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SHA:688177

6 stories mentioning SHA:688177Updated 1d ago

Every FINWIRES story that references SHA:688177, newest first.

Asia

Bio-Thera Solutions' Yonghe Plant Fails Part of EU GMP Inspection; Shares Slip 2%

Bio-Thera Solutions (SHA:688177) said its Yonghe plant received mixed results from its E.U. Good Manufacturing Practices (GMP) inspection.While the drug substance portion passed and its GMP certificate was updated, the drug product portion failed due to inadequate deviation management, according to a Monday filing with the Shanghai bourse.Shares of the pharmaceutical company were down 2% in recent trade.

SHA:688177
Asia

Bio-Thera Solutions Gets Europe's Results on On-Site Inspection

Bio-Thera Solutions (SHA:688177) received the results of the European Union's inspection of its Yonghe manufacturing facility, according to a Shanghai bourse filing on Monday.The French National Agency for the Safety of Medicines and Health Products conducted an inspection on the site between Feb. 4 and Feb. 12.The European Medicines Agency handed a GMP or good manufacturing practice certificate to the company after the factory's drug substance operations passed regulatory standards. However, the regulator found deficiencies in the deviation management measures for the finished formulation of the drugs.

SHA:688177
Asia

Bio-Thera Solutions Obtains Singapore Nod for Ustekinumab Biosimilar

Bio-Thera Solutions (SHA:688177) received marketing approval from Singapore's Health Sciences Authority for ustekinumab biosimilar BAT2206.The drug is indicated for psoriasis and Crohn's disease in children and adults, according to a Thursday filing with the Shanghai bourse.Shares of the pharmaceutical company were down 1% in recent trade.

SHA:688177
Asia

CICC Reviews Bio-Thera Solutions' Proposed Forex Hedging Activities

China International Capital (HKG:3908, SHA:601995) conducted a review into Bio-Thera Solutions' (SHA:688177) proposed foreign exchange hedging activities, according to a Shanghai bourse filing on Friday.The financial services provider said it has no objection to the proposal, which is found that are intended to improve Bio-Thera's ability to manage foreign exchange risks.

HKG:3908SHA:601995SHA:688177
Asia

Bio-Thera Solutions Gets Registration Certificates for Ustekinumab Injection

Bio-Thera Solutions (SHA:688177) received drug registration certificates from China's National Medical Products Administration for ustekinumab injection, according to a Friday disclosure on the Shanghai bourse.The certificates include ustekinumab injection and ustekinumab injection in intravenous infusion form, trading as Aisali and Xisali, respectively.The Chinese drugmaker's shares slipped 1% during the afternoon trade.

SHA:688177
Asia

Bio-Thera Solutions Gets Nod for BAT8013 for Injection's Clinical Trial

Bio-Thera Solutions (SHA:688177) obtained approval from China's National Medical Products Administration for the clinical trial of BAT8013 for injection, according to a Shanghai bourse disclosure on Wednesday.The drug is being developed as a treatment for advanced or metastatic solid tumors.

SHA:688177

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