Celltrion signs license-in deal with US biotech Kaigene worth up to $580.5m
In short
Celltrion said on 22 October it signed a global license-in agreement with Maryland-based biotech Kaigene for the autoimmune drug candidate KG013. The deal is worth up to $580.5 million including an upfront payment and milestones, and gives Celltrion exclusive worldwide development and sales rights.
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Celltrion said on 22 October that it had signed a global license-in agreement with Kaigene, a biotech company based in Maryland in the United States, for the autoimmune disease drug candidate KG013. Under the agreement, Celltrion secured exclusive worldwide rights to develop and sell the candidate. [ 1 , 2 , 3 , 4 ]
The agreement is worth up to $580.5 million, which includes an upfront payment and the amounts due as development, approval and commercialization milestones are reached. Royalties on net sales are to be paid separately after commercialization. Newsis, Electronic Times and Asia Economy put the value at about 769.5 billion won, while Yonhap gave about 768.6 billion won. [ 1 , 2 , 3 , 4 ]
Kaigene will hold the right to take part in co-selling in the Korean market only, according to Newsis, Electronic Times and Asia Economy. [ 1 , 3 , 4 ]
KG013 targets APRIL, a signalling protein involved in the survival and function of antibody-producing B cells, and is a next-generation antibody drug candidate for IgA nephropathy and other immune diseases. Celltrion said existing treatments either suppress immune cells broadly or lower blood pressure to delay kidney damage, while APRIL-targeting treatment acts more selectively on the underlying mechanism of IgA nephropathy by reducing pathogenic IgA. [ 1 , 2 , 3 , 4 ]
Celltrion said KG013 is being developed with greatly improved potency and persistence in the body compared with first-generation treatments, so that disease can be controlled with smaller doses and longer intervals between doses. The company plans to develop it as a best-in-class drug with greater convenience and treatment continuity for patients. [ 1 , 3 , 4 ]
Kaigene was described as a biotech specializing in multi-antibody drugs based on its own platform technology for degrading pathogenic autoantibodies. Electronic Times named the platform PDEG. Celltrion brought in two candidates from Kaigene last year, including a fetal Fc receptor inhibitor, and Electronic Times and Asia Economy reported that this makes three autoimmune pipeline candidates in total. Both said KG006, which breaks down immunoglobulin G, and KG013, which suppresses IgA and IgM production, have complementary mechanisms. [ 1 , 2 , 3 , 4 ]
A Celltrion official said the company aims to maximize synergy with its existing main product lines and keep its competitive edge in the autoimmune treatment market. Electronic Times quoted the official as saying the company treats autoimmune disease, together with cancer and obesity and metabolic disease, as a core axis of new drug development. [ 1 , 2 , 3 ]
Why it matters
The deal adds a third autoimmune drug candidate from Kaigene to Celltrion's pipeline, according to two outlets. Celltrion said it aims to build on its existing main product lines in the global autoimmune market.
Key facts
- Celltrion announced on 22 October a global license-in agreement with Kaigene, a biotech in Maryland, US, for the autoimmune drug candidate KG013. [ 1 , 2 , 3 , 4 ]
- The deal is worth up to $580.5 million, including an upfront payment and later development, approval and commercialization milestones. [ 1 , 2 , 3 , 4 ]
- Royalties on net sales are to be paid separately after commercialization. [ 1 , 3 , 4 ]
- Celltrion gained exclusive worldwide rights to develop and sell KG013. [ 1 , 2 , 3 , 4 ]
- Kaigene keeps the right to take part in co-selling in the Korean market only. [ 1 , 3 , 4 ]
- KG013 targets the signalling protein APRIL and is intended to treat IgA nephropathy and other immune diseases. [ 1 , 2 , 3 , 4 ]
- Celltrion brought in two candidates from Kaigene last year, including a fetal Fc receptor inhibitor. [ 2 , 3 , 4 ]
Confirmed by several sources
- Celltrion said it signed a global license-in agreement with Kaigene for KG013 and secured exclusive worldwide development and sales rights. [ 1 , 2 , 3 , 4 ]
- The agreement is worth up to $580.5 million including the upfront payment and milestones. [ 1 , 2 , 3 , 4 ]
- KG013 targets APRIL, a signalling protein involved in the survival and function of antibody-producing B cells, for IgA nephropathy and other immune diseases. [ 1 , 2 , 3 , 4 ]
Still unclear
- The won value of the deal differs between outlets: about 769.5 billion won in three outlets and about 768.6 billion won in Yonhap. The outlets give different dollar-to-won conversions of the same $580.5 million.
- The size of the upfront payment is not given. The documents give only the maximum total including upfront and milestone payments.
- Whether KG013 will prove better than first-generation APRIL-targeting treatments is not established. The improvements in potency and persistence are described as development goals reported from Celltrion's explanation.