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]

Core Viewpoint - Zhaoke Ophthalmology-B (06622) has seen a significant stock price increase, attributed to the announcement of obtaining a medical device registration certificate for TONO-i from the National Medical Products Administration of China [1] Company Developments - The company reported a stock price increase of over 10%, with a current price of 3.4 HKD and a trading volume of 11.32 million HKD [1] - TONO-i will be a key part of the company's glaucoma medical product portfolio, addressing the demand gap in China for low diagnosis and treatment rates [1] - The device provides ophthalmologists with a tool to easily, accurately, and thoroughly monitor patients' intraocular pressure, enhancing patient compliance with glaucoma medication [1] 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, 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, which has since been expanded to include Thailand and Malaysia, effective from August 2024 [1]

Core Viewpoint - Zhaoke Ophthalmology-B (06622) has seen a significant stock price increase, rising over 10% and currently trading at 3.4 HKD, with a transaction volume of 11.32 million HKD, following the announcement of obtaining a medical device registration certificate for TONO-i from the National Medical Products Administration of China [1] Group 1: Product Development - The TONO-i device will be a crucial part of the company's glaucoma medical product portfolio, addressing the demand gap in China for low diagnosis and treatment rates [1] - TONO-i provides ophthalmologists with a tool to easily, accurately, and thoroughly monitor patients' intraocular pressure, facilitating immediate and continuous feedback on treatment efficacy, thereby improving patient compliance with glaucoma medication [1] Group 2: Distribution Agreement - In November 2022, the company entered into an exclusive distribution agreement with C&VTech, a leading company in the field of developing diagnostic, therapeutic, and preventive medical devices for 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]

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]

Core Viewpoint - Zhaoke Ophthalmology-B (06622) has received orphan drug designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma, a rare childhood eye cancer, which establishes a clear regulatory pathway for new drug clinical trial applications in the U.S. [1] Group 1: FDA Approval and Market Implications - The orphan drug designation allows Zhaoke Ophthalmology to have exclusive rights in the U.S. market for seven years post-approval of the new drug application, providing significant market protection [1] - The FDA cannot approve any other products based on Mephalan for retinoblastoma indications, even if the formulation is modified [1] Group 2: Strategic Partnerships - Zhaoke Ophthalmology has recently entered into a strategic partnership with FAREVA, a leading French pharmaceutical company, to become a trusted partner for drug manufacturing in China [1]

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 ...