Group 1 - The company announced that the Phase II clinical trial for BRIMOCHOL™PF, a candidate drug for presbyopia, enrolled its first patient on March 24, 2025 [1] - The Phase II trial is a multicenter, randomized, double-blind, crossover, and placebo-controlled study aimed at evaluating the efficacy and safety of BRIMOCHOL™PF eye drops in Chinese presbyopia patients, involving 14 centers and a total of 119 patients [1] - On March 21, 2025, the company entered into a distribution and supply agreement with Lunatus Marketing & Consulting FZCO for BRIMOCHOL™PF, granting Lunatus exclusive rights to import, distribute, promote, market, and sell the drug in several Middle Eastern countries [1] Group 2 - On April 8, 2025, the company's partner Tenpoint Therapeutics Ltd. announced the submission of a new drug application for BRIMOCHOLPF to the FDA for the treatment of presbyopia [2] - Tenpoint is a global clinical-stage biotechnology company formed from the merger of Tenpoint Therapeutics Ltd. and Visus Therapeutics, Inc., focusing on developing breakthrough therapies to restore vision in aging eyes [2]

Core Viewpoint - The recent performance of Zhaoke Ophthalmology shows significant revenue growth and a narrowing net loss, while investors are particularly interested in the approval timeline for its key product, low-concentration atropine eye drops [1][4]. Financial Performance - Zhaoke Ophthalmology reported a revenue of 69.32 million HKD for 2024, representing a year-on-year increase of 268.6% [1]. - The company's net loss decreased by 38.3% compared to the previous year [1]. - Cash reserves reached 1.12 billion HKD [1]. Product Approval and Market Potential - Zhaoke Ophthalmology's low-concentration atropine eye drops (NVK002) have been accepted for a simplified new drug application by the National Medical Products Administration [1]. - The target patient group for NVK002 includes children and adolescents aged 3 to 17 [1]. - The market demand for atropine eye drops is believed to be larger than that for PD-1 treatments, indicating significant growth potential [5]. Competitive Landscape - Currently, the only approved low-concentration atropine eye drops are held by Xingqi Eye Medicine, which has faced challenges in meeting sales expectations [2][3]. - Xingqi Eye Medicine's total revenue from eye drops, including atropine, was reported at 512 million CNY, suggesting that the sales of atropine may not reach the previously forecasted 1.5 billion CNY [3]. - Zhaoke Ophthalmology is preparing to scale operations rapidly upon the approval of NVK002, indicating a proactive approach to market entry [5]. Future Outlook - Zhaoke Ophthalmology is targeting three major indications: childhood myopia, dry eye syndrome, and wet age-related macular degeneration, with several products expected to enter the market within the next 1 to 2 years [5].

Financial Performance - Total revenue for the year ended December 31, 2024, was RMB 69,324,000, compared to RMB 18,750,000 for the year ended December 31, 2023, representing a significant increase of 269%[6]. - Gross profit for the same period was RMB 51,797,000, up from RMB 14,247,000, indicating a growth of 264%[6]. - The adjusted loss for the year was RMB 228,828,000, a reduction from RMB 363,015,000 in the previous year, reflecting an improvement of approximately 37%[7]. - The total comprehensive loss for the year was RMB 156,906,000, compared to RMB 323,931,000 in the previous year, showing a reduction of approximately 51%[6]. - Total revenue for 2024 reached RMB 69.3 million, a year-on-year increase of 268.6% from RMB 18.8 million in 2023, with RMB 32.6 million coming from drug sales[12]. - The company reported a net loss of approximately RMB 237.5 million for the year ended December 31, 2024, compared to a loss of about RMB 385.0 million in 2023, reflecting a reduction of about 38.4%[58]. - The company achieved a milestone payment of RMB 33.5 million from a product licensing agreement, contributing to the increase in revenue[58][59]. - Other income rose slightly to approximately RMB 87.3 million in 2024 from RMB 82.0 million in 2023, primarily due to government subsidies for research and development[63]. Research and Development - The company has made significant progress in developing its innovative product pipeline, with three flagship drug assets in the potential market approval stage[8]. - The Phase III clinical trial for TAB014 was completed in September 2024, with positive topline results expected in January 2025, leading to a submission for a biologics license application[12]. - The NVK002 (low-dose atropine) clinical trials were successfully completed, with significant efficacy and safety results announced in October 2024[19]. - The innovative therapy Cyclosporine A Eye Gel for dry eye syndrome has entered Phase III clinical trials, with patient enrollment underway[12]. - The company is currently conducting several early-stage clinical studies, including BRIMOCHOL™ PF and CARBACHOL™ PF, with expected effective management of R&D expenses[67]. - Research and development expenses decreased to RMB 203.7 million in 2024 from RMB 333.1 million in 2023, reflecting improved operational efficiency[56][66]. - The company plans to invest 200 million HKD in research and development over the next two years to accelerate innovation[162]. Market Expansion and Strategy - The company is strategically expanding its market presence beyond Greater China to selected markets including South Korea, Malaysia, Thailand, Australia, and New Zealand[9]. - The company signed distribution agreements in South Korea, Malaysia, Thailand, Australia, and New Zealand to commercialize BRIMOCHOL™ PF, enhancing its market presence in the Asia-Pacific region[12]. - The company aims to enhance brand visibility and financial stability through the commercialization of more generic drugs[12]. - The company plans to expand the application of ZKY001, a peptide aimed at promoting corneal wound healing, following the approval of its first indication[27]. - The company is preparing to obtain regulatory approval for the eye drops used to treat allergic conjunctivitis (Epinastine Hydrochloride) in the coming months[29]. - The company is expanding its market presence in Southeast Asia, targeting a 30% increase in market share by 2026[162]. Operational Efficiency - The company achieved a 38.8% reduction in R&D expenses, totaling approximately RMB 203.7 million for the year ending December 31, 2024, compared to RMB 333.1 million in 2023[32]. - General and administrative expenses were approximately RMB 70.8 million for the year ended December 31, 2024, a decrease of about RMB 13.6 million from RMB 84.4 million in 2023[71]. - Sales and distribution expenses increased from RMB 51.9 million in 2023 to approximately RMB 63.5 million in 2024, reflecting increased marketing activities[74]. - The company reported a significant reduction in operational costs by 10% through efficiency improvements in the supply chain[160]. Corporate Governance and Compliance - The company plans to continue evaluating its corporate governance structure to ensure alignment with shareholder interests and compliance with applicable guidelines[138]. - The audit committee has reviewed the annual performance and recommended approval to the board, ensuring compliance with applicable accounting standards and regulations[147]. - The company has strengthened its internal coordination and reporting arrangements for similar transactions to ensure compliance with listing rules[105]. Future Outlook - The company plans to maintain positive momentum and continuous growth through 2025, focusing on clinical programs and brand positioning[49]. - The company anticipates launching innovative drugs with significant efficacy within the next 12 to 24 months, reinforcing its leadership position in the ophthalmic sector[53]. - The company expects to achieve a revenue guidance of 1.5 billion HKD for the next fiscal year, reflecting a projected growth of 25%[160]. - The company is exploring potential acquisitions to strengthen its product portfolio, with a focus on companies specializing in rare diseases[162].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 49,769,000, compared to RMB 11,304,000 for the same period in 2023, representing a significant increase [7]. - Gross profit for the period was RMB 42,840,000, up from RMB 10,154,000 in the previous year, indicating a strong improvement in profitability [7]. - The loss for the period was RMB 75,802,000, a decrease from RMB 233,778,000 in the same period last year, indicating a narrowing of losses [7]. - Non-HKFRS adjusted loss for the period was RMB 75,689,000, compared to RMB 218,178,000 in the prior year, highlighting a significant improvement [8]. - The company reported a total comprehensive income loss of RMB 15,351,000 for the period, compared to RMB 135,031,000 in the previous year, indicating a positive trend [7]. - Other income increased to RMB 44,514,000 from RMB 39,523,000, contributing positively to the financial performance [7]. - Total comprehensive income for the period was a loss of RMB 15.4 million for the six months ended June 30, 2024, compared to a loss of RMB 135.0 million in the same period of 2023 [90]. - Adjusted loss for the period was RMB 75.7 million for the six months ended June 30, 2024, compared to RMB 218.2 million in the same period of 2023 [90]. Research and Development - R&D expenses decreased to RMB 89,797,000 from RMB 205,346,000 year-over-year, reflecting a reduction in investment in research and development [7]. - Zhaoke Ophthalmology reported R&D expenses of approximately RMB 89.8 million for the first half of 2024, a decrease from RMB 205.3 million in the same period of 2023 [16]. - R&D expenses for the six months ended June 30, 2024, were RMB 89.8 million, a decrease of 56.3% from RMB 205.3 million in the same period of 2023 [70]. - Clinical trial professional service fees accounted for RMB 31.2 million of R&D expenses for the six months ended June 30, 2024, compared to RMB 141.5 million in the same period of 2023 [100]. Clinical Trials and Product Development - The Phase III clinical trial of NVK002, aimed at myopia progression control in children, completed the last patient visit in August 2024 [11]. - The company anticipates announcing topline results from the China CHAMP trial of NVK002 and completing the Phase III trial of TAB014 for wet age-related macular degeneration by the end of 2024 [18]. - The ANDA for NVK002, a low-dose atropine eye drop for myopia control, has been filed, with the Phase III clinical trial completing on August 5, 2024 [24][25]. - The company has started the Phase II study of BRIMOCHOL PF and CARBACHOL PF for presbyopia, following IND approval in January 2024 [13]. - TAB014, a bevacizumab-based antibody for wAMD, is in Phase III clinical trials, with patient recruitment completed ahead of schedule [48]. - The Phase III trial for TAB014 is expected to be completed by the end of 2024, followed by an NDA submission [48]. - Zhaoke Ophthalmology has conducted Phase II clinical trials for ZKY001, focusing on corneal epithelial defects (CED) after eye surgery, with potential for rapid adoption in other corneal repair applications [50][51]. Market Expansion and Licensing - Zhaoke Ophthalmology is exploring licensing opportunities outside China, with partnerships established in Southeast Asia, South Korea, and Australia [19]. - The company is strategically expanding its market presence beyond Greater China into other selected markets [23]. - The company is actively exploring licensing and collaboration opportunities across Asia, Australia, and the U.S., with discussions ongoing with the FDA regarding a potential clinical trial for CsA Ophthalmic Gel [85]. - The company has established partnerships with leading firms in overseas markets, including a distribution agreement with Kwangdong Pharmaceutical Co., Ltd. for BRIMOCHOL PF in South Korea [29]. Financial Management and Assets - The company has a cash balance of approximately RMB 1.3 billion as of June 30, 2024, providing ample resources for key programs and achieving positive cash flow [16]. - Total current assets as of June 30, 2024, were RMB 1,757.1 million, a slight decrease from RMB 1,794.6 million as of December 31, 2023 [117]. - The company primarily funded its working capital requirements through net proceeds from the Global Offering during the reporting period [119]. - The company aims to maintain healthy liquidity for its operations by closely monitoring cash uses and balances [119]. Shareholder Information - As of June 30, 2024, Lee's Pharm holds a long position of 140,379,600 shares, representing approximately 25.70% of the shareholding [142]. - Lee's Pharm International has a beneficial ownership of 138,192,000 shares, accounting for approximately 25.30% of the shareholding [142]. - The total issued share capital of the company as of June 30, 2024, is 546,139,172 shares [140]. - The company has recorded interests of various directors, with each holding 200,000 shares under the Post-IPO Share Option Scheme [140]. Employee and Corporate Governance - The company employed a total of 297 employees as of June 30, 2024, with 33.4% in R&D [129]. - Zhaoke launched a new tiered mentorship program and a rotational scheme to support employee development during the reporting period [78]. - Zhaoke is committed to enhancing its ESG performance and published its fourth ESG report in April 2024 to inform stakeholders about its socially responsible practices [80].

Financial Performance - Total revenue for the six months ended June 30, 2024, was approximately RMB 49.8 million, a significant increase from RMB 11.3 million in the same period of 2023, representing a growth of over 340%[2] - The company recorded a gross profit of RMB 42.8 million for the first half of 2024, compared to RMB 10.2 million in the same period of 2023, indicating a substantial improvement in profitability[2] - The net loss for the six months ended June 30, 2024, was RMB 75.8 million, a decrease from a net loss of RMB 233.8 million in the same period of 2023, showing a reduction of about 68%[2] - The total comprehensive loss for the period was RMB 15.4 million, a significant improvement from RMB 135.0 million in the same period of 2023[2] - Other income increased to approximately RMB 44.5 million for the six months ended June 30, 2024, from RMB 39.5 million in the same period of 2023, primarily due to increased bank interest income[35] - The company recorded a loss of approximately RMB 75.8 million for the six months ended June 30, 2024, compared to a loss of approximately RMB 233.8 million for the same period in 2023[42] - The pre-tax loss for the six months ended June 30, 2024, was RMB 75,802,000, compared to RMB 233,778,000 for the same period in 2023, indicating an improvement in financial performance[71] Research and Development - Research and development expenses decreased to RMB 89.8 million in the first half of 2024 from RMB 205.3 million in the same period of 2023, reflecting a reduction of approximately 56%[2] - The company's R&D expenses for the six months ended June 30, 2024, were RMB 89.8 million, a decrease of 56.3% compared to RMB 205.3 million in the first half of 2023, reflecting the nearing completion of Phase III clinical trials for NVK004 and TAB014[23] - The simplified new drug application for NVK002, a low-dose atropine eye drop for controlling myopia in children and adolescents, has made encouraging progress with the regulatory authority, and the final patient visit for the two-year Phase III clinical trial (China CHAMP) is expected to complete on August 5, 2024[7] - The cyclosporine A eye gel, developed for the treatment of moderate to severe dry eye disease, has received approval for a new drug trial, with an additional Phase III clinical trial designed based on the requirements of the drug review center, and the new drug application is planned for resubmission soon[7] - The company has received approval for new drug trial applications for innovative products BRIMOCHOL PF and CARBACHOL PF for treating presbyopia, with Phase II clinical trials already underway in China[7] - The company completed a one-year Phase III clinical trial for NVK002, with positive top-line results, and submitted a simplified new drug application[22] - The company plans to submit a new drug application for Cyclosporine A eye gel by the end of 2024, indicating ongoing product development efforts[28] Market Expansion and Strategy - The company is strategically expanding its market presence beyond Greater China, targeting other selected markets to leverage growth opportunities[5] - The company has established partnerships with leading companies in multiple overseas markets, including a distribution agreement with Kwangdong Pharmaceutical Co., Ltd. for BRIMOCHOL PF in South Korea, and collaborations in Malaysia and Thailand for distributing other products[8] - The company is actively exploring overseas opportunities for the Cyclosporine A eye gel and is in effective discussions with the FDA for a potential new drug application submission by the end of 2024[13] - The company is actively exploring licensing and collaboration opportunities in Asia, Australia, and the United States to accelerate global expansion[28] - The company aims to achieve significant milestones in the second half of 2024, focusing on obtaining regulatory approvals for its core assets[27] Corporate Governance and Social Responsibility - The company emphasizes its commitment to social responsibility and aims to raise public awareness of eye diseases and treatment solutions[5] - The company published its fourth ESG report in April 2024, enhancing transparency and compliance regarding its social responsibility practices[26] - The company maintains a high level of corporate governance, ensuring shareholder interests are protected[80] Sales and Distribution - The sales network has been strengthened, covering over 1,200 hospitals and ophthalmology institutions, and significant progress has been made in drug access, following the market launch of the glaucoma drug Brimonidine Tartrate Eye Drops in 2023[8] - The online sales strategy focuses on leading e-commerce platforms such as JD Health and Alibaba Health, enhancing product sales[19] - The company recorded revenue from ophthalmic drugs of RMB 13,572,000 for the six months ended June 30, 2024, compared to RMB 2,250,000 in the same period of 2023, representing a significant increase[61] Financial Position - Total current assets as of June 30, 2024, were approximately RMB 1,757.1 million, including cash and cash equivalents of about RMB 1,266.9 million[45] - Total liabilities as of June 30, 2024, were approximately RMB 351.8 million, down from RMB 372.0 million as of December 31, 2023[44] - The company’s cash management policy focuses on maintaining healthy operating liquidity, with current liabilities amounting to approximately RMB 318.3 million as of June 30, 2024[45] - Total assets as of June 30, 2024, were approximately RMB 2,384.9 million, slightly down from RMB 2,420.3 million as of December 31, 2023[44] Employee and Workforce - The total number of employees as of June 30, 2024, was 297, with R&D personnel constituting 33.4% of the workforce[50] Future Outlook - The company has provided a positive outlook for the next quarter, projecting a revenue growth of 20% to 25%[92] - New product launches are expected to contribute an additional RMB 100 million in revenue by the end of 2024[91] - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by 2025[90]

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]

Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 18,750 thousand, with a gross profit of RMB 14,247 thousand[5]. - The net loss for the year was RMB 385,038 thousand, an improvement from a net loss of RMB 407,317 thousand in 2022, showing a reduction of 5.8%[6]. - The adjusted net loss under non-Hong Kong Financial Reporting Standards was RMB 363,015 thousand, slightly higher than RMB 360,633 thousand in the previous year[6]. - For the fiscal year ending December 31, 2023, the company reported revenue of RMB 18,750,000, an increase from the previous year[81]. - The operating loss for the year was RMB 376,567,000, compared to RMB 404,175,000 in the previous year, indicating a reduction in losses[134]. - The basic loss per share was RMB 0.71, slightly improved from RMB 0.75 in the previous year[135]. - The total comprehensive loss for the year was RMB 323,931,000, compared to RMB 196,415,000 in the previous year[159]. - The company recorded a loss of approximately RMB 385.0 million for the year ended December 31, 2023, compared to a loss of approximately RMB 407.3 million for the year ended December 31, 2022, reflecting an improvement[118]. Research and Development - Research and development expenses rose to RMB 333,050 thousand, compared to RMB 296,430 thousand in 2022, indicating an increase of 12.3%[5]. - The company’s R&D expenses for the year were approximately RMB 333.1 million, up 12.4% from RMB 296.4 million in 2022, primarily due to ongoing investments in multiple late-stage clinical trials[82]. - Research and development expenses increased to RMB 333,050,000 from RMB 296,430,000, reflecting ongoing investment in innovation[156]. - The company has ongoing research and development activities for other candidate drugs, with an allocation of RMB 888.86 million, accounting for 46% of the total funds raised[182]. - The company plans to conduct clinical trials for innovative treatments for presbyopia in China in 2024, pending regulatory approval[79]. - The company completed the final patient visit for the small CHAMP trial on August 3, 2023, and announced positive topline results in October 2023, demonstrating strong safety and efficacy for NVK0022 as a potential treatment for childhood myopia[28]. - The FDA accepted the new drug application for NVK002 in June 2023, and the partner Vyluma is advancing the regulatory approval process in the U.S.[29]. - The company submitted simplified new drug applications for five glaucoma generics and one for allergic conjunctivitis, indicating ongoing product development efforts[10]. Market Expansion and Partnerships - The company is focusing on expanding its market presence in selected regions outside Greater China while maintaining its primary focus on the Greater China area[22]. - The company is focused on expanding its presence in the Southeast Asian market through a distribution agreement with TRB Thailand for EyeGiene® reusable eye masks[43]. - The company established a strategic partnership with Aibono to explore opportunities in the ophthalmic product development and commercialization sector[39]. - The company has established a strategic partnership with KDP for the exclusive distribution rights of BRIMOCHOL PF in South Korea[75]. - The company aims to enhance public awareness of eye diseases and treatment solutions, reflecting its commitment to social responsibility[22]. - The company is actively seeking partnerships to enhance its product portfolio and establish more effective sales channels[76]. Financial Position - Total assets as of December 31, 2023, were RMB 2,420,338,000, down from RMB 2,570,623,000 in the previous year[95]. - Cash and cash equivalents at the end of 2023 were approximately RMB 1,461,623,000, a decrease from RMB 1,716,351,000 in 2022[95]. - The company's total net assets decreased to RMB 2,048,318,000 from RMB 2,348,373,000 in the previous year[141]. - The company’s collateralized bank balance was approximately RMB 265.7 million as of December 31, 2023, compared to RMB 172.1 million in 2022, indicating an increase of about 54.4%[98]. - As of December 31, 2023, the company's uncollateralized bank loans amounted to RMB 206.6 million, due within one year or upon demand[97]. - The company aims to optimize resource allocation and control cash expenditures to mitigate financial and business risks from external environments[80]. Employee and Operational Costs - Employee costs increased to RMB 57.206 million from RMB 49.391 million, reflecting the growth in the workforce[55]. - The total employee costs for the year ended December 31, 2023, were approximately RMB 126.8 million, down from RMB 132.1 million in 2022, primarily due to a reduction in share-based payment expenses[131]. - Sales and distribution expenses rose from RMB 29.9 million to approximately RMB 51.9 million, mainly due to an increase in the commercialization team and marketing activities for the product Beimu Sima Tahlor Eye Drops[58]. - The company's total sales and distribution expenses for the year ended December 31, 2023, were RMB 51.9 million, significantly higher than RMB 29.9 million in 2022, representing an increase of about 73.5%[115]. Corporate Governance - The board believes that the current arrangement of having the same person serve as both Chairman and CEO is beneficial for the company and its shareholders[190]. - The board will continue to review the effectiveness of the corporate governance structure to assess the need for separating the roles of Chairman and CEO[190]. - The company is committed to maintaining a high level of corporate governance, which is crucial for its development and safeguarding shareholder interests[190]. - The company has not experienced significant impacts on its performance or financial position due to the new accounting policies introduced during the accounting period[195]. - The consolidated financial statements have been prepared in accordance with all applicable Hong Kong Financial Reporting Standards[194]. Product Development and Sales - The company has established a comprehensive portfolio of innovative and generic products targeting major ophthalmic diseases, including dry eye syndrome and glaucoma[26]. - The company achieved sales of ophthalmic drugs amounting to RMB 4,736 thousand and ophthalmic products amounting to RMB 8,414 thousand for the year ended December 31, 2023[51]. - Exclusive distribution revenue reached RMB 5,600 thousand for the year ended December 31, 2023[51]. - The company has initiated the production of Beimu Sima Tahlor Eye Drops following its approval by the National Medical Products Administration in February 2023[70]. - The new eye gel, administered once daily, aims to significantly improve patient adherence and quality of life[30]. - The new drug application for BRIMOCHOL PF and Carbachol PF was approved by the National Medical Products Administration on January 24, 2024[33].

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].