Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 48

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 48
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amab, of a number of other companies that have bispecific CD3xCD20-targeted product candidates in development for the treatment of B-cell malignancies, which are competing with epcoritamab. These include: Regeneron Pharmaceuticals’ odronextamab, which was approved by the EMA in August 2024 for third line plus LBCL and DLBCL and was filed in the US for third line plus FL; and from Roche: mosunetuzumab, which has BTD and which received conditional marketing authorization as LUNSUMIO® in Europe in third line plus FL in June 2022 and accelerated approval in the U.S. in December 2022; and glofitamab, which received accelerated approval (as COLUMVI®) in both the U.S. and in Europe in June and July of 2023, respectively and was filed in 2024 for R/R DLBCL in combination with GemOx. We are aware that odronextamab, LUNSUMIO and COLUMVI are also being evaluated in other Phase III trials in multiple other B-cell malignancies. We are also aware that there are a variety of CD20 and CD19 antibodies, immunomodulators, ADCs, BTK inhibitors, tyrosine kinase 

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inhibitors and CAR-T therapies that are either approved or in development for non-Hodgkin’s lymphomas. Some of these include ADC Therapeutics’ ZYNLONTA®, approved by the FDA in April 2021 for R/R LBCL and approved in Europe in December 2022, INCYTE’s MONJUVI®, approved by the FDA in combination with lenalidomide in July 2020 in R/R DLBCL, Beigene’s BRUKINSA approved by the FDA in March 2024 for third line plus FL in combination with obinutuzumab, and several CAR-T therapies, Novartis’s KYMRIAH®, approved in the U.S. and EU in R/R FL in May 2022, BMS’s Breyanzi®, approved in the U.S. in June 2022 for R/R LBCL, Gilead Sciences (“Gilead”)’s YESCARTA®, approved in the U.S. in R/R LBCL in April 2022 and second line DLBCL in Europe in October 2022 and Tecartus, approved for R/R MCL in