此外，在BRIO II研究监测的逾72000个治疗日中，BRIMOCHOL™ PF耐受性良好，未观察到治疗相关 的严重不良事件。在该药物的临床试验中，眼部发红并非常见报告的副作用。于BRIO I及BRIO II研究 中，眼部充血(眼部发红)不良事件的报告率低。在BRIO II研究中，接受BRIMOCHOL™ PF的受试者出 现眼部充血(眼睛发红)不良事件的报告率(2.8%)低于单独接受卡巴胆硷的受试者(10.7%)。 就兆科眼科而言，此批准乃其制定商业化策略前的强大催化剂。本公司已为 BRIMOCHOL™ PF建立伙 伴关系网络，现时包罗亚太区(包括南韩、澳洲、新西兰、泰国、印尼、台湾╱香港╱澳门地区、新加 坡及越南)及中东内的八名商业伙伴。凭借FDA的认可，兆科预料可加快该药物面世，标志着一项重要 的全球里程碑。 兆科眼科-B(06622)发布公告，本公司的伙伴Tenpoint Therapeutics, Ltd.(Tenpoint)已接获美国食品药品监 督管理局(FDA)批准商业化卡巴胆硷及酒石酸溴莫尼丁滴眼液(2.75%/0.1%)的监管批准。此滴眼液于临 床试验期间名为BRIMOCHOL™ PF，在美 ...

兆科眼科-B(06622)发布公告，本公司的伙伴Tenpoint Therapeutics,Ltd.(Tenpoint)已接获美国食品药品监 督管理局(FDA)批准商业化卡巴胆硷及酒石酸溴莫尼丁滴眼液(2.75%/0.1%)的监管批准。此滴眼液于临 床试验期间名为BRIMOCHOL PF，在美国的商用名称将为YUVEZZI，作为用于治疗老花眼的创新药 物。 此外，在BRIO II研究监测的逾72000个治疗日中，BRIMOCHOL PF耐受性良好，未观察到治疗相关的 严重不良事件。在该药物的临床试验中，眼部发红并非常见报告的副作用。于BRIO I及BRIO II研究 中，眼部充血(眼部发红)不良事件的报告率低。在BRIO II研究中，接受BRIMOCHOL PF的受试者出现 眼部充血(眼睛发红)不良事件的报告率(2.8%)低于单独接受卡巴胆硷的受试者(10.7%)。 此批准在Tenpoint成功完成第3期临床试验后取得。第一次的关键第3期BRIO I研究展示出组合疗法对比 个别单一疗法活性药复合物较具优势。于第二次的安慰剂对照第3期BRIO II研究，BRIMOCHOL PF达 到所有主要近距离视力的改善研究 ...

此外，在BRIO II研究监测的逾72000个治疗日中，BRIMOCHOL™ PF耐受性良好，未观察到治疗相关 的严重不良事件。在该药物的临床试验中，眼部发红并非常见报告的副作用。于BRIO I及BRIO II研究 中，眼部充血(眼部发红)不良事件的报告率低。在BRIO II研究中，接受BRIMOCHOL™ PF的受试者出 现眼部充血(眼睛发红)不良事件的报告率(2.8%)低于单独接受卡巴胆硷的受试者(10.7%)。 就兆科眼科而言，此批准乃其制定商业化策略前的强大催化剂。本公司已为 BRIMOCHOL™ PF建立伙 伴关系网络，现时包罗亚太区(包括南韩、澳洲、新西兰、泰国、印尼、台湾╱香港╱澳门地区、新加 坡及越南)及中东内的八名商业伙伴。凭借FDA的认可，兆科预料可加快该药物面世，标志着一项重要 的全球里程碑。 此批准在Tenpoint成功完成第3期临床试验后取得。第一次的关键第3期BRIO I研究展示出组合疗法对比 个别单一疗法活性药复合物较具优势。于第二次的安慰剂对照第3期BRIO II研究，BRIMOCHOL™ PF 达到所有主要近距离视力的改善研究终点，统计上双眼未矫正近视力(BUCNVA)显著提 ...

Group 1 - The company has entered into a distribution and supply agreement with PT Ferron Par Pharmaceuticals for the commercialization of BRIMOCHOL™ PF in Indonesia, granting PT Ferron exclusive rights for import, promotion, distribution, marketing, and sales of the product [1] - The company will receive an upfront payment and may earn additional milestone payments based on specific achievements [1] - The developer of BRIMOCHOL™ PF, Tenpoint Therapeutics, announced that the FDA has accepted the new drug application for the product, with a review deadline set for January 28, 2026 [1] Group 2 - BRIMOCHOL™ PF is a preservative-free, experimental eye drop intended to correct near vision loss due to aging, and is part of a multi-center, randomized, double-blind study involving 629 participants across 47 trial centers in the U.S. [2] - The study compares the safety and efficacy of BRIMOCHOL™ PF with other treatments for presbyopia [2] Group 3 - PT Ferron Par Pharmaceuticals, a member of the Dexa Group, has been operating since 2001 and is one of the top 15 largest pharmaceutical companies in Indonesia according to IQVIA data [3] - The company has received recognition from regulatory agencies in the UK and Portugal, enhancing its market influence and operational capabilities through a diverse product portfolio and strong strategic partnerships [3]

Core Insights - LENZ Therapeutics has achieved a significant milestone with the submission of a New Drug Application (NDA) for LNZ100 in China, marking the first regulatory submission outside the United States [1][4] - The NDA submission is backed by positive results from the Phase 3 JX07001 clinical trial, demonstrating significant improvements in near vision for patients with presbyopia [2][4] - Under the License and Collaboration Agreement with CORXEL, LENZ is eligible for up to $95 million in regulatory and sales milestones, along with tiered royalties on net sales in Greater China [3] Company Overview - LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on developing the first aceclidine-based eye drop for improving near vision in presbyopia patients [5] - LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine, targeting a global population of approximately 1.8 billion people affected by presbyopia, including 128 million in the United States [5] - The U.S. FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025, for LNZ100 [5]