Taiwan Liposome Company Ltd. (TLC) in collaboration with 3SBio recently get an acceptance of Marketing Authorization Application (MAA) for Ampholipad. The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA, formerly China Food and Drug Administration) has provided that acceptance.
TLC is a clinical-stage specialty pharmaceutical company is developer of innovative nanomedicines and commercializes them to cater the areas of unmet medical need. Ampholipad is a complex generic of Gilead’s AmBisome (amphotericin B liposome for injection) developed by TLC which has been used to treat patients with systemic fungal infections and is not available in mainland China yet.
Ampholipad is approved and has been in Taiwanese markets for many years. The drug recently received an approval to expand productions that came boosting its annual production to more than a million vials.
TLC partnered with 3SBio Inc. to commercialize Ampholipad in mainland China. 3SBio is a fully integrated biotechnology company. Its higher penetration in the market and stronger sales force helped the company to generate operating revenue of RMB 5.3 billion (approximately $750 million) last year. Accomplish this regulatory target will bring in a milestone payment for TLC as part of the partnership agreement with 3SBio.
The unavailability of AmBisome in China is an exceptional opportunity for Ampholipad to start excels in the market before the brand drug does. China being a region that has not been available with AmBisome, is unchartered territory for liposomal amphotericin B, said George Yeh, President of TLC. Ampholipad by TLC proved its similarity with the brand drug and the company believes that ist availability in China could transform the way the disease has currently been treated in the country.
Joining the advantageous lower toxicity of TLC’s liposomal formulation with more than 3,000 professionals comprising robust sales and marketing force of 3SBio across the country, ensures the huge commercial potential of Ampholipad in China.