Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 49

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 49
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2020 in both the US and Europe. In addition, in June 2019 Roche received accelerated approval in the U.S. for POLIVY®, a first-in-class anti-CD79b ADC, in combination with bendamustine and rituximab for adults with R/R DLBCL who have received at least two prior therapies. In August 2021 Roche announced that the Phase III POLARIX trial met its primary endpoint. The positive readout of POLARIX met the post-marketing requirement to convert the accelerated approval into a full approval, potentially raising the bar for other drugs, including epcoritamab, to enter the 1L DLBCL space. POLIVY was granted full approval by the European Commission in May 2022 and by the FDA in April 2023.
With respect to acasunlimab, we are aware of a number of other companies that have bispecific PD-L1x4-1BB products in development for the treatment of solid tumors including Merus N.V.’s MCLA-145, F-Star Therapeutics Inc.’s FS222, Antengene’s ATG-101, Biotheus’ PM1003, Leads Biolabs’ PM1003, AP Biosciences AP203 and HankeMab’s HK010. 
With respect to Rina-S competitors, Abbvie’s ELAHERE® was the first folate receptor-alpha (FRα) targeting ADC approved, initially in the US and recently in the EU. We are aware of several other FRα ADCs in development, including luveltamab from Sutro Biopharma, AZD5335 from AstraZeneca, farletuzumab from Eisai, and BAT8006 from BioThera Solutions.
In addition, many other pharmaceutical and biotechnology companies are developing and/or marketing therapies for the same types of cancer that our products and product candidates are designed and being developed to treat. We are also aware of other companies that have or are developing technologies that may be competitive with ours, including bispecific antibodies, CAR-T and RNA-based technologies. In addition, our DuoBody and other technology collaboration partners may develop compounds utilizing our technology that may compete with product candidates that we are developing.
In addition, in the U.S., the BPCIA created an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” or “biosimilar” to or “interchangeable” with an FDA-approved biological product.