TLC BioSciences Secures Marketing Approval for Ampholipad® in China

SOUTH SAN FRANCISCO, CA and TAIPEI, Taiwan TLC BioSciences (TLC), a late clinical-stage specialty pharmaceutical company focused on addressing unmet medical needs through the development and commercialization of nanomedicines, today announced that its generic drug Ampholipad (TLC166) has received marketing approval from the National Medical Products Administration (NMPA) of China. Ampholipad is a complex generic version of Gilead's AmBisome (liposomal amphotericin B for injection, 50mg), indicated for the treatment of serious, life-threatening fungal infections. Complex generics possess intricate chemical compositions and challenging manufacturing processes, making their development, clinical validation, and approval more demanding than standard generics. Following the approval of AmBisome in China in 2023, TLC demonstrated the quality and bioequivalence of Ampholipad to AmBisome within two years, obtaining NMPA approval. This achievement highlights TLC's adherence to international pharmaceutical standards in manufacturing quality and showcases the expertise of TLC's R&D, manufacturing, non-clinical, clinical, and regulatory teams. “We are grateful to the TLC team for enduring this rigorous journey,” said George Yeh, President of TLC. “Securing this approval was a formidable challenge, as the drug registration process in China is intricate, involving multiple stages of rigorous review and regulatory compliance. The approval of Ampholipad will help meet clinical treatment needs in China, providing more effective therapeutic options for patients." The commercialization of Ampholipad in the Chinese market will be led by 3SBio, which specializes in the development, manufacturing, and sales of biopharmaceutical products. 3SBio boasts a top-tier sales force and significant market share. In the first half of 2024, 3SBio's revenue reached RMB 4.389 billion, ranking among the top 50 pharmaceutical companies in China and earning the title of "Best Industrial Enterprise in China's Pharmaceutical R&D Product Line 2024”. According to Research and Markets, the global antifungal therapeutics market was valued at $16.5 billion in 2023 and is projected to reach $22 billion by 2030, with a compound annual growth rate (CAGR) of 4.2% from 2023 to 2030. The approval of Ampholipad in China is expected to boost TLC's near-term revenue growth. TLC remains committed to developing innovative therapeutics and promoting its products globally, bringing greater benefits to patients.

The release as fetched from its publisher. tlcbio.com ↗