Financial Performance - The company's revenue for the year ended December 31, 2024, was HKD 1,669,817, a decrease of 3.9% compared to HKD 1,736,972 in 2023[3] - Net profit for the year increased by 11.6% to HKD 307,222 from HKD 275,260 in the previous year[3] - Total comprehensive income for the year was HKD 260,658, an increase from HKD 244,925 in 2023[4] - Total external customer revenue for the year ended December 31, 2024, was HKD 1,662,297,999, a decrease from HKD 1,731,873,976 in 2023[16] - The group's revenue for the year ending December 31, 2024, was approximately HKD 1,669.8 million, a decrease of 3.9% from HKD 1,737.0 million in 2023[68] - Despite the revenue decline, the group achieved a net profit of approximately HKD 307.2 million, an increase of 11.6% from HKD 275.3 million in 2023[68] Assets and Liabilities - Total assets rose by 5.5% to HKD 2,983,045, while total liabilities decreased by 4.9% to HKD 859,325[3] - The company's total assets increased to HKD 1,246,836,875 in 2024, up from HKD 1,153,040,731 in 2023, marking an increase of approximately 8.1%[25] - The company’s total liabilities related to intangible assets increased to HKD 929,878,947 in 2024, up from HKD 854,313,383 in 2023, reflecting an increase of about 8.8%[25] - The group’s debt-to-asset ratio was 28.8% as of December 31, 2024, down from 32.0% in 2023[77] Cash Flow and Dividends - The company's cash and cash equivalents increased by 9.3% to HKD 557,167 from HKD 509,845 in 2023[3] - The company declared a total dividend of HKD 0.12 per share, a 33.3% increase from HKD 0.09 in 2023[3] - The proposed final dividend is HKD 0.06 per share for 2024, compared to HKD 0.045 per share in 2023, representing a 33.3% increase[22] - The group's cash and cash equivalents amounted to approximately HKD 557,200,000 as of December 31, 2024, compared to HKD 509,800,000 as of December 31, 2023[77] Research and Development - The company plans to continue expanding its market presence and investing in new product development[3] - Research and development costs recognized as expenses were HKD 25,009,026 in 2024, down from HKD 39,144,729 in 2023[19] - The group plans to increase R&D investment and strengthen collaborations with research institutions and universities to foster innovation[66] - The company is actively pursuing multiple R&D projects at various clinical stages, focusing on single-dose ophthalmic products and biologics[44] Product Development and Market Potential - The company received NMPA approval for preservative-free single-dose sodium hyaluronate eye drops and sodium hyaluronate (0.3%) in August and September 2024, respectively, expanding its product offerings[42] - The estimated number of moderate to severe dry eye patients in China is around 111,600,000 by 2024, indicating a significant market potential for SkQ1[47] - The total investment cost for SkQ1's clinical development and global rights amounts to approximately HKD 344,000,000, representing 11.5% of the company's total assets as of December 31, 2024[47] - The joint development agreement with Shanghai Junshi Biosciences for the anti-VEGF product has a maximum commitment investment of USD 67,000,000 (approximately HKD 520,300,000)[50] Operational Efficiency - The gross profit margin remained stable at 89.8%, while the net profit margin improved to 18.4% from 15.8%[3] - The current ratio improved to 1.81 from 1.54, indicating better short-term financial health[3] - Employee costs (excluding director remuneration) amounted to HKD 309,070,741 in 2024, compared to HKD 298,225,948 in 2023[19] - Distribution and selling expenses were approximately HKD 934.2 million, a decrease of 7.7% from HKD 1,012.0 million in 2023[70] Corporate Governance and Management - The company has adhered to the corporate governance code as per the listing rules throughout the year[90] - The audit committee has reviewed and recommended the approval of the audited consolidated financial statements for the year ending December 31, 2024[97] - The company has appointed Mr. Yan Xianlong as the CEO effective July 1, 2025, pending shareholder approval[91] - Mr. Yan Xianlong has over 10 years of experience in translational and therapeutic research prior to joining the company in 2015[92] Legal and Regulatory Matters - A court ruling in May 2024 ordered the contractor to pay approximately HKD 31.1 million as compensation for breach of contract, which is lower than the amount claimed by the company[63] - The company is actively defending against allegations from Guangxi Wanshoutang Pharmaceutical Co., Ltd. regarding exclusive sales agreements and has filed a counterclaim for outstanding payments[64]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 5.12, indicating a potential upside of 73% from the current price of HKD 2.95 [18][40][41]. Core Insights - The company experienced a temporary decline in performance due to adverse market conditions influenced by tightened regulatory policies in the healthcare sector, leading to a 9.8% decrease in revenue to HKD 812 million for the first half of 2024 [3][14]. - The company is advancing the research and development of Bevacizumab (HLX04-O), which is currently undergoing Phase III clinical trials in multiple regions including the US, EU, China, and Australia, with a new drug application expected to be submitted in 2025 [25][42]. - The potential market for Bevacizumab is significant, particularly for conditions like wet AMD and diabetic macular edema, with an estimated 15.8 million patients in China [25][42]. Financial Summary - The company reported a net profit of HKD 157 million for the first half of 2024, a decrease of 7.3% year-on-year [3][14]. - Revenue projections for 2024-2026 are estimated at HKD 16.82 billion, HKD 18.23 billion, and HKD 19.82 billion respectively, with corresponding EPS of HKD 0.47, HKD 0.50, and HKD 0.54 [12][18]. - The company’s total assets are valued at HKD 2.54 billion, with total liabilities of HKD 1.13 billion, indicating a solid financial position [8][20].

欢迎出席益生生物科技2024年度业绩发布会今天出席会议的有益生生物科技总术会主席闫明志先生 董事总经理方海舟先生Managing Director Mr. 方海舟大家好副董事总经理严贤龙先生Deputy Managing Director Mr. Malcolm Young大家好首席财务总监邱丽文女士Chief Financial Officer Mr. Agnes YaoHello, good morning以及首席科学家薛琪博士and Chief Scientific Officer Dr. Quinn Xue 益社生物科技是一间专注于研发、生产和销售基因工程药物BFGF的生物制药企业拥有包括背复书、背复记、背复心在内的六种基因工程药物在中国上市销售此外,公司还拥有包含一系列不含防腐剂干剂量的眼液和视力顺软灵石落合碘胶囊等多元化产品组合 主席我们我们马上开始了可以打开摄像头你有回音回音很厉害对刚才Jeffrey关掉了对现在OK吗可以 好的我也再次提醒一下大家整个业绩会过程中除了播放视频的时候之外其他时候我们的视频都是打开的所以观众都是可以看到我们的提醒一下那么我们现在就开始了尊敬的各位投资者分析师大家上午 ...

Financial Performance - Revenue for the six months ended June 30, 2024, was HKD 811,630,000, a decrease of 9.8% compared to HKD 899,359,000 for the same period in 2023[1] - Gross profit for the period was HKD 724,612,000, down from HKD 810,462,000, reflecting a decline of 10.6%[1] - The company reported a net profit of HKD 157,440,000, compared to HKD 169,811,000 in the previous year, representing a decrease of 7.3%[1] - Basic earnings per share for the period were HKD 0.2774, down from HKD 0.2972, a decrease of 6.6%[1] - The company’s total comprehensive income for the period was HKD 94,632,000, down from HKD 169,811,000 in the previous year, representing a decline of about 44.3%[3] - Profit for the period decreased by 7.3% to approximately HKD 157.4 million, down from approximately HKD 169.8 million in the previous year[62] Assets and Liabilities - Total assets as of June 30, 2024, were HKD 2,965,806,000, up from HKD 2,827,558,000 at the end of 2023, indicating a growth of 4.9%[2] - Current assets increased to HKD 1,387,634,000 from HKD 1,245,277,000, reflecting an increase of 11.4%[2] - The company's total liabilities rose to HKD 950,326,000 from HKD 903,781,000, an increase of 5.2%[2] - The net asset value increased to HKD 2,015,480,000 from HKD 1,923,777,000, showing a growth of 4.8%[2] Cash Flow and Financing - Cash generated from operating activities before tax was HKD 197,380,000, down from HKD 204,855,000 in the previous year, indicating a decline of about 3.5%[4] - The company experienced a significant increase in cash flow from operating activities, amounting to HKD 161,833,000, compared to HKD 140,978,000 in the prior year, reflecting an increase of approximately 14.8%[4] - The company’s cash flow from financing activities showed a net outflow of HKD 30,169,000, compared to an inflow of HKD 14,028,000 in the previous year, indicating a shift in financing strategy[4] - The net cash flow from financing activities for the six months ended June 30, 2024, was HKD 96,789,000, with cash and cash equivalents increasing to HKD 598,414,000[5] Revenue Segmentation - For the six months ended June 30, 2024, the total revenue from external customers was HKD 811,630,000, with ophthalmology contributing HKD 375,560,000 and surgery contributing HKD 436,070,000[10] - Revenue from the ophthalmology segment contributed approximately HKD 375.5 million, a decrease of 1.6%, while the surgical segment recorded revenue of approximately HKD 436.1 million, a decrease of 15.8%[62] - The flagship biopharmaceutical products, Beifu Shu® and Beifu Ji®, accounted for approximately 86.4% of total revenue, with Beifu Shu® contributing 35.4% and Beifu Ji® contributing 51.0%[62] Research and Development - Research and development costs recognized as expenses were HKD 12,479,000 in 2024, down from HKD 20,250,000 in 2023, showing a decrease of 38.5%[20] - The company has initiated a five-year R&D plan starting from 2021 to enhance its capabilities in the ophthalmology field, focusing on growth factors, antibodies, and drug formulation technologies[58] - As of June 30, 2024, the company has a pipeline of 5 commercially available preservative-free single-dose eye drops, with plans to commercialize additional products in the next 2 to 5 years[58] Market Expansion and Strategy - The company plans to continue its market expansion and product development strategies, although specific figures were not disclosed in the current report[3] - The company has a strong focus on expanding its market presence in lower-tier cities in China and Southeast Asia[57] - The group is strategically expanding into new therapeutic areas such as oncology, orthopedics, and neurology through strategic investments[52] Shareholder Information - The company declared an interim dividend of HKD 0.06 per share for the six months ended June 30, 2024, up from HKD 0.045 per share in 2023, an increase of 33.3%[22] - The total number of shares repurchased was 35,000, with a maximum price of HKD 2.45 per share during January 2024[82] - As of June 30, 2024, the company’s major shareholder, Yan Mingchi, holds 153,945,667 shares, representing approximately 27.13% of the issued share capital[78] Legal and Compliance - The company is involved in a legal dispute with Guangxi Wanshoutang Pharmaceutical Co., which it firmly denies, and is seeking professional legal advice[61] - The company has complied with the corporate governance code as per the listing rules throughout the review period[82] - All directors confirmed compliance with the securities trading regulations during the six-month period ending June 30, 2024[86]

Financial Performance - Revenue for the six months ended June 30, 2024, was HKD 811,630,000, a decrease of 9.8% compared to HKD 899,359,000 for the same period in 2023[2] - Profit for the period was HKD 157,440,000, down 7.3% from HKD 169,811,000 in the previous year[2] - Gross profit margin decreased to 89.3% from 90.1% year-on-year[2] - Net profit margin was 19.4%, compared to 18.9% in the same period last year[2] - The total comprehensive income for the period was HKD 94,632,000, down from HKD 169,811,000, indicating a decline of 44.3%[9] - The profit before tax for the six months ended June 30, 2024, was HKD 197,380,000, slightly down from HKD 204,855,000 in the previous year, a decrease of 3.6%[10] - The company reported a net profit attributable to shareholders of HKD 157,440,000 for the six months ended June 30, 2024, down from HKD 169,811,000 in 2023, reflecting a decrease of approximately 7%[28] - Basic earnings per share for the six months ended June 30, 2024, was HKD 0.27, compared to HKD 0.30 for the same period in 2023, indicating a decline of about 10%[28] Assets and Liabilities - Total assets increased by 4.9% to HKD 2,965,806,000 from HKD 2,827,558,000[3] - Total liabilities rose by 5.2% to HKD 950,326,000 from HKD 903,781,000[3] - Cash and cash equivalents increased by 17.4% to HKD 598,414,000 from HKD 509,845,000[3] - The current ratio improved to 1.68 from 1.54[4] - As of June 30, 2024, the net current assets increased to HKD 563,430,000 from HKD 434,533,000 as of December 31, 2023, representing a growth of 29.6%[8] - Total assets less current liabilities rose to HKD 2,141,602,000, up from HKD 2,016,814,000, indicating an increase of 6.2%[8] - The total liabilities increased to HKD 950,326,000 from HKD 903,781,000, reflecting a rise of 5.1%[8] - The net asset value reached HKD 2,015,480,000, compared to HKD 1,923,777,000, marking an increase of 4.8%[8] Cash Flow - Operating cash flow for the six months ended June 30, 2024, was HKD 161,833,000, compared to HKD 140,978,000 for the same period in 2023, showing a growth of 14.8%[10] - The net cash used in investing activities was HKD 40.82 million, a significant improvement from HKD 106.80 million in the same period last year[11] - The company reported a net cash inflow from financing activities of HKD 5.95 million, contrasting with a net outflow of HKD 71.62 million in the prior year[11] - The cash flow from operating activities was not detailed, but the overall cash position improved significantly due to better management of cash inflows and outflows[11] Dividends - The company declared an interim dividend of HKD 0.06 per share, up from HKD 0.045 per share in the previous year[2] - The company paid dividends amounting to HKD 25,539,000 during the period[9] - The board declared an interim dividend of HKD 0.06 per share for the six months ending June 30, 2024, compared to HKD 0.045 for the same period in 2023[101] Research and Development - Research and development costs recognized as expenses were HKD 12,479,000 in 2024, down from HKD 20,250,000 in 2023, reflecting a reduction of about 38%[24] - The company has a pipeline of 16 R&D projects, with 4 ophthalmology projects currently in clinical stages, which are seen as mid-term growth drivers[67] - The company has initiated a five-year R&D plan to enhance its capabilities in the ophthalmology sector, focusing on therapies that meet unmet clinical needs[65] Market and Product Development - The company continues to focus on the development and sales of biopharmaceuticals, with ongoing investments in new product development and market expansion strategies[12] - The company has established strategic collaborations with Antikor Biopharma Limited and Fuhong Hanlin to advance its biopharmaceutical development in oncology and ophthalmology[66] - The group has received NMPA approval for preservative-free single-dose eye drops, expanding its product portfolio[58] - The flagship biopharmaceutical products, Beifu Shu® series and Beifu Ji® series, contributed approximately 86.4% of total revenue, with Beifu Shu® series at 35.4% and Beifu Ji® series at 51.0%[73] Employee and Management - The group had a total of 1,459 full-time employees as of June 30, 2024, a decrease from 1,481 employees as of December 31, 2023[87] - Total employee compensation for the review period was approximately HKD 159.4 million, compared to approximately HKD 173 million in the previous period[87] - The remuneration paid to key management personnel for the six months ended June 30, 2024, was HKD 3,644,000, compared to HKD 3,675,000 for the same period in 2023[55] Corporate Governance - The company has complied with the corporate governance code as per the listing rules throughout the review period[99] - The audit committee reviewed the accounting principles and practices adopted by the group, discussing internal controls and financial reporting matters[100] - All directors confirmed compliance with the standards set forth in the code regarding securities transactions during the review period[103]

欢迎各位投资者参加华安医药联合录影中举办的夏季现场策略会本场会议主持人是华安医药唐国超唐老师 本场是上市公司易胜生物科技的交流很荣幸能够邀请到公司的领导董事总经理方海东方总和高级II经理陈月峰陈总与我们一起交流我们今天的交流呢分为公司介绍和问答环节两个部分首先呢有请公司领导陈总用20到30分钟的时间对公司的一个经营情况最新进展的做一个讲解就请陈总 谢谢李总,然后谢谢今天出空参加我们公司专场的投资者们,我是医生生物的IR陈月峰,下面先由我对公司进行一个介绍。 医生生物是一家专注于研发、生产和销售基因工程药物RBBFGF的生物制药企业已有包括贝福输、贝福计、贝福鑫在内的6种基因工程药物在中国上市销售 此外,公司还拥有一系列不含防腐剂的单剂量低盐液和贝弗氏立胜软磷脂洛克碘胶囊等产品主要应用于眼科及皮肤科、处方药领域的创伤修复及疾病治疗在中国已经成功覆盖逾12500家医院及1800家药店 公司依托自身在生产因子和抗体领域的研发平台拥有多个临床阶段的项目涵盖多项领域和适应症总而言之益胜是生产因子的领先者因为我们拥有全球首款的BFGF产品BFGF冻干粉 全球首款BFGF沿用聚集被服输的眼液以及在此基础上开发了一系列的全球 ...

欢迎各位投资者参加华安医药联合录影中举办的夏季现场策略会本场会议主持人是华安医药谈博超谈老师 本场是上市公司易胜生物科技的交流很荣幸能够邀请到公司的领导董事总经理方海东方总和高级II经理陈月峰陈总与我们一起交流我们今天的交流分为公司介绍和问答环节两个部分首先有请公司领导陈总用20到30分钟的时间对公司的一个经营情况最新进展的做一个讲解有请陈总 谢谢李总,然后谢谢今天出空参加我们公司专场的投资者们我是一生生物的IR陈月峰,下面先由我对公司进行一个介绍 医生生物是一家专注于研发、生产和销售基因工程药物RBBFGF的生物制药企业已有包括贝福输、贝福计、贝福鑫在内的6种基因工程药物在中国上市销售 此外,公司还拥有一系列不含防腐剂的单剂量滴眼液和贝弗氏立胜软磷脂洛合碘胶囊等产品主要应用于眼科及皮肤科、处方药领域的创伤修复及疾病治疗在中国已经成功覆盖逾12500家医院及1800家药店 公司依托自身在生产因子和抗体领域的研发平台拥有多个临床阶段的项目涵盖多项领域和适应症总而言之益胜是生产因子的领先者因为我们拥有全球首款的BFGF产品BFGF冻干粉 全球首款BFGF沿用致敬被服输的眼液以及在此基础上开发了一系列的全球首款的产 ...

因此,可抗体领域的研发平台拥有多个临床接盖的项目涵盖多项领域和适应症总而言之,益胜是生产因子的领先者因为我们拥有全球首款的BFGF产品被伏记冻干粉 全球首款BFGF沿用致敬被服输的眼液以及在此基础上开发了一系列的全球首款的产品进行同时我们也是眼科修复的领导者我们的被服输眼科系列已经连续五年荣登中国医药品牌榜我们的强大的眼科组合也占据国内眼科非常领先的地位 同时我们也是创伤修复领域的领导者我们BFGF的外科系列倍福星产品倍福星外用凝胶是连续多年在中国的皮肤科 处方 药 市场销售第一的这么一个产品广泛应用于皮肤烧伤尤其是近年来成长非常快的市场比如说医美等领域 我们企业的发展愿景是成为眼科创商修复领域的领先者以及全球肿瘤领域的重要参与者公司的发展历程主要可以分为四个阶段从1990年到99年我们花了将近十年的时间进行了我们第一代的生长因子产品的开发然后并成功 在中国的货币上市这当时在全球也是一个首创所以我们是first in class的产品那么第二个阶段就是2000年到2009年我们开始了自由网络的建设我们现在的自由网络我们现在已经拥有了全国最大的眼科的以及一部分的外科的网络之一 那么在第二个十年我们同时也获得了第 ...

Financial Performance - The group's consolidated revenue for the year ended December 31, 2023, was approximately HKD 1,706,600,000, an increase of 29.5% compared to approximately HKD 1,317,700,000 in 2022[8]. - The group recorded a profit after tax of approximately HKD 275,300,000 for the year ended December 31, 2023, representing a 22.1% increase from approximately HKD 225,400,000 in 2022[8]. - The gross profit for the year was HKD 1,539,293,089, with a gross margin reflecting a strong operational efficiency[178]. - The net profit for the year was HKD 275,259,617, compared to HKD 225,411,310 in the previous year, showing an increase in profitability[178]. - Basic earnings per share increased to HKD 0.4827 from HKD 0.3927 in 2022, reflecting improved earnings performance[178]. - The overall comprehensive income for the year was HKD 244,925,110, a substantial increase from HKD 66,318,478 in 2022, indicating strong financial health[178]. - The total comprehensive income for the year ended December 31, 2023, was HKD 244,925,110, compared to a loss of HKD 132,597,063 in the previous year[183]. Cash and Assets - As of December 31, 2023, the group's cash and cash equivalents amounted to approximately HKD 509,800,000, down from approximately HKD 543,500,000 in 2022[9]. - The company reported a net cash outflow from financing activities of HKD 309,924,789 for the year ended December 31, 2023, compared to HKD 169,110,470 in the previous year[157]. - The cash and cash equivalents at the end of the year were HKD 509,845,284, down from HKD 543,486,017 at the end of the previous year[157]. - Total assets amounted to HKD 2,827,558,498, with total liabilities of HKD 903,781,273, resulting in a net asset value of HKD 1,923,777,225[180]. - The company reported a significant increase in non-current assets, totaling HKD 1,582,280,872, compared to HKD 1,498,418,728 in the previous year[180]. - The total equity as of December 31, 2023, was HKD 1,923,777,225, reflecting a stable financial position[183]. Research and Development - The group has 16 research and development projects in various stages, with 4 ophthalmology projects currently in clinical stages, identified as mid-term growth drivers[6]. - The core product, Elysium®, has become a significant growth driver for the group, acquired in March 2022, including its intellectual property and marketing rights[11]. - The company holds a total of 84 patent certificates, including 63 invention patents, indicating a strong focus on innovation[194]. - The company aims to enhance its R&D capabilities and position in the ophthalmology field through a five-year development plan initiated in 2021[193]. - The company is focusing on the development of a new gel formulation of bovine alkaline fibroblast growth factor for eye use, indicating ongoing innovation in product offerings[199]. - The company is committed to improving product efficacy and safety, as evidenced by the development of preservative-free options[199]. Market Expansion and Product Development - The group is actively pursuing market expansion and new product development strategies to enhance its competitive position in the biotechnology sector[6][11]. - The group aims to expand its market presence in lower-tier cities in China and cultivate pharmacies as auxiliary sales channels[59]. - The company is expanding its product line with the introduction of lecithin-iodine complex capsules, aiming to capture a broader market segment[200]. - The company is also launching absorbable dressings, which may enhance its presence in the medical supplies market[200]. - The company is exploring new market opportunities through the introduction of various health-related products, including mouthwash for dental care[200]. Corporate Governance and Shareholder Information - The independent auditor's report confirmed that the financial statements reflect a true and fair view of the company's financial position as of December 31, 2023[140]. - The company has maintained sufficient public float throughout the review year and as of the report date[92]. - As of December 31, 2023, major shareholders include Yan Mingjie with 152,020,667 shares (26.78%) and Liu Huijuan with 153,945,667 shares (27.12%) of the company's ordinary shares[109]. - The company has proposed a final dividend of HKD 25,541,325 for the review year[75]. - The board has proposed a final dividend of HKD 0.045 per share, up from HKD 0.025 per share in the previous year, bringing the total dividend for 2023 to HKD 0.09 per share[197]. Environmental and Social Responsibility - The group is committed to creating an environmentally friendly work environment by promoting energy conservation and recycling initiatives[19]. - The company made charitable donations totaling approximately HKD 481,000 during the review period, down from HKD 983,000 in 2022[96]. - The group emphasizes the importance of human resources as a key asset and aims to continue being an attractive employer[25].

Investment Rating - The report suggests a positive outlook for the company, indicating that it is significantly undervalued with a PE ratio of only 4.9 times, despite rapid business growth, and recommends active attention to the stock [5]. Core Insights - The company has experienced rapid revenue and profit growth in 2023, with total revenue reaching 1.707 billion HKD, a year-on-year increase of 29.5%, and net profit of 275 million HKD, up 22.1% [12]. - The ophthalmology and surgical product lines are both showing strong growth, with the core product, the single-dose eye drop Beifu Shu, expected to drive significant revenue growth, targeting 1 billion HKD in sales [3][5]. - The company is actively expanding its online prescription drug sales and has a strong market share in both ophthalmology and surgical growth factor products [5]. Revenue Breakdown - In 2023, ophthalmology products accounted for 44% of total revenue, while surgical products made up 56%. The growth in revenue was primarily driven by the Beifu Shu series, which saw a 46.4% increase, and the Beifu Xin series, which achieved a 21.7% growth [12]. - The Beifu Xin series generated nearly 1 billion HKD in revenue, performing exceptionally well in the surgical and dermatology markets, particularly in the medical aesthetics sector, which has a market potential exceeding 1 billion HKD [12]. Product Development and Pipeline - The company is progressing well with its R&D pipeline, particularly with the Bevacizumab product, which is currently in Phase III clinical trials in the US, EU, China, and Australia, with an expected new drug application submission in 2025 [4][14]. - The company has exclusive global rights to SkQ1 eye drops and is conducting Phase III clinical trials in the US, showing promising safety and tolerability compared to placebo [4].