Zai Lab and argenx Announce Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in China
Zai Lab and argenx announced NMPA approval of VYVGART Hytrulo for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in China. This marks the first and only approved CIDP treatment in China, administered as a weekly 30-90 second subcutaneous injection. The approval is based on the ADHERE study, where Chinese participants showed a 69% reduction in relapse risk compared to placebo, with 78% demonstrating clinical improvement. The treatment addresses approximately 50,000 diagnosed CIDP patients in China, offering a new option beyond traditional corticosteroids and plasma-derived therapies.
Zai Lab e argenx hanno annunciato l'approvazione da parte della NMPA di VYVGART Hytrulo per il trattamento della polineuropatia demielinizzante infiammatoria cronica (CIDP) in Cina. Questo rappresenta il primo e unico trattamento approvato per la CIDP in Cina, somministrato come un'iniezione sottocutanea settimanale di 30-90 secondi. L'approvazione si basa sullo studio ADHERE, in cui i partecipanti cinesi hanno mostrato una riduzione del 69% del rischio di recidiva rispetto al placebo, con il 78% che ha dimostrato un miglioramento clinico. Il trattamento si rivolge a circa 50.000 pazienti CIDP diagnosticati in Cina, offrendo una nuova opzione oltre ai tradizionali corticosteroidi e alle terapie derivate dal plasma.
Zai Lab y argenx anunciaron la aprobación por parte de la NMPA de VYVGART Hytrulo para el tratamiento de la polineuropatía desmielinizante inflamatoria crónica (CIDP) en China. Este es el primer y único tratamiento aprobado para la CIDP en China, administrado como una inyección subcutánea semanal de 30-90 segundos. La aprobación se basa en el estudio ADHERE, donde los participantes chinos mostraron una reducción del 69% en el riesgo de recaída en comparación con el placebo, con un 78% demostrando mejora clínica. El tratamiento aborda aproximadamente a 50.000 pacientes diagnosticados con CIDP en China, ofreciendo una nueva opción más allá de los corticosteroides tradicionales y las terapias derivadas del plasma.
자이랩과 아르겐스는 중국에서 만성 염증성 탈수초성 다발신경병증(CIDP) 치료를 위한 VYVGART Hytrulo의 NMPA 승인을 발표했습니다. 이는 중국에서 승인된 유일한 CIDP 치료제로, 주당 30-90초 동안의 피하 주사로 투여됩니다. 이 승인은 ADHERE 연구를 근거로 하며, 중국 참가자들은 위약 대비 재발 위험이 69% 감소했으며, 78%가 임상적 개선을 나타냈습니다. 이 치료는 중국에서 약 50,000명의 CIDP 진단환자를 대상으로 하여 전통적인 코르티코스테로이드 및 혈장 유래 치료 외에 새로운 옵션을 제공합니다.
Zai Lab et argenx ont annoncé l'approbation par la NMPA de VYVGART Hytrulo pour le traitement de la polyneuropathie démyélinisante inflammatoire chronique (CIDP) en Chine. C'est le premier et le seul traitement CIDP approuvé en Chine, administré par injection sous-cutanée hebdomadaire de 30 à 90 secondes. L'approbation repose sur l', où les participants chinois ont montré une réduction de 69 % du risque de rechute par rapport au placebo, avec 78 % montrant une amélioration clinique. Ce traitement vise environ 50 000 patients diagnostiqués avec CIDP en Chine, offrant une nouvelle option au-delà des corticostéroïdes traditionnels et des thérapies dérivées du plasma.
Zai Lab und argenx haben die Genehmigung von VYVGART Hytrulo zur Behandlung der chronischen entzündlichen demyelinisierenden Polneuropathie (CIDP) in China durch die NMPA bekannt gegeben. Dies ist die erste und einzige zugelassene CIDP-Behandlung in China, die als wöchentliche subkutane Injektion von 30-90 Sekunden verabreicht wird. Die Genehmigung basiert auf der ADHERE-Studie, in der chinesische Teilnehmer ein um 69% reduziertes Rückfallrisiko im Vergleich zu Placebo aufwiesen, wobei 78% eine klinische Verbesserung zeigten. Die Behandlung richtet sich an ungefähr 50.000 diagnostizierte CIDP-Patienten in China und bietet eine neue Option neben herkömmlichen Kortikosteroiden und plasmaabgeleiteten Therapien.
- First and only approved treatment for CIDP in China
- 69% reduction in relapse risk compared to placebo in Chinese patients
- 78% of Chinese participants showed clinical improvement
- Favorable safety and tolerability profile consistent with global trial results
- Received priority review designation and Breakthrough Therapy Designation
- None.
Insights
The NMPA approval of VYVGART Hytrulo represents a significant breakthrough in CIDP treatment in China. The clinical data shows impressive efficacy with a
The subcutaneous administration route (30-90 second injection) offers a significant advantage over existing treatments like corticosteroids and plasma-derived therapies. The consistent safety profile between Chinese and global populations strengthens the therapy's potential for widespread adoption. This approval could significantly impact Zai Lab's market position in the autoimmune disease space, especially given the therapy's potential expansion into other IgG-mediated conditions.
This approval marks Zai Lab's third successful launch in the efgartigimod franchise, demonstrating strong execution capabilities in bringing innovative therapies to the Chinese market. The priority review designation and Breakthrough Therapy status highlight the regulatory authorities' recognition of the therapy's importance. Being the first and only approved treatment for CIDP in China gives Zai Lab a significant first-mover advantage in this untapped market.
The partnership with argenx continues to strengthen Zai Lab's position in one of the world's fastest-growing healthcare markets. The successful development and commercialization of VYVGART Hytrulo could serve as a blueprint for future rare disease therapies in China, potentially leading to additional partnership opportunities and market expansion.
First and only NMPA-approved treatment for patients with CIDP in
Third approval for efgartigimod franchise in
“We are pleased to receive NMPA approval for VYVGART Hytrulo, marking a groundbreaking milestone for CIDP patients in China,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “This approval brings a much-needed treatment option to patients who have been suffering from CIDP for far too long. We appreciate the NMPA for their thorough assessment and recognition of the therapy’s differentiated profile and the large unmet patient medical need in
“VYVGART Hytrulo is a precision therapy for patients living with CIDP, many of whom have been waiting for a new treatment innovation,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We are grateful to our partners at Zai Lab for collaborating with argenx to reach CIDP patients in
“CIDP is a serious and debilitating disease with approximately 50,000 diagnosed patients in
The NMPA approval is supported by the positive results from the ADHERE (NCT04281472) study, a multicenter, randomized, double-blind, placebo-controlled trial evaluating VYVGART Hytrulo for the treatment of CIDP. The ADHERE study included an open-label period to identify responders who then entered a randomized-withdrawal, double-blinded period. Zai Lab enrolled patients into the ADHERE trial in
In May 2024, Zai Lab announced that the Centre for Drug Evaluation (CDE) accepted the sBLA with priority review designation for VYVGART Hytrulo for CIDP in
About VYVGART Hytrulo
VYVGART Hytrulo is a subcutaneous product that consists of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous delivery of biologics. The product is a single subcutaneous injection (1,000 mg fixed dose) delivered over 30-to-90 seconds and given weekly. VYVGART Hytrulo can be administered by a healthcare professional or at home by the patient or caregiver after adequate training in the subcutaneous injection technique. It is approved in
Zai Lab has an exclusive license agreement with argenx to develop and commercialize efgartigimod in mainland
About CIDP in
There are an estimated 50,000 patients diagnosed with CIDP in mainland
1 Chronic inflammatory demyelinating polyneuropathy and diabetes, 2020.
About Zai Lab
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the
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This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for development and commercialization of efgartigimod in
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FAQ
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