Daratumumab

GSK (NYSE: GSK) has licensed Halozyme Therapeutics’ (Nasdaq: HALO) Enhanze drug delivery platform for subcutaneous formulations of multiple oncology targets, including antibody-drug conjugates, in what marks the first time the enzyme-based technology has been applied to the ADC modality. The companies entered a global collaboration and license agreement announced May 7, with the first clinical trial projected to initiate in 2026. The agreement also includes an option for GSK to nominate additional future drug targets beyond the initial set. Financial terms were not fully disclosed. GSK will make an upfront payment to Halozyme, along with potential development, regulatory, and sales-based milestone payments, plus royalties on net sales of products incorporating the Enhanze platform. Specific figures for the upfront fee, milestones, and royalty rates were not provided. Deal context Enhanze is built around rHuPH20, a recombinant human hyaluronidase enzyme that transiently degrades hyaluronan in the subcutaneous tissue, temporarily expanding the interstitial space to allow larger volumes of drug — typically up to 10 mL — to be absorbed via injection. The effect is reversible, with the subcutaneous matrix regenerating within approximately 24 to 48 hours. The mechanism enables co-formulation or co-administration of therapeutic biologics with rHuPH20, converting drugs that would otherwise require intravenous infusion into subcutaneous injectables that can be administered in minutes. The platform has an established regulatory record, underpinning approved subcutaneous formulations including Darzalex Faspro (daratumumab and hyaluronidase-fihj), Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf), and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), among others. The GSK agreement extends the platform into ADC territory for the first time. ADCs are large, structurally complex molecules comprising a monoclonal antibody linked to a cytotoxic payload, and have historically been administered intravenously given their size and formulation requirements. The specific GSK ADC targets covered under the agreement were not named. The companies have an existing relationship through ViiV Healthcare, the HIV-focused joint venture majority-owned by GSK, which signed an Enhanze collaboration with Halozyme in June 2021 covering four HIV targets with the goal of developing ultra-long-acting subcutaneous medicines, structured around a USD 40 million upfront payment and up to USD 175 million in milestones. The oncology deal adds GSK to Halozyme’s existing Enhanze licensee list, which includes Roche, Janssen, AbbVie, Pfizer, Bristol Myers Squibb, argenx, Eli Lilly, Takeda, Chugai Pharmaceutical, Acumen Pharmaceuticals, and Merus N.V. Halozyme states the platform has reached more than one million patients through 10 commercialized products across more than 100 markets. For GSK, the collaboration provides a formulation pathway for oncology assets — including ADC programs — that could reduce patient treatment burden by enabling subcutaneous rather than intravenous administration. The ADC space has expanded rapidly across the industry, with multiple programs in late-stage development or recently approved across tumor types. Subcutaneous delivery, if achievable for ADC formats, could affect how those drugs are administered in clinical and outpatient settings. For Halozyme, the agreement extends the Enhanze platform into a modality where it has not previously operated commercially, and adds a major pharmaceutical partner in oncology. The company has characterized its royalty revenue model as high-margin and durable; adding ADC-linked royalty streams, if GSK programs advance to approval, would represent a new revenue category. The agreement also includes the option structure for additional targets, which could generate further upfront and milestone payments if exercised. Halozyme has separately expanded its drug delivery portfolio through the Hypercon microparticle hyperconcentration technology, acquired via Surf Bio, which the company positions as complementary to Enhanze for biologics requiring reduced injection volume rather than enzymatic matrix modification. That platform has been licensed to Janssen, Eli Lilly, argenx, Vertex Pharmaceuticals, and Oruka Therapeutics, though it is not part of the GSK oncology agreement. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Copyright © 2026. AllSci Corp. All rights reserved.

May 7, 2026 Copenhagen, Denmark; Interim Report for the Three Months Ended March 31, 2026 Highlights Genmab revenue increased 25% compared to the first three months of 2025, to $896 million FDA approved an sBLA to remove the recommendation for 24-hour hospitalization for patients with third line plus relapsed/refractory DLBCL Remained focused on disciplined investment in our late-stage portfolio, EPKINLY® (epcoritamab), Rina-S®, and petosemtamab, including launch readiness “We made tangible progress in the first quarter as we continue to integrate Merus™ and advance our late-stage portfolio - EPKINLY, Rina-S and petosemtamab. Across the business, our focus remained on disciplined execution, progressing these programs toward key readouts and preparing for potential launches to have an impact on more patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Three Months of 2026 Revenue was $896 million for the first three months of 2026 compared to $715 million for the first three months of 2025. The increase of $181 million, or 25%, was primarily driven by higher DARZALEX® and Kesimpta® royalties achieved under our collaborations with Johnson & Johnson (J&J) and Novartis Pharma AG (Novartis), respectively, and higher EPKINLY net product sales. Royalty revenue was $742 million in the first three months of 2026 compared to $589 million in the first three months of 2025, an increase of $153 million, or 26%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta. Net sales of DARZALEX, including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.) by J&J were $3,964 million in the first three months of 2026 compared to $3,237 million in the first three months of 2025, an increase of $727 million or 22%. Cost of product sales were $65 million for the first three months of 2026 compared to $42 million for the first three months of 2025. The increase of $23 million, or 55%, was primarily driven by the profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales. Operating expenses, excluding Acquisition and integration related charges, were $606 million for the first three months of 2026 compared to $485 million for the first three months of 2025. The increase of $121 million, or 25%, was primarily driven by the expansion of our product pipeline, including advancement of Rina-S and petosemtamab, and the continued investment in Genmab’s global commercialization capabilities to prepare for the upcoming projected launches of Rina-S and petosemtamab. Acquisition and integration related charges, which related primarily to severance and retention in connection with the acquisition of Merus, were $45 million in the first three months of 2026. Amortization of acquired intangible assets was $12 million for the first three months of 2026 compared to $3 million for the first three months of 2025. The increase of $9 million, was primarily driven by the amortization of the Merus technology platform acquired in December 2025. Operating profit was $180 million in the first three months of 2026 compared to $188 million in the first three months of 2025. Operating Profit excluding Acquisition and integration related charges and Amortization of acquired intangible assets, was $237 million in the first three months of 2026 compared to $191 million in the first three months of 2025. OutlookGenmab is maintaining its 2026 financial guidance published February 17, 2026. Conference CallGenmab will hold a conference call to discuss the results for the first three months of 2026 today, Thursday, May 7, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register-conf.media-server.com/register/BI96fe01e0770b4c3c962997a86df525ee. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations. ContactMarisol Peron, Senior Vice President, Global Communications & Corporate AffairsT: +1 609 524 0065; E: mmp@genmab.com Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.com *FDA = U.S. Food and Drug Administration; sBLA = supplemental biologics license application; DLBCL= diffuse large B-cell lymphoma; Rina-S = rinatabart sesutecan The Interim Report contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in the Interim Report nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®; HexElect®; KYSO®, ABBIL1TY™, RAINFOL™; ProfoundBio™ and Rina-S® are trademarks of ProfoundBio, U.S., Co. and Genmab (Suzhou) Co., Ltd. Tivdak® is a trademark of Seagen Inc.; EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.; Biclonics® and BIZENGRI® are registered trademarks of Merus N.V. Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT®, RYBREVANT FASPRO™, TECVAYLI® and TALVEY® are trademarks of Johnson & Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC. Download the full Interim Report for the First Three Months of 2026 on attachment or at www.genmab.com/investor-relations. CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 070526_CA25_Genmab Interim Report Q1 2026