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 ...

Core Viewpoint - Zhaoke Ophthalmology is considered an undervalued innovative ophthalmic drug company, with significant potential for growth as it approaches a clinical drug harvest period and has seen a stock price increase of approximately 140% this year, despite a low price-to-book ratio of less than 1 [4][15]. Product Pipeline and Market Potential - Zhaoke Ophthalmology has a comprehensive pipeline focusing on three main products: NVK002 for myopia control, a modified cyclosporine A eye gel for moderate to severe dry eye syndrome, and TAB014 for wet age-related macular degeneration (wAMD) [5][10][11]. - The NVK002 product, a low-concentration atropine eye drop, has received significant regulatory attention, with a simplified new drug application accepted and a new drug listing application approved for the 0.02% concentration [5][7]. - The market for myopia treatment is substantial, with over 40 million children in China being potential users, indicating a large growth opportunity for NVK002 [7][9]. Competitive Landscape - The competition for NVK002 is intense, with other companies like Xingqi Eye Medicine already having launched similar products. Zhaoke aims to differentiate itself by enhancing patient compliance and addressing the stability issues of atropine [8][9]. - The modified cyclosporine A eye gel has shown promising clinical results, with a patient compliance rate of 98.94%, and is expected to receive faster approval due to proactive communication with regulatory authorities [10][11]. Future Outlook - Zhaoke Ophthalmology aims to have a total of 12 products on the market within the next 18 months, which would significantly enhance its influence in the ophthalmic field [14][15]. - The company has also received orphan drug designation from the FDA for a treatment for retinoblastoma, indicating its commitment to expanding its product offerings [12]. - The CEO expressed confidence in the company's future, emphasizing the importance of timely product approvals and the potential for market growth in various ophthalmic conditions [17].

Performance Summary - Ningde Times (03750.HK) reported a revenue of 178.886 billion yuan for the first half of the year, an increase of 7.27% year-on-year, with a net profit of 30.512 billion yuan, up 33.02% year-on-year [2] - Hisense Home Appliances (00921.HK) achieved a total operating revenue of 49.34 billion yuan, a year-on-year increase of 1.44%, and a net profit of 2.077 billion yuan, up 3.01% year-on-year [2] - New Oriental-S (09901.HK) recorded a net revenue of 4.9 billion USD for the fiscal year 2025, a year-on-year increase of 13.6%, with a net profit of 372 million USD, up 20.1% year-on-year [2] - Weisheng Holdings (03393.HK) reported an operating income of 1.368 billion yuan, a year-on-year increase of 11.88%, and a net profit of 305 million yuan, up 12.24% year-on-year [2] - Yingda Real Estate (00432.HK) had a total revenue of 736 million HKD, a year-on-year growth of 35%, but reported a net loss of approximately 249 million HKD, an increase of 62.75% year-on-year [2] - Saint Bella (02508.HK) announced a profit alert, expecting a net profit of over 320 million yuan, turning from loss to profit year-on-year [2] - Aoneng Construction (01183.HK) issued a profit alert, expecting a net profit increase of over 125% to no less than 18 million MOP year-on-year [2] - Da Cheng Corn Group (03889.HK) issued a profit warning, expecting a net loss of approximately 65 to 85 million HKD, turning from profit to loss year-on-year [2] Company News - Sinopec Oilfield Services (01033.HK) announced that its subsidiary won a natural gas pipeline engineering project with a bid amount of 3.597 billion yuan, accounting for 4.44% of the 2024 revenue [2] - CSPC Pharmaceutical Group (01093.HK) signed an exclusive licensing agreement with MADRIGAL for SYH2086, with potential total payments of up to 2.075 billion USD [2] - China Biopharmaceutical (01177.HK) reported successful external licensing cooperation for LM-299, with a milestone payment of 300 million USD expected to be received soon [2] - Chunquan Industrial Trust (01426.HK) reported an average rental rate of approximately 86% for Huamao Property in the second quarter [2] - Sihuan Pharmaceutical (00460.HK) completed the first patient enrollment in a Phase III clinical trial for the new indication of the innovative drug Annelazole Sodium for gastroesophageal reflux disease [2] - Zhaoke Ophthalmology-B (06622.HK) received orphan drug designation from the FDA for Mephalan for the treatment of retinoblastoma in children [2] - Yunnan Construction Investment Concrete (01847.HK) continues to sign concrete supply contracts for the expansion project of Kunming Changshui International Airport, with a contract amount of approximately 283 million yuan [2] Buyback and Increase Dynamics - Vitasoy International (00345.HK) repurchased 2.122 million shares for approximately 19.6 million HKD at a price range of 9.2 to 9.26 HKD [2] - China Eastern Airlines (00670.HK) spent approximately 7.2536 million HKD to repurchase 2.5 million shares at a price range of 2.89 to 2.92 HKD [2]

Core Viewpoint - The company has received Orphan Drug Designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma (RB), a rare pediatric eye cancer [1] Group 1 - The ODD provides a clear regulatory pathway for the company to submit a New Drug Application (NDA) in the United States [1] - If Mephalan is successfully developed and approved, the company will enjoy seven years of exclusive market rights in the U.S. following the NDA approval [1] - The exclusivity includes marketing authorization holder (MAH) status and data exclusivity, ensuring that the FDA cannot approve any other RB indication products based on Mephalan, even if the formulation is modified [1]

智通财经APP讯，兆科眼科-B(06622)发布公告，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(Orphan Drug Designation，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(marketing authorization holder，MAH)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。 ...

Core Viewpoint - The company, Zhaoke Ophthalmology-B (06622.HK), has received Orphan Drug Designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma (RB), a rare childhood eye cancer [1] Group 1: Regulatory Approval - The ODD provides 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 market rights in the U.S. post-approval [1] - The exclusivity includes marketing authorization holder (MAH) status and data exclusivity, preventing the FDA from approving any other RB indication products based on Mephalan, even if the formulation is modified [1] Group 2: Drug Mechanism and Current Use - Mephalan is an alkylating agent that interferes with DNA replication and cell division, blocking the growth and spread of cancer cells [1] - Currently, Mephalan is primarily used as a pre-treatment for autologous hematopoietic stem cell transplantation in multiple myeloma patients or for palliative treatment in cases where oral therapy is not applicable [1]

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－ 用於治療兒童視網膜母細胞瘤的美法侖 取得美國FDA孤兒藥資格認證 本 公 告 乃 由 兆 科 眼 科 有 限 公 司（「本公司」）董 事 會（「董事會」）自 願 作 出。 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。 取 得ODD為 在 美 國 提 交 新 藥 臨 床 試 驗 申 請（「新藥試驗申請」）建 立 清 晰 的 監 管 路 徑。再 者，如 果 美 法 侖 獲 成 功 研 發 並 獲 批 准，本 公 司 將 在 新 藥 上 市 申 請（「新 藥 申 請」）批 准 後 享 有 七 年 美 國 市 場 獨 家 權 利。此 項 完 善 保 護 涵 蓋 上 市 許 可 持 有 人 （marketing authoriza ...

Core Viewpoint - Alcon's FDA approval of Tryptyr 0.003% eye drops for dry eye disease (DED) marks a significant development in the ophthalmic market, while the stock performance of Zhaoke Ophthalmology (06622) reflects broader trends in the pharmaceutical sector, with a notable increase in stock prices across the industry [1][5]. Company Developments - Zhaoke Ophthalmology's stock surged by 19.21% on the same day as Alcon's announcement, continuing a trend where the company's stock has doubled in value over recent months, with a maximum increase of 147.69% since April [1][3]. - The company received FDA approval for a new drug clinical trial application for cyclosporine eye gel, a core product aimed at treating moderate to severe dry eye disease, which is expected to enhance its market position [3][5]. Market Dynamics - The dry eye treatment market in China is projected to grow significantly, with an estimated market size of approximately 160 billion yuan in 2024 and expected to exceed 200 billion yuan by 2025, reflecting a compound annual growth rate (CAGR) of over 15% [5][12]. - Current treatments for dry eye, primarily sodium hyaluronate eye drops, have limitations, leading to a shift towards more effective alternatives like cyclosporine eye gel, which is gaining market share due to its superior efficacy and lower side effects [5][11]. Product Efficacy - Cyclosporine A (CsA) eye gel has shown to significantly improve symptoms in moderate to severe dry eye patients, with a clinical trial indicating a marked improvement in patient outcomes compared to control groups [6][12]. - The formulation of cyclosporine eye gel enhances its bioavailability, achieving peak concentrations in the cornea and conjunctiva that are significantly higher than traditional formulations, thus improving treatment effectiveness [6][7]. Financial Performance - Zhaoke Ophthalmology reported a substantial revenue increase of 268.6% in 2024, with drug sales contributing significantly to this growth, although the company remains in a loss position [12][13]. - The reduction in research and development expenses, alongside increased revenue, has led to a narrowing of losses, indicating a potential turnaround for the company [12][13]. Future Prospects - The anticipated approval and commercialization of cyclosporine eye gel could position Zhaoke Ophthalmology favorably in the market, especially given the high patient compliance rates associated with its formulation [7][11]. - The company is also advancing its pipeline with NVK002, a low-dose atropine product for myopia management, which has received regulatory attention and could further enhance its market presence [13].