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August 26, Sansheng Pharmaceuticals ("3SBio") (HKEX: 1530) and its partner Taiwan Microlipids Co., Ltd. ("TLC") (Nasdaq: TLC, TWO: 4152) announced that TLC's Ampholipad™ registration application has been accepted by the National Drug Administration's Drug Review Center (CDE), a chemical generic of Gilead Inc.'s AmBisome® (B-lipid injection of b lipids for both sexes) for the treatment of systemic fungal infections. Chinese mainland market is currently without AmBisome ® or its generic products on the market.Ampholipad ™ been approved for sale in Taiwan for many years and has recently been approved to expand production to more than one million units per year. TLC has authorized partner Sansheng Pharmaceuticals to take charge of ampholipad™ commercialization Chinese mainland in the world. Under the cooperation agreement, TLC can receive a milestone payment for this drug registration application.application for this drug registration, thanks to ™ consistent test data from Ampholipad. The clinical data of Ampholipad™ not only verify the biological equivalent of AmBisome® in the overall blood drug concentration and the blood drug concentration encased in the microlipid form, but also in the most difficult non-wrapped microlipid morphological blood drug concentration in international regulations. At the same time, Ampholipad™ integrated chemical and production control information has also demonstrated its ® drug equivalent to AmBisome."
(Agency)