HQ Team
January 11, 2025: US-based Vertex Pharmaceutical Inc. has signed a licensing pact with China’s Zai Lab Ltd. to develop and commercialise the Boston-headquartered company’s medicine, which is under trial, for treating chronic kidney diseases.
Zai will have an exclusive right to sell Vertex’s povetacicept (pove) in mainland China, Hong Kong SAR, Macau SAR, Taiwan region and Singapore — the licensed territory, according to a Vertex statement.
Pove is a recombinant fusion protein therapeutic and dual antagonist of B cell activating factor (BAFF), and APRIL, a proliferation-inducing ligand, is being studied for the treatment of Immunoglobulin A nephropathy (IgAN) and other B cell-mediated diseases.
Recombinant proteins are genetically engineered as therapeutics to treat or prevent disease. They are created by combining two or more proteins into a single molecule.
B cell activating factor
A dual antagonist of B cell activating factor (BAFF) is a drug that inhibits both BAFF and APRIL. BAFF and APRIL are cytokines that support the survival and differentiation of B cells.
A ligand is a molecule that binds to a receptor, which is a protein molecule. Ligands can be drugs, hormones, or neurotransmitters.
Vertex will receive an upfront payment, as well as certain regulatory milestone payments and tiered royalties, on net sales of pove in the region of focus for Zai Lab.
Zai Lab will utilize its extensive research and development expertise to help advance clinical trials and make regulatory submissions in the licensed territory.
No financial details
“Leveraging its large commercial footprint, Zai Lab will be responsible for all commercialization activities in the licensed territory once pove becomes an approved product,” according to the statement.
Vertex didn’t provide the financial details of the agreement.
“Zai Lab’s deep R&D and commercialization expertise, as well as infrastructure in the region, make them the ideal partner for Vertex as we work to bring pove to patients in China and the broader area,” said Reshma Kewalramani, MD, Chief Executive Officer and President of Vertex.
Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab said: “Pove is an important expansion of our portfolio as we continue to solidify our leading position in immunology in China.”
End-stage trials
Pove is being studied for the treatment of Immunoglobulin A nephropathy (IgAN) and other B cell-mediated diseases.
The end-stage trial of povetacicept 80 mg versus placebo on top of standard of care in about 480 people with IgAN is currently on in multiple regions, including the US, EU and Asia.
The study is designed to have a pre-planned interim analysis evaluating urine protein to creatinine ratio for the povetacicept arm versus placebo after a certain number of patients reach 36 weeks of treatment.
If positive, the interim analysis may serve as the basis for Vertex to seek accelerated approval in the US. The final analysis will occur at two years of treatment.
A separate trial is underway on studying povetacicept in autoimmune glomerulonephritis, including IgAN, primary membranous nephropathy, lupus nephritis, and ANCA-associated vasculitis with glomerulonephritis.
