argenx and Zai Lab Announce Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy in China
VYVGART Hytrulo has received NMPA approval in China for treating adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), becoming the first and only approved therapy for this condition in the country. The treatment, administered as a weekly 30-to-90 second subcutaneous injection, demonstrated significant efficacy in clinical trials, showing a 69% reduction in relapse risk compared to placebo in Chinese participants. The approval was based on the ADHERE study results, where 78% of Chinese participants showed clinical improvement during the open-label period.
VYVGART Hytrulo ha ricevuto l'approvazione NMPA in Cina per il trattamento di adulti affetti da neuropatia periferica demielinizzante infiammatoria cronica (CIDP), diventando la prima e unica terapia approvata per questa condizione nel paese. Il trattamento, somministrato come un'iniezione sottocutanea settimanale della durata di 30-90 secondi, ha dimostrato una significativa efficacia negli studi clinici, mostrando una riduzione del 69% nel rischio di ricaduta rispetto al placebo nei partecipanti cinesi. L'approvazione si è basata sui risultati dello studio ADHERE, dove il 78% dei partecipanti cinesi ha mostrato un miglioramento clinico durante il periodo in aperto.
VYVGART Hytrulo ha recibido la aprobación de la NMPA en China para el tratamiento de pacientes adultos con neuropatía periférica desmielinizante inflamatoria crónica (CIDP), convirtiéndose en la primera y única terapia aprobada para esta condición en el país. El tratamiento, administrado como una inyección subcutánea semanal de 30 a 90 segundos, demostró una eficacia significativa en los ensayos clínicos, mostrando una reducción del 69% en el riesgo de recaída en comparación con el placebo en los participantes chinos. La aprobación se basó en los resultados del estudio ADHERE, donde el 78% de los participantes chinos mostró una mejora clínica durante el período de estudio abierto.
VYVGART Hytrulo는 성인 만성 염증성 탈수초 다발신경병증(CIDP) 치료를 위한 NMPA의 승인을 중국에서 받았으며, 이로써 중국에서 이 질환에 대한 유일하게 승인된 치료법이 되었습니다. 치료는 주간 30-90초 동안의 피하 주사로 진행되며, 임상 시험에서 위약에 비해 중국 참여자에서 69%의 재발 위험 감소를 보이며 상당한 효능을 입증했습니다. 승인은 ADHERE 연구 결과에 기반을 두고 있으며, 그 결과 중국 참여자 중 78%가 공개 라벨 기간 동안 임상 개선을 보였습니다.
VYVGART Hytrulo a reçu l'approbation de la NMPA en Chine pour le traitement des patients adultes atteints de neuropathie inflammatoire démyélinisante chronique (CIDP), devenant ainsi la première et unique thérapie approuvée pour cette condition dans le pays. Le traitement, administré sous forme d'injection sous-cutanée hebdomadaire de 30 à 90 secondes, a démontré une efficacité significative lors des essais cliniques, affichant une réduction de 69 % du risque de rechute par rapport au placebo chez les participants chinois. L'approbation a été fondée sur les résultats de l'étude ADHERE, où 78 % des participants chinois ont montré une amélioration clinique durant la période ouverte.
VYVGART Hytrulo hat in China die NMPA-Zulassung zur Behandlung von Erwachsenen mit chronischer entzündlicher demyelinisierender Polyneuropathie (CIDP) erhalten und ist damit die erste und einzige zugelassene Therapie für diese Erkrankung im Land. Die Behandlung, die als wöchentliche subkutane Injektion von 30 bis 90 Sekunden verabreicht wird, zeigte in klinischen Studien eine signifikante Wirksamkeit und eine Risikominderung von 69 % für Rückfälle im Vergleich zur Placebo-Gruppe bei chinesischen Teilnehmern. Die Genehmigung basierte auf den Ergebnissen der ADHERE-Studie, in der 78 % der chinesischen Teilnehmer während der offenen Studienphase eine klinische Verbesserung zeigten.
- First and only approved CIDP treatment in China
- 69% reduction in relapse risk compared to placebo in Chinese patients
- 78% of Chinese participants showed clinical improvement in trials
- Received priority review designation and Breakthrough Therapy Designation
- Expands market presence in one of world's fastest-growing markets
- None.
Insights
The NMPA approval of VYVGART Hytrulo for CIDP in China represents a significant milestone, marking the first and only approved treatment for this condition in the Chinese market. The data is particularly compelling, showing a
With approximately 50,000 diagnosed CIDP patients in China, this approval opens up a substantial market opportunity. The subcutaneous administration route (30-90 second injection) offers a significant advantage over existing treatments like corticosteroids and plasma-derived therapies, potentially driving strong adoption rates. The priority review designation and Breakthrough Therapy status further underscore the therapeutic's importance.
This approval strengthens argenx's commercial position in one of the world's largest pharmaceutical markets. The collaboration with Zai Lab, which has a strong presence in China, provides an excellent commercialization pathway. The approval for CIDP follows the existing approval for another indication, demonstrating successful pipeline expansion and regulatory execution.
The addressable market opportunity is substantial, considering the high unmet need and treatment options. The therapy's differentiated profile, coupled with Zai Lab's established infrastructure, positions it well for market penetration. This development could significantly impact argenx's revenue growth in the Asia-Pacific region.
First and only NMPA-approved treatment for patients with CIDP in China
Second VYVGART Hytrulo indication approved in China
November 11, 2024 – 7:30am ET
Amsterdam, the Netherlands— argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) approved the supplemental Biologics License Application (sBLA) for VYVGART Hytrulo 1,000mg (5.6ml)/vial [efgartigimod alfa injection (subcutaneous injection)] for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only therapy approved in China for the treatment of CIDP, a debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system.
“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 China, and to the NMPA for approving VYVGART Hytrulo for CIDP. Zai has a strong record of impeccable execution and a shared value of doing all that we can, together, for patients in need. We look forward to continuing our partnership with Zai as argenx continues to reach more patients in one of the world’s fastest growing markets.”
“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 China. We will continue to work with argenx to explore the potential in other immunoglobulin G (IgG)-mediated autoimmune indications.”
“CIDP is a serious and debilitating disease with approximately 50,000 diagnosed patients in China1, with only a small fraction of patients able to achieve remission on corticosteroids and plasma-derived therapies, the current standard of care.” said Prof. Ting Chang, M.D., Deputy Chief Physician and Associate Professor, Department of Neurology, Tangdu Hospital. “In addition, existing treatment options are problematic and challenging for some patients. VYVGART Hytrulo provides a new, safe and effective treatment option that can meaningfully improve and stabilize disease symptoms and potentially lessen the burden of treatment for these patients. This is an important advancement for the patient community, and we are grateful to Zai Lab for their work supporting patients who have been devastated by this disease for so long.”
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 Greater China and treatment response in these participants was consistent with global study outcomes. Subgroup analysis of Chinese participants demonstrated a
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 China. The CDE granted the Breakthrough Therapy Designation for the treatment of patients with CIDP in September 2023.
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 the United States (marketed as VYVGART® Hytrulo for generalized myasthenia gravis (gMG) and CIDP), EU (marketed as VYVGART® SC for gMG), Japan (marketed as VYVDURA® for gMG) and China (marketed as VYVGART Hytrulo® for gMG and CIDP).
Zai Lab has an exclusive license agreement with argenx to develop and commercialize efgartigimod in mainland China, Hong Kong, Macau, and Taiwan (collectively, Greater China).
About CIDP in China
There are an estimated 50,000 patients diagnosed with CIDP in mainland China.1 Current treatment options are primarily corticosteroids and intravenous immunoglobulin (IVIg), with plasma exchange (PLEX) generally reserved for refractory patients. There is limited access to PLEX or IVIg in many parts of the world, including China. Because most patients require treatment for an extended period, there remains a significant unmet need for alternative treatment options that are effective, well-tolerated, and convenient for patients with CIDP in China.
1 Chronic inflammatory demyelinating polyneuropathy and diabetes, 2020.
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 U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube.
About Zai Lab
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide.
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.
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bpetok@argenx.com
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Zai Lab Investor Relations:
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+1 (917) 886-6929 / +86 136 8257 6943
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argenx Forward-looking Statements
The contents of this announcement include statements that are, or may be deemed to be, “forward- looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “aims,” or “continues,” and include statements argenx makes concerning the continued partnership between argenx and Zai Lab; its ability to reach more patients in China; the growth and expansion of the Chinese market; and its goal of translating immunology breakthroughs into a world- class portfolio of novel antibody-based medicines. By their nature, forward- looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements in products and product candidates; the acceptance of argenx's products and product candidates by patients as safe, effective and cost-effective; the impact of governmental laws and regulations on our business; disruptions caused on our reliance of third parties suppliers, service provides and manufacturing; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.
FAQ
When did VYVGART Hytrulo receive NMPA approval for CIDP in China?
How is VYVGART Hytrulo administered for CIDP treatment?
What was the efficacy of VYVGART Hytrulo in Chinese CIDP patients?
How many CIDP patients are diagnosed in China?
