VYVGART

Approvals and Regulatory Plan

Our two approved medicines, VYVGART and VYVGART SC, are FcRn blockers. VYVGART is approved in more than 30 countries for the treatment of adults with gMG who are anti-acetylcholine receptor (AChR) antibody positive (AChR-AB+) and for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs), including seronegative patients, in Japan. VYVGART is now also approved for the treatment of adult patients with ITP in Japan. Our second product, VYVGART SC, is a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme Therapeutics, Inc.’s (Halozyme) ENHANZE^® SC drug delivery technology. It has been approved for the treatment of adults with gMG who are AChR-AB+ as VYVGART HYTRULO in the U.S. and China, as VYVGART in the EU, and as VYVGART SC in the UK, Israel. It has also been approved as VYVDURA in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal ISTs, including seronegative patients. VYVGART SC has now also been approved for the treatment of adults with CIDP in the U.S. and China as VYVGART HYTRULO and in Japan as VYVDURA.

More approvals and launches of both VYVGART and VYVGART SC in multiple jurisdictions and countries are planned following pricing and reimbursement negotiations. The following table summarizes the status of regulatory approvals and commercialization efforts for VYVGART IV, VYVGART SC and PFS as March 17, 2025:

Commercialization

We have established our own sales force in the U.S., Japan, Europe and Canada for VYVGART for the treatment of gMG and CIDP (where approved). We plan to expand our own sales and marketing capabilities and promote our products and product candidates in other regions if we decide there is a business case to do so after regulatory approval has been obtained.

Development and commercialization may also be done through collaborations with third parties. In January 2021, we entered into an exclusive out-license agreement with Zai Lab (Zai Lab Agreement), a commercial-stage biopharmaceutical company, for the development and commercialization of efgartigimod in Greater China, (which includes Mainland China, Hong Kong, Taiwan and Macau, Greater China). Zai Lab announced approval of VYVGART in Mainland China in June 2023 for the treatment of adult gMG patients and in 2024 Zai Lab also announced the approval of VYVGART SC for gMG and CIDP. Under the Zai Lab Agreement, we received and continue to be eligible for certain sales-based milestone payments and royalties based on annual product net sales of efgartigimod in Greater China.

In October 2021, we announced an exclusive distribution agreement with Medison to commercialize efgartigimod for gMG in Israel (Medison Agreement). Medison filed for and obtained approval for VYVGART in April 2023 and for VYVGART SC in September 2024. On June 6, 2022 we announced an exclusive multi-regional agreement with Medison to commercialize efgartigimod in 14 countries, including Poland, Hungary, Slovenia, Czech Republic, Romania, Bulgaria, Lithuania, Croatia, Slovakia, Estonia, Latvia, Greece, and Cyprus, for the treatment of adult patients with gMG (Medison Multi-Regional Agreement).

In January 2022, we entered into a partnership agreement with Genpharm, under which Genpharm shall purchase VYVGART from us for the resale in the Gulf Cooperation Council (comprising Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain and Oman) on an exclusive basis for Genpharm’s own account and own name (Genpharm Agreement).

In 2023, we entered into the Handok Agreement for the distribution of VYVGART in South Korea and in 2024 we received approval for VYVGART in South Korea.

We intend to sign additional distribution partnerships for other territories.

In the U.S., argenx advertises certain products via digital and traditional media channels, including the internet and television.

For a discussion of total revenues by geographic market, please see “Note 17 Segment Reporting” in our consolidated financial statements.

Pre-Approval Access Program

We are committed to improving the lives of people suffering from rare diseases. We are driven to discover new treatment approaches fueled by the resilience of patients to urgently deliver them. We aim to do this in partnership; we listen to patients, supporters and advocacy communities, and we hear their stories. Their insights guide us as we develop our investigational therapies and motivate us to advance the understanding of rare diseases.

We have a Pre-Approval Access program (PAA) for patients with gMG which opened on February 21, 2021 for patients who are unable to participate in an ongoing clinical trial. In 2024, we approved access to this PAA for over 403 gMG patients in 14 countries. The PAA program remains open in countries where VYVGART is not yet launched or reimbursed.