Efgartigimod Alfa

An immune antibody-cleaving drug from Hansa Biopharma could soon make it easier for some patients to get kidney transplants in the US. The Swedish biotech reported Wednesday that its drug imlifidase delivered in a Phase 3 US study for highly sensitized adult kidney transplant patients. These are patients who have antibodies that react to certain proteins from most donor kidneys, which means that they likely need to wait longer for a match or often face challenges finding one. Imlifidase is an enzyme that cleaves IgG antibodies, which are immune antibodies that are meant to fight foreign invaders. In this case, the hope is that culling them could stop the immune system from attacking the newly transplanted organ. At one year, kidney transplant patients who received imlifidase had significantly better results on a blood test for kidney function compared to those in the control group. Imlifidase has conditional approval to treat highly sensitized adult kidney transplant patients in the EU and other countries, where it is marketed as Idefirix. Now, Hansa will be seeking accelerated approval in the US using the results from the late-stage trial. “The chances of them getting a natural cross-match is obviously there, but still quite elusive for a lot of these patients,” Hansa CEO Renée Aguiar-Lucander said. “Having a procedure that can actually give some consistency, predictability of an outcome — where you can use organs that previously have not really been able to be allocated to this patient population — it’s actually quite a breakthrough solution,” Aguiar-Lucander added. She joined Hansa in April as its new CEO after she sold her previous company Calliditas, where she was CEO for seven years, to Japan’s Asahi Kasei for over $1 billion. Hansa’s stock price is up by as much as 25% on the Stockholm exchange on Thursday. The Phase 3 study compared a measure of kidney function called eGFR in patients who received a kidney transplant with imlifidase and those who received one using each institution’s specific desensitization protocol, according to a federal clinical trials database. For patients in the control arm, if the desensitization protocol isn’t successful, then the kidney would be turned down. Aguiar-Lucander noted that as a result, the number of patients in the control arm who accepted a kidney transplant at randomization was lower than in the imlifidase arm. Hansa reported that the mean eGFR was 51.5 in the imlifidase arm versus 19.3 in the control arm, where a higher number indicates better kidney function. (eGFR measures are reported in mL/min/1.73m2.) The p-value was <0.0001. The company also said imlifidase was “generally well-tolerated,” and that full results of the late-stage trial would be shared at a medical meeting next year. Hansa plans to submit an application at the end of the year to ask the FDA for accelerated approval of imlifidase based on the trial outcomes. Aguiar-Lucander said it’s estimated that about 10% to 15% of the patients on the waitlist are highly sensitized. In the US, there are around 90,000 people waiting for a kidney, according to UNOS . Unlike the class of IgG antibody-recycling drugs being developed primarily for autoimmune diseases, such as argenx’s Vyvgart, imlifidase works more rapidly in cleaving the antibodies and with a more potent effect. Aside from kidney transplantation, Hansa is also studying imlifidase to help more patients receive gene therapy. There, it’s looking at imlifidase in patients who’ve developed antibodies against the viral delivery packages for the gene therapies. Hansa is partnered with Sarepta Therapeutics, the maker of the Duchenne muscular dystrophy gene therapy Elevidys. However, the study of Elevidys and imlifidase is one of several paused in Europe after Sarepta reported the first patient death following its gene therapy. The biotech also expects to report data next month on imlifidase being used alongside a gene therapy developed by Genethon for a rare disease called Crigler-Najjar syndrome.

Fujifilm Biotechnologies has expanded its partnership with argenx as it will produce autoimmune blockbuster Vyvgart at its new plant in Holly Springs, N.C., starting in 2028. With both companies on an upward trajectory, argenx and its manufacturing partner Fujifilm Biotechnologies are taking a logical next step by expanding their collaboration.In addition to manufacturing drug substance for argenx’s autoimmune blockbuster Vyvgart at its facility in Hillerød, Denmark, Fujifilm will also make the product at its large-scale complex in Holly Springs, N.C. The CDMO will initiate production of Vyvgart at the plant in 2028.Fujifilm's Holly Springs site is slated to become operational this year and has already secured contracting work from several large drugmakers. Meanwhile, the CDMO giant is moving ahead with an expansion that's set to double the number of 20,000-liter mammalian cell culture bioreactors at the facility to 16. Argenx will be the first tenant in the plant's expansion phase, according to a Sept. 18 release.Sales are increasing rapidly for Vyvgart, which was approved for generalized myasthenia gravis (gMG) in 2021 and for chronic inflammatory demyelinating polyneuropathy (CIDP) in 2024. The product generated revenue of $2.2 billion last year and is on track for a significant increase this year, as its sales reached $1.7 billion in the first half of 2025.Besides the drug's approved uses, Vyvgart is under investigation as a potential treatment for other Immunoglobulin G (IgG) deficiency disorders. Fujifilm’s business is growing as well, with several high-profile drugmakers signing up for space in Holly Springs, including Regeneron, with a $3 billion, 10-year arrangement, and Johnson & Johnson, with a $2 billion, 10-year deal, which was revealed last month.Argenx and Fujifilm first linked up in 2022 in a deal to produce Vyvgart, or efgartigimod, in Denmark. They expanded their partnership in 2024 to include additional manufacturing services. Deals are coming quickly for Fujifilm as the industry reacts to the threat of sector-specific tariffs on pharmaceutical imports under the second Trump administration.While many companies are making huge investments to build their own manufacturing sites in the U.S., some are turning to CDMOs that have plants in the U.S.“Our expanded partnership with Fujifilm Biotechnologies at its Holly Springs site adds to our existing U.S. manufacturing footprint and further strengthens our global supply chain,” Filip Borgions, the chief technology innovation officer at argenx, said in a release.Fujifilm began building the $2 billion Holly Springs campus in 2021, billing it then as the largest end-to-end biologics production plant in the world, with the expectation to employ roughly 725 at the facility.Then, in April of last year, Fujifilm upped its ante on the site, earmarking an additional $1.2 billion for its construction and increasing its expected headcount at the facility to 1,400 by 2031.