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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 Medicine 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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Luye Pharma’s Subsidiary Boan Bio Reports 2024H1 Revenue Growth and First Full Year of Profitability
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Luye Pharma Group, a Chinese pharmaceutical company listed in Hong Kong (HKG: 2186), has announced its 2024H1 financial report through its controlling subsidiary, Shandong Boan Biotechnology Co., Ltd (HKG: 6955). The report reveals a significant year-on-year (YOY) increase in total revenues, which stood at RMB 363 million, a rise of…
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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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Walvax Biotechnology Reports 2024H1 Revenue Dip Amid Intense Vaccine Market Competition
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Walvax Biotechnology Co., Ltd, a Chinese vaccine manufacturer listed on the Shenzhen Stock Exchange (SHE: 300142), has released its financial report for the first half of 2024. The company reported operating revenue of RMB 1.433 billion, marking a significant year-on-year (YOY) decrease of 33.88%. The non-net profit attributable to the…
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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 Bio Pharmaceutical Receives NMPA Approval for Xeligekimab, First Domestic Anti-IL-17 Antibody
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Chongqing Genrix Bio Pharmaceutical 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…
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Takeda’s Entyvio Receives Historic Patent Term Adjustment in China, a First for the Country
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On August 16, a significant milestone was reached as the China National Intellectual Property Administration (CNIPA) awarded Japanese pharmaceutical company Takeda (NYSE: TAK)’s Entyvio (vedolizumab) a Patent Term Adjustment (PTA) for patent NO. ZL201711310404.0, marking the first case of its kind in China. This decision deviates from the typical Patent…
