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.
The Monetary Authority of Singapore has revised its "single family office" (SFOs) framework to streamline the process for SFOs to establish operations in Singapore, according to a MAS release.An SFO in Singapore is a privately held corporate entity set up by one "ultra-high-net-worth" family to manage assets, investments, and wealth of a single family.The registration protocols have been simplified, effective June 15, with offices required to notify MAS of their operations through a MAS-licensed bank.Annual reporting has been made more straightforward for SFOs, with information on total assets under management and the name of its bank.
Klevo Rewards (ASX:KLV) said it plans to launch a trial of its KLVAUD Australian dollar-backed stablecoin by June 30, according to a Monday filing with the Australian bourse.The company's Fly Wallet subsidiary received legal advice indicating that the stablecoin may qualify as an eligible stablecoin under the current regulatory framework, subject to conditions, per the filing.KLVAUD is planned to be fully backed one-to-one by Australian dollars held in segregated reserve accounts, and aims to support Fly Wallet's broader payments system, the company said.Klevo Rewards shares fell 4% in recent Monday trade.
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.