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Pharmaceutical Network August 28th August 26th, 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®AmBisome® (a bisexual mycomycin B lipid injection) used to treat 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 exceed one million units per year.
TLC has authorized partner Sansheng Pharmaceuticals to be responsible for the commercialization ™ ampholipad Chinese mainland in the world.
agreement, TLC will receive a milestone payment for this drug registration application.
this drug registration application, thanks to ampholipad ™ consistent test data.
Ampholipad™ clinical data not only in the overall blood drug concentration and blood drug concentration wrapped in microlipid form, but also in the most difficult in international regulations not wrapped in microlipid morphology blood drug concentration to verify the biological equivalent of AmBisome®.
same time, Ampholipad™ integrated chemical and production control information also demonstrated its ® drug equivalent to AmBisome.
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