LENZ Therapeutics Announces NMPA Submission of New Drug Application for LNZ100 in China for the Treatment of Presbyopia
LENZ Therapeutics (NASDAQ:LENZ) announced that its partner CORXEL Pharmaceuticals has submitted a New Drug Application (NDA) for LNZ100 to China's NMPA for presbyopia treatment. The submission is supported by successful Phase 3 JX07001 clinical trial results, where LNZ100 achieved its primary and secondary endpoints.
The NDA submission triggers the first milestone payment under the April 2022 licensing agreement, under which LENZ is eligible to receive up to $95.0 million in regulatory and sales milestones, plus tiered mid single-digit to low double-digit royalties on Greater China net sales.
LENZ Therapeutics (NASDAQ:LENZ) ha annunciato che il suo partner CORXEL Pharmaceuticals ha presentato una Domanda di Nuovo Farmaco (NDA) per LNZ100 all'NMPA cinese per il trattamento della presbiopia. La presentazione è supportata dai risultati positivi della Fase 3 del trial clinico JX07001, in cui LNZ100 ha raggiunto gli endpoint primari e secondari.
La presentazione della NDA attiva il primo pagamento di milestone previsto dall'accordo di licenza di aprile 2022, in base al quale LENZ può ricevere fino a 95,0 milioni di dollari in milestone regolatorie e di vendita, oltre a royalties a più livelli dal medio singolo al basso doppio cifre sulle vendite nette nella Grande Cina.
LENZ Therapeutics (NASDAQ:LENZ) anunció que su socio CORXEL Pharmaceuticals ha presentado una Solicitud de Nuevo Medicamento (NDA) para LNZ100 ante la NMPA de China para el tratamiento de la presbicia. La presentación está respaldada por los exitosos resultados del ensayo clínico de Fase 3 JX07001, donde LNZ100 alcanzó sus objetivos primarios y secundarios.
La presentación de la NDA desencadena el primer pago por hitos bajo el acuerdo de licencia de abril de 2022, mediante el cual LENZ es elegible para recibir hasta 95,0 millones de dólares en hitos regulatorios y de ventas, además de regalías escalonadas de un dígito medio bajo a un dígito doble bajo sobre las ventas netas en la Gran China.
LENZ Therapeutics (NASDAQ:LENZ)는 파트너사인 CORXEL Pharmaceuticals가 노안 치료제 LNZ100에 대한 신약 신청서(NDA)를 중국 NMPA에 제출했다고 발표했습니다. 이 제출은 3상 JX07001 임상시험에서 LNZ100이 1차 및 2차 평가변수를 모두 달성한 성공적인 결과를 바탕으로 이루어졌습니다.
NDA 제출은 2022년 4월 체결된 라이선스 계약에 따른 첫 번째 마일스톤 지급을 촉발하며, LENZ는 규제 및 판매 마일스톤으로 최대 9,500만 달러를 받을 자격이 있으며, 중국 대륙 순매출에 대해 중간 단일 자리수에서 낮은 두 자리수 구간의 계층형 로열티도 받게 됩니다.
LENZ Therapeutics (NASDAQ:LENZ) a annoncé que son partenaire CORXEL Pharmaceuticals a soumis une demande de nouveau médicament (NDA) pour LNZ100 auprès de la NMPA chinoise pour le traitement de la presbytie. Cette soumission est appuyée par les résultats positifs de l'essai clinique de phase 3 JX07001, où LNZ100 a atteint ses critères d’évaluation primaires et secondaires.
La soumission de la NDA déclenche le premier paiement d’étape selon l’accord de licence d’avril 2022, selon lequel LENZ peut recevoir jusqu’à 95,0 millions de dollars en jalons réglementaires et commerciaux, ainsi que des redevances échelonnées allant du milieu des chiffres simples au bas des chiffres doubles sur les ventes nettes en Grande Chine.
LENZ Therapeutics (NASDAQ:LENZ) gab bekannt, dass sein Partner CORXEL Pharmaceuticals einen Zulassungsantrag (NDA) für LNZ100 zur Behandlung von Presbyopie bei der chinesischen NMPA eingereicht hat. Die Einreichung basiert auf erfolgreichen Ergebnissen der Phase-3-Studie JX07001, in der LNZ100 seine primären und sekundären Endpunkte erreichte.
Die Einreichung der NDA löst die erste Meilensteinzahlung aus dem Lizenzvertrag vom April 2022 aus, wonach LENZ bis zu 95,0 Millionen US-Dollar an regulatorischen und Verkaufsmeilensteinen erhalten kann, plus auf die Nettoumsätze in Großchina.
- Successful Phase 3 trial results showing statistically significant improvement in near vision
- Potential for up to $95.0 million in regulatory and sales milestone payments
- Additional revenue stream through tiered royalties on Greater China sales
- First regulatory submission outside US, expanding global market presence
- Pre-commercial stage company with no current revenue from product sales
- Regulatory approval in China still pending and subject to uncertainty
Insights
LENZ's NDA submission in China triggers milestone payment and validates global commercialization strategy with strong Phase 3 data.
The NDA submission for LNZ100 in China represents a significant regulatory milestone for LENZ Therapeutics in its global commercialization strategy. This first regulatory submission outside the US was supported by robust Phase 3 clinical data that demonstrated statistically significant three-line or greater improvement in near vision without compromising distance vision.
The submission triggers the first milestone payment under LENZ's licensing agreement with CORXEL, opening access to a potential $95 million in regulatory and sales milestones, plus tiered royalties ranging from mid-single to low double-digits on net sales in Greater China. This validation of LENZ's business model demonstrates how strategic partnerships can accelerate global commercialization while creating multiple revenue streams.
The China submission is particularly valuable as it positions LENZ to potentially access the world's largest presbyopia market. With consistent results between the Chinese Phase 3 trial and the US CLARITY trial, LENZ has demonstrated that aceclidine's efficacy profile translates across different populations, strengthening the global commercial thesis for LNZ100.
This milestone converts LENZ's licensing strategy from theoretical to tangible, with concrete progress toward commercialization in a major market. For a pre-commercial company, each regulatory advancement that triggers milestone payments helps extend the runway while building credibility for future partnership opportunities in other territories.
Submission of NDA for LNZ100 in China by CORXEL Pharmaceuticals results in achievement of first milestone due to LENZ under the Development and Commercialization Agreement
SAN DIEGO, July 28, 2025 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ, “LENZ” or the “Company”), a pre-commercial stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that CORXEL Pharmaceuticals (“CORXEL”) has submitted the New Drug Application (NDA) for LNZ100 to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China (PRC). LENZ licensed the Greater China rights to CORXEL for the development and commercialization of LNZ100 in April 2022.
The NDA submission was supported by positive data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. In this Phase 3 safety and efficacy trial, LNZ100 (
The submission of the NDA for LNZ100 results in the achievement of the first milestone under the License and Collaboration Agreement with CORXEL (the “License”). Under the terms of the License, LENZ is eligible to receive up to
“This exciting milestone in our development partnership with CORXEL has come as a result of tremendous collaboration between the teams,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “This submission was supported by the impressive data generated from the Phase 3 clinical trial of LNZ100 in China, consistent with the data from the CLARITY trial. This is the first regulatory submission outside of the United States, further reinforcing the opportunity for LNZ100 to become a global therapy for the treatment of presbyopia.”
About LENZ Therapeutics
LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in patients with presbyopia. LENZ’s product candidate LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day”. LENZ is headquartered in San Diego, California. For more information, visit: LENZ-Tx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of United States federal securities laws. You can identify forward-looking statements by words such as “may,” “will,” “could,” “can,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “poised,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of LNZ100 to have best-in-class performance and LNZ100 as a global therapy; the size of the addressable population for LNZ100; expectations regarding the commercial opportunity and beneficial characteristics of LNZ100; and plans and expectations regarding the commercialization of LNZ100 in China or the United States, if approved. These statements are based on numerous assumptions concerning the development of LENZ’s products and target markets and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements, including those risk factors described in the section titled “Risk Factors” in LENZ’s Quarterly Report on Form 10-Q filed for the quarter ended March 31, 2025 and in LENZ’s subsequent filings with the SEC. LENZ cannot assure you that the forward-looking statements in this press release or the assumptions upon which they are based will prove to be accurate. The forward-looking statements in this press release are as of the date of this press release. Except as otherwise required by applicable law, LENZ disclaims any duty to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Contact:
Dan Chevallard
LENZ Therapeutics
IR@LENZ-tx.com
FAQ
What is the status of LENZ Therapeutics' LNZ100 drug application in China?
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