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Merck Ends Phase III Keytruda Studies in NSCLC and cSCC Due to Insufficient Results
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US-based Merck, Sharp & Dohme Inc. (NYSE: MRK) announced the discontinuation of two Phase III trials evaluating its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) in new indications, due to insufficient efficacy. The decisions to halt the trials were made following recommendations from their respective independent data monitoring committees. The trials…
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Tonghua Golden-Horse, UCB Seek China Approvals for Alzheimer’s, Myasthenia Gravis Drugs
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China’s Tonghua Golden-Horse Pharmaceutical Industry Co. Ltd. and Belgium-based UCB (FRA: UNC) are seeking marketing approvals in China for two advanced treatments targeting neurodegenerative and autoimmune conditions, according to the Center for Drug Evaluation (CDE) website. Tonghua Golden-Horse’s octohydroaminoacridine succinate, designed to treat mild to moderate Alzheimer’s disease (AD), and…
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Doma Biopharmaceutical Receives FDA Clearance for Phase I Trial of EGFR-MET Targeting ADC, DM005
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a Chinese pharmaceutical firm, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for its innovative bispecific antibody-drug conjugate (ADC), DM005. This development marks a significant milestone for the company as it advances its pipeline towards…
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Jiyuan Biotechnology’s Stem Cell Therapy for Type 2 Diabetes Gains NMPA Tacit Approval for Clinical Trials
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BEIJING—Jiyuan Biotechnology, a leading Chinese biopharmaceutical company, has secured tacit clinical trial approval from the National Medical Products Administration (NMPA) for its cutting-edge therapy targeting type 2 diabetes. This marks the first clinical trial approval in China for domestically developed gene-modified mesenchymal stem cells. The therapy in question involves the…
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CNGB Virogin’s VG161 On Track for Breakthrough Designation in China for Advanced Liver Cancer
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BEIJING—CNGB Virogin, a joint venture between Virogin Biotech and China National Biotec Group, is poised to secure a breakthrough therapy designation (BTD) from China’s National Medical Products Administration (NMPA) for its innovative drug VG161. The targeted indication for this recombinant human IL12/15-PDL1B herpes simplex type I oncolytic virus injection is…
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Sinopharm and Ruidio Pharmaceutical Advance in Priority Review for Innovative Drugs and Vaccines
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BEIJING—The Center for Drug Evaluation (CDE) has indicated that two Chinese companies, Foshan Ruidio Pharmaceutical Co., Ltd and Chengdu Institute of Biological Products Co., Ltd., part of Sinopharm, are on the path to priority review for their respective medical innovations. Ruidio’s Technetium [99mTc] hydrazine nicotinamide polyethylene glycol bicyclic RGD peptide…
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Jiangsu Simcere and AnDiConBio’s Anti-Influenza Drug ADC189 Doses First Patient in Phase III Study
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JIANGSU—In a significant development for the pharmaceutical industry, Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in collaboration with AnDiConBio, has initiated a Phase III clinical study for their anti-influenza drug, ADC189. This study marks a crucial step in the advancement of pediatric treatment options, with the first patient dosed in…
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Sino Biopharmaceutical’s Anlotinib-Penpulimab Combo Meets Milestone in Phase III HCC Study
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HONG KONG—Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the successful completion of a pre-set interim analysis in its Phase III clinical study. The study combines anlotinib with penpulimab as a first-line treatment for advanced hepatocellular carcinoma (HCC), achieving the optimal efficacy thresholds for…
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Jiangxi Jemincare Secures First Generic Approval for GSK’s Requip in China
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Jiangxi Jemincare Group, based in China, has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of GSK’s Requip (ropinirole), marking the first generic approval for this medication in China. The drug is indicated for the treatment of Parkinson’s disease (PD) and PD with non-motor…
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Sanofi Halts Flu Vaccine Distribution in China Amid Potency Concerns
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Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has reportedly suspended the distribution and sale of its flu vaccines in China following concerns over declining potency identified during routine batch checks. According to FiercePharma.com, which cites an email from a Sanofi spokesperson, the suspension will affect supplies of both Vaxigrip and…
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JW Therapeutics’ CAR-T Therapy Carteyva Secures NMPA Approval for Mantle Cell Lymphoma Indication
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JW Therapeutics, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2126), has received additional indication approval from the National Medical Products Administration (NMPA) for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection). This approval extends to adult patients with…
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Shanghai-Based ANEXT Commences Clinical Trials for Exosome Product ANEXT FIT CELL in Respiratory Conditions
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ANEXT, a Shanghai-based exosome specialist, has launched two clinical studies for their product ANEXT FIT CELL, which is derived from mesenchymal stem cells exosomes. One study aims to evaluate the product’s efficacy in treating cough symptoms following infection, while the other is focused on safety and preliminary efficacy in the…
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Legend Biotech’s Carvykti Receives NMPA Approval for Relapsed/Refractory Multiple Myeloma After Multi-Center Phase II Study
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Legend Biotech Corporation (NASDAQ: LEGN) has secured a significant milestone with the announcement of marketing approval from China’s National Medical Products Administration (NMPA) for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). This therapy is intended for patients with relapsed/refractory multiple myeloma (MM) who have undergone…
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Jiangsu Hengrui’s Vunakizumab Receives NMPA Approval as First Homegrown Autoimmune IL-17A Drug
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Jiangsu Hengrui Pharmaceuticals Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 600276), has announced that the National Medical Products Administration (NMPA) has approved its market filing for vunakizumab, an IL-17A monoclonal antibody (mAb), for the treatment of moderate to severe plaque psoriasis suitable for systemic…
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Hinova Pharmaceuticals’ HP515 Receives NMPA Approval for NASH Clinical Study
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Hinova Pharmaceuticals Inc., a biotech firm headquartered in Chengdu and listed on the Shanghai Stock Exchange (SHA: 688302), has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 chemical drug candidate, HP515. The molecule is intended for the treatment of nonalcoholic…
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Bio-Thera Solutions’ BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy
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Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange (SHA: 688177), has received approval from the National Medical Products Administration (NMPA) to advance its antibody drug conjugate (ADC) BAT8006 into clinical trials in combination with bevacizumab. This trial will focus on maintenance therapy for…
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Chongqing Genrix Biopharmaceutical Receives NMPA Approval for Xeligekimab, First Domestic Anti-IL-17 Antibody
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Chongqing Genrix Biopharmaceutical Co., Ltd, a Chinese biopharmaceutical company, has received marketing approval from China’s National Medical Products Administration (NMPA) for its self-developed Category 1 biologic product, xeligekimab. This marks the first domestically developed anti-IL-17 antibody in China approved for the treatment of moderate-to-severe plaque psoriasis. The introduction of xeligekimab…
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Regeneron Secures EU Approval for Ordspono, Its First Bispecific Antibody
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Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has secured its first global market approval for Ordspono (odronextamab) from the European Commission (EC). This marks a significant milestone as Ordspono becomes the company’s first bispecific antibody (BsAb) to receive approval, designated for the treatment of adult patients with relapsed or refractory (R/R) follicular…
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Shanghai Fudan-Zhangjiang Enrolls First Patient in Phase III Trial for TROP2 ADC FDA018 in TNBC
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 1349) and the Shanghai Stock Exchange (SHA: 688505), has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate FDA018. This TROP2 antibody-drug conjugate (ADC) is…
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China’s Guilin Sanjin Pharmaceutical Advances BC011 with NMPA Approval for Phase I Clinical Trial
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Guilin Sanjin Pharmaceutical Co. Ltd, a Chinese pharmaceutical company listed on the Shenzhen Stock Exchange (SHE: 002275), has announced that its subsidiary, Dragon Boat Pharmaceutical (Shanghai) Co., Ltd, has obtained approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its drug candidate BC011,…
