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<p>LENZ Therapeutics Inc.（LENZ）的合作伙伴莲花制药股份有限公司（1795.TW, LTUS.PK）已向食品药品安全部提交新药申请，寻求批准 VIZZ 用于治疗韩国成年人的老花眼。</p>
<p>VIZZ 是一种无防腐剂、单次使用、每日一次的眼药水，含有阿莫克林，一种选择性缩瞳剂。缩瞳剂是一类药物，能够暂时收缩瞳孔，以提高老花眼患者的聚焦深度。</p>
<p>向食品药品安全部提交的 NDA 申请得到了来自三项随机、双盲、对照的第三阶段研究（称为 CLARITY 试验）的积极数据支持，这些试验在美国进行。在试验中，VIZZ 达到了所有主要和次要的近视改善终点，显示出在 30 分钟内改善近视的能力，并持续长达 10 小时。</p>
<p>LENZ Therapeutics 与莲花制药合作，在 2025 年 5 月签署的协议下，在韩国及包括泰国、菲律宾、越南、马来西亚、文莱、印度尼西亚和新加坡在内的东南亚某些国家商业化 VIZZ 以治疗老花眼。</p>
<p>在韩国的 NDA 提交标志着两家公司之间独占许可和商业化协议后的首次正式监管提交。</p>
<p>根据 2025 年 5 月协议的条款，LENZ 有权获得高达 1.25 亿美元的预付款、监管和商业里程碑付款，以及未来净销售的分级双位数版税。</p>
<p>老花眼是与年龄相关的近视下降，随着眼睛逐渐失去对近物体的聚焦能力，导致近视模糊。</p>
<p>LENZ Therapeutics 的 VIZZ 于今年 7 月在美国获得批准，用于治疗成年人的老花眼。</p>
<p>LENZ 周一的交易收盘价为 30.40 美元，下降了 30.40%。</p>
<p>如有意见和反馈，请联系：editorial@rttnews.com</p>
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LENZ

<p>LENZ Therapeutics 的合作伙伴 Lotus Pharmaceutical 已向韩国食品药品安全部提交了 VIZZ 的新药申请，该药物用于治疗老花眼。此次提交基于积极的三期临床试验数据。根据 2025 年的协议，LENZ 将获得高达 1.25 亿美元的里程碑付款和版税。VIZZ 于 7 月份在美国获得批准</p>

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</div><p>LENZ Therapeutics Inc.'s (LENZ) partner Lotus Pharmaceutical Co., Ltd. (1795.TW,LTUS.PK) has submitted a New Drug Application to the Ministry of Food and Drug Safety seeking approval of VIZZ, for the treatment of presbyopia in adults in South Korea.</p>
<div class="lb-trans"><p>LENZ Therapeutics Inc.（LENZ）的合作伙伴莲花制药股份有限公司（1795.TW, LTUS.PK）已向食品药品安全部提交新药申请，寻求批准 VIZZ 用于治疗韩国成年人的老花眼。</p>
</div><p>VIZZ is a preservative-free, single-use, once-daily eye drop containing aceclidine, a pupil-selective miotic agent. Miotics are a class of drugs that temporarily constrict the pupil to provide increased depth of focus in presbyopes.</p>
<div class="lb-trans"><p>VIZZ 是一种无防腐剂、单次使用、每日一次的眼药水，含有阿莫克林，一种选择性缩瞳剂。缩瞳剂是一类药物，能够暂时收缩瞳孔，以提高老花眼患者的聚焦深度。</p>
</div><p>The NDA Submission to the Ministry of Food and Drug Safety was backed by positive data from three randomized, double-masked, controlled Phase 3 studies known as CLARITY trials conducted in the United States. In the trials, VIZZ achieved all primary and secondary near vision improvement endpoints, demonstrating the ability to improve near vision within 30 minutes and last up to 10 hours.</p>
<div class="lb-trans"><p>向食品药品安全部提交的 NDA 申请得到了来自三项随机、双盲、对照的第三阶段研究（称为 CLARITY 试验）的积极数据支持，这些试验在美国进行。在试验中，VIZZ 达到了所有主要和次要的近视改善终点，显示出在 30 分钟内改善近视的能力，并持续长达 10 小时。</p>
</div><p>LENZ Therapeutics is partnered with Lotus Pharma to commercialize VIZZ for the treatment of presbyopia in the Republic of Korea and certain countries in Southeast Asia, including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia and Singapore, under an agreement signed in May of 2025.</p>
<div class="lb-trans"><p>LENZ Therapeutics 与莲花制药合作，在 2025 年 5 月签署的协议下，在韩国及包括泰国、菲律宾、越南、马来西亚、文莱、印度尼西亚和新加坡在内的东南亚某些国家商业化 VIZZ 以治疗老花眼。</p>
</div><p>The NDA submission in South Korea marks the first official regulatory submission for approval after the exclusive license and commercialization agreement between the two companies.</p>
<div class="lb-trans"><p>在韩国的 NDA 提交标志着两家公司之间独占许可和商业化协议后的首次正式监管提交。</p>
</div><p>As per the May 2025 agreement terms, LENZ is entitled to receive up to $125 million in upfront, regulatory and commercial milestone payments, as well as tiered, double-digit royalties on future net sales.</p>
<div class="lb-trans"><p>根据 2025 年 5 月协议的条款，LENZ 有权获得高达 1.25 亿美元的预付款、监管和商业里程碑付款，以及未来净销售的分级双位数版税。</p>
</div><p>Presbyopia is the age-related decline in near vision that occurs as the eye gradually loses its ability to focus on close objects, resulting in blurry near vision.</p>
<div class="lb-trans"><p>老花眼是与年龄相关的近视下降，随着眼睛逐渐失去对近物体的聚焦能力，导致近视模糊。</p>
</div><p>LENZ Therapeutics' VIZZ was approved in the U.S. for the treatment of presbyopia in adults this July.</p>
<div class="lb-trans"><p>LENZ Therapeutics 的 VIZZ 于今年 7 月在美国获得批准，用于治疗成年人的老花眼。</p>
</div><p>LENZ closed Monday's trading at $30.40, down 30.40%.</p>
<div class="lb-trans"><p>LENZ 周一的交易收盘价为 30.40 美元，下降了 30.40%。</p>
</div><p>For comments and feedback contact: editorial@rttnews.com</p>
<div class="lb-trans"><p>如有意见和反馈，请联系：editorial@rttnews.com</p>
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LENZ Therapeutics 的合作伙伴 Lotus Pharma 正在寻求韩国批准 VIZZ 药物用于治疗老花眼