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Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced the summary report of a Phase III clinical study for its fixed dose preparation ainuovirine, lamivudine, tenofovir disoproxil (ACC008) as a switch therapy for previously treated HIV-1 patients. The drug was previously approved to treat treatment-naïve HIV-1 patients in China in…
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China-based Everest Medicines (HKG: 1952) has announced the completion of patient enrollment for the China open-label extension (cOLE) of the Phase III NefIgArd study. This cOLE study provides an additional 9 months of treatment with Nefecon to all qualifying patients who have completed the NefIgArd study, aiming to evaluate the…
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China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase II clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its drug TST002 (blosozumab) in Chinese patients with decreased bone density.…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based biopharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline candidate, ZG006. The molecule is set to enter trials targeting general advanced solid tumors. ZG006: A Pioneering Tri-Specific AntibodyZG006 is…
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The National Medical Products Administration (NMPA) has indicated on its website that benaglutide, developed by Shanghai Benemae Pharmaceutical Co., Ltd, has been granted approval for adult weight management in China. This marks the second hypoglycemic drug approved for weight loss in the country, following Huadong Medicine Co., Ltd’s (SHE: 000963)…
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Nanjing Leads Biolabs Co., Ltd, a China-based biopharmaceutical company, has announced receiving clinical trial approvals from both the National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb), LBL-034. The drug targets GPRC5D and CD3 and is intended to treat recurrent/refractory (r/r)…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its Category 1 biologic preparation, DR10624, aimed at weight management for overweight or obese populations. DR10624: A Novel Agonist for Weight…
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China-based Akeso Biopharma (HKG: 9926) has announced the first patient enrollment in a Phase Ia/Ib clinical study for its TIGIT monoclonal antibody (mAb) AK127, combined with cadonilimab (AK104), a novel bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), for the treatment of advanced malignant solid…
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US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has released final results from two Phase III studies evaluating the once-weekly GIP receptor and GLP-1 receptor agonist, Mounjaro (tirzepatide), as a treatment for obesity. The studies showed that tirzepatide achieved up to 26.6% mean weight loss over durations of either…
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Swiss giant Roche’s (SWX: ROG) Herceptin (trastuzumab). This biosimilar drug is intended to treat human epidermal growth factor receptor 2 (HER2) positive early breast cancer,…
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US pharmaceutical major Eli Lilly and Company (NYSE: LLY) has revealed the complete results of the Phase III TRAILBLAZER-ALZ 2 study for donanemab, demonstrating that the drug significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease (AD). Donanemab’s Efficacy in Early Symptomatic Alzheimer’s DiseaseThe study showed…
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China’s Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate SIM0278, which is intended to treat moderate to severe atopic dermatitis (AD). This development marks a significant step forward in addressing the…
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China-based vaccines specialist CanSino Biotechnology Inc., (HKG: 6185) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its adsorbed tetanus vaccine, CS-2047, aimed at preventing tetanus in adults. Emphasis on Tetanus Prevention in Adult ImmunizationThe National Health Commission (NHC) has previously released…
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Shanghai-based BRL Medicine Inc. has announced that it has received Investigational New Drug (IND) approval from China’s Center for Drug Evaluation (CDE) for its CD19-targeted chimeric antigen receptor (CAR)-T cell therapy, BRL-301. The therapy is set to be assessed as a treatment for acute lymphocytic leukemia (ALL). BRL-301: A Universal…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed positive topline results from two Phase III trials assessing the company’s 21-valent pneumococcal conjugate vaccine candidate, V116. This vaccine, the first of its kind designed for use in adults, is being evaluated in a comprehensive clinical trial program involving 2,600 patients.…
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Everest Medicines (HKG: 1952) has announced the commercial launch of its Xerava (eravacycline) antibiotic in China, with the first prescription being administered at Huashan Hospital affiliated to Fudan University in Shanghai. This launch signifies the Chinese firm’s inaugural commercial-stage product release within the country. Eravacycline: A Novel Intravenous Antibiotic for…
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Jiangsu Recbio Technology Co., Ltd, a China-based company, has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for REC610, a novel adjuvanted recombinant shingles vaccine, for review. Phase I Clinical Trial Design and ObjectivesThe Phase I clinical trial is a randomized, double-blind, and GSK…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) subsidiary, Shanghai Henlius Biotech, Inc. (HKG: 2696), has announced the completion of a Phase I/II study for its anti-VEGF monoclonal antibody (mAb) HLX04-O in the treatment of wet age-related macular degeneration (wAMD). The drug has reportedly demonstrated a good safety…
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China-based SSY Group Ltd (HKG: 2005) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its stiripentol dry suspension, a drug used to treat Dravet syndrome. SSY’s product is confirmed to have passed the generic quality consistency evaluation (GQCE) process, marking a significant…