Shanghai Henlius Biotech announced that it has entered into a strategic collaboration with Sandoz, a global leader in generics and biosimilars, covering up to 10 proposed monoclonal antibody (mAb) and/or antibody-drug conjugate (ADC) biosimilar products or components developed by Henlius. The parties have also signed collaboration terms for an initial three agreed products and an option for one additional asset.
Under the strategic collaboration agreement, Henlius will grant Sandoz exclusive rights for registration and commercialization outside China for up to 10 partnered products worldwide. Most of the partnered products are currently at early stages of development, and the two parties will collaborate closely from the early stages of project development. Based on a multi-product portfolio framework, the collaboration will cover key stages across the product lifecycle, including product development, regulatory submissions, manufacturing, launch, commercialization and lifecycle management.
Henlius will leverage its integrated biologics platform to undertake the development, manufacturing and supply of the partnered products, thereby accelerating the development and translation of early-stage molecules. Sandoz has a diversified portfolio of approximately 1,300 medicines, a business presence in around 100 countries and reaches over 1 billion patients worldwide. It has established a strong track record in product registration, market access, launch and commercialization. Leveraging its extensive global footprint, deep localized operating capabilities and market-validated commercialization system, Sandoz will incorporate ex-China market insights and commercial perspectives into product development and registration strategies at an early stage, driving the efficient execution of the partnered products in global markets. Through deep synergies across the entire product lifecycle, the two parties will continue to unlock the global commercial value of the partnered products.
This collaboration represents an important part of Henlius' globalization strategy. It not only demonstrates the company's comprehensive strengths in biologics R&D, quality systems, international registration, large-scale manufacturing and global supply, but also further validates the global value of its biosimilars platform. Henlius has established a diversified pipeline spanning biosimilars and innovative biologics, with multiple self-developed biologic products approved in China, the EU, the United States and other global markets.
By partnering with leading global pharmaceutical companies, Henlius continues to expand product access to more countries and regions and accelerate the global commercialization of more biologics. At the same time, the company is continuing to build its own ex-China commercialization capabilities and, based on the market potential, competitive landscape and commercialization needs of different products, is flexibly adopting a combination of independent advancement and strategic partnerships to bring products to global markets through diversified pathways and further unlock the value of its R&D, manufacturing and global supply platforms.