Zai Lab Receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of Small Cell Lung Cancer (SCLC)
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has received Orphan Drug Designation (ODD) from the U.S. FDA for ZL-1310, their first-in-class DLL3 antibody-drug conjugate (ADC) designed to treat small cell lung cancer (SCLC). The designation comes after promising results from an ongoing Phase 1a/1b study in patients with previously treated extensive-stage SCLC.
The ODD grants several benefits, including waiver of Prescription Drug User Fee Act registration application fee, tax credits for certain clinical trials, and potential seven-year U.S. market exclusivity upon approval. The drug has shown promising objective response rates and favorable safety profile in Phase 1 trials for patients with recurrent SCLC.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) ha ricevuto la Designazione di Farmaco Orfano (ODD) dalla FDA statunitense per ZL-1310, il loro anticorpo-coniugato farmacologico (ADC) di prima classe progettato per trattare il cancro polmonare a piccole cellule (SCLC). La designazione arriva dopo risultati promettenti da uno studio in corso di Fase 1a/1b su pazienti con SCLC in stadio avanzato già trattati in precedenza.
La ODD conferisce diversi vantaggi, tra cui l'esenzione dalla tassa di registrazione della Prescription Drug User Fee Act, crediti d'imposta per determinati studi clinici e la potenziale esclusività di mercato negli Stati Uniti per sette anni dopo l'approvazione. Il farmaco ha mostrato tassi di risposta obiettiva promettenti e un profilo di sicurezza favorevole negli studi di Fase 1 per pazienti con SCLC ricorrente.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) ha recibido la Designación de Medicamento Huérfano (ODD) de la FDA de EE. UU. para ZL-1310, su conjugado anticuerpo-fármaco (ADC) de primera clase diseñado para tratar el cáncer de pulmón de células pequeñas (SCLC). La designación llega tras resultados prometedores de un estudio en curso de Fase 1a/1b en pacientes con SCLC de estadio avanzado que han sido tratados previamente.
La ODD otorga varios beneficios, incluidos la exención de la tasa de solicitud de registro de la Prescription Drug User Fee Act, créditos fiscales para ciertos ensayos clínicos y la potencial exclusividad en el mercado estadounidense durante siete años tras la aprobación. El fármaco ha mostrado tasas de respuesta objetiva prometedoras y un perfil de seguridad favorable en ensayos de Fase 1 para pacientes con SCLC recurrente.
자이랩(Zai Lab) (NASDAQ: ZLAB; HKEX: 9688)은 미국 FDA로부터 희귀의약품 지정(ODD)을 ZL-1310에 대해 받았습니다. ZL-1310은 소세포폐암(SCLC) 치료를 위해 설계된 1세대 DLL3 항체-약물 접합체(ADC)입니다. 이 지명은 이전에 치료를 받은 광범위한 SCLC 환자들을 대상으로 하는 진행 중인 1a/1b 단계 연구에서 유망한 결과가 나온 후에 이루어졌습니다.
ODD는 처방약 사용자 수수료법에 따른 등록 신청 수수료 면제, 특정 임상 시험에 대한 세금 크레딧, 승인 후 미국 시장에서의 7년간 독점 판매 권한 등 여러 혜택을 제공합니다. 이 약물은 재발성 SCLC 환자들을 대상으로 한 1상 임상 시험에서 유망한 객관적 반응률과 긍정적인 안전성 프로필을 보여주었습니다.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) a reçu la désignation de médicament orphelin (ODD) de la FDA américaine pour ZL-1310, leur premier conjugé anticorps-médicament (ADC) de sa catégorie, conçu pour traiter le cancer du poumon à petites cellules (SCLC). Cette désignation est survenue après des résultats prometteurs d'une étude en cours de phase 1a/1b chez des patients ayant déjà été traités pour un SCLC à un stade avancé.
La désignation ODD offre plusieurs avantages, notamment l'exonération des frais de demande d'inscription du Prescription Drug User Fee Act, des crédits d'impôt pour certains essais cliniques, et une exclusivité potentielle du marché américain pendant sept ans après approbation. Le médicament a montré des taux de réponse objective prometteurs et un profil de sécurité favorable lors des essais de phase 1 chez des patients atteints de SCLC récurrent.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) hat von der U.S. FDA die Orphan Drug Designation (ODD) für ZL-1310 erhalten, ein erster Vertreter eines DLL3-Antikörper-Wirkstoff-Konjugats (ADC), das zur Behandlung von kleinzelligem Lungenkrebs (SCLC) entwickelt wurde. Die Auszeichnung erfolgt nach vielversprechenden Ergebnissen einer laufenden Phase 1a/1b-Studie bei zuvor behandelten Patienten mit ausgedehntem SCLC.
Die ODD gewährt mehrere Vorteile, darunter die Befreiung von der Antragsgebühr für die Registrierung des Prescription Drug User Fee Act, Steuererleichterungen für bestimmte klinische Studien und potenzielle siebenjährige Markt-Exklusivität in den USA nach Genehmigung. Das Medikament hat vielversprechende objektive Ansprechquoten und ein positives Sicherheitsprofil in Phase 1 Studien für Patienten mit rezidivierendem SCLC gezeigt.
- Received FDA Orphan Drug Designation for ZL-1310
- Promising objective response rates in Phase 1 trial
- Potential 7-year market exclusivity upon approval
- Eligible for tax credits and fee waivers
- None.
Insights
The FDA's Orphan Drug Designation for Zai Lab's ZL-1310 represents a strategic milestone in addressing the significant unmet need in Small Cell Lung Cancer (SCLC) treatment. SCLC affects approximately 30,000 patients annually in the US, with a particularly poor prognosis and treatment options after first-line therapy.
The designation brings substantial benefits that could accelerate ZL-1310's path to market:
- Seven years of market exclusivity upon approval
- Tax credits of up to
50% for clinical trial costs - Waiver of PDUFA fees (approximately
3.1 million in 2024)
From a technical perspective, ZL-1310's DLL3 (Delta-like ligand 3) antibody-drug conjugate approach is particularly innovative. DLL3 is specifically expressed in SCLC tumors but minimally present in normal tissues, potentially offering a wider therapeutic window and better safety profile compared to traditional chemotherapy. The promising objective response rates from the Phase 1 trial suggest potential clinical differentiation.
For investors, this development strengthens Zai Lab's oncology portfolio and could represent a significant market opportunity. The global SCLC therapeutics market is projected to reach
“Receiving an Orphan Drug Designation for ZL-1310 recognizes its potential to treat patients with SCLC. These patients have an urgent need for innovative treatment options with improved efficacy, safety and ready access in tertiary care and community settings,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “ZL-1310 has demonstrated promising objective response rates and a favorable safety profile from the ongoing Phase 1 trial in patients with recurrent SCLC recently disclosed. We look forward to continuing to advance the clinical development of this promising asset across lines of therapy in SCLC and other DLL3-expressing tumors.”
ZL-1310 will be eligible for certain development incentives, including a waiver of the Prescription Drug User Fee Act registration application fee, tax credits for certain clinical trials and the potential to receive a seven-year U.S. market exclusivity period granted upon product approval.
This important regulatory designation follows promising data from the ongoing global Phase 1a/1b study in patients with previously treated extensive-stage SCLC (ES-SCLC) after at least one prior platinum-based chemotherapy regimen, which was presented at the EORTC-NCI-AACR (ENA) Symposium 2024 in October 2024.
About ZL-1310
ZL-1310 is a novel ADC in Zai Lab’s growing, global oncology pipeline that targets Delta-like ligand 3 (DLL3), an antigen that is overexpressed in many neuroendocrine tumors, is typically associated with poor clinical outcomes, and is a validated therapeutic target for SCLC. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody linked to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN®, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, including off-target payload toxicity.
The ongoing Phase 1a/1b clinical trial is evaluating ZL-1310 as monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for the treatment of ES-SCLC.
About Small Cell Lung Cancer (SCLC)
SCLC is one of the most aggressive and lethal solid tumors, accounting for ~
References:
1 J Thorac Oncol. 2023 Jan;18(1):31-46; Lung Cancer Foundation of America.
2 WHO Globocan 2022.
3 Sabari JK, et al. Nat Rev Clin Oncol. 2017;14:549-561.
4 Phase 3 IMpower133 (atezolizumab) and
5 National Cancer Institute. www.cancer.gov. Accessed October 15, 2024.
About Zai Lab
Zai Lab (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.X.com/ZaiLab_Global, www.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing next generation ADCs, including ZL-1310, the potential benefits of ZL-1310, and the potential treatment of SCLC and neuroendocrine tumors. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in
Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.sec.gov.
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For more information, please contact:
Investor Relations:
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Source: Zai Lab Limited
FAQ
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