ANNUAL 年 2024 報 REPORT CONTENTS 目 錄 Corporation Information 2 公司資料 Chairman and CEO Statement 5 主席兼行政總裁報告 Operation Highlights 8 營運摘要 Management Discussion and Analysis 9 管理層討論及分析 Profiles of Directors and Senior Management 36 董事及高級管理層履歷 Corporate Governance Report 47 企業管治報告 Report of Directors 74 董事會報告 Independent Auditor's Report 108 獨立核數師報告 Consolidated Statement of Profit or Loss 117 綜合損益表 Consolidated Statement of Profit or Loss and Other Comprehensive Income 118 綜合損益及其他全面收益表 Consolidated Statement of ...

根据协议条款，公司有权授予Lunatus于沙地阿拉伯王国、阿拉伯联合酋长国、科威特、阿曼、巴林及 卡塔尔进口、分销、推广、营销及销售BRIMOCHOL™PF的独家权利。作为协议的一部分，Lunatus将 代表公司取得相关的当地药物注册。公司可按照若干成就获得里程碑付款。 于2025年4月8日，公司的伙伴Tenpoint Therapeutics Ltd.(Tenpoint)宣布已向美国食品药品监督管理局 (FDA)提交用于治疗老花眼的BRIMOCHOLPF的新药上市申请。Tenpoint由Tenpoint Therapeutics Ltd.与 Visus Therapeutics, Inc.合并而成，为一间全球性临床阶段生物技术公司，开发突破性的疗法，以恢复老 化眼睛的视力。 智通财经APP讯，兆科眼科-B(06622)发布公告，BRIMOCHOL™PF(公司候选药物之一，适应症为老花 眼)的第II期临床试验已于2025年3月24日入组首名患者。 该第II期临床试验为一项多中心、随机、双盲、交叉及安慰剂对照研究。该试验的主要目的为评估 BRIMOCHOL™PF滴眼液对中国老花眼患者的疗效及安全性。该试验由温州 ...

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。 本 公 告 載 有 前 瞻 性 陳 述，當 中 涉 及 風 險 及 不 明 朗 因 素。除 過 往 事 實 的 陳 述 外， 所 有 陳 述 均 屬 前 瞻 性 陳 述。該 等 陳 述 涉 及 已 知 及 未 知 風 險、不 明 朗 因 素 及 其 他 因 素，當 中 部 分 非 本 公 司 所 能 控 制，可 能 導 致 實 際 業 績、表 現 或 成 果 與 前 瞻 性 陳 述 所 明 示 或 暗 示 者 存 在 重 大 差 異。 閣下不應倚賴前瞻性陳述預測未來事 件。我 們 概 不 負 責 更 新 或 修 訂 任 何 前 瞻 性 陳 述，即 使 出 現 新 資 料、未 來 事 件 或 其 他 事 項 亦 然。 Zhaoke Ophthalmology Limited 兆科眼科有限公司 （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 ...

Zhaoke Ophthalmology Limited 兆 科 眼 科 有 限 公 司 (Incorporated in the British Virgin Islands with limited liability and continued in the Cayman Islands) (於英屬處女群島註冊成立並於開曼群島存續的有限公司) (Stock Code 股份代號 : 6622) NEW REDER IN NO 00 00 00 00 00 000 000 ------------------- N NO OR ON No No Do Do No on on an NOT 200 000 000 No 20 00 00 00 Contents 目錄 Page 頁碼 Corporation Information 2 公司資料 Financial Summary 6 財務概要 Chairman and CEO Statement 8 主席兼行政總裁報告 Management Discussion and Analysis 管理層討論及分析 Overview 13 概覽 Business Rev ...

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。 本 公 告 載 有 前 瞻 性 陳 述，當 中 涉 及 風 險 及 不 明 朗 因 素。除 過 往 事 實 的 陳 述 外， 所 有 陳 述 均 屬 前 瞻 性 陳 述。該 等 陳 述 涉 及 已 知 及 未 知 風 險、不 明 朗 因 素 及 其 他 因 素，當 中 部 分 非 本 公 司 所 能 控 制，可 能 導 致 實 際 業 績、表 現 或 成 果 與 前 瞻 性 陳 述 所 明 示 或 暗 示 者 存 在 重 大 差 異。 閣下不應倚賴前瞻性陳述預測未來事 件。本 公 司 概 不 負 責 更 新 或 修 訂 任 何 前 瞻 性 陳 述，即 使 出 現 新 資 料、未 來 事 件 或 其 他 事 項 亦 然。 Zhaoke Ophthalmology Limited 兆科眼科有限公司 （於英屬處女群島註冊成立並於開曼群島存續的有限公司） ...

Clinical Trials and Regulatory Approvals - NVK002 successfully completed Phase III Mini-CHAMP clinical trial in China, showing strong safety and efficacy as a potential treatment for myopia in children[3] - The company plans to resubmit the NDA for CsA Ophthalmic Gel later this year after addressing regulatory questions[2] - The company expects to make progress with NDA submissions for both 0.01% and 0.02% doses of NVK002 in China, with the CHAMP study anticipated to complete last patient out this summer[5] - The company anticipates starting Phase I and Phase II trials for BRIMOCHOL PF in China, with the completion of the pivotal Phase III study in the U.S. expected this year[5] - TAB014's Phase III clinical trial patient recruitment was completed ahead of schedule, with an NDA submission expected thereafter[16] - The company is focusing on regulatory review for Epinastine after completing its Phase III clinical trial and ANDA filing[5] - The glaucoma product portfolio, comprising seven drugs and one home-use device, is either in ANDA review or at the commercial stage, with Bimatoprost expected to receive approval this year[5] - The company has submitted ANDAs for the majority of its generic glaucoma drugs, with Bimatoprost expected to receive regulatory approval first in 2024[35] - Regulatory approval was received in January 2024 to initiate a clinical trial for BRIMOCHOL PF and Carbachol PF later in 2024[35] - The Phase III clinical trial for NVK002 treatment for myopia completed in August 2023, showing statistically significant efficacy in slowing myopia progression[145] - BRIMOCHOL PF and Carbachol PF received regulatory approval to initiate clinical trials in China in January 2024, targeting presbyopia treatment[145] Financial Performance - The company reported a cash balance of approximately RMB 1.5 billion at the end of 2023, enabling it to pursue key plans and achieve a positive cash flow turning point[6] - For the year ended December 31, 2023, the company recorded a total loss of approximately RMB 385.0 million, a decrease from RMB 407.3 million in 2022, primarily due to first-time sales revenue and increased interest income[40] - The company achieved its first year of revenue with RMB 18.8 million, mainly from sales of its glaucoma drug Bimatoprost Timolol and a Type II medical device for mild dry eye[40] - R&D expenses for the year were approximately RMB 333.1 million, representing an increase of about 12.4% from RMB 296.4 million in 2022, driven by investments in late-stage clinical trials[40] - Selling and distribution expenses rose to approximately RMB 51.9 million in 2023 from RMB 29.9 million in 2022, attributed to an increase in the commercialization team and marketing activities[50] - General and administrative expenses decreased to approximately RMB 84.4 million in 2023 from RMB 86.1 million in 2022, mainly due to a reduction in equity-settled share-based payment expenses[46] - Bank interest income increased significantly to RMB 77.4 million in 2023 from RMB 30.4 million in 2022, benefiting from higher deposit interest rates[42] - The total comprehensive income for the year was a loss of RMB 323.9 million, compared to a loss of RMB 196.4 million in 2022[40] - The company incurred equity-settled share-based payment expenses of RMB 22.0 million in 2023, down from RMB 46.7 million in 2022, indicating a decrease of approximately 52.8%[59] - The non-HKFRS adjusted loss for the year was RMB 363.0 million, slightly higher than the adjusted loss of RMB 360.6 million for the previous year, indicating a marginal increase of approximately 0.1%[59] Market Expansion and Partnerships - The company has established distribution agreements to bring its drugs to South Korea and Malaysia, and is building a presence in Thailand[5] - The company signed an amendment to expand its licensed territories to include multiple regions beyond mainland China, enhancing its market reach[14] - In November 2023, Zhaoke Ophthalmology acquired the commercial rights to Eyprotor from Lee's Pharm to enhance its commercialization capabilities[21] - The company signed a distribution and supply agreement with KDP in March 2023, granting exclusive rights to market NVK002 in South Korea[28] - Zhaoke Ophthalmology plans to establish new licensing partnerships in South Korea, Malaysia, and Thailand in the first quarter of 2024[31] - On March 15, 2024, the company finalized a distribution agreement with TRB Thailand for EyeGiene® reusable eyemasks, expanding its presence in Southeast Asia[32] - In June 2023, the company entered an exclusive agreement with Eyedetec Medical for the Eye Lipid Mobilizer™ in Greater China, South Korea, and ASEAN countries[32] - A strategic partnership was established with Eyebright Medical in August 2023 to jointly develop and commercialize ophthalmic products[32] - The company is actively exploring opportunities in Southeast Asia and evaluating potential activities in Australia following successful out-licensing agreements in South Korea, Malaysia, and Thailand[35] - The company announced its expansion into Malaysia through a distribution agreement for Bimatoprost Timolol eye drops with Pharmaniaga, marking its first overseas distribution deal[171] Research and Development - Zhaoke Ophthalmology's R&D expenses for the year ended December 31, 2023, were RMB333.1 million, reflecting a 12.4% increase from RMB296.4 million in 2022[27] - The R&D team consists of approximately 100 professionals with extensive experience in global biotechnology and pharmaceutical companies[8] - The company is exploring partnership opportunities with leading domestic and international pharmaceutical firms and research institutions[9] - The company aims to leverage its strengths and those of its partners to achieve mutually beneficial goals in the ophthalmology field[10] - The company has made significant progress in its R&D programs, including completing patient enrollment for the TAB014 Phase III trial and ANDA submissions for almost all glaucoma products[107] - The company is focused on enhancing its commercialization capabilities through an omni-channel approach and brand equity improvements[35] - The company is committed to addressing significant unmet medical needs and improving visual health globally despite challenging external conditions[179] Product Launches and Sales - The company launched its first approved drug, Bimatoprost Timolol eye drop, in February 2023, and by the end of 2023, the sales and marketing team had expanded to 71 individuals covering over 1,200 hospitals[21] - The company launched its Bimatoprost Timolol eye drop on JD Health in May 2023, complementing its Tmall flagship store launched in August 2022[21] - The company successfully launched its first pharmaceutical product, Bimatoprost Timolol eye drop, in February 2023, focusing on private hospitals and e-commerce platforms for distribution[145] - Sales of ophthalmic drugs reached RMB 4.736 million, while sales of ophthalmic products totaled RMB 8.414 million for the year ended December 31, 2023[182] - The company generated RMB 5.6 million in revenue from granting exclusive distribution rights for its innovative drug candidate, compared to nil in 2022[40] - Zhaoke Ophthalmology's digital engagement improved in 2023, enhancing online sales on Tmall and JD Health, and building a strong presence on social media platforms[95] - Zhaoke Ophthalmology's WeChat account, Zhaoke Boshi, has grown to over 15,000 followers, establishing a significant online ophthalmologist community[95] Strategic Focus and Future Outlook - The company is focused on expanding its market presence and increasing brand awareness for its first pharmaceutical product, Bimatoprost Timolol eye drop, through various marketing campaigns[70] - The company is committed to rigorous control over cash expenditures and optimizing resource allocation to mitigate financial risks[97] - The company expressed excitement about future possibilities and readiness to face upcoming challenges[98] - The company aims to leverage insights gained from early commercialization efforts to ensure it remains at the forefront of the market[108] - The company is advancing its key clinical programs and expects to move several drugs through the pipeline in the coming years[118] - The company aims to address the significant healthcare demand gap and improve visual health for patients in China and globally[37]

(a) 收 益 香港財務報告準則第15號範圍內的客戶合約收益 (ii) 該 金 額 指 從 政 府 收 到 的 補 貼，以 鼓 勵 技 術 研 發 以 及 補 償 生 產 線 資 本 支 出。 截 至2023年12月31日止年度 全年業績公告 | --- | --- | --- | |--------------------------------------|-------------------------------------|-----------------------------| | | | | | 財務摘要 | 截 至 12 月 31 2023 年 人民幣千元 | 日止年度 2022 年 人民幣千元 | | 收 益 銷售成本 | 18,750 | – | | | (4,503) | – | | 毛 利 | 14,247 | – | | 其他收入 | 82,044 | 38,041 | | 其他虧損淨額 | (3,515) | (29,731) | | | | | | 研發開支 | (333,050) | (296,430) | | 一般及行政費用 | (84,404) | (86,109) ...

智通财经APP讯，兆科眼科-B(06622)发布公告，兆科(香港)眼科药物有限公司(兆科眼科有限公司的全资附属公司)与Kwangdong PharmaceuticalCo.,Ltd.(KDP，主要从事药品生产及分销的领先韩国企业)就BRIMOCHOLPF(卡巴可2.75%╱酒石酸溴莫尼丁0.1%固定剂量复方)不含防腐剂外用滴眼液(该产品)订立分销及供应协议。 根据协议条款，公司有权将该产品在大韩民国的独家分销权授予KDP，以代表公司取得药品註册，并独家进口、推广、分销、营销及销售该产品。公司将收取一笔不可退还及不可抵扣的预付款，并可按照若干监管成就及商品销售额获得额外的里程碑付款及特许权使用费。 于2023年4月25日，董事会宣布，公司的合作伙伴-Visus Therapeutics Inc.发表BRIMOCHOLPF用于治疗老花眼的第3期关键BRIO-I试验的正面顶线结果。BRIO-I达到符合美国FDA及欧盟EMA╱英国MHRA预定的主要研究终点，当中展示出以卡巴可及溴莫尼丁单方作为活性对照组，每日一次固定剂量复方BRIMOCHOLPF的元素表现。BRIMOCHOLPF在8小时近距离视力方面具有重大统计显着 ...

截至2023年6月30日止6個月，我 們的財務成本由截至2022年6月30 日止6個月約人民幣1.3百萬元增加 至約人民幣3.6百萬元，主要由於有 關跨境資金安排的銀行貸款利息所 致。 9. 非香港財務報告準則計量方式 and and the successful and the count 下表載列於所示期間的期內虧損與 經調整期內虧損的對賬： The table below sets forth a reconciliation of the loss for the period to adjusted loss for the period during the periods indicated: 兆科眼科有限公司 中期報告 2023 47 As at December 31, 2022 於2023年 6月30日 於2022年 12月31日 RMB'000 RMB'000 人民幣千元 人民幣千元 (Unaudited) (Audited) （未經審核） （經審核） 10. 流動資金及資金來源以及借款 48 Zhaoke Ophthalmology Limited Interim Report 202 ...

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。 本 公 告 載 有 前 瞻 性 陳 述，當 中 涉 及 風 險 及 不 明 朗 因 素。除 過 往 事 實 的 陳 述 外， 所 有 陳 述 均 屬 前 瞻 性 陳 述。該 等 陳 述 涉 及 已 知 及 未 知 風 險、不 明 朗 因 素 及 其 他 因 素，當 中 部 分 非 本 公 司 所 能 控 制，可 能 導 致 實 際 業 績、表 現 或 成 果 與 前 瞻 性 陳 述 所 明 示 或 暗 示 者 存 在 重 大 差 異。 閣下不應倚賴前瞻性陳述預測未來事 件。本 公 司 概 不 負 責 更 新 或 修 訂 任 何 前 瞻 性 陳 述，即 使 出 現 新 資 料、未 來 事 件 或 其 他 事 項 亦 然。 Zhaoke Ophthalmology Limited 兆科眼科有限公司 （於英屬處女群島註冊成立並於開曼群島存續的有限公司） ...