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Amoytop Biotech Opts for NASH Drug Candidate KN069 in Licensing Deal with Alphamab Oncology
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Xiamen Amoytop Biotech Co., Ltd (SHA: 688278), a biopharmaceutical company based in China, has exercised its option rights for KN069, a drug candidate for non-alcoholic steatohepatitis (NASH), under a licensing agreement with fellow Chinese firm Alphamab Oncology (HKG: 9966). The original deal, signed in December 2023, granted Amoytop the choice…
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Jiangsu Suzhong Pharma’s Sutetinib Earns Breakthrough Designation for NSCLC from China’s NMPA
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Jiangsu Suzhong Pharma Group Co., Ltd, a leading pharmaceutical company based in China, has received a breakthrough therapy designation from the National Medical Products Administration (NMPA) for its drug candidate sutetinib, which is under development for locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific non-resistant rare EGFR…
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Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Cleared for Clinical Trial by NMPA
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate, PLAT001. This novel injectable drug is under evaluation for the treatment of general advanced or metastatic solid tumors.…
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Hinova Pharmaceuticals Receives NMPA Approval to Test Myelofibrosis Drug Candidate HP560
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biopharmaceutical company based in Chengdu, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 chemical drug candidate, HP560. The molecule is being evaluated as a potential treatment for myelofibrosis,…
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Belief BioMed and Takeda’s Hemophilia B Gene Therapy BBM-H901 Accepted for NMPA Review
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Belief BioMed Group (BBM), a Shanghai-based gene therapy specialist, and Takeda have announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for BBM-H901, a gene therapy for hemophilia B. This development marks a significant milestone for the treatment, which is being designed…
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Pfizer’s Hemophilia A Gene Therapy Shows Promise in Phase III AFFINE Study
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Pfizer Inc. (NYSE: PFE), a US pharmaceutical giant, has announced positive topline results from the Phase III AFFINE study for its gene therapy candidate, giroctocogene fitelparvovec, for the treatment of hemophilia A. With these results, Pfizer is now poised to prepare for regulatory submission for this one-time gene therapy, which…
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Novo Nordisk’s Wegovy Approved in the UK to Reduce Cardiovascular Risks in Overweight Adults
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Novo Nordisk (NYSE: NVO)’s anti-obesity drug Wegovy (semaglutide) has received a new indication approval in the United Kingdom, with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granting approval for its use in reducing the risk of serious heart problems or strokes in overweight or obese adults. This marks…
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IASO Biotherapeutics’ CAR-T Therapy Fucaso Receives FDA IND Approval for Multiple Sclerosis
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China-based IASO Biotherapeutics has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to explore the potential of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), in treating multiple sclerosis (MS). This marks the second IND nod…
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ST Phi Therapeutics’ Universal Cell Therapy for Solid Tumors Gets Green Light for Clinical Trial in China
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ST Phi Therapeutics, a Hangzhou-based cell therapy specialist, has secured tacit approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial for its innovative cell therapy, CNK-UT002. This marks a significant milestone, as CNK-UT002 is the first universal cell therapy for solid tumors to be approved for…
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Innorna’s Herpes Zoster mRNA Vaccine IN001 Receives Clinical Trial Approval in China
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Shenzhen-based Innorna Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to commence clinical trials for its proprietary IN001, a novel mRNA vaccine designed to combat herpes zoster. This marks a significant milestone for the company, as IN001 is the first mRNA-based herpes…
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Bayer’s BAY 3375968 Receives NMPA Approval for Clinical Trial in Advanced Solid Tumors
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Bayer AG (ETR: BAYN), a multinational pharmaceutical giant based in Germany, has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 drug BAY 3375968. This novel Fc optimized anti-CCR8 antibody is currently the subject of a Phase I clinical study globally. BAY 3375968 has…
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Chipscreen’s HDAC Inhibitor Chidamide to be Tested in Combination Therapy for CRC by NMPA
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical trial. The trial is designed to evaluate the efficacy and safety of Epidaza (chidamide) in combination with the PD-1 inhibitor sintilimab…
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ViiV Healthcare’s Dovato Shows Non-Inferior Efficacy and Less Weight Gain in Pivotal PASO DOBLE Study
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ViiV Healthcare, the HIV-focused subsidiary majority-owned by GSK with Pfizer and Shionogi as shareholders, has reported positive topline results from the Phase IV PASO DOBLE study. This clinical trial compared ViiV’s two-drug regimen Dovato (dolutegravir/lamivudine) to Gilead’s three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate) in the treatment of HIV-1 over a…
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Jiangsu Hansoh’s Loxenatide Matches Dapagliflozin in Diabetes Nephropathy Clinical Trial
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Jiangsu Hansoh Pharmaceutical Co., Ltd, a leading pharmaceutical company based in China, has published the results of a clinical study for its polyethylene glycol (PEG) loxenatide—a Category 1 novel chemical drug—in the treatment of diabetes nephropathy (DKD) in the Frontiers in Endocrinology journal. The study’s data indicate that loxenatide is…
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China’s NMPA Considers Breakthrough Designations for Xiangxue and Innostellar’s Therapies
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Xiangxue Pharmaceutical Co., Ltd (SHE: 300147) and Innostellar Biotherapeutics Co., Ltd have both been noted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) as potential candidates for breakthrough therapy designations (BTDs). Xiangxue’s TAEST16001, a T-cell receptor TCR affinity-enhanced specific T-cell (TAEST) therapy, and Innostellar’s…
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Johnson & Johnson Pursues FDA Approval for Spravato as Monotherapy for Treatment-Resistant Depression
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Johnson & Johnson (J&J, NYSE: JNJ), a leading global healthcare company, is pursuing expanded approval for its anti-depression drug Spravato (esketamine) in the U.S. by submitting a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). The application seeks to establish Spravato CIII nasal spray as…
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RemeGen’s Telitacicept Earns Full NMPA Approval for RA Treatment and PMN Clinical Study Green Light
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RemeGen (HKG: 9995), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted full approval for its drug telitacicept, which is used in combination with methotrexate for the treatment of moderate to severe rheumatoid arthritis (RA) patients who have not responded well to…
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AccurEdit Therapeutics Receives CDE Approval for Gene Editing Drug ART001 Targeting Amyloidosis
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AccurEdit Therapeutics (Suzhou) Co., Ltd, a leading specialist in gene editing therapies based in China, has received approval from the Center for Drug Evaluation (CDE) for its investigational drug ART001. This drug is designed to target transthyroxine protein amyloidosis, a severe genetic disorder. ART001 marks a significant advancement in China’s…
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ICER Analysis Flags Pfizer’s ATTR-CM Therapy Vyndamax/Vyndaqel as Costly, Suggests Price Cut
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The Institute for Clinical and Economic Review (ICER), a US-based non-profit organization specializing in drug cost-effectiveness analysis, has released a pricing analysis for treatments of the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM). The report particularly focuses on Pfizer’s Vyndamax/Vyndaqel (tafamidis) capsules, which were approved for ATTR-CM in the US…
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Jiangsu QYuns Therapeutics and Huadong Medicine Partner on QX005N Injection Development and Promotion
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Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has entered into a co-development and market promotion service agreement with Huadong Medicine Co., Ltd (SHE: 000963) for the development and commercialization of QX005N injection. Under the terms of the agreement, Huadong will participate in the clinical…
