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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 (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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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, 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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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 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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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, 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 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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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 (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 (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 (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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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 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…
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Innovent Biologics Inc. (Innovent) (HKG: 1801), a leading biopharmaceutical company based in China, has announced positive results from the Phase III DREAMS-1 clinical trial for mazdutide (IBI362), a dual agonist targeting the glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) for the treatment of type 2 diabetes (T2D) in Chinese…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study combining its CDK 4/6 inhibitor, Dalpiciclib (SHR6390), with HRS-1358 for the treatment of breast cancer. This marks a significant step in expanding…
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading biopharmaceutical company based in China, has announced the submission of a market filing application for its epidermal growth factor receptor (EGFR) inhibitor, Ameile (almonertinib), to the National Medical Products Administration (NMPA). The application seeks approval for Ameile as an adjuvant therapy…
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The National Medical Products Administration (NMPA) has granted approval for Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321)’s Category 1 drug Bilessglu (chiglitazar sodium) for use in combination with metformin to treat type 2 diabetes. This decision marks another milestone for the Chinese pharmaceutical company, which has developed chiglitazar as a…
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Apeiron Therapeutics, a Shanghai-based biopharmaceutical company, has reached an agreement to sell all rights to its oral CDK7 inhibitor GTAEXS617 to Exscientia plc (NASDAQ: EXAI), a US-based AI-driven pharmaceutical company. The total transaction value amounts to USD 30 million, comprising an upfront cash payment of USD 10 million and a…