Trabedersen

欧康维视生物-B（01477.HK）深度研究投资报告：BD+自研双轮驱动，眼科创新药龙头迈入盈利拐点一、公司核心概况欧康维视生物成立于2018年，总部位于江苏苏州，2020年登陆港交所，是中国眼科创新药领域龙头企业，专注于眼科全疾病领域创新疗法的研发、生产与商业化，致力于成为全球领先的眼科医药综合解决方案提供商。公司通过“自主研发+全球BD授权引进”双轮驱动战略，构建了覆盖眼前节与眼后节核心疾病的全面产品矩阵，涵盖葡萄膜炎、干眼症、青光眼、近视防控、黄斑病变等重点赛道。截至2025年12月，公司总市值达90.8亿港元，2020-2024年营收CAGR高达89.7%，2024年实现营收4.17亿元（+69.4%），经调整净亏损持续收窄至1.84亿元，商业化进入加速期。核心竞争优势集中于三方面：一是管线布局全面领先，拥有34种药物资产，21款产品处于商业化阶段，3款进入III期临床，2款提交NDA，是国内眼科药企中后期管线最丰富的企业之一；二是BD合作资源顶级，与全球眼科巨头爱尔康达成深度战略合作，引入8款干眼症/手术滴眼液（含7款成熟产品），爱尔康持股16.7%成为战略股东，形成研发、渠道协同效应；三是商业化能力突出，2024年渠道覆盖2万+医院（含2765家三甲），销售团队超270人，核心产品纳入医保后快速放量，苏州生产基地年产能达4.55亿剂，保障供应稳定性。核心商业化产品中，优施莹®（氟轻松玻璃体内植入剂）作为全球首个36个月缓释制剂，2023年纳入医保后2024年销售额同比激增396.65%至1336万元；智维泰®（西替利嗪滴眼液）2024年7月获批上市，成为国内首款FDA批准的过敏性结膜炎治疗药物；通过BD引进的适利达®、新泪然®等成熟产品快速贡献营收，2025上半年爱尔康合作产品整合带动营收同比大增75.4%。二、行业背景与增长逻辑1. 行业高景气：需求+政策+进口替代三重共振中国眼科用药市场正处于结构性增长黄金期，2024年市场规模已突破220亿元，预计2025年达250亿元，2030年有望突破430亿元，2025-2030年CAGR维持12.3%。核心增长驱动因素：• 需求端刚性扩容：中国眼科疾病患者超6亿人次，干眼症患病率14.5%（患者达2.1亿）、青光眼患者2100万、糖尿病视网膜病变患者3000万，近视防控领域青少年总体近视率52.7%，核心适应症患者基数庞大且持续增长，叠加电子设备普及、老龄化加深等因素，用药需求持续释放；• 政策端红利释放：《“十四五”全国眼健康规划》重点支持眼科创新药研发，医保目录动态调整加速创新药准入，真实世界研究政策缩短审批周期，低浓度阿托品等品类纳入优先审评，为创新药商业化铺路；• 进口替代空间广阔：当前国内眼科用药市场外资占比60%-70%，诺华、参天、爱尔康三大巨头垄断高端市场，而国产创新药企在缓释制剂、生物类似药等领域逐步突破技术壁垒，政策支持下国产替代率有望从当前不足30%提升至2030年45%。2. 细分赛道分化：创新剂型与新兴场景成增长核心• 干眼症赛道：2024年市场规模48亿元，预计2030年达120亿元（CAGR16.3%），从对症缓解向病因治疗升级，新型抗炎药、TRPM8激动剂等创新机制药物成为竞争焦点，欧康维视通过BD引入爱尔康8款产品+自研OT-202双靶点抑制剂，形成全方位布局；• 近视防控赛道：低浓度阿托品作为核心干预手段，2024年市场规模超15亿元，预计2030年突破60亿元，行业处于规范化商业化初期，欧康维视OT-101凭借低刺激率优势处于全球III期临床，有望抢占先发优势；• 眼底病赛道：糖尿病黄斑水肿、葡萄膜炎等适应症缺乏长效治疗方案，36个月缓释植入剂等创新剂型解决用药依从性痛点，市场规模快速增长，公司优施莹®、OT-703等产品形成差异化竞争壁垒。3. 竞争格局：龙头集中化加速，BD+自研成核心竞争力国内眼科创新药市场呈现“双轨竞争”格局：一是本土企业（欧康维视、兴齐眼药、兆科眼科）通过“自研+BD”快速补全管线，聚焦差异化创新；二是跨国药企加速本土化布局，通过合作授权巩固市场份额。行业竞争焦点已从价格战转向“产品矩阵完整性+技术差异化+商业化效率”，头部企业凭借管线深度、渠道覆盖和产能优势，推动行业CR5从2020年18.3%提升至2024年26.7%，集中度持续提升。三、财务表现与关键指标分析（单位：亿元）1. 核心财务数据（2023-2025上半年）指标 2023财年 2024财年 2025上半年 同比变化（2025H1 vs 2024H1） 营业收入 2.46 4.17 2.94 +75.4% 归母净利润 -3.79 -2.68 -1.32 亏损收窄31.1% 毛利率 51.2% 53.9% 36.1% -17.8pct（短期产品结构影响） 经调整净利率 -58.1% -44.1% -36.7% 亏损率收窄7.4pct 研发投入 1.05 1.21 0.39 +14.7%（2024vs2023） 经营活动现金流净额 -1.83 -1.56 -0.96 净流出减少38.5% 账面资金 - - 5.78 支撑后续研发与商业化 2. 财务亮点解析• 业绩增长进入快车道：2024年营收同比增长69.4%，2025上半年增速进一步提升至75.4%，核心驱动力为爱尔康合作产品整合落地与优施莹®医保放量，公司预计2025年经营层面扭亏，2026年实现财务报表盈利；• 盈利质量持续优化：2024年毛利率提升至53.9%，显著高于行业平均水平，反映高端产品占比提升；经调整亏损率从2023年58.1%收窄至2024年44.1%，规模效应逐步显现，2025上半年亏损进一步收窄；• 研发投入精准高效：研发费用率维持30%左右，重点聚焦III期及NDA阶段核心管线，OT-702（阿柏西普生物类似药）、OT-502等关键产品推进顺利，研发转化效率行业领先；• 供应链与现金流稳健：苏州生产基地进入审批收官阶段，年产能4.55亿剂保障商业化供应；账面资金5.78亿元，足以支撑未来2-3年研发与市场推广需求，财务风险较低。四、核心竞争优势与风险提示1. 核心竞争优势（护城河）• 管线布局“全+深”：覆盖眼前节+眼后节全疾病领域，21款商业化产品提供稳定现金流，3款III期+2款NDA管线形成梯队，在近视防控、黄斑水肿等赛道具备差异化优势，解决未被满足的临床需求；• BD合作战略卡位：与爱尔康的股权+产品合作形成双赢，快速获得7款成熟商业化产品与1款临床阶段新药，借助爱尔康品牌背书与渠道资源加速市场渗透，同时获得未来产品优先谈判权；• 商业化能力突出：渠道覆盖2万+医院，三甲医院覆盖率超70%，销售团队专业度高，核心产品优施莹®纳入医保后快速放量，2024年销售额同比增长396.65%，商业化落地效率验证；• 技术平台差异化：在缓释植入剂、双靶点抑制剂等领域形成技术壁垒，OT-202（Syk/VEGFR-2双靶点）为国内首个干眼First-in-class新药，OT-101（阿托品）眼刺激率显著低于竞品，技术优势转化为产品竞争力。2. 主要风险提示• 研发审批风险：核心管线OT-101（近视防控）、OT-702（生物类似药）等仍处于临床或NDA阶段，审批进度可能不及预期；• 医保降价风险：创新药纳入医保后面临降价压力，可能影响产品毛利率，若后续集采扩围至眼科创新药，将进一步挤压盈利空间；• 市场竞争加剧：兴齐眼药、兆科眼科等本土企业在近视防控、干眼症领域管线布局重叠，外资企业加速本土化，市场竞争可能加剧；• 合作整合风险：与爱尔康的产品整合、渠道适配存在不确定性，若协同效应未达预期，可能影响业绩增长节奏。五、估值分析与投资评级1. 相对估值截至2025年12月，公司股价11.14港元，对应2024年PS（TTM）约21.7倍，PB1.59倍。对比国内眼科创新药同行（兴齐眼药PS 18倍、兆科眼科PS 25倍），公司PS估值处于行业中枢，考虑到2025-2027年营收CAGR 50%的高增长预期、管线价值与爱尔康合作溢价，当前估值具备合理性。与全球眼科龙头爱尔康（PS 8倍、PE 28倍）相比，公司作为成长型创新药企，高估值反映未来增长潜力。2. 绝对估值（DCF模型）假设未来5年营收复合增长率50%（受益于BD产品放量、自研新药获批），2026年实现净利润转正，终端增长率3%，加权平均资本成本（WACC）8%，测算得出公司内在价值约120亿港元，对应目标价14.7港元，当前股价存在32%的估值修复空间。3. 投资评级与目标价• 投资评级：买入• 目标价：14.0-15.0港元（对应2025年PS 18-19倍，贴合高增长预期与管线价值）• 核心催化因素：OT-702（阿柏西普生物类似药）NDA获批、爱尔康合作产品销售额超预期、OT-101全球III期临床揭盲、优施莹®医保渗透率持续提升、苏州生产基地正式投产。六、总结欧康维视生物作为国内眼科创新药龙头，通过“BD引进成熟产品快速起量+自研创新药构筑长期壁垒”的双轮驱动战略，成功实现从管线布局到商业化落地的跨越式发展。公司依托与爱尔康的深度战略合作，快速补全商业化产品矩阵并获得渠道协同，同时核心自研管线在近视防控、干眼症、眼底病等黄金赛道具备差异化优势，2025年已迈入盈利拐点。当前公司估值尚未完全反映管线价值与高增长潜力，随着BD合作产品持续放量、自研新药逐步获批，公司有望实现“业绩高速增长+估值修复”的戴维斯双击。长期来看，在国内眼科用药进口替代加速与创新药政策支持的背景下，公司有望进一步巩固龙头地位，成长为全球眼科创新药领域的核心参与者，估值具备持续提升空间。风险提示：核心管线审批不及预期、医保降价超预期、市场竞争加剧、合作整合效果不佳。需要我补充OT-702的最新NDA审批动态，或优施莹®2025年全年销售预测数据吗？

AGOURA HILLS, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) in collaboration with the Brush and Key Foundation, today announced the publication of a peer-reviewed research article in the International Journal of Molecular Sciences titled “Comparative Tumor Microenvironment Analysis for HCC and PDAC Using KMplotter.” Chang, W.-H.; Shah, D.; Myers, S.; Potts, M.; Qazi, S.; Trieu, V. International Journal of Molecular Sciences 2025, 26, 11920. The study presents a comprehensive, data-driven analysis of two emerging biomarkers—DNMT3A (DNA methyltransferase 3A) and GMPS (guanine monophosphate synthetase)—across hepatocellular carcinoma (HCC) and pancreatic ductal adenocarcinoma (PDAC). By integrating survival outcomes, transcriptomic profiling, and tumor microenvironment (TME) analyses from more than 7,000 patients, the authors demonstrate that the prognostic significance of these biomarkers is highly context-dependent, shaped by immune composition, metabolic reprogramming, and innate immune sensing pathways. Training the Next Generation of Scientists The publication also reflects the educational mission of the Brush and Key Foundation, which supports young scholars through mentored research experiences that bridge scientific inquiry, critical thinking, and professional development. The paper’s author- Drashya Shah, an intern supported by the Brush and Key Foundation, shared the following reflection: “My experience working with the Brush and Key Foundation for Young Artists has been truly valuable and enriching. Throughout the research and writing process, I received consistent guidance and insightful feedback at every stage, which helped me refine my ideas and present my findings with clarity and precision. This collaborative environment not only strengthened the quality of my paper but also significantly boosted my confidence as a researcher. The skills and knowledge I gained through this journey are lifelong, and I will undoubtedly carry them forward into my future education and professional work. I am deeply grateful to everyone involved for their unwavering support and encouragement.” “This work exemplifies how advanced bioinformatics, translational oncology, and structured mentorship can intersect to generate meaningful scientific insight,” said Dr. Vuong Trieu, co-author and contributor to the study. “Equally important, it demonstrates how hands-on research training helps prepare the next generation of scientists.” Dr. Wen-Han Chang, corresponding author, added, “The work highlights why biomarkers cannot be interpreted in isolation. Tumor context—immune composition, metabolic state, and innate sensing—fundamentally alters prognostic meaning and therapeutic opportunity.” About the Brush and Key Foundation The Brush and Key Foundation is a nonprofit organization dedicated to mentoring and educating young scholars through hands-on research, structured guidance, and interdisciplinary learning. The foundation emphasizes critical thinking, scientific communication, and real-world research experience to help students build durable skills applicable to future academic and professional pursuits. About Oncotelic Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma “DIPG” (through OT-101) through its 45% joint venture, melanoma (through CA4P), and Acute Myeloid Leukemia “AML” (through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019. Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease ("PD"). Over 60,000 new patients are being diagnosed with PD in the United States and currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics. AL-101 is also being developed for Erectile Dysfunction ("ED"). ED is the most prevalent male sexual disorder globally. The percentages of men affected by ED are as follows: 14.3-70% of men aged 60 years, 6.7-48% of men aged 70 years, and 38% of men aged 80 years (Geerkens MJM et al. (2019). Eur Urol Focus. pii: S2405-4569(19)30079-3). However, with the increasing administration of PDE5 inhibitors in clinical practice, it was found that approximately 30-35% of ED patients are treatment failures (McMahon CN et al. (2006). BMJ, 332: 589-92). AL-101 is designed to target treatment failure ED patients who do not respond to PDE5 inhibitors. Through similar mechanism of action, AL-101 is being developed for Female Sexual Dysfunction ("FSD"). Female sexual dysfunction is a prevalent problem, afflicting approximately 40% of women and there are few treatment options. FSD is more typical as women age and is a progressive and widespread condition. (Allahdadi, KJ et al. (2009) Cardiovascular & hematological agents in medicinal chemistry, 7(4), 260-269). There is no available drug for the treatment of FSD. In June 2019, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder ("HSDD") in premenopausal women. This is the only available drug treatment. Vyleesi has essentially replaced the only other drug for HSDD - however, it has a long list of drug-drug interactions, including commonly used antidepressants, such as fluoxetine and sertraline. In addition, it has a black box warning regarding its use with alcohol, a combination that has been associated with hypotension and syncopal episodes. Therefore, there is an urgent need for effective therapy against FSD and HSDD. Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”) that involve substantial risks and uncertainties. We generally identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “would,” “intend,” “target,” “aim,” “project,” “believe,” “estimate,” “predict,” “potential,” “seek,” “indicate,” or “continue” or the negative of these terms or other similar words, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future, such as our estimates regarding anticipated operating income or losses, future performance, future revenues and projected expense, including that to fund our clinical and other development programs; our liquidity and our expectations regarding our needs for and ability to raise additional capital; our ability to continue as a going concern; our ability to select and capitalize on commercially desirable product opportunities as a result of limited financial resources; our ability to manage our expenses effectively and raise the funds needed to continue our business; our ability to retain the services of our current or future executive officers, directors and principal consultants; the competitive nature of our industry and the possibility that our products or product candidates may become obsolete or may not generate revenues as expected or at all; our ability to obtain and maintain regulatory approval of our existing products and any future products we may develop; the development of and the process of commercializing AI/Blockchain and other technologies for supporting the development of OT- 101 and Artemisinin for COVID-19, OT-101, including development of OT-101, Artemisinin, OXi4503, CA4P and our 2021 in-licensing of apomorphine; the initiation, timing, progress and results of our preclinical and clinical trials, research and development programs; regulatory and legislative developments in the United States and foreign countries; the timing, costs and other limitations involved in obtaining regulatory approval for any product; the further preclinical or clinical development and commercialization of our product candidates; the entering into any corporate transactions to develop our products through partnerships, joint ventures or other corporate transactions; our ability to make a proposed initial public offering between us and our joint-venture partners for the joint venture, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof: building and the success of our nanoparticle platform and the related success of launching the platform; the expected valuation of the JV, and therefore a corresponding increase in the valuation of the Company, by virtue of it’s ownership in the JV; the success of the launch of Pet2DAO, a corporation with a DAO infrastructure, the success of Pet2DAO and the plans surrounding the pet and animal health, the ability for the Company to register the tokens of Pet2DAO, the actual filing of a registration statement and approval of the tokens as registrable securities with the Securities and Exchange Commission (“SEC”) through a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become tradable; our ability to obtain and maintain orphan drug exclusivity for some of our product candidates; the potential benefits of our product candidates over other therapies; our ability to enter into and maintain any collaboration with respect to product candidates; our ability to continue to develop or commercialize our products or product candidates in the event any license agreements in place with third parties expire or are terminated; the performance and conduct of third parties, including our third-party manufacturers and third party service providers used in our clinical trials; our ability to obtain and maintain intellectual property protection for our products and operate our business without infringing upon the intellectual property rights of others; the potential liability exposure related to our products and our insurance coverage for such exposure; our ability to form alliances with other third parties to develop the products in our pipeline through partnerships, joint ventures, mergers or acquisitions; the successful development of our sales and marketing capabilities; the size and growth of the potential markets for our products and our ability to serve those markets; the rate and degree of market acceptance of any future products; the volatility of the price of our common stock; the ability to achieve secondary trading of our stock in certain states; the dilutive effects of potential future equity issuances; our expectation that no dividends will be declared on our common stock in the foreseeable future; our ability to maintain an effective system of internal controls; the payment and reimbursement methods used by private or governmental third-party payers; our ability to retain adequate staffing levels; unfavorable global economic conditions; unfavorable global epidemic and pandemic conditions; a failure of our internal computer systems or those of our contractors and consultants; potential misconduct or other improper activities by our employees, contractors or consultants; the ability of our business continuity and disaster recovery plans to protect us in the event of a natural disaster; and other factors discussed elsewhere in this document or any document incorporated by reference herein or therein. Contact Information:For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com