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Kelun Pharmaceutical’s Generic Mulpleta Gains NMPA Approval in China
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Japan-based Shionogi’s Mulpleta (lusutrombopag). This Category 4 chemical drug becomes the first generic Mulpleta in China, marking a significant milestone in the…
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Sino Biopharmaceutical’s Chia Tai Tianqing Secures Exclusive Promotion Rights for Naldemedine in China
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced an exclusive market promotion agreement between its subsidiary Chia Tai Tianqing and Ping An-Shionogi Co., Ltd, a joint venture between China-based commercial insurance firm Ping An Insurance (Group) Ltd and Japanese pharmaceutical firm Shionogi & Co., Ltd. Under this initially 11-year accord,…
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Vocabria Receives Positive CHMP Opinion for HIV Treatment in Adolescents
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GSK plc (NYSE: GSK) has announced that ViiV Healthcare, an HIV specialist majority owned by GSK with Pfizer and Shionogi as shareholders, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of…
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Shionogi Files for Chinese Approval of Cefiderocol to Combat Gram-Negative Bacterial Infections
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Shionogi Co., Ltd, a prominent Japanese pharmaceutical company, has announced the filing of a New Drug Application (NDA) in China for its innovative next-generation siderophore cephalosporin antibiotic, cefiderocol. The drug, marketed as Fetcroja or Fetroja in 10 different markets including Europe, Japan, and the United States, is now under consideration…
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Shionogi’s Xofluza Gains Approval in Taiwan for Pediatric Influenza Treatment and Prophylaxis
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Shionogi & Co., Ltd, a leading Japanese pharmaceutical company, has announced that it has received approval for a supplemental new drug application (sNDA) in Taiwan for its influenza treatment and prophylaxis drug, Xofluza (baloxavir marboxil). This first-in-class, oral anti-viral medication is now approved for use in children aged between 5…
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Shionogi’s Acquisition of Qpex Impacts Brii Biosciences’ Rights to Anti-infective Drugs
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Japan’s Shionogi & Co., Ltd (TYO: 4507) announced on June 26, 2023, its planned acquisition of US anti-infectives specialist Qpex Biopharma Inc., for USD 100 million upfront and an additional USD 40 million based on certain development and regulatory milestones. This deal has significant implications for China-based biotech Brii Biosciences…
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Sino Biopharmaceutical Secures Rights to Shionogi’s COVID-19 Therapy Ensitrelvir
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its subsidiary Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd (CTTQ) has entered into a preliminary five-year licensing agreement with Japan-based Shionogi & Co., Ltd. Under the agreement, CTTQ will take exclusive market promotion rights to Shionogi’s oral COVID-19 therapy ensitrelvir in…
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Shanghai Pharmaceuticals Secures Exclusive Rights for Shionogi’s Ensitrelvir in China
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Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has announced an import and distribution agreement with Japan-based Shionogi & Co., Ltd, becoming the exclusive importer and agent of the latter’s oral COVID-19 therapy ensitrelvir in mainland China. The two-year deal also includes a collaboration on innovative and generic drugs. Financial details of…
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Hansoh Pharma Licenses GHDDI’s GDI-4405 for Global Development in COVID-19
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced a licensing agreement with the Global Health Drug Discovery Institute (GHDDI) to develop the COVID-19 therapy GDI-4405. Hansoh will gain exclusive global rights to the drug’s clinical development, manufacturing, and commercialization. Agreement DetailsHansoh will pay GHDDI an upfront fee of RMB…
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Shionogi Files NDA for S-217622 COVID-19 Antiviral Drug in China
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Japan-based Shionogi & Co., Ltd has submitted a New Drug Application (NDA) to the National Medical Products Administration (NMPA) in China for its oral antiviral drug S-217622, developed through a joint venture with Ping An Life Insurance Company under the name Ping An-Shionogi Co., Ltd. Drug ProfileS-217622 is an oral…
