LIEGE: Belgian biopharmaceutical company Hyloris Pharmaceuticals SA said on Monday it has signed an exclusive license and distribution agreement with China’s Grand Life Sciences Group Co., Ltd. for HY-094, its investigational injectable iron therapy.
The partnership grants Grand Life Sciences the rights to develop and commercialize HY-094 in China, a market for intravenous (IV) iron drugs projected to grow to $151.2 million by 2030, from $40.0 million in 2024, according to data cited by Hyloris.
HY-094 is a new chemical entity being developed to treat iron deficiency anemia, a condition affecting an estimated 1.3 billion people globally. The candidate has shown promise in clinical trials by demonstrating comparable efficacy to leading IV iron therapies while potentially offering a better safety profile and a more convenient dosing schedule.
According to Hyloris, a Phase II trial in 146 patients showed HY-094 had significantly lower administration-related complications than the leading IV iron product (2.7% vs. 29.7%). It also did not cause a clinically relevant drop in blood phosphate levels—addressing a key safety concern called hypophosphatemia—and showed lower levels of free iron, suggesting lower toxicity.
Hyloris and its co-development partner, AFT Pharmaceuticals, will share an upfront payment, development and sales milestones, and royalties from the deal. Grand Life Sciences will also contribute to the global Phase III clinical program, which is expected to run until 2028 and support regulatory submissions worldwide.
“We are confident in the potential of our intravenous iron product and believe this partnership will support its successful introduction and growth in this rapidly expanding market,” said Stijn Van Rompay, Co-CEO of Hyloris.
The global IV iron drug market is forecast to grow from approximately $3.2 billion in 2023 to over $7.41 billion by 2033, driven by rising awareness of iron deficiency and its associated health impacts.
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