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RemeGen’s Novel Bispecific Antibody RC148 Receives Clinical Trial Approval
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China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical trial approval for its novel bispecific antibody (BsAb), RC148. This development marks a significant step forward in the company’s efforts to address the complex challenges of treating multiple solid tumors. RC148 Development and Phase I Study…
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Jiangsu Hengrui’s Camrelizumab and Apatinib Combo Accepted for FDA Review for HCC Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that the US Food and Drug Administration (FDA) has accepted for review the Biologic License Application (BLA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, combined with the small-molecule targeted cancer therapy apatinib, as a first-line treatment for unresectable or…
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Jacobio Pharma’s Glecirasib Enters Breakthrough Therapy Review for Pancreatic Cancer Treatment
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China-based Jacobio Pharma (HKG: 1167) has announced that its novel KRAS G12C inhibitor, glecirasib, has entered into the breakthrough therapy review process for the treatment of locally advanced or metastatic pancreatic cancer with the KRAS G12C mutation. The drug is being developed as a second-line treatment in combination with gemcitabine…
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Jiangsu Aidea’s ACC008 Demonstrates Non-Inferior Efficacy to Genvoya in Phase III HIV Study
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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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Everest Medicines Completes Enrollment for Nefecon’s Phase III Extension Study in China
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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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Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density
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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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Zelgen Biopharmaceuticals’ ZG006 Earns NMPA Approval for Clinical Trials in Solid Tumors
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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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Shanghai Benemae’s Benaglutide Approved by NMPA for Adult Weight Management in China
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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’ LBL-034 Secures Clinical Trial Approvals from NMPA and FDA
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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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Huadong Medicine Receives NMPA Approval for Phase I Clinical Trial of DR10624 for Weight Management
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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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Akeso Biopharma Initiates Phase Ia/Ib Study for TIGIT mAb AK127 in Solid Tumors Combination Therapy
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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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Eli Lilly’s Tirzepatide Demonstrates Up to 26.6% Weight Loss in Phase III Obesity Studies
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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 Receives NMPA Approval for Biosimilar Herceptin for HER2+ Cancers
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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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Eli Lilly’s Donanemab Shows Significant Slowdown in Alzheimer’s Disease Progression in Phase III Study
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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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Jiangsu Simcere Pharmaceutical Receives NMPA Approval for Atopic Dermatitis Drug SIM0278
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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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CanSino Biotechnology Receives NMPA Approval for Tetanus Vaccine CS-2047
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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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BRL Medicine Inc. Receives IND Approval for CD19-Targeted CAR-T Therapy BRL-301 from CDE
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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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MSD’s V116 Vaccine Shows Superior Immune Response in Phase III Trials
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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 Launches Xerava Antibiotic in China, Marking Commercial Milestone
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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…
