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Novo Nordisk’s Mim8 Shows Promise in Hemophilia A Trial with 98% Caregiver Preference
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Denmark-based Novo Nordisk A/S (NYSE: NVO) released interim results from the Phase III FRONTIER3 study, demonstrating the benefit of Mim8 in 70 children (aged 1-11 years old) with hemophilia A, both with and without inhibitors. The trial initially assessed once-weekly prophylaxis treatment with the investigational drug, offering participants the option…
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Biokin Pharmaceutical’s BL-M07D1 Gains NMPA Approval for Phase III Study
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for its BL-M07D1. The randomized, controlled trial will assess BL-M07D1 versus trastuzumab emtansine as a postoperative adjuvant treatment for HER2-positive breast cancer…
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AbbVie’s Emblaveo Wins FDA Approval for Complicated Intra-Abdominal Infections
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US-based pharmaceutical giant AbbVie (NYSE: ABBV) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Emblaveo (aztreonam and avibactam). The drug is the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic approved for use in combination with metronidazole for patients 18…
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Zhongsheng Pharma Gains FDA Approval for Phase II Study of RAY1225
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II study assessing its polypeptide drug candidate RAY1225 in obese and overweight patients. This marks a significant step forward in the global development of…
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Bio-Thera’s Biosimilars BAT2306 and BAT2506 Accepted for Review by NMPA and EMA
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that the market filings for its biosimilars BAT2306 and BAT2506 have been accepted for review by China’s National Medical Products Administration (NMPA) and the European Medicines Agency (EMA), respectively. BAT2306 is a biosimilar version of Novartis’ (NYSE: NVS) Cosentyx (secukinumab), while BAT2506 is…
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CanSino’s Tetanus Vaccine NDA Accepted for Review by NMPA
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China-based vaccines specialist CanSino Biotechnology Inc. (HKG: 6185) announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for its adsorbed tetanus vaccine for review. The vaccine is indicated for the prevention of non-neonatal tetanus. This acceptance marks a significant milestone in the development and…
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Huahai Pharma Set to Launch IL-17 Antibody HB0017 Clinical Study for HS
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) is poised to initiate a clinical study for its interleukin-17 (IL-17) monoclonal antibody (mAb) HB0017 in hidradenitis suppurativa (HS) after receiving approval from the National Medical Products Administration (NMPA). This marks a significant step forward in the development of novel treatments for…
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Hotgen Biotech Gains NMPA Approval for AA001 Clinical Trials in Alzheimer’s Disease
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China’s Hotgen Biotech Co., Ltd (SHA: 688068) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody (mAb) AA001. The drug is intended for the treatment of mild cognitive impairment caused by Alzheimer’s disease (AD) and mild to moderate AD. This…
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Merck Initiates Phase III waveLINE-010 Study for Zilovertamab Vedotin in DLBCL
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US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced the initiation of the pivotal Phase III waveLINE-010 study. This study is designed to assess zilovertamab vedotin, an investigational antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), in combination with rituximab plus cyclophosphamide, doxorubicin, and…
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Chipscreen Biosciences Gains NMPA Approval for Epidaza Phase III Study
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China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III study assessing its Epidaza (chidamide) combined with CHOP in naive, peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH). This approval marks a significant step…
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Alphamab and CSPC Gain NMPA Approval for JSKN003 Phase III Trial in HER2-Positive Breast Cancer
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Chinese partners Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that they have received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for JSKN003 versus trastuzumab emtansine in HER2-positive advanced breast cancer. This approval marks a significant milestone in…
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Gene Cradle’s GC310 Receives Tacit Approval from NMPA for Wilson’s Disease
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Beijing-based gene therapy specialist Gene Cradle announced that it has received tacit clinical approval from the National Medical Products Administration (NMPA) for its GC310, an adeno-associated virus (AAV) gene therapy for hepatolenticular degeneration, also known as Wilson’s disease. This approval marks a significant step forward in the development of a…
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Hanx Biopharmaceuticals Gains NMPA Approval for HX044 Clinical Trials
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China-based Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HX044. This follows the initiation of a Phase I study for the CTLA-4 bispecific antibody (BsAb) in Australia. The approval marks a significant step in the global…
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Likang Life Sciences Gains FDA Approval for LK101 Clinical Trials
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Beijing-based cell therapy developer Likang Life Sciences announced that it has received approval from the US Food and Drug Administration (FDA) to conduct clinical trials for its LK101, an mRNA neoantigen vaccine. This marks a significant milestone in the development of personalized cancer treatments. Innovative Vaccine TechnologyLK101 is an innovative…
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EMA Committee Backs Subcutaneous Rybrevant for Lung Cancer Treatment
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion this week regarding the approval of a subcutaneous (SC) formulation of Johnson & Johnson’s (J&J, NYSE: JNJ) Rybrevant (amivantamab). The recommendation covers the drug’s use in combination with Lazcluze (lazertinib) for…
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Akeso Completes Enrollment for Global Phase III Trial of Ivonescimab in Lung Cancer
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China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) assessing its PD-1/VEGF bispecific antibody (BsAb) ivonescimab. The trial compares ivonescimab combined with platinum-based chemotherapy to PD-1 inhibitor tislelizumab in combination with platinum-based chemotherapy in first-line squamous non-small cell lung…
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Bayer Files for EMA Approval of Kerendia for Heart Failure
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Bayer AG (FRA: BAYN) announced that it has made another market filing with the European Medicines Agency (EMA) for its drug Kerendia (finerenone), a mineralocorticoid receptor (MR) antagonist. The German pharmaceutical giant is seeking approval in the EU for the drug to treat adult patients with heart failure (HF) with…
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Sino Biopharmaceutical’s Tulobuterol Patch Gains NMPA Approval
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its subsidiary Beijing Tide Pharmaceutical Co., Ltd has received marketing approval from the National Medical Products Administration (NMPA) for its tulobuterol patch. This marks the first approval of its kind domestically in China for a transdermal patch designed to relieve respiratory distress…
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Astellas Pharma Submits NDA for Avacincaptad Pegol in Japan for Geographic Atrophy
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Japan-based major Astellas Pharma (TYO: 4503) announced that it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking conditional approval for its avacincaptad pegol intravitreal solution (ACP). The drug is a synthetic aptamer that inhibits the complement C5 protein and is intended…
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Roche’s Susvimo Approved by FDA for Diabetic Macular Edema
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Swiss pharmaceutical giant Roche (SWX: ROG) announced that it has received approval from the US Food and Drug Administration (FDA) for another indication of its Susvimo (ranibizumab) 100 mg/mL, this time to treat diabetic macular edema (DME). With this approval, Susvimo becomes the first and only FDA-approved treatment shown to…
