been dosed in a Phase IIb clinical study for its pipeline candidate HTD1801 in non-alcoholic steatohepatitis (NASH). The randomized, double-blind, placebo-controlled study is designed to assess the histological improvement of HTD1801 compared with placebo in subjects with NASH and…
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MSD Submits Initial Quotation for Molnupiravir in China Amid New COVID-19 Rules
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Under new rules specifically for the launch of COVID-19 therapeutics in China, US-based Merck Sharp & Dohme (MSD, NYSE: MRK) has proactively submitted the initial quotation and materials for its molnupiravir, the world’s first oral COVID-19 therapy. The Tianjin Medical Purchasing Center has publicized the quoted price at RMB 1,500…
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Treadwell Therapeutics’ CFI-402257 Granted Fast-Track Status by FDA
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China-based clinical-stage biotech Treadwell Therapeutics has announced receiving fast-track status from the US Food and Drug Administration (FDA) for its CFI-402257, a best-in-class inhibitor of threonine tyrosine kinase (TTK, also known as Mps1). The designation was granted for the drug’s potential as a treatment for adult patients with ER+/HER2- advanced…
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Jiangsu Kanion’s KYS202002A Greenlit for Clinical Study in Multiple Myeloma
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its pipeline candidate KYS202002A in recurrent/refractory multiple myeloma (R/R MM). This marks a significant step forward in the development of this innovative therapy targeting a…
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Yiling Pharmaceutical’s BIO-008 Accepted for Review by China’s NMPA
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that its clinical trial filing for BIO-008, an in-house developed Category 1 biologic being developed to treat advanced solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development…
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Luye Pharma Launches Named Patient Program for Lurbinectedin in Hong Kong
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China-based Luye Pharma Group (HKG: 2186) has announced the launch of a Named Patient Program (NPP) in Hong Kong, enabling access to lurbinectedin (LY01017), an RNA polymerase II inhibitor used to treat patients with relapsed small-cell lung cancer (SCLC). The program will provide immediate access to the drug for SCLC…
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Innovent Biologics Doses First Patient in Phase III Study for Mazdutide
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the first patient has been dosed in the multi-center, randomized, double-blind, placebo-controlled Phase III DREAMS-1 study for its mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. The drug is being assessed for safety and efficacy in treating Chinese…
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Cosunter’s COVID-19 Drug GST-HG171 Shows Superior Efficacy in Trial
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced positive results from an investigator-initiated trial (ITT) for its Category 1 product GST-HG171/ritonavir in COVID-19 patients. The randomized, controlled trial was designed to assess the efficacy and safety of the drug in mild/common COVID-19 adult patients and included a test…
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Fosun Foundation Donates COVID-19 Therapy Azvudine to Rural China
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The Fosun Foundation, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), and Henan Genuine Biotech Co., Ltd have announced the donation of RMB 100 million (USD 14.76 million) worth of the oral COVID-19 therapy azvudine to 180 counties in middle and western rural China. The donation will be…
