股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2026年1月31日 | 狀態: 新提交 | | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | 公司名稱: | 兆科眼科有限公司 | | | 呈交日期: | 2026年2月3日 | | | I. 法定/註冊股本變動 | | | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06622 | 說明 | 兆科眼科有限公司 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,600,000,000,000 | USD | 0.00000025 | USD | | 400,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 1,60 ...

Group 1 - The stock of Zhaoke Ophthalmology-B (06622.HK) has increased by over 5%, currently up 5.28% at HKD 3.79 [1] - The trading volume reached HKD 6.119 million [1]

公告指，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。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)再涨超5%，截至发稿，涨5.28%，报3.79港元，成交额611.9万港元。 消息面上，1月29日晚，兆科眼科公布，公司的伙伴Tenpoint Therapeutics,Ltd.已接获美国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。 ...

智通财经APP获悉，兆科眼科-B(06622)再涨超5%，截至发稿，涨5.28%，报3.79港元，成交额611.9万港 元。 公告指，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。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。 消息面上，1月29日晚，兆科眼科公布，公司的伙伴Tenpoint Therapeutics, Ltd.已接获美国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。 ...

Core Insights - The approval of BRIMOCHOL™ PF marks a significant breakthrough in the treatment of presbyopia, introducing the world's first combination eye drop for this condition [2][4][11] - The drug's approval by the FDA highlights its efficacy and safety, addressing a substantial unmet clinical need in the presbyopia treatment market [4][5][11] Drug Approval and Clinical Data - BRIMOCHOL™ PF has been validated through two key Phase III clinical trials, demonstrating superior efficacy compared to its individual active components [4][5] - The first Phase III trial (BRIO-I) confirmed the drug's effectiveness, while the second trial (BRIO-II) showed significant improvements in uncorrected near visual acuity without compromising distance vision [4][5] - The drug has shown good tolerability with no serious treatment-related adverse events reported during over 72,000 treatment days [4][5] Market Potential and Strategic Positioning - Approximately 1.2 billion people globally are affected by presbyopia, with a significant portion of the population over 50 years old impacted [5] - The approval of BRIMOCHOL™ PF fills a market gap for combination therapies in presbyopia, positioning the company favorably against competitors [5][11] - The company is actively pursuing global business development (BD) partnerships, having licensed the drug to eight countries in the Asia-Pacific region and six in the Middle East [2][6][8] Business Development Strategy - The company's BD strategy focuses on leveraging partnerships to expedite market entry in key regions, contrasting with the self-reliant approach of some competitors [6][8] - The FDA's approval is expected to facilitate faster regulatory processes in other countries, potentially simplifying or waiving clinical trial requirements based on FDA data [8][9] - This proactive approach is anticipated to significantly shorten the commercialization timeline compared to the typical 3-5 year approval cycle in the region [9] Financial Outlook and Growth Potential - The approval of BRIMOCHOL™ PF is expected to be a core revenue driver for the company in the coming years, alongside other innovative products in its pipeline [9][11] - The company's stock has shown a recovery, with a more than 150% increase since 2025, reflecting positive market expectations for its growth [11] - The ongoing development of other products, such as cyclosporine eye gel and low-concentration atropine, further supports the company's international expansion and diversification strategy [9][11]

（原标题：兆科眼科-B(06622)：Tenpoint接获FDA在美国就BRIMOCHOL? PF发出的批准） 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，BR ...

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 ...

Core Insights - Tenpoint Therapeutics, Ltd. has received FDA approval for the commercialization of BRIMOCHOL PF (2.75%/0.1%), an innovative eye drop for the treatment of presbyopia, which will be marketed as YUVEZZI in the U.S. [1][2] Group 1: Clinical Trial Results - The approval follows the successful completion of Phase 3 clinical trials, with the first key Phase 3 study (BRIO I) demonstrating that the combination therapy is more effective than individual active drug compounds [1] - In the second placebo-controlled Phase 3 study (BRIO II), BRIMOCHOL PF met all primary endpoints for near vision improvement, showing a statistically significant increase in binocular uncorrected near visual acuity (BUCNVA) by three lines or more, while binocular uncorrected distance visual acuity (BUCDVA) did not decrease by one line or more [1] Group 2: Safety and Tolerability - During the monitoring of over 72,000 treatment days in the BRIO II study, BRIMOCHOL PF was well-tolerated, with no treatment-related serious adverse events observed [2] - The incidence of eye redness (conjunctival hyperemia) as a reported adverse event was low, with a rate of 2.8% in BRIMOCHOL PF recipients compared to 10.7% in those receiving only carbachol [2] Group 3: Commercial Strategy - The FDA approval serves as a strong catalyst for the company's commercialization strategy, as it has established a partnership network for BRIMOCHOL PF, including eight commercial partners across the Asia-Pacific region and the Middle East [2] - With FDA recognition, the company anticipates accelerating the market entry of the drug, marking a significant global milestone [2]

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 ...

此批准在Tenpoint成功完成第3期临床试验後取得。第一次的关键第3期BRIOI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BRIOII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)显着提升三行或以上，而 双眼未矫正远视力(BUCDVA)未有一行或以上下降。 此外，在BRIOII研究监测的逾72,000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BRIOI及BRIOII研究中， 眼部充血(眼部发红)不良事件的报告率低。在BRIOII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。公司已为BRIMOCHOL™PF建立夥伴 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夥伴。凭藉FDA的认可，兆科预料 ...