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） ...

Company Transition and Milestones - In 2022, Zhaoke Ophthalmology transitioned from a pure R&D company to a commercial pharmaceutical company, achieving significant milestones despite macro challenges[14] - The company launched its first commercialized product, the heat compress eyepatch 堡得视®, in 2022, marking its transition from a pure R&D company to a commercial pharmaceutical company[74] - The launch of the Heat Compress Eyepatch in August 2022 marked the beginning of Zhaoke's commercialization strategy, allowing direct engagement with consumers[52] Clinical Programs and Product Development - The company advanced key clinical programs with late-stage initiatives addressing major front-of-the-eye diseases, solidifying its leadership in the ophthalmology sector in China[15] - Zhaoke Ophthalmology submitted two New Drug Applications (NDAs) and initiated the commercialization of its first product on Tmall, enhancing its market presence[15] - CsA Ophthalmic Gel NDA application accepted for review by NMPA in June 2022, passed GMP standards in January 2023[6] - NVK002 completed patient recruitment for Phase III clinical trials in China ahead of schedule in July 2022, strengthening position in low-dose atropine market[6] - The NVK002 clinical trial is expected to be completed in summer 2023, with plans for NDA submission based on combined global studies[41] - The Phase III clinical trial for Epinastine is expected to be completed, followed by an NDA submission[41] - Zhaoke Ophthalmology aims to file an IND for a Phase Ib/II study for Brimochol later this year[41] - The company is actively reviewing results from three Phase II studies for ZKY001, aiming to progress to Phase III this year[41] Market Opportunities and Growth Projections - The market size for DED drugs in China is projected to grow from US$430 million in 2019 to US$6.7 billion by 2030, representing a CAGR of 28.4%[32] - The market for myopia treatment in China is expected to increase from US$200 million in 2019 to US$3.0 billion by 2030, with a CAGR of 35.9%[32] - China has the highest number of glaucoma patients globally, accounting for approximately 25% of the total, with the market for glaucoma drugs anticipated to rise from US$163 million in 2019 to US$2.0 billion by 2030, at a CAGR of 25.4%[32] - The ophthalmology drug market in China is projected to reach approximately US$11 billion by 2027, driven by increasing demand and supportive public policies[67] Financial Performance - The company reported a loss for the year of RMB 407,317,000 in 2022, a significant reduction from a loss of RMB 2,129,780,000 in 2021[59] - Total R&D expenses for 2022 were RMB 296,430,000, an increase from RMB 220,058,000 in 2021[59] - Non-HKFRS adjusted loss for the year was RMB 360,633,000, compared to RMB 228,311,000 in 2021[59] - As of December 31, 2022, total assets amounted to RMB 2,570,623, a slight decrease from RMB 2,605,407 in 2021[63] - Other income rose to RMB 38,041,000 in 2022, compared to RMB 21,133,000 in 2021, indicating growth in non-operational revenue streams[199] Product Pipeline and Regulatory Approvals - Zhaoke Ophthalmology has one of the largest drug portfolios in the industry, with advanced programs in Phase III or later for major front-of-the-eye diseases[68] - The glaucoma product line includes seven drugs and one home-use IOP measurement device, with five to six ANDA submissions anticipated in 2023[41] - The NDA submission for CsA Ophthalmic Gel was accepted for review in June 2022, and it passed all regulatory inspections by January 2023, marking a significant milestone[49] - CsA Ophthalmic Gel is expected to receive regulatory approval and commercialization in China by early 2024, with ongoing discussions for U.S. IND filing by the end of 2023[91] - The proprietary hydrogel formulation of CsA Ophthalmic Gel allows for once-a-day dosing, improving patient compliance compared to traditional treatments[89] Strategic Partnerships and Collaborations - Partnership with Visus established in May 2022 for Brimochol, targeting presbyopia, solidifying leadership in three major front-of-the-eye diseases[6] - Strategic partnerships established with leading pharmaceutical supply chain service providers in March 2022 for broad collaboration[24] - The company is committed to exploring partnerships with domestic and international pharmaceutical firms to expand its drug portfolio[171] - A corporate gift agreement was established with Johns Hopkins University to support translational research and academic exchange[169] Community Engagement and Corporate Culture - Zhaoke Ophthalmology built a leading content portal for Chinese ophthalmologists through its Boshi WeChat account, strengthening its engagement with the medical community[15] - The company aims to address public awareness of eye diseases through campaigns like the "Glaucoma Commonweal Campaign" and "National Eyecare Day Commonweal Campaign"[179] - Emphasis on strong corporate culture as a key to success, fostering collaboration and transparency among employees[28] - Approximately 53% of the company's total employees were women, with 42% of them in managerial and executive positions[178] Digital Innovation and Marketing Strategies - The company is committed to driving digital innovation and building a state-of-the-art business model to meet the unmet needs of patients[42] - The digital platform Zhaoke Boshi has over 11,000 followers and features contributions from over 60 leading KOLs and ophthalmologists, enhancing the company's outreach in the ophthalmic community[156] - The company launched a flagship store on Tmall to build brand awareness among Chinese consumers focused on eye care[164] - Zhaoke Ophthalmology's innovative model incorporates digital, social, and e-commerce channels to enhance brand visibility beyond traditional sales methods[150] Expansion Plans and Global Footprint - The company is committed to expanding its presence in the Greater Bay Area, benefiting from supportive measures from regional and local governments[31] - Zhaoke Ophthalmology aims to enhance its scientific and commercial leadership in ophthalmology while expanding its footprint outside of China, particularly in South Korea and Southeast Asia[42] - Zhaoke Ophthalmology entered a distribution agreement with Kwangdong Pharmaceutical Co., Ltd. for NVK002 in South Korea, expanding its global footprint[108]

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。 截 至2022年12月31日止年度 全年業績公告 於 本 公 告 內，「兆 科 眼 科」及「我 們」均 指 本 公 司 及（如 文 義 另 有 所 指）本 集 團。本 公 告 所 載 若 干 金 額 及 百 分 比 數 字 已 作 四 捨 五 入 調 整，或 取 整 至 一 或 兩 個 小 數 位。任 何 圖 表 或 其 他 部 分 與 所 列 總 數 或 總 額 如 有 任 何 歧 異，乃 ...

Financial Performance - Total comprehensive income for the period was a loss of RMB 46,362,000, compared to a loss of RMB 1,985,332,000 in the previous year, indicating a significant reduction in losses [27]. - The net loss for the period was RMB 161,026,000, a substantial improvement from the loss of RMB 1,987,658,000 reported in the same period last year [27]. - Non-HKFRS adjusted net loss for the period was RMB 138,932,000, compared to RMB 123,294,000 in the previous year, showing an increase in adjusted losses [27]. - General and administrative expenses were RMB 39,510,000, down from RMB 100,612,000, marking a 60.8% decrease [27]. - Finance costs decreased significantly to RMB 1,307,000 from RMB 1,764,390,000, indicating a reduction in financial burden [27]. - Other income and (loss)/gain, net was a loss of RMB 5,624,000, compared to a gain of RMB 7,345,000 in the previous year [27]. - As of June 30, 2022, the company reported a total loss of approximately RMB 161.0 million, a significant decrease from RMB 1,987.7 million for the same period in 2021, primarily due to changes in the carrying amount of preferred shares liability [190]. - R&D expenses for the six months ended June 30, 2022, were approximately RMB 100.9 million, representing a decrease of about 18.2% from RMB 123.4 million for the same period in 2021, mainly due to the commencement of Phase III clinical trials for key products [191]. - Other income increased to approximately RMB 11.9 million for the six months ended June 30, 2022, compared to RMB 7.4 million for the same period in 2021, driven by increased bank interest income and government subsidies [196]. - The company recorded approximately RMB 17.5 million of other net loss for the six months ended June 30, 2022, compared to RMB 65,000 for the same period in 2021, primarily due to foreign exchange gains or losses [198]. - The company has RMB 1,569,352,000 in cash or cash equivalents as of June 30, 2022, providing strong support for advancing clinical programs [182]. Research and Development - Research and development expenses amounted to RMB 100,929,000, down from RMB 123,435,000 in the prior year, reflecting a 18.2% decrease [27]. - The company continues to focus on R&D to enhance its product offerings and market position [29]. - The company is focusing on R&D for PAN-90806, a small molecule asset in a U.S. Phase II clinical trial, to strengthen its competitive position in the ophthalmology market [56]. - The company has a diverse pipeline of innovative drugs targeting multiple complex diseases, with several candidates in various clinical trial phases [86]. - Key drug candidates include Cyclosporine A ophthalmic gel, currently in preclinical stage, and NVK002 (Atropine), which is in Phase III trials in the US [87]. - The company is actively pursuing clinical trials for several drug candidates, with some not requiring Phase I trials before advancing to Phase II or III [89]. - The ongoing Phase III trials for RGN-259 (Thymosin β4) in the US highlight the company's commitment to advancing its innovative therapies [87]. - The company is focused on optimizing the formulation of PAN-90806 and plans to commence human trials after completing necessary animal studies [134]. Product Development and Launches - The launch of the 堡得视® heat compress eyepatch, approved as a class 2 medical device in China, began on August 15, 2022, with positive initial revenue visibility [41]. - The first commercialized product, the 堡得视® heat compress eyepatch, was launched in August 2022 for patients with mild dry eye disease (DED) [76]. - The company anticipates launching its first generic drug this year and has established a robust commercialization strategy, including online and offline channels [71]. - The company has commercialized Bimatoprost Timolol, a generic drug for glaucoma, marking its entry into the underserved glaucoma market [140]. - The company has launched a content-driven platform on WeChat, Zhaoke Boshi, which has grown to nearly 10,000 followers and features contributions from over 60 leading KOLs in ophthalmology [147]. - The company introduced two innovative drugs, BRIMOCHOL™ PF and Carbachol PF, in May 2022, becoming the first Chinese ophthalmic pharmaceutical company with advanced-stage candidates for all three major front-of-the-eye diseases [78]. Market Opportunities and Strategies - The company aims to address the myopia condition affecting over 163 million children and adolescents in China, indicating a substantial market opportunity [38]. - The market size for DED drugs in China is projected to grow from $430 million in 2019 to $6.7 billion by 2030, representing a CAGR of 28.4% [57]. - The market for myopia treatments in China is expected to increase from $200 million in 2019 to $3 billion in 2023, with a CAGR of 35.9% [57]. - The company is well-positioned to capture opportunities in the Greater Bay Area, supported by government policies promoting healthcare excellence [60]. - The company aims to integrate strong R&D capabilities and innovative commercialization strategies to capitalize on market opportunities [61]. - The diagnosis rates for wAMD and DME in China remain low at below 3%, indicating significant growth potential in back-of-the-eye treatments [53]. - The ophthalmology drug market in China is expected to reach approximately RMB 11 billion by 2030, driven by increasing patient demand and new public policies in the healthcare sector [66]. - The company is focused on expanding its market presence in Greater China, South Korea, and ASEAN countries, with several drugs already commercialized in China [87]. Partnerships and Collaborations - The company has established partnerships with three leading pharmaceutical supply chain service companies in March 2022 to enhance procurement and logistics management [79]. - The company is exploring strategic partnerships and collaborations to enhance its research and development capabilities and market reach [88]. - The company has established multiple licensing partnerships with leading firms in China, the U.S., and Europe to build its global footprint [157]. - Strategic partnerships have been signed with three leading Chinese pharmaceutical supply chain companies to collaborate on procurement, logistics, and market developments [159]. - The company is committed to exploring further partnerships with domestic and international pharmaceutical firms to strengthen R&D capabilities and expand its drug portfolio [160]. Clinical Trials and Regulatory Approvals - The early completion of patient recruitment for the Phase III clinical trials of NVK002 involved 1,300 patients across nearly 40 sites in China, completed two to three months ahead of schedule [37]. - The NDA for CsA Ophthalmic Gel, an innovative treatment for DED, is under review by the CDE in China, with potential to be the company's first innovative commercialized drug in the country [47]. - The NDA submission for CsA Ophthalmic Gel was accepted for review by the CDE in June 2022 [76]. - The Phase III clinical trial for TAB014 involves approximately 60 centers and aims to enroll a total of 488 patients, with the primary objective to evaluate changes in best corrected visual acuity at week 52 compared to Lucentis® [125]. - NVK002 is positioned as the first clinically-proven pharmaceutical product for myopia progression, with two concentrations (0.01% and 0.02%) being tested for efficacy and safety in children and adolescents [104]. - The China CHAMP trial for NVK002 has completed enrollment of 777 patients, while the Mini-CHAMP trial has enrolled 526 patients, both ahead of schedule [113]. - NVK002 could be available in the PRC market as early as 2024, potentially making the company one of the first to commercialize a myopia drug in China [114]. - BRIMOCHOL™ PF and Carbachol PF are preservative-free eye drops designed for presbyopia, with Phase III pivotal trials commenced in March 2022 [119].

Company Growth and Strategy - Zhaoke Ophthalmology reported significant growth in executing its dual strategy of commercialization and advancement of key clinical programs during its first year post-listing[40]. - The company aims to rapidly build its commercialization capabilities to leverage the global potential of its brand and portfolio[41]. - Zhaoke Ophthalmology is focusing on commercialization in 2022, with plans to leverage digital, social, and e-commerce channels alongside traditional sales methods[67]. - The company is developing an innovative commercialization strategy, integrating traditional and online sales channels to adapt to the evolving market dynamics in China[4]. Research and Development (R&D) - Despite challenges from COVID-19, the company maintained a strong focus on R&D, which is considered the backbone of its business[41]. - Zhaoke Ophthalmology has a comprehensive drug portfolio of 25 treatments, including 13 innovative drugs and 12 generic drugs, targeting five major ophthalmic indications[48][49]. - The company is actively exploring new partnerships to develop centers of excellence and accelerate the R&D of ophthalmic drugs[70]. - Zhaoke Ophthalmology has initiated engagement with U.S. advisors to evaluate pipeline products for potential development in North America[69]. - R&D expenses increased significantly to RMB (220,058,000) in 2021 from RMB (81,779,000) in 2020, indicating a focus on innovation[132]. Clinical Trials and Drug Development - The company conducted China's largest Phase III clinical trial for dry eye disease (DED) with 644 patients, achieving strong results and planning to submit a New Drug Application (NDA) to the NMPA[57]. - Zhaoke Ophthalmology's innovative drug NVK002 aims to be the world's first approved ophthalmic solution to control myopia progression in children, with two concurrent Phase III clinical trials approved[58]. - The Phase III clinical trial of CsA Ophthalmic Gel involved 644 patients across 41 centers in China, making it the largest DED trial conducted in the country[162]. - The Phase III trial results were announced at the 7th National Dry Eye Conference in Shanghai, indicating successful primary endpoint achievement[162]. - Zhaoke Ophthalmology plans to submit the NDA for CsA Ophthalmic Gel to the NMPA in 2022 and is exploring opportunities for submission to the FDA for clinical pathway exploration in the U.S.[164]. Financial Performance - Total revenue for the year ended December 31, 2021, was RMB 34,542,000, a decrease from RMB 62,975,000 in 2020[132]. - The company reported a net loss of RMB (2,129,780,000) for the year, compared to a loss of RMB (726,981,000) in 2020, reflecting increased operational costs[132]. - Current assets rose to RMB 2,208,894,000 in 2021, up from RMB 913,623,000 in 2020, showcasing improved liquidity[135]. - Total assets increased to RMB 2,605,407,000 in 2021, compared to RMB 1,226,586,000 in 2020, indicating growth in the company's asset base[135]. - The total liabilities decreased significantly to RMB (109,920,000) in 2021 from RMB (1,972,554,000) in 2020, suggesting improved financial health[135]. Product Pipeline and Market Opportunities - The company has a pipeline of 25 drug candidates, including 13 innovative and 12 generic drugs, targeting major ophthalmic diseases[142]. - Zhaoke Ophthalmology is exploring market opportunities outside of China for CsA Ophthalmic Gel[164]. - The China CHAMP trial for NVK002 aims to enroll 770 patients across 19 centers, while the Mini-CHAMP trial will enroll 526 patients across 18 centers, with the first patient enrolled on March 16, 2022[176]. - Zhaoke Ophthalmology's NVK002 is expected to be available in the mainland Chinese market as early as 2024, potentially making it one of the first companies to commercialize a myopia drug in the region[176]. Regulatory and Compliance - The manufacturing facility in Nansha, Guangzhou, passed the on-site GMP inspection for Bimatoprost Timolol in May 2021, ensuring compliance with quality standards[187]. - Zhaoke Ophthalmology passed the GMP inspection for Epinastine HCl in May 2021, marking a significant step in the ANDA review process[3]. - The manufacturing facility in Nansha, Guangzhou, spans approximately 7,600 sq.m. and is equipped with state-of-the-art machinery, designed to meet international regulatory standards[4]. Strategic Partnerships and Team Development - The company has established partnerships with three leading Chinese pharmaceutical companies to enhance distribution and collaboration in R&D and clinical research[69]. - Strategic hires have been made, including the appointment of a new Chief Medical Officer and General Counsel, to strengthen the team[126].

o O C INTERIM REPORT 2021 O O O O 0 o 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量群島存續的有限公司) (Stock Code 股份代號 : 6622) 0 o 0 0 . o o O o . O o o . O o o 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 14 概覽 Business Overview 15 業務概覽 Financial Review 34 財務回顧 Other Informati ...