Group 1 - The core point of the news is that Yuan Da Pharmaceutical (00512) has seen a stock increase of over 3% following the completion of patient enrollment for its global Phase III clinical trial of the innovative ophthalmic drug CBT-001 for treating pterygium [1] - The Phase III trial is a randomized, double-blind, placebo-controlled study aimed at enrolling 660 patients aged 12 and above, assessing the safety and efficacy of CBT-001 eye drops in reducing conjunctival congestion and preventing the progression of pterygium [1] - CBT-001 is developed by Cloudbreak Pharma Inc. and is an innovative modified product of the already marketed drug OFEV, which has shown high safety and clinical efficacy in previous trials [1] Group 2 - After China joined the international multi-center Phase III clinical trial for CBT-001, the first patient enrollment in China was achieved in March 2024 [2] - The company holds exclusive production and commercialization rights for CBT-001 in mainland China, Hong Kong, Macau, and Taiwan, covering indications for preventing pterygium growth and reducing conjunctival congestion [2]

Core Viewpoint - Xingqi Eye Pharmaceutical is actively enhancing its technological capabilities and research and development (R&D) capacity through a planned stock issuance to raise up to 850 million yuan for R&D center construction and working capital supplementation [1][2][4]. Fundraising and Investment - The company plans to issue shares to specific investors, raising no more than 850 million yuan, with the net proceeds allocated entirely to the R&D center project and working capital [2][3]. - The stock issuance will not exceed 30% of the total share capital prior to the issuance, amounting to a maximum of 73.6 million shares [2]. - The R&D center aims to create a benchmark in the ophthalmology field, integrating smart laboratory matrices and collaborative innovation platforms, with a total investment of 984 million yuan [3]. Financial Performance - Xingqi Eye Pharmaceutical has achieved continuous growth in revenue and net profit for six consecutive years from 2019 to 2024 [1][6]. - In Q1 2025, the company reported a revenue of 536 million yuan, a year-on-year increase of 53.24%, and a net profit of 146 million yuan, soaring by 319.86% [6][7]. - The gross margin for Q1 2025 reached 80.16%, an increase of 4.06 percentage points year-on-year, while the net margin was 27.21%, up by 17.28 percentage points [7]. R&D Focus and Team - The company emphasizes R&D as the core driver of its development, holding 72 invention patents and 60 approved ophthalmic drug numbers, with 38 products included in the medical insurance directory [4][5]. - As of December 31, 2024, the company had 271 R&D personnel, accounting for 11.17% of the total workforce, with a significant portion holding master's degrees or higher [5]. Market Position and Strategy - Xingqi Eye Pharmaceutical is recognized as a leading domestic company in ophthalmic drug R&D, with a diverse product line covering various categories of eye medications [6]. - The company aims to enhance its competitive edge through differentiated innovation and to establish itself as an innovation-driven pharmaceutical enterprise [4].

Summary of Oculus Fireside Chat Company Overview - **Company**: Oculus - **Industry**: Ophthalmology and Neuro-Ophthalmology - **Key Focus**: Development of a diversified and unique ophthalmology pipeline addressing unmet needs in ophthalmology and neuro-ophthalmology diseases with novel assets [1][2] Core Assets 1. **OCS O1**: - Based on OptiReach technology, designed for diabetic macular edema (DME) - Targets early intervention and non-responders among the 1.8 million diagnosed patients, with only 500,000 currently treated [4][34] - Aims to address the 1.3 million patients not receiving adequate treatment [4][36] 2. **OCS O2 (Lickamimab)**: - First precision medicine for dry eye disease, targeting patients with TNF R1 genotype - Approximately 10 million patients suffer from moderate to severe dry eye, with 20% having the TNF R1 gene, showing significantly better responses [5][44] 3. **OCS O5 (Privel Sector)**: - A novel neuroprotective treatment for acute optic neuritis, an orphan disease with no current neuroprotective treatments available - Positive data from Phase 2 ACUITY trial showing biological, anatomical, and functional efficacy [6][9][11] Market Dynamics - **DME Market**: - Current treatments are invasive (anti-VEGF and steroid implants), leading to low compliance; 60% of diagnosed patients are untreated [33] - OCS O1 aims to fill the treatment void for early-stage patients and provide a non-invasive option for those already treated [34][36] - **Acute Optic Neuritis**: - Estimated 65,000 patients in the US and Europe, with no approved products currently available [20] - OCS O5 is positioned to improve low contrast visual acuity (LCVA) and preserve neuronal health [20][24] Clinical Development and Regulatory Pathways - **OCS O5**: - Moving towards registrational studies based on positive Phase 2 results, with FDA interactions planned for the second half of the year [27][28] - **OCS O1**: - Phase 3 trial ongoing with over 800 patients, expecting results in Q2 of next year [39][41] - **Dry Eye Program**: - Phase 3 study design approved by the FDA, focusing on TNF R1 positive patients with a primary endpoint of global ocular discomfort score [42][44] Upcoming Catalysts - Regulatory interactions with the FDA for OCS O5 across three indications (acute optic neuritis, MS relapses, NAION) [47] - Top-line results from the DME trial expected in Q2 of next year [48] - Dry eye study results anticipated in the second half of next year [48] Additional Insights - The company emphasizes the importance of non-invasive treatments in improving patient compliance and outcomes in ophthalmology [35][41] - The potential for OCS O5 to expand into other indications beyond acute optic neuritis, such as glaucoma, is acknowledged [18][24]

Fundraising Plan - The company plans to raise a total of no more than 850 million yuan, with the net amount after deducting issuance costs to be used entirely for project construction [1] - The total investment for the projects exceeds the net amount raised, with the company planning to cover the shortfall through self-funding or other financing methods [1] Necessity and Feasibility of Fundraising - The R&D center construction project is a continuation of a previous fundraising initiative, aimed at addressing a funding gap to ensure smooth project development [2][3] - The project aims to establish a comprehensive R&D headquarters with international vision, focusing on intelligent, digital, and international research capabilities [2] Project Details - The total investment for the R&D center is 984.23 million yuan, with 207.97 million yuan already invested from previous fundraising efforts and 650 million yuan planned from the current fundraising [3][4] - The project will include advanced facilities such as a high-standard data center and automated systems to enhance research efficiency and data reliability [3] R&D Focus and Market Position - The company emphasizes the importance of R&D as a core driver for pharmaceutical development, with a focus on building a strong pipeline of innovative products [5][6] - Recent product launches, including a treatment for dry eye syndrome, have significantly contributed to revenue growth, with total revenue increasing from approximately 689 million yuan in 2020 to about 1.943 billion yuan in 2024 [5][6] Future R&D Directions - The company is expanding its product line in the ophthalmology sector, focusing on innovative treatments for various eye diseases, including age-related macular degeneration and diabetic macular edema [7][8] - The development of new treatment methods, including gene therapy, is seen as a key opportunity for the company to enhance its market position [7] Financial Impact of Fundraising - The fundraising will improve the company's liquidity and capital structure, enhancing its ability to manage risks and support sustainable growth [12][13] - The successful implementation of the fundraising projects is expected to strengthen the company's core competitiveness and long-term viability [13]

Group 1 - The National Medical Products Administration (NMPA) of China has approved the listing application for the ophthalmic product JinYinKang® (Diquafosol Sodium Eye Drops) by the company, with the approval number "国药准字H20254149" [1] - JinYinKang® represents the second ophthalmic drug in the company's pipeline, following JinYinShu®, and aims to provide diverse treatment options for patients with dry eye syndrome [1] - The product works by activating the P2Y2 receptor to stimulate tear and mucin secretion, improving tear film stability and repairing corneal epithelial damage in patients diagnosed with dry eye and associated corneal epithelial defects [1] Group 2 - The company has established a new production base in Dongguan, featuring integrated Blow-Fill-Seal (BFS) technology and a sterile production line, ensuring drug quality and convenience with preservative-free, single-dose packaging [1] - Strategic partnerships with active pharmaceutical ingredient (API) suppliers have been formed to acquire high-quality raw materials at costs below the industry average [1] - The company has expanded its sales team and integrated online and offline channel resources to cover hospitals, pharmacies, and major e-commerce platforms, ensuring rapid market penetration and competitiveness for JinYinKang® [1] Group 3 - The approval of JinYinKang® is expected to create a synergistic effect with JinYinShu®, driving sustained growth in the company's performance [2] - JinYinShu® is targeted to be included in medical insurance coverage by the end of 2025, enhancing the accessibility and market penetration of the company's ophthalmic drugs [2] - The diversification of sales channels and product pipeline will strengthen the company's position in the ophthalmic market [2]

Summary of the Conference Call for Xingqi Eye Pharmaceutical Company Overview - **Company**: Xingqi Eye Pharmaceutical - **Industry**: Ophthalmic Pharmaceuticals Key Financial Performance - **2024 Revenue**: 1.943 billion CNY, up 32.42% YoY [2] - **2024 Net Profit**: 338 million CNY, up 40.84% YoY [2] - **Q1 2025 Revenue**: 536 million CNY, up 53.24% YoY [5] - **Q1 2025 Net Profit**: 146 million CNY, up 319.86% YoY [5] - **Proposed Dividend**: 10 CNY per 10 shares and a bonus issue of 4 shares per 10 shares, pending shareholder approval [2][4] Research and Development - **R&D Investment**: 235 million CNY in 2024, accounting for 12.11% of revenue, up 29.55% YoY [6] - **Approved Ophthalmic Drugs**: 60, with 38 included in medical insurance and 6 in the national essential drug list [6][7] - **Clinical Trials**: - 0.01% Atropine eye drops approved; - Voriconazole eye drops completed Phase I; - Cyclosporine eye drops completed Phase IV; - 0.02% and 0.04% Atropine eye drops completed Phase III trials [7][19] Production and Quality Management - **Production Capacity**: Four GMP-certified production lines for 0.01% Atropine eye drops, currently meeting market demand [13] - **Quality Management Initiatives**: Enhanced quality management systems and lean 6S management mechanisms [8] Marketing and Sales Strategy - **Sales Network**: Comprehensive online and offline channels, including partnerships with over 200 chain pharmacies and coverage of more than 12,000 locations [3][14] - **Target for 2025**: Reach over 20 million people aware of the treatment and ensure over 1 million children receive appropriate medication [17][25] - **Atropine Sales Contribution**: Over 10% of the company's main business revenue [13] Market Dynamics and Competition - **Market Potential**: High prevalence of myopia among children in China, with over 50% affected [24] - **Competitor Landscape**: Anticipation of increased competition from other companies like Heng Rui, with a focus on maintaining market share through comprehensive marketing strategies [24] Future Outlook - **2025 Revenue Growth Expectation**: Anticipated double-digit growth, with a focus on operational efficiency and cost management [26] - **Net Profit Margin Target**: Aiming for a net profit margin of 25% to 30% [28] - **Expansion Plans**: Continued investment in R&D and potential entry into overseas markets [30] Strategic Vision - **Long-term Goals**: To become a globally competitive research and manufacturing enterprise in the ophthalmic field, focusing on sustainable growth and innovation [12][34] Additional Insights - **Sales Team Expansion**: Increased sales personnel to 1,100, with a focus on promoting Atropine products [27] - **Sales Expense Management**: Maintaining stable sales expense ratios while driving sales growth [32][33]

Core Viewpoint - In 2024, Xingqi Eye Medicine (300573.SZ) demonstrated strong growth in the ophthalmic prescription drug sector, achieving significant revenue and profit increases, solidifying its leading position in the industry [1][2]. Financial Performance - The company reported a total revenue of 1.943 billion yuan in 2024, representing a year-on-year increase of 32.42% [2]. - Net profit reached 338 million yuan, up 40.84% year-on-year, with a non-recurring net profit growth of 44.54% to 348 million yuan [2]. - The net cash flow from operating activities was 417 million yuan, reflecting a 31.31% increase [2]. Product Performance - The eye drop segment showed remarkable growth, generating 1.366 billion yuan in revenue, a 106.08% increase, and accounting for 70.3% of total revenue [2]. - Key products driving this growth included low-concentration atropine eye drops (brand name "Mei Ou Pin") and cyclosporine eye drops (II) [2]. Investor Returns - The company proposed a profit distribution plan, intending to distribute a cash dividend of 10 yuan per 10 shares, totaling 175 million yuan, and a capital reserve conversion of 4 shares for every 10 shares held [3]. Production and Quality Management - The company focused on enhancing production and quality management, optimizing resource allocation, and upgrading production facilities to improve efficiency and support smart factory initiatives [4]. - Quality management improvements included passing various regulatory inspections and certifications, indicating a stable and effective quality management system [5]. Research and Development - In 2024, R&D expenses reached 221 million yuan, a 31.90% increase, with the company holding 66 invention patents [6]. - Significant progress was made in R&D, including the approval of clinical trials for new products aimed at treating common eye diseases [6][7]. Future Outlook - For 2025, the company reported a revenue of 536 million yuan in Q1, a 53.24% increase, and a net profit of 146 million yuan, up 319.86% year-on-year [8]. - The company outlined four key operational plans for 2025: production and quality centers, product R&D, marketing, and internal control management, with a focus on unmet clinical needs and innovation [9].

Group 1 - The company plans to distribute a cash dividend of 10 yuan per 10 shares and a capital reserve conversion of 4 shares for every 10 shares at the end of 2024, totaling a dividend payout of 175 million yuan [1] - The total dividend distribution for 2024, including the mid-year payout of 87.21 million yuan, amounts to 262 million yuan, representing 77.64% of the net profit attributable to shareholders [1] - The company has conducted a total of 9 year-end dividends and 4 mid-year dividends since its listing in 2016, with a cumulative dividend amount of 999.5 million yuan and an average dividend rate of 81.82% [5] Group 2 - The company specializes in the field of ophthalmic drugs, with 60 approved ophthalmic drug numbers, of which 38 are included in the medical insurance catalog and 6 in the national essential drug catalog [4] - In 2024, the company achieved significant growth, with operating revenue of 1.943 billion yuan, a year-on-year increase of 32.42%, and a net profit of 338 million yuan, a year-on-year increase of 40.84% [4] - The company’s net cash flow from operating activities reached 417 million yuan, reflecting a year-on-year growth of 31.31% [4]

兴齐眼药在接待机构调研时曾表示，公司低浓度硫酸阿托品滴眼液是处方药物，患者可通过具有资质的 公立医院、民营医院、视光中心等机构进行处方购买。根据国家药监局相关规定,医疗机构制剂是指医 疗机构根据本单位临床需要经批准而配制、自用的固定处方制剂。医疗机构配制的制剂,应当是市场上 没有供应的品种。同时,市场上已有供应的品种不得作为医疗机构制剂申报。公司0.01%低浓度硫酸阿托 品是经过严格三期临床研究验证获得国家药监局正式批准上市的可在全国多渠道流通的产品，具有循证 证据充分、制剂工艺创新、舒适稳定且无抑菌剂的特点；医疗机构制剂仅限在本医疗机构范围内使用， 受众人群有限。 兴齐眼药表示，2025年，公司将继续加大研发投入力度，丰富公司眼科细分领域的产品线，进一步加强 在眼底疾病治疗领域的生物药布局。公司将根据研发计划和研发预算，借助眼用凝胶、眼用即型凝胶、 眼用缓释制剂等七个工艺技术平台以及质量研究、药理药代研究和药物包材研究等评价技术平台，以自 主创新为主，产学研联合开发为辅，不断推进研发管线的全面化、差异化布局。 兴齐眼药（300573）4月21日晚披露2024年年度报告，报告期内，公司实现营业收入19.43亿 ...

更适合长期治疗的慢性反复发作患者。 本文为IPO早知道原创 作者｜C叔 微信公众号｜ipozaozhidao 据IPO早知道消息，2月25日，兆科眼科（6622.HK）宣布其全资附属子公司兆科（广州）眼科药物 有限公司，与浙江视方极医药科技有限公司（下称"视方极"）联合发布国内首款单剂量不含抑菌剂 的盐酸氮䓬斯汀滴眼液产品（顺敏®），为过敏性结膜炎患者提供更全面的治疗方案选择。 近年来，中国国内过敏性结膜炎的发病率逐年上升，预计到2030年，全国过敏性结膜炎患者将超过 3亿人。盐酸氮䓬斯汀滴眼液的推出有望为广大过敏性结膜炎患者带来新的希望，3分钟迅速起效， 持续时间长达10小时。0.4毫升单支装不添加抑菌剂，更适合长期治疗的慢性反复发作患者。该产品 的成功上市不仅有助于进一步满足临床用药需求，也为过敏性结膜炎患者提供了优质的治疗方式。 此次兆科眼科和视方极的联手合作是双方在眼科药物领域发展的重要里程碑。结合兆科眼科的商业化 实力及视方极的产品研发优势，双方加强互补合作，旨在为中国眼科治疗领域落实更多的创新成果， 为患者提供更安全更高效的解决方案。 视方极为国内创新型医药企业，2021年成立于浙江杭州，已构建眼 ...