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Merck and Moderna Launch Phase III Study for Individualized Neoantigen Therapy in Lung Cancer
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US pharmaceutical companies Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) and Moderna Inc. (NASDAQ: MRNA) have initiated the Phase III INTerpath-009 study to evaluate V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab). The study will focus on patients with resectable Stage…
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Merck’s Keytruda Gains Two Additional EU Indications for Gynecologic Cancer Treatment
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Merck, Sharp & Dohme Inc., known as MSD (NYSE: MRK), has received two additional indication approvals from the European Union for its immunotherapy drug Keytruda (pembrolizumab), increasing the total number of approved uses in the region to 30. The PD-1 inhibitor is now approved for use in combination with carboplatin…
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Jiangsu Hengrui Pharmaceuticals Advances Clinical Trials for Cancer Therapies with NMPA Clearance
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received clinical clearance from China’s National Medical Products Administration (NMPA) for a suite of cancer treatments, including HRS-4642 (adebrelimab), SHR-1826, SHR-8068, and a bevacizumab biosimilar. The company is set to initiate a multi-center, open Phase Ib/II study to evaluate the safety, tolerability,…
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AstraZeneca’s Fasenra Approved by EU for Eosinophilic Granulomatosis Treatment
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UK pharmaceutical giant AstraZeneca Inc. (NASDAQ: AZN) has received marketing approval from the European Commission for its drug Fasenra (benralizumab) as an additional treatment for adult patients suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The approval follows the successful outcomes of the MANDARA Phase III trial, marking…
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AbbVie Inks $1.4 Billion Deal to Acquire Alzheimer’s Drug Developer Aliada Therapeutics
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US pharmaceutical company AbbVie (NYSE: ABBV) has entered into a definitive agreement to acquire all outstanding equity of Aliada Therapeutics, Inc., a fellow US firm, for $1.4 billion in cash. The acquisition includes ALIA-1758, an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody in development for the treatment of Alzheimer’s disease (AD). Aliada’s…
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CSPC Pharmaceutical’s SYS6020 Receives NMPA Approval for Myasthenia Gravis Clinical Trial
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its SYS6020. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy intended for myasthenia gravis (MG). Notably,…
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Eli Lilly’s Ebglyss Shows Positive Results in Phase III Study for Atopic Dermatitis Patients Previously Treated with Dupilumab
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Eli Lilly & Co. (NYSE: LLY), a leading U.S. pharmaceutical company, has announced the results of the Phase III Adapt study for its interleukin-13 (IL-13) inhibitor, Ebglyss (lebrikizumab). The study demonstrated that Ebglyss improved skin conditions, including on the hands and face, and reduced itch in patients with moderate-to-severe atopic…
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Biogen’s Felzartamab Demonstrates Promising Results in Phase II Study for IgA Nephropathy
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Biogen Inc. (NASDAQ: BIIB), a prominent biopharmaceutical company based in the U.S., has announced comprehensive results from the Phase II IGNAZ study for felzartamab in the treatment of IgA nephropathy. The findings were showcased at Kidney Week 2024, the annual meeting of the American Society of Nephrology. The study demonstrated…
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Humanwell Healthcare Receives NMPA Approval for Chemically Synthesized Semaglutide Clinical Trial
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading healthcare company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 2.2 chemically synthesized semaglutide injection, intended for the treatment of type 2 diabetes. Semaglutide, a glucagon-like peptide-1…
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RiboX Therapeutics’ Circular RNA Therapy RXRG001 Gets FDA Green Light for Dry Mouth Clinical Trial
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RiboX Therapeutics, a Shanghai-based developer of circular RNA (circRNA) therapies, has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate the Phase I/IIa clinical study SPRINX-1 for its candidate RXRG001. This study will evaluate the efficacy and safety of RXRG001 in patients suffering…
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AstraZeneca’s Zoladex Receives NMPA Approval for Higher Dosage Form in Breast Cancer Treatment
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a UK-based pharmaceutical giant, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Zoladex (goserelin sustain-released implant) 10.8mg. This new dosage form is intended for use in premenopausal and perimenopausal women with breast cancer who can be…
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MicuRx Pharmaceuticals’ Antibiotic MRX-5 Completes Successful Phase I Clinical Trial in Australia
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MicuRx Pharmaceuticals Inc. (SHA: 688373), a Sino-US pharmaceutical company, has announced the successful completion of a Phase I clinical study for its in-house developed antibiotic, MRX-5, in Australia. This new benzodiazole antibiotic is designed to treat infections caused by Mycobacterium, with a particular focus on non-tuberculosis Mycobacterium (NTM). The Phase…
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Chinese ADCs from Escugen, Hansoh, and MediLink Therapeutics Eye Breakthrough Designations in China
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The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has indicated on its website that three antibody drug conjugates (ADCs) from Chinese pharmaceutical companies are on track to receive breakthrough therapy designations (BTDs) in China. These include Shanghai Escugen’s ESG401, Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692)’s…
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LaNova Medicines Regains Rights to Claudin 18.2 Targeting ADC LM-302 from BMS
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LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the reclamation of control over LM-302, an antibody drug conjugate (ADC) targeting Claudin 18.2, from US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY). LaNova had previously signed an agreement with Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to…
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Zhuhai Beihai Biotech’s Beizary Receives FDA Clearance for Multiple Cancer Indications
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Zhuhai Beihai Biotech Co., Ltd has announced that it has received marketing clearance from the US Food and Drug Administration (FDA) for its in-house developed drug, Beizary, a modified version of docetaxel, which is indicated for the treatment of various cancers including breast cancer, non-small cell lung cancer, head and…
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BeiGene’s PD-1 Inhibitor Tevimbra Scores First US Prescription, Offers More Affordable Option
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BeiGene Ltd, a leading China-based biotechnology company (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has announced the first prescription of its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab), in the United States. This marks a significant milestone for the company as it expands its global reach. Tislelizumab received approval in the US…
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RemeGen’s Telitacicept Receives Priority Review Status from China’s CDE for gMG Treatment
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RemeGen (HKG: 9995), a China-based pharmaceutical company, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another market filing for its drug telitacicept with priority review status. The filing seeks approval for the treatment of generalized myasthenia gravis (gMG), a serious…
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RemeGen’s Taitaxipu Receives CDE Acceptance for New Indication Application in China
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RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a new indication application for its Claudin18.2-targeted antibody, Taitaxipu (Telitacicept), in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. This…
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Chongqing Zhifei Biological’s Influenza Vaccine Application Accepted by China’s Drug Evaluation Center
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On October 24, 2024, the Center for Drug Evaluation of the National Medical Products Administration indicated that the influenza virus split vaccine marketing application from Chongqing Zhifei Biological Products Co., Ltd. (SHE: 300122)’s wholly-owned subsidiary, Zhifei Longkoma, has been accepted, with the acceptance number CXSS2400114. Currently, Chongqing Zhifei Biological has…
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BMS Launches Cardiac Myosin Inhibitor Camzyos in China for Obstructive Hypertrophic Cardiomyopathy
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced the official market launch of its cardiac myosin inhibitor Camzyos (mavacamten) in China. The drug is indicated for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded II to III under the New York Heart Association (NYHA) functional classification, aiming to improve…
