China’s National Medical Products Administration (NMPA) approval of Zai Lab and argenx’s Vyvgart Hytrulo (efgartigimod alfa injection) marks a transformative milestone in chronic inflammatory demyelinating polyneuropathy (CIDP) care, offering the first targeted therapy for this debilitating autoimmune disorder. This approval signals a paradigm shift in CIDP management, underscoring innovation’s role in improving patient outcomes, says GlobalData, a leading data and analytics company.
Zai Lab and argenx have reportedly received the approval on 11 November 2024, making China the first country in the Asia-Pacific (APAC) region to authorise this treatment. Vyvgart Hytrulo is the first and only approved therapy for patients with CIDP, a progressive autoimmune disorder, marking a significant milestone for both companies. As a once-weekly subcutaneous injection, it addresses unmet needs, surpassing traditional options like corticosteroids and IVIg.
Zai Lab obtained exclusive rights in January 2021 to develop and commercialise efgartigimod in Greater China* from argenx. Vyvgart is already approved in the US for generalised myasthenia gravis (gMG) and CIDP. Additionally, it is approved in the EU for gMG and in Japan for gMG and primary immune thrombocytopenia (ITP) under brand names Vyvgart and Vyvdura.
According to GlobalData’s Pharmaceutical Intelligence Center, the diagnosed prevalent cases of CIDP in China are expected to increase at an annual growth rate (AGR) of 0.2 per cent from 56,009 in 2023 to 56,163 in 2027.
Chilamula Srija, Pharma Analyst at GlobalData, comments, “With the approval of Vyvgart Hytrulo, Zai Lab and argenx have taken a significant step toward CIDP care in China. As the first approved treatment for this challenging autoimmune disorder, Vyvgart Hytrulo offers new hope to patients who have long faced limited options for disease management. The previous treatment options were limited to corticosteroids, intravenous immunoglobulin (IVIg), and plasma exchange for refractory patients in China.”
Vyvgart will be available as a convenient once-weekly subcutaneous injection, The NMPA approval is supported by the positive results from the ADHERE (NCT04281472) study. 78 per cent of Chinese participants treated demonstrated clinical improvement in relative risk of relapse based on time to relapse on the inflammatory neuropathy cause and treatment (INCAT) deterioration and a significant 69 per cent reduction in relapse risk compared to placebo.
This approval establishes Vyvgart Hytrulo as efgartigimod’s second approval in China, following its approval for gMG in June 2023 and its inclusion in the National Reimbursement Drug List (NRDL) in December 2023. The NRDL inclusion secured for gMG lowers the barrier for adoption in CIDP by facilitating reimbursement despite the drug’s high cost. As reported by argenx, the annual cost of treatment of Vyvgart Hytrulo is $ 450,000 in the US.
According to GlobalData’s Drug Database, four drugs are in clinical development for CIDP in China. These include one drug in Phase III, one in Phase II/III, and two in Phase I. Sanofi‘s riliprubart, a late-stage candidate in Phase III, is poised to challenge Vyvgart Hytrulo in the near-term. Additionally, Johnson & Johnson‘s nipocalimab (Phase II/III), Nanjing IASO Biotherapeutics’ equecabtagene autoleucel, and CSPC NBP Pharmaceutical’s batoclimab (both in Phase I) hold potential to further diversify and enhance the CIDP treatment landscape, pending successful outcomes.
Chilamula concludes, “While the competition is anticipated from Sanofi in the near-term, Vyvgart’s first-to-market advantage and established efficacy strongly cements its positioning in the Chinese CIDP market. This approval offers a promising start for CIDP patients and underscores the potential for further innovation in China’s CIDP treatment landscape.”
*Greater China includes mainland China, Hong Kong, Taiwan, and Macau.