TLC in conjunction with 3SBio announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA, formerly China Food and Drug Administration) has accepted its Marketing Authorization Application (MAA) for Ampholipad™, TLC's complex generic of Gilead's AmBisome® (amphotericin B liposome for injection) used for the treatment of systemic fungal infections. AmBisome® is currently not available in mainland China. Ampholipad™, which has been approved and sold in Taiwan for many years, recently received a scale-up production approval, bumping its production to over a million vials a year.

Ampholipad™ will be commercialized in mainland China by TLC's partner, 3SBio Inc., a fully integrated biotechnology company with high market penetration and a robust sales force whose operating revenue for 2019 exceeded RMB 5.3 billion (USD 750 million). Under the terms of the partnership, TLC will receive a milestone payment for achieving this regulatory landmark. AmBisome's unavailability in China creates a rare opportunity for Ampholipad™ to become available before the brand drug.

The huge commercial potential of Ampholipad™ is ensured by combining the advantages the lower toxicity of TLC's liposomal formulation and the strong sales and marketing team of 3SBio, with 3,000 professionals across China. The MAA is supported by evidence of sameness demonstrated by clinical data in which Ampholipad™ demonstrated bioequivalence to AmBisome® in not only the total form and the encapsulated form plasma drug concentrations, but also in the un-encapsulated form, the most difficult standard to achieve, as well as by comprehensive chemistry and manufacturing control information which demonstrate pharmaceutical equivalence to AmBisome®.