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 ...

Financial Performance - As of June 30, 2023, the group’s current assets amounted to approximately RMB 1,942.4 million, including cash and cash equivalents of about RMB 1,674.7 million[7]. - The total remuneration costs incurred by the group for the six months ended June 30, 2023, were approximately RMB 72.8 million, an increase from approximately RMB 68.9 million for the same period in 2022[14]. - The financial cost increased from approximately RMB 1.3 million for the six months ended June 30, 2022, to approximately RMB 3.6 million for the same period in 2023, primarily due to bank loan interest related to cross-border funding arrangements[1]. - For the six months ending June 30, 2023, R&D expenses reached approximately RMB 205.3 million, an increase of approximately 103.5% from RMB 100.9 million for the same period in 2022[122]. - The company reported a loss before taxation of RMB 233,238,000, compared to a loss of RMB 161,026,000 in the previous year[172]. - Total comprehensive income for the period was a loss of RMB 135,031,000, compared to a loss of RMB 46,362,000 in the same period of 2022[172]. - As of June 30, 2023, the company reported revenue of RMB 11,304,000, with a gross profit of RMB 10,154,000[172]. - Other income for the period was RMB 39,523,000, compared to RMB 11,866,000 in the same period of 2022[172]. Research and Development - The company’s R&D team comprised approximately 100 professionals at the end of the reporting period, led by an international management team with extensive industry experience[20]. - The treatment for myopia progression control, NVK002, completed its one-year Phase III bridging trial in early August 2023, with patient recruitment for TAB014 expected to complete by the end of this year[19]. - The company is preparing for the Phase III clinical trial of another self-developed innovative asset, ZKY001[19]. - The company has filed multiple ANDA submissions for its generic assets, addressing unmet ophthalmic medical needs in China[33]. - The company has filed 2 additional ANDA submissions to the NMPA for Travoprost and Travoprost Timolol, indicating ongoing efforts in drug development[158]. - The continuing R&D activities for other key drug candidates utilized approximately HK$ 888.86 million, accounting for 46.00% of the total expected net proceeds[119]. - R&D activities for innovative and generic drug candidates utilized approximately HK$ 57.97 million, representing 3.00% of the total expected net proceeds[119]. - Zhaoke Ophthalmology is progressing its R&D efforts, with a new drug application for Cyclosporine A eye gel under review and multiple clinical projects in late-stage development[142]. Product Development and Commercialization - Zhaoke Ophthalmology's Bimatoprost Timolol eye drop (晶贝莹®) received marketing authorization from the NMPA in February 2023, with the first prescription issued on March 8, 2023[36][44]. - The company aims to enhance brand recognition through the commercialization of its first approved drug, which will support future innovative drug launches[36]. - The eye drop product is now available on JD Health, increasing accessibility for glaucoma patients[36]. - Zhaoke Ophthalmology launched its first commercialized drug, Bimatoprost Timolol eye drop, in May 2023 on JD Health, enhancing patient access to its products[137]. - The company has commercialized two products on Tmall: the heat compress eyepatch for mild dry eye disease in August 2022 and the Far Infrared Eye Heat Compress eyepatch in March 2023, expanding its product line[134]. Strategic Partnerships and Agreements - A strategic partnership was established with Aibono to explore opportunities in research, development, and commercialization of ophthalmic products[28]. - An exclusive licensing, supply, and distribution agreement was signed with Eyedetec Medical for the Eye Lipid Mobilizer™ in Greater China and several Southeast Asian countries[32]. - In March 2023, the company signed a distribution agreement with KDP for exclusive rights to market NVK002 in South Korea, including upfront and milestone payments[122]. - In June 2023, an exclusive license and distribution agreement was established with Eyedetec Medical for the Eye Lipid Mobilizer™ in Greater China and Southeast Asia[124]. - A strategic partnership was formed with Eyebright Medical in August 2023 to explore R&D and commercialization of ophthalmic products[125]. Share Options and Capital Structure - The Pre-IPO Share Option Scheme allows for the issuance of up to 45,732,000 shares, representing approximately 8.41% of the total issued share capital of 543,843,992 shares as of June 30, 2023[58]. - The company conditionally granted a total of 45,732,000 options to 109 grantees under the Pre-IPO Share Option Scheme, which represents approximately 8.41% of the total issued share capital as of June 30, 2023[77]. - The exercise price of the options granted under the Pre-IPO Share Option Scheme ranges from US$0.09 to US$1.14 per share[77]. - The Post-IPO Share Option Scheme was conditionally approved on April 1, 2021, allowing for a maximum of 53,515,550 shares to be issued, representing approximately 9.84% of the total issued share capital as of June 30, 2023[81]. - The total issued share capital of the company as of June 30, 2023, was 543,843,992 shares[71]. - The company has adopted two share option schemes that require disclosure under the Listing Rules[73]. - As of June 30, 2023, the number of options available for future grant under the Post-IPO Share Option Scheme was 45,695,550[110]. - The total number of outstanding options as of June 30, 2023, is 5,940,000 shares[100]. Financial Position and Assets - As of June 30, 2023, non-current assets amounted to RMB 594,951,000, a slight decrease from RMB 597,876,000 as of December 31, 2022[192]. - Current assets totaled RMB 1,942,415,000, compared to RMB 1,972,747,000 at the end of 2022, indicating a decrease in liquidity[192]. - Net current assets increased to RMB 1,778,207,000 from RMB 1,661,033,000, reflecting improved short-term financial health[192]. - Total assets less current liabilities were RMB 2,255,984,000, down from RMB 2,376,083,000, showing a decline in overall asset value[192]. - Non-current liabilities, including lease liabilities, were reported at RMB 26,390,000, a decrease from RMB 27,703,000[194]. - Total equity stood at RMB 2,229,594,000, down from RMB 2,348,373,000, indicating a reduction in shareholder equity[194]. - Cash and cash equivalents increased to RMB 1,716,351,000 from RMB 1,674,729,000, suggesting a positive cash flow situation[192]. - Trade and other payables rose to RMB 108,395,000 from RMB 83,418,000, indicating increased obligations[192]. - The company reported inventories of RMB 4,068,000, reflecting a new addition to current assets[192]. Corporate Governance and Compliance - The Audit Committee reviewed the interim financial report for the six months ended June 30, 2023, ensuring compliance with accounting standards[165]. - The interim financial report is unaudited, highlighting the need for caution in interpreting the figures presented[191]. - The company believes the current arrangement of having the same individual serve as both Chairman and CEO is beneficial and does not harm the balance of power[96]. - The company has not been involved in any material litigation or arbitration during the six months ended June 30, 2023[145]. - There were no significant events affecting the group after the reporting period up to the date of the report[91]. - The company does not recommend the distribution of an interim dividend for the six months ended June 30, 2023[92]. - The company did not declare an interim dividend for the six months ending June 30, 2023[126].

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 11,304,000, with a gross profit of RMB 10,154,000[5]. - Other income and gains amounted to RMB 31,236,000, compared to a loss of RMB 5,624,000 in the same period last year[5]. - The net loss for the period was RMB 233,778,000, compared to RMB 161,026,000 in the previous year[5]. - The adjusted loss for the period was RMB 218.178 million, compared to RMB 138.932 million in the same period of 2022, indicating an increase in loss of approximately 57% year-over-year[23]. - The company recorded total revenue of RMB 11.3 million in the first half of 2023, with RMB 2.3 million from the commercialization of its anti-glaucoma generic drug and RMB 3.6 million from its eye mask series[25]. - Other income for the six months ended June 30, 2023, was RMB 39,523 million, compared to RMB 11,866 million for the same period in 2022[140]. - The company reported a net cash position as of June 30, 2023, with no significant or contingent liabilities[135]. - The group reported a pre-tax loss of RMB 3,637 thousand for the six months ended June 30, 2023, compared to RMB 1,307 thousand for the same period in 2022[176]. - The group generated a basic loss per share of RMB 233,778,000 for the six months ended June 30, 2023, compared to RMB 161,026,000 for the same period in 2022[180]. Research and Development - Research and development expenses increased to RMB 205,346,000 from RMB 100,929,000 year-on-year[5]. - R&D expenses for the six months ended June 30, 2023, were approximately RMB 205.3 million, a significant increase from RMB 100.9 million for the same period in 2022, primarily due to ongoing investments in multiple late-stage clinical trials[121]. - Clinical trial professional service fees increased significantly from RMB 44.5 million in 2022 to RMB 141.5 million in 2023, reflecting the company's commitment to advancing its clinical trials[147]. - The company is actively pursuing a balanced strategy in drug development, focusing on both innovative candidates and a range of generic drugs to meet the significant market demand in China[54]. - The company has built a strong team of approximately 100 professionals in its R&D department, led by an international management team with extensive industry experience[108]. Product Development and Pipeline - The company launched its first approved drug, Beimu Sima Tirole, in March 2023, with sales beginning in May 2023[9]. - The Cyclosporine A eye gel is currently under regulatory review, with commercialization targeted for 2024 in China[10]. - The Phase III trial for the innovative drug BRIMOCHOL PF™ has shown positive results, with plans to submit a new drug application in China[12][13]. - The product pipeline includes multiple innovative drugs targeting major ophthalmic diseases, including dry eye syndrome, myopia, and presbyopia[17]. - The company aims to submit a new drug application for its cyclosporine A eye gel in the United States in 2024, following a pre-application meeting with the FDA in February 2023[19]. - The NVK002 low-concentration atropine product has made significant progress in both China and the United States, with the completion of the final patient visit in the Phase III bridging trial in August 2023[27]. - The company plans to submit a new drug application for BRIMOCHOL PF™ in China in the second half of 2023, with the goal of starting Phase I studies in 2024[30]. - The Phase III clinical trial for NVK002 in China involves 18 centers and 777 patients, with significant milestones achieved in the research process[42]. - The company aims to achieve regulatory approval for its first innovative drug, Cyclosporine A eye gel, by 2024, as part of its aggressive growth strategy[113]. Market Strategy and Growth - The company is expanding its innovative business ecosystem by integrating multi-channel content and new sales strategies[16]. - The global ophthalmic drug market is projected to reach approximately USD 11 billion by 2027, presenting a significant growth opportunity for the company[24]. - The company aims to establish itself as a one-stop solution provider for ophthalmologists in China[7]. - The company has established a distribution and supply agreement for NVK002 with Kwangdong Pharmaceutical Co., Ltd. in March 2023, marking a step towards expanding its global footprint[31]. - Zhaoke Ophthalmology aims to be one of the first companies to commercialize low-concentration atropine products in China by combining data from the small CHAMP study with Vyluma's research[71]. - The company has established licensing partnerships with leading companies in China, the US, and Europe, continuing to build a global presence[92]. Operational and Financial Management - General and administrative expenses for the six months ended June 30, 2023, were approximately RMB 42.6 million, an increase of about RMB 3.1 million compared to RMB 39.5 million for the same period in 2022, mainly due to additional consulting fees related to digital infrastructure and management systems[126]. - The company had a capital commitment of approximately RMB 240.7 million as of June 30, 2023, down from RMB 277.2 million as of December 31, 2022, mainly due to progress in production facility projects and R&D activities[136]. - The company's current liabilities were approximately RMB 281.4 million as of June 30, 2023, which included trade and other payables of approximately RMB 108.4 million and bank loans of approximately RMB 159.5 million[154]. - The current ratio decreased from 10.1 as of December 31, 2022, to 6.9 as of June 30, 2023, indicating a decline in liquidity[155]. - The total salary cost for the group was approximately RMB 72.8 million for the six months ended June 30, 2023, an increase from RMB 68.9 million for the same period in 2022, primarily due to an increase in employee salaries and benefits[181]. Compliance and Governance - The group has adopted new and revised standards in accordance with the applicable disclosure requirements of the Hong Kong Stock Exchange[168]. - The accounting policies adopted for the financial report are consistent with those used in the consolidated financial statements for the fiscal year ended December 31, 2022[189]. - The group has a single operating segment and does not present any segment information[175]. - There were no significant impacts on the group's performance or financial position due to the recent accounting policy changes[190].

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]

Financial Performance - For the year ended December 31, 2022, total revenue was RMB 8,310,000, a decrease of 76.0% compared to RMB 34,542,000 in 2021[4]. - The company reported a net loss of RMB 407,317,000 for the year, compared to a net loss of RMB 2,129,780,000 in 2021, indicating a significant improvement[4]. - The total comprehensive loss for the year was RMB 196,415,000, a reduction from RMB 2,180,971,000 in the prior year[4]. - The company reported an operating loss of 404,175, with interest expenses of 3,142[76]. - The company recorded a total loss of approximately RMB 407.3 million for the year ended December 31, 2022, compared to a loss of approximately RMB 2,129.8 million for the year ended December 31, 2021, primarily due to changes in the accounting treatment of preferred shares[187]. - Other income increased from approximately RMB 21.1 million in 2021 to about RMB 38.0 million in 2022, primarily due to an increase in bank interest income from time deposits by approximately RMB 30.4 million[162]. - General and administrative expenses decreased from approximately RMB 162.1 million in 2021 to about RMB 86.1 million in 2022, a reduction of approximately RMB 76.0 million[166]. - The company’s cash and cash equivalents, along with time deposits, amounted to RMB 1,716.4 million, indicating a strong financial position to support ongoing clinical projects and further drug commercialization investments[158]. Research and Development - Research and development expenses increased to RMB 296,430,000, up 34.6% from RMB 220,058,000 in the previous year[4]. - The company expanded its R&D team from approximately 80 professionals in 2021 to 100 professionals by the end of the reporting period in 2022[146]. - The company is focused on developing partnerships with leading domestic and international pharmaceutical companies to strengthen R&D capabilities and expand its drug portfolio[149]. - The company aims to address significant unmet medical needs in eye health through innovative research and development efforts[159]. - Clinical trial professional service costs increased to RMB 155.6 million in 2022 from RMB 113.2 million in 2021, representing a growth of 37.5%[192]. - The company is actively reviewing results from three recently completed Phase II studies (CED, pterygium, and TPRK) to advance its self-innovated asset ZKY001 into Phase III research[184]. Product Development and Commercialization - The company achieved a major milestone with the successful completion of patient recruitment for the NVK002 Phase III clinical trial in China ahead of schedule[3]. - The launch of the first commercial product, a heat compress eye mask, marks the company's entry into the consumer eye health market[3]. - The company has established an exclusive distribution agreement for the TONO-i device in Greater China, enhancing its glaucoma product portfolio[3]. - The approval of the first generic drug for glaucoma treatment in China represents a significant advancement in the company's product line[3]. - The company plans to launch innovative drugs and generics, including the glaucoma treatment Bimatoprost and the newly approved glaucoma drug Beimei Suo Taimu Luer (晶贝莹®)[9]. - The company aims to register and commercialize Cyclosporine A ophthalmic gel in China by early 2024, targeting the widespread issue of dry eye syndrome globally[53]. - The company plans to submit a new drug trial application for Brimochol in China by the end of the year, with the potential to proceed to Phase III studies if successful[157]. - The company is expanding its product offerings on Tmall to enhance brand recognition among a broader customer base[154]. - The company has initiated two Phase III clinical trials for NVK002, including a two-year trial in China and a one-year bridging trial[56]. - The company successfully launched the glaucoma generic drug, Betamethasone Tartrate Eye Drops, which received approval from the National Medical Products Administration in February 2023[140]. Market Position and Strategy - The company is positioned as the only ophthalmic pharmaceutical company in China with late-stage candidates for dry eye, myopia, and presbyopia[7]. - The Chinese ophthalmic drug market is projected to reach approximately USD 11 billion by 2027, driven by increasing patient numbers and supportive public policies[20]. - The company is committed to becoming a leading player in the global ophthalmic industry, with significant progress in advancing key clinical projects[21]. - The company believes that combining pharmaceuticals with medical devices will ultimately provide better treatment options for patients[128]. - The strategic partnership with three leading Chinese pharmaceutical companies aims to enhance distribution capabilities and operational efficiency[175]. Operational and Organizational Development - The company has increased its production capacity tenfold since the establishment of its production facility[124]. - The production facility covers an area of approximately 7,600 square meters and is equipped with advanced machinery meeting international standards[123]. - The sales and marketing team is planned to expand from 45 to over 100 personnel by the end of 2023 following the approval of the simplified new drug application for Beimei Su Thiamol Eye Drops[125]. - The company is investing in production facilities to transition from a pure R&D company to a commercial pharmaceutical company[124]. - The company has a comprehensive internal production capability covering manufacturing, packaging, and quality verification[123]. Community Engagement and Brand Recognition - The "Zhao Ke Bo Shi" platform has surpassed 11,000 followers since its launch in September 2021, featuring over 60 top KOLs and ophthalmologists contributing content or participating in discussions[127]. - The company has established an active online dialogue platform among ophthalmologists through its WeChat account, enhancing brand recognition within the medical community[180]. - The company aims to establish brand recognition in the digital world through innovative uses of platforms like WeChat and other online channels[126]. - The company believes that traditional sales methods must be complemented by digital, social, and e-commerce channels due to rapid changes in the Chinese ophthalmology industry[126]. Future Outlook - The company expects substantial progress in the new drug application approval process for its flagship product, Cyclosporine A eye gel, aiming for commercialization in 2024[181]. - The company plans to complete the Phase III clinical trial of Epinastine (targeting allergic conjunctivitis) and subsequently submit a simplified new drug application in 2023[137]. - NVK002 is expected to complete a small CHAMP clinical trial by summer, with plans to submit a new drug application if positive results are obtained[155]. - The company is actively seeking opportunities outside of China for the commercialization of Cyclosporine A ophthalmic gel due to its unique efficacy[53].

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].

Financial Performance - For the six months ended June 30, 2021, the company reported a net loss of RMB 1,987,658,000, compared to a loss of RMB 66,551,000 for the same period in 2020[31]. - The total comprehensive loss for the period was RMB 1,985,332,000, compared to a loss of RMB 66,658,000 in 2020[31]. - Non-HKFRS adjusted loss for the period was RMB 123,294,000, compared to RMB 42,855,000 in the same period last year[31]. - The company reported an adjusted loss for the period of RMB 123,294,000, compared to RMB 42,855,000 in the previous year[173]. - For the six months ended June 30, 2021, the company recorded a total loss of approximately RMB1,987.7 million, compared to a loss of approximately RMB66.6 million for the same period in 2020, primarily due to changes in the carrying amount of preferred shares liability[175][198]. Expenses - Research and development expenses increased significantly to RMB 7,345,000 from RMB 1,452,000 year-over-year[31]. - General and administrative expenses rose to RMB 123,435,000, up from RMB 38,087,000 in the previous year[31]. - Selling and distribution expenses surged to RMB 100,612,000, compared to RMB 5,470,000 in the prior period[31]. - Research and development expenses reached approximately RMB 123.4 million for the six months ended June 30, 2021, an increase of approximately 223.9% from RMB 38.1 million for the same period in 2020[149]. - General and administrative expenses were approximately RMB100.6 million for the six months ended June 30, 2021, an increase of approximately RMB95.1 million from approximately RMB5.5 million for the same period in 2020, mainly due to IPO-related expenses and increased staff costs[192]. - Selling and distribution expenses increased from RMBNil for the six months ended June 30, 2020, to approximately RMB6.6 million for the same period in 2021, primarily due to an increase in headcount and marketing-related expenses[193]. - Finance costs increased significantly from approximately RMB24.4 million for the six months ended June 30, 2020, to approximately RMB1,764.4 million for the same period in 2021, primarily due to changes in the carrying amount of financial liabilities related to preferred shares[197]. - Financial costs increased significantly from approximately RMB 244 million for the six months ended June 30, 2020, to approximately RMB 1,764.4 million for the six months ended June 30, 2021, primarily due to changes in the carrying amount of financial liabilities related to the redemption and conversion features of Series A and Series B preferred shares[200]. Market Opportunities - The ophthalmology market in mainland China is expected to grow at a CAGR of 21.8% from 2020 to 2030, reaching US$20.2 billion[41]. - In 2019, the global ophthalmic drug market size was estimated to be US$34 billion, which is 13 times larger than China's market size of US$2.6 billion[41]. - The Chinese ophthalmology market is projected to grow at a CAGR of over 20% in the next decade, presenting significant opportunities for the company[66]. Product Pipeline and Development - Zhaoke Ophthalmology has a pipeline of 25 drug candidates, including 13 innovative drugs and 12 generic drugs[48]. - The company has invested over RMB 200 million in building a state-of-the-art manufacturing facility in Nansha, Guangzhou, compliant with GMP standards[49]. - The company has passed GMP inspections for two generic products in May, validating its manufacturing capabilities[49]. - The company aims to commercialize several drugs as early as 2022, contributing to future revenue growth[66]. - The pivotal Phase III clinical trial for the Cyclosporine A (CsA) ophthalmic gel for DED has completed enrollment and met its primary endpoint, with plans to submit a New Drug Application (NDA) to the NMPA by the end of 2021[59][62]. - The company has a comprehensive drug portfolio of 25 innovative and generic treatments targeting major eye diseases, with several potential blockbuster candidates in the pipeline[66]. - The company aims to submit a New Drug Application (NDA) to the NMPA by the end of 2021, with commercialization of CsA ophthalmic gel expected as early as 2023[110][112]. - NVK-002, a low concentration atropine for myopia, is one of the world's most advanced candidates, with a Phase III clinical trial ongoing in the US and Europe, and results expected by the end of 2022[114][115]. - The IND submission for NVK-002 in China was accepted for review on July 14, 2021, with potential commercialization in mainland China planned for 2024[118]. - TAB014 (Bevacizumab) for wAMD is expected to commence Phase III clinical trials in Q3 2021, delayed due to COVID-19 impacts[119]. - PAN-90806 is an innovative drug for treating wAMD and DME, expected to reduce treatment discontinuation and improve patient compliance[123]. - The company plans to commence a Phase II bridging study in China for PAN-90806 in 2023 and a Phase III pivotal trial in wAMD by 2025[123]. - ZKY001 is currently in a Phase II clinical study for corneal epithelial defect (CED), with 51 subjects enrolled as of July 23, 2021, and expected completion by the end of 2021[125]. - Epinastine HCl, targeting allergic conjunctivitis, is expected to be commercialized at a lower price than current treatments, with an ANDA submitted in June 2020 and approval expected in 2022[134]. - The company passed the GMP inspection for the manufacturing facility for Epinastine HCI in May 2021, ensuring consistent production according to stringent quality standards[140]. Strategic Initiatives - The company is committed to delivering value for all stakeholders following its listing[36]. - The company aims to become a trusted partner for ophthalmologists by providing comprehensive product solutions and sharing cutting-edge science[46]. - The company plans to strengthen its foundational capabilities across research, development, clinical, commercial, and digital infrastructure[61]. - The company is exploring value-creating opportunities for partnerships with domestic and international pharmaceutical companies[61]. - The company has established a tailored commercialization strategy for the Chinese ophthalmology market, focusing on private eye hospitals, public hospitals, and e-commerce platforms[146]. - The company aims to expand its commercialization team to 200-300 members over the next five years[146]. - The research and development team is expected to grow to about 80 professionals in the second half of 2021[149]. - The company emphasizes the importance of research and development in driving its competitive strategy as an ophthalmic pharmaceutical company[146]. - Despite delays in clinical trials due to COVID-19, the company has maintained close communication with suppliers and partners to ensure continued progress in research and development[150]. - The company established licensing partnerships with seven firms across the PRC, United States, and Europe to enhance its presence in the global ophthalmology market[153]. - A license and supply agreement was signed with NTC for the exclusive rights to sell NTC010 in China, an innovative eye drop for cataract surgery-related inflammation and infection, already approved in certain EU countries[153]. - The company is committed to enhancing its digital technology investments to improve sales and marketing capabilities[165]. - A sustainability steering committee has been established to oversee ESG initiatives and responsibilities within the company[156].