Core Viewpoint - The company, Zhaoke Ophthalmology-B (6622.HK), has seen a significant stock price increase of 17.36%, reaching HKD 3.65, potentially marking a new closing high since January 4, 2024 [1] Group 1: Product Development - The company has obtained a medical device registration certificate for TONO-i from the National Medical Products Administration, which will be a key part of its glaucoma product portfolio [1] - TONO-i aims to address the demand gap in China for low diagnosis and treatment rates in glaucoma management, indicating the company's commitment to dual approaches in treatment and diagnosis [1] Group 2: Strategic Partnerships - In November 2022, the company entered into an exclusive distribution agreement with C&VTech, a leading company in the development of medical devices for the diagnosis, treatment, and prevention of glaucoma [1] - The agreement grants the company exclusive rights to register, import, promote, distribute, market, and sell TONO-i in Greater China, with rights later expanded to include Thailand and Malaysia, effective from August 2024 [1]

消息面上，兆科眼科发布公告，公司已向国家药品监督管理局取得TONO-i的医疗器械注册证。TONO-i 将作为公司旗下青光眼医疗产品组合的重要部分，满足中国低诊断及治疗比率的需求缺口。TONO-i为 眼科医生提供一种工具，透过测量轻易、准确及透彻地监察患者的眼压，有助患者提供疗效的即时及持 续反馈，提高患者青光眼药物治疗的依从性。 兆科眼科-B(06622)再涨超10%，截至发稿，涨9.32%，报3.4港元，成交额1132.54万港元。 值得注意的是，2022年11月，公司与C&VTech达成一项有关TONO-i的独家分销协议。C&VTech为一间 于开发诊断、治疗及预防青光眼的医疗器材领域具有领先地位的公司。根据该协议的条款，公司拥有于 大中华登记、进口、推广、分销、营销及出售TONO-i的独家权利。该等权利其后透过合约修订扩大至 包括泰国及马来西亚，自2024年8月起生效。 ...

值得注意的是，2022年11月，公司与C&VTech达成一项有关TONO-i的独家分销协议。C&VTech为一间 于开发诊断、治疗及预防青光眼的医疗器材领域具有领先地位的公司。根据该协议的条款，公司拥有于 大中华登记、进口、推广、分销、营销及出售TONO-i的独家权利。该等权利其后透过合约修订扩大至 包括泰国及马来西亚，自2024年8月起生效。 智通财经APP获悉，兆科眼科-B(06622)再涨超10%，截至发稿，涨9.32%，报3.4港元，成交额1132.54万 港元。 消息面上，兆科眼科发布公告，公司已向国家药品监督管理局取得TONO-i的医疗器械注册证。TONO-i 将作为公司旗下青光眼医疗产品组合的重要部分，满足中国低诊断及治疗比率的需求缺口。TONO-i为 眼科医生提供一种工具，透过测量轻易、准确及透彻地监察患者的眼压，有助患者提供疗效的即时及持 续反馈，提高患者青光眼药物治疗的依从性。 ...

Core Viewpoint - The company has obtained a medical device registration certificate for TONO-i from the National Medical Products Administration, marking a significant advancement in its glaucoma product portfolio [1] Group 1: Product Overview - TONO-i is an innovative, non-contact, portable, and lightweight tonometer designed for painless and infection-free use without anesthesia [1] - The device aims to address the low diagnosis and treatment rates for glaucoma in China, providing a crucial tool for ophthalmologists to monitor patients' intraocular pressure accurately and continuously [1] Group 2: Strategic Partnerships - In November 2022, the company entered into an exclusive distribution agreement with C&V Tech, a leading company in the field of glaucoma diagnostic, treatment, and prevention medical devices [1] - The agreement grants the company exclusive rights to register, import, promote, distribute, market, and sell TONO-i in Greater China, with rights later expanded to include Thailand and Malaysia, effective from August 2024 [1]

Core Viewpoint - The company has obtained a medical device registration certificate for TONO-i from the National Medical Products Administration, marking a significant advancement in its glaucoma product portfolio [1] Group 1: Product Overview - TONO-i is an innovative, non-contact, portable, and lightweight tonometer designed for painless and infection-free use without anesthesia [1] - The device aims to address the low diagnosis and treatment rates for glaucoma in China, providing a tool for ophthalmologists to easily and accurately monitor patients' intraocular pressure [1] Group 2: Market Strategy - TONO-i will play a crucial role in the company's commitment to glaucoma management through both treatment and diagnosis [1] - In November 2022, the company entered into an exclusive distribution agreement with C&V Tech, a leading company in the field of glaucoma diagnostic and treatment medical devices [1] - The agreement grants the company exclusive rights to register, import, promote, distribute, market, and sell TONO-i in Greater China, with rights later expanded to include Thailand and Malaysia, effective from August 2024 [1]

Core Viewpoint - The company has received a medical device registration certificate for TONO-i from the National Medical Products Administration, marking a significant advancement in its glaucoma product portfolio [1] Group 1: Product Overview - TONO-i is an innovative, non-contact, portable, and lightweight tonometer designed for painless and infection-free use without anesthesia [1] - The device aims to address the low diagnosis and treatment rates for glaucoma in China, providing an essential tool for ophthalmologists to monitor intraocular pressure accurately and continuously [1] Group 2: Strategic Partnerships - In November 2022, the company entered into an exclusive distribution agreement with C&VTech, a leading company in the field of glaucoma diagnostic and treatment medical devices [1] - The agreement grants the company exclusive rights to register, import, promote, distribute, market, and sell TONO-i in Greater China, which has since been expanded to include Thailand and Malaysia, effective from August 2024 [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Zhaoke Ophthalmology Limited （於英屬處女群島註冊成立並於開曼群島存續的有限公司） （股份代號：6622） 兆科眼科有限公司 自 願 性 公 告－ 向國家藥品監督管理局取得供測量眼壓的 TONO-i的醫療器械註冊證 本 公 告 由 兆 科 眼 科 有 限 公 司（「本公司」）董 事 會（「董事會」）自 願 作 出。 – 1 – 關於青光眼 按 照 灼 識 諮 詢，青 光 眼 是 全 球 第 二 位 的 致 盲 因 素，是 一 種 與 高 眼 壓 導 致 視 神 經 損 傷 相 關 的 慢 性 及 漸 進 性 疾 病。眼 壓 由 眼 內 房 水 產 生 與 房 水 排 放 比 率 的 平 衡 決 定。幾 乎 所 有 的 青 光 眼 個 案 為 原 發 性 青 光 眼，通 常 可 分 為 開 角 型 青 光 眼 及 閉 角 ...

Core Viewpoint - The company Zhaoke Ophthalmology (06622) has seen a significant stock price increase following the announcement of receiving orphan drug designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma in children, which could lead to exclusive market rights in the U.S. for seven years if approved [1] Group 1 - Zhaoke Ophthalmology's stock rose over 9% during trading, with a current increase of 5.59%, reaching HKD 3.02, and a trading volume of HKD 12.43 million [1] - The FDA granted orphan drug designation (ODD) for Mephalan, establishing a clear regulatory pathway for the company to submit a new drug clinical trial application in the U.S. [1] - If Mephalan is successfully developed and approved, the company will enjoy seven years of exclusive rights in the U.S. market post-approval, including data exclusivity and market authorization holder status [1] Group 2 - Zhaoke Ophthalmology recently announced a strategic partnership with FAREVA, a leading French pharmaceutical company, to become a trusted partner for drug manufacturing in China [1] - The memorandum of understanding signed with FAREVA indicates Zhaoke Ophthalmology's role as a recommended partner for FAREVA's clients seeking drug production in China [1]

消息面上，兆科眼科近日公告，美国食品药品监督管理局（FDA）已向公司拥有专利配方、用于治疗儿 童视网膜母细胞瘤（RB，一种罕见的儿童眼癌）的美法仑授出孤儿药资格认证(ODD)。取得ODD为在 美国提交新药临床试验申请(新药试验申请)建立清晰的监管路径。再者，如果美法仑获成功研发并获批 准，公司将在新药上市申请批准后享有七年美国市场独家权利。此项完善保护涵盖上市许可持有人地位 及数据独家权利，尤其重要的是，即使配方有所创新，FDA亦不得批准任何其他以美法仑为基础的RB 适应症产品。 智通财经APP获悉，兆科眼科-B(06622)盘中涨超9%，截至发稿，涨5.59%，报3.02港元，成交额1243.26 万港元。 值得注意的是，据兆科眼科官微消息，7月15日，公司宣布最近与法国领先医药企业FAREVA达成战略 合作。兆科眼科最近与总部位于法国的全球医药用品、化妆品及家用品委托制造商FAREVA签署了谅解 备忘录。根据该备忘录，兆科眼科将成为FAREVA客户在中国寻求药品生产的值得信任的推荐合作伙 伴。 ...

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: | 2025年7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: | 2025年8月4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 ...