September 3, 2026, Shanghai – ShanZeBIO today officially announced that, through close collaboration with Clinigen, a leading global pharmaceutical services provider, it has successfully obtained the Marketing Authorization (MA) for Avelox in Singapore. This is the first MA transfer for ShanZeBIO since it reached an agreement with Bayer on the global rights to Avelox this February, marking the company’s official acquisition of full and independent rights to the product, and the full-scale launch of Avelox’s global operations with innovator quality and standards.
ShanZeBIO is a specialized platform company invested by HSG and dedicated to the acquisition, introduction and commercialization of innovative pharmaceutical products from around the world. From rights transfer to the completion of the first overseas market access, the company took only half a year, fully demonstrating ShanZeBIO’s comprehensive capabilities in rapid market access, full product lifecycle management, and global operations.
This MA transfer in Singapore also marks a significant milestone for ShanZeBIO in its independent operation and internationalization strategy for Avelox – formally gaining autonomous management control over the entire process from manufacturing and logistics to distribution, ensuring uniform global product management with high-standard quality systems, and setting a benchmark for the company’s future in-licensing and operation of more global innovative products.
Securing Full and Independent Rights to the Product, with Complete Control Across the Entire Chain
MA is the requisite authorization for drug market entry. Holding the MA means exercising regulatory oversight over the entire product lifecycle, including manufacturing and distribution, and also means having full independent control over the entire product chain.
As a key market in the Asia-Pacific region, Singapore’s drug regulatory system is highly aligned with international standards. Adhering to innovator quality and establishing high-standard pharmacovigilance and quality management systems have been central to ShanZeBIO’s rapid achievement of the Singapore MA transfer, and also form the foundation for ensuring the safety, efficacy, and consistency of the product in every market.
Obtaining the MA signifies that the company now formally holds full autonomous control and independent decision-making authority over the entire chain for Avelox, enabling it to independently lead the product’s commercialization process in global markets as an autonomous operator. This provides institutional safeguards for the company’s commercial operations.
Rooted in China, Expanding to the World – The Globalization Strategy Officially Sets Sail
With Singapore as its starting point, ShanZeBIO is simultaneously advancing the development of Avelox’s global MA network, while actively pursuing the in-licensing of additional global innovative products – steadily building toward a globally diversified pipeline.
ShanZeBIO remains committed to leveraging a global perspective and proven commercialization models to ensure that cutting-edge innovative products benefit patients worldwide, positioning global expansion as one of its core development strategies. This Singapore MA transfer for Avelox represents a major breakthrough on the company’s path to independent product operations, and also embodies ShanZeBIO’s mission of “Rooted in China, expanding to the world, providing sustainable healthcare solutions for patients globally”.