OpRegen (Lineage Cell Therapeutics)

Issued on behalf of Avant Technologies Inc. VANCOUVER, BC, Jan. 29, 2026 /PRNewswire/ -- USA News Group News Commentary – Global capital is officially rotating into "Longevity Infrastructure" which is now valued at a massive $27 trillion by 2030[1]. This transition is moving the entire healthcare sector toward regenerative medicine which is projected to reach $578.59 billion by 2033[2]. We are witnessing a total structural reset that creates massive upside for bio-restorative platforms capable of a systemic re-rating. This emerging investment class includes Avant Technologies, Inc. (OTCQB: AVAI), MannKind (NASDAQ: MNKD), Altimmune (NASDAQ: ALT), Lineage Cell Therapeutics (NYSE-A: LCTX), and Arrowhead Pharmaceuticals (NASDAQ: ARWR). The latest data shows cell therapy markets hitting $8.85 billion by 2026[3] while AI-driven drug discovery platforms are accelerating to $24.51 billion[4]. These figures confirm that institutions are now positioning for the convergence of cell-encapsulation technology and precision metabolic delivery. This structural shift is opening a massive window for platforms that can address the $65.2 billion metabolic syndrome opportunity with curative infrastructure rather than simple symptom management. For the smart money, these cell-based and gene-targeted therapies are officially the longevity alpha of the 2026 cycle. Avant Technologies, Inc. (OTCQB: AVAI) made waves at the 15th European Pancreas and Islet Transplantation Association (EPITA) Symposium, where Dr. Eva Maria Lilli Brandtner is evaluating advanced cells for potential application in a diabetes therapy. The Austria-based event, which ran January 25-27, 2026, brought together global scientists and clinicians focused on biological therapies for diabetes. EPITA stands as one of the world's flagship associations for networking on islet transplantation and beta cell replacement, making Avant's participation particularly significant for the emerging biotechnology company. Dr. Brandtner is assessing promising cells for inclusion with Avant's Cell-in-a-Box® technology, developed in partnership with SGAustria Pte. Ltd. This clinically proven microencapsulation platform solves a critical problem: when doctors transplant therapeutic cells into patients, the immune system typically destroys them within days or weeks. The traditional solution requires lifelong immunosuppressive drugs that carry serious risks, including infections, organ damage, and elevated cancer risk. "While stem cell-derived beta cells undoubtedly represent a breakthrough in unlimited insulin sources, immune protection still remains a key challenge," Dr. Brandtner said. " Avant's Cell-in-a-Box® technology addresses this effectively, positioning us to contribute meaningfully to beta cell replacement therapies for type 1 and insulin-dependent type 2 diabetes patients worldwide." The cell encapsulation technology creates a protective barrier around therapeutic cells while still allowing nutrients, oxygen, and therapeutic proteins to pass through freely. This approach eliminates the need for immunosuppressive drugs while preventing potential complications such as cell escape or tumor formation, making it a cornerstone for safe and scalable diabetes therapies. Avant operates through two joint ventures targeting massive markets. Insulinova, Inc. partners with SGAustria to develop treatments for type 1 diabetes and insulin-dependent type 2 diabetes. The approach uses genetically modified cells that produce, regulate, and store insulin, essentially creating a bioartificial pancreas that restores natural glucose control. The diabetes market opportunity is substantial: 589 million people globally live with type 1 and insulin-dependent type 2 diabetes, projected to reach 853 million by 2050 according to the International Diabetes Federation. The second venture, Klothonova, partners with Singapore-based Austrianova to develop therapies for age-related diseases and anti-aging therapies using cells that produce the Klotho protein. Research from the Mayo Clinic links declining Klotho levels to arterial stiffness, endothelial dysfunction, and vascular calcification. Both platforms are backed by over 50 peer-reviewed publications representing decades of development. The addressable markets span Alzheimer's disease ($32.8 billion by 2033), cardiovascular disease (32% of global deaths), and kidney disease (850 million affected worldwide). CONTINUED… Read this and more news for Avant Technologies Inc. at and MannKind Corporation (NASDAQ: MNKD) announced FDA approval of an updated Prescribing Information for Afrezza (insulin human) Inhalation Powder, revising recommendations for starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens including multiple daily injections or insulin pump therapy. The updated initial conversion table is based on clinical trials in adults showing significantly improved mealtime glycemic excursions with the revised dosing approach. "We expect that this label update will help support healthcare providers by providing clearer starting dose guidance when transitioning patients to inhaled insulin from subcutaneous mealtime insulin—whether injections or insulin pumps," said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Diabetes at MannKind. "We believe this refinement to the label helps support appropriate initiation of therapy while reinforcing Afrezza's established clinical profile." The updated labeling was supported by modeling data and in vivo results from the Dose Optimization study and INHALE-3 trial demonstrating improved postprandial glucose outcomes following conversion to inhaled insulin using the now-approved conversion dose. Afrezza is the only ultra rapid-acting inhaled insulin approved by the FDA to improve glycemic control in adult patients with diabetes mellitus, administered at the beginning of meals using a small portable inhaler that delivers insulin via MannKind's proprietary Technosphere technology. Altimmune (NASDAQ: ALT) received FDA Breakthrough Therapy Designation for pemvidutide for treatment of patients with metabolic dysfunction-associated steatohepatitis. Breakthrough Therapy Designation is intended to expedite development and review of medicines treating serious conditions that have shown preliminary clinical evidence indicating potential for substantial improvement over available therapies. "The FDA's Breakthrough Therapy Designation for pemvidutide in MASH reinforces the promise of its clinical profile and potential to address significant unmet needs in this serious, progressive liver disease," said Jerry Durso, President and CEO of Altimmune. "As I step into the CEO role, this designation represents an important validation for pemvidutide." Altimmune completed a productive end-of-phase 2 meeting with the FDA resulting in alignment on parameters for a registrational Phase 3 trial of pemvidutide in MASH patients with moderate to advanced liver fibrosis. The company plans to initiate a Phase 3 trial evaluating multiple pemvidutide doses over a 52-week treatment period incorporating biopsy-based endpoints to support a potential accelerated approval. Lineage Cell Therapeutics (NYSE-A: LCTX) has received delivery of a novel gene-edited hypoimmune cell line from Factor Bioscience under their strategic collaboration. The proprietary induced pluripotent stem cell line contains hypoimmunity edits designed to support non-immune privileged indications and includes an additional disease-specific edit with potential to differentiate this cell line from competing therapies. "Our partnership with Factor supports our plan to create novel and superior product candidates by combining our manufacturing and process development capabilities with cutting-edge cell engineering and editing technologies," stated Brian M. Culley, CEO of Lineage Cell Therapeutics. "This achievement under our collaboration with Factor supports our plan to broaden our cell therapy platform through the addition of new technologies and indications, as we await further updates from our lead cell therapy program, OpRegen, for dry age-related macular degeneration with geographic atrophy." Lineage will evaluate the cell line for its ability to adapt to the company's proprietary AlloSCOPE manufacturing platform. The clinical-stage biotechnology company develops allogeneic cell therapies for serious medical conditions with a pipeline including OpRegen for retinal disease and OPC1 for spinal cord injuries. Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced it has dosed the first subjects in a Phase 1/2a clinical trial of ARO-DIMER-PA, the first clinical candidate designed to silence expression of two genes simultaneously in one molecule for treatment of atherosclerotic cardiovascular disease due to mixed hyperlipidemia. The investigational RNA interference therapeutic targets both proprotein convertase subtilisin kexin 9 and apolipoprotein C3 genes, representing an important step forward enabled by Arrowhead's proprietary Targeted RNAi Molecule platform. " Arrowhead is at the forefront of innovation in the RNAi field, and we're proud of the versatile capabilities of our TRiM platform, now including the first-ever clinical candidate that can potentially silence expression of two genes in one RNAi molecule," said Chris Anzalone, Ph.D., President and CEO at Arrowhead Pharmaceuticals. "ARO-DIMER-PA is designed to silence both the PCSK9 and APOC3 genes, which together have substantial clinical validation as important targets for reducing LDL-cholesterol, triglycerides, and total atherogenic lipoproteins." In preclinical studies, ARO-DIMER-PA potently lowered serum PCSK9 and APOC3 and ameliorated high levels of non-HDL-cholesterol, LDL-cholesterol, and triglycerides in hyperlipidemic nonhuman primates. The initiation advances Arrowhead's growing cardiometabolic portfolio including commercial product REDEMPLO approved in the United States, Canada, and China for familial chylomicronemia syndrome, ongoing Phase 3 study of zodasiran in homozygous familial hypercholesterolemia, and Phase 1/2 studies of ARO-INHBE and ARO-ALK7 for obesity. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Avant Technologies Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares Avant Technologies Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Avant Technologies Inc. which were purchased in the open market. MIQ reserves the right to buy and sell, and will buy and sell shares of Avant Technologies Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES CITED: Logo - 21% more press release views with Request a Demo

2004年，首款抗血管内皮生长因子（VEGF）药物获批，眼底病治疗正式告别激光光凝的粗放时代，迈入精准的单克隆抗体时代。过去二十年，以阿柏西普（Aflibercept，靶点VEGF）和雷珠单抗（Ranibizumab，靶点VEGF）为代表的标准治疗方案（SoC），成功将新生血管性年龄相关性黄斑变性（nAMD）从“必然致盲”的绝症转变为“可控”的慢性病。然而，站在2026年的时间节点回望，随着全球老龄化加剧和糖尿病患病率攀升，单一靶点抗VEGF治疗的局限性已触及科学与临床的临界点，眼科研发正迎来一场全方位的范式转移。一、抗VEGF时代：辉煌背后的三大核心瓶颈1. 视力获益的“天花板”与长期二次衰减 临床研究和真实世界证据（RWE）显示，尽管抗VEGF药物（靶点VEGF）在治疗初期能带来显著视力提升，但仍有约30-40%的患者对现有药物应答不足。更严峻的挑战来自视力的长期维持：著名的CATT研究及其后续长期随访数据揭示，受治者在初始视力增益后，通常在5-7年出现视力二次下降，这一现象的主因并非原始病灶的复发，而是视网膜下纤维化（Subretinal Fibrosis）和不可逆的黄斑萎缩（Macular Atrophy, MA）。2. 沉重治疗负担导致真实世界预后不佳 全球nAMD患者群体约有2,000万，糖尿病黄斑水肿（DME）患者基数更为庞大。由于抗VEGF单抗（靶点VEGF）在眼内的半衰期限制，患者往往需要接受频繁的玻璃体内注射（IVT）。在真实世界中，患者常因往返医院的不便、对眼部注射的心理恐惧以及经济压力，导致治疗依从性大幅下滑，这已成为影响预后的首要原因。3. 分子层面的代偿性逃逸机制引发耐药性 长期单一阻断VEGF-A会诱发机体产生代偿机制，导致VEGF-C、VEGF-D以及促炎因子IL-6等水平的代偿性升高（IL-6作为IL-6家族核心成员，可通过结合IL-6R、gp130激活JAK-STAT等通路，加剧炎症与血管渗漏）。2026年的研发共识明确指出，必须通过机制升维与范式转移——即从“单一靶点向多靶点协同”以及“短期给药向极效长效化”转变，才能打破这一耐药循环。二、未来开发方向：极效长效化与多特异性协同 从 JPM 2026 前后多家公司的公开展示与市场解读来看，眼科研发正经历一场从单纯“抑制血管”到“重建微环境平衡”的范式2.1 长效化革命与给药范式转移 解决依从性问题的核心在于长效化，而给药途径的“去创伤化”也在加速推进： • TransCon技术实现半年长效：EYC-0305（靶点VEGF）作为一款抗VEGF长效资产，其通过精密设计的化学链接子（Linker）将药物共价结合在惰性载体上。该链接子在眼内生理pH环境下发生非酶促自发水解，且释放速率符合零级动力学（Linear Release），确保药物浓度在6个月以上的时间内保持恒定。 • 皮下给药替代静脉输注：MHB018A（靶点IGF-1R）明慧医药开发的MHB018A是针对IGF-1R的单域抗体，利用VHH纳米抗体特性实现皮下注射的高效吸收，理想情况下可有效规避了静脉给药产生的高高峰值（Cmax）所关联的听损毒性。2.2 多靶点协同逻辑：超越单一因子的复杂病理 为应对VEGF逃逸机制，多特异性抗体已成为2026年的研发新标杆，其中KSI-101（靶点VEGF×IL-6） 凭借双机制协同优势，成为炎症性黄斑水肿（MESI）领域的核心突破： • KSI-101（靶点VEGF×IL-6）作为Kodiak Sciences开发的双特异性蛋白，其采用“VEGF Trap+抗IL-6抗体”的双机制设计——既阻断VEGF介导的血管渗漏，又抑制IL-6驱动的炎症反应，期望协同修复视网膜屏障紧密连接（tight junction）。     APEX研究（Phase 1b）数据显示，在MESI人群中，治疗第4周即出现有临床意义的视力提升，至第20周仍持续获益，5mg和10mg剂量组超50%患者视力改善≥15个字母（≥3行视力表）；两个最高剂量组超90%患者实现“完全干燥”（无视网膜内/视网膜下积液），且耐受性良好，无严重治疗相关不良事件。目前该药物已推进至Phase 3 PEAK和PINNACLE研究，招募速度超预期，有望成为MESI一线治疗方案。    KSI-101 和 KSI-501 均为 Kodiak Sciences 开发的双靶点抗体类生物药，靶向 VEGF 和 IL-6，后者利用其ABC（Antibody Biopolymer Conjugate）平台实现高亲和和耐久性。KSI-101 的主要适应症为炎症性黄斑水肿（MESI），已进入 Phase 3；KSI-501 在 wet AMD 与 DME 中开展 Phase 3 DAYBREAK 研究。 • ANX007（靶点C1q）在GA领域，Annexon开发的ANX007（靶点C1q）采取上游干预补体系统的策略，ARCHER研究证明，其能显著降低中心凹累及患者15个字母视力丢失的风险，降幅达72% (仍需在更大样本的注册性研究中验证其可重复性) • 双抗药物升级：IBI302（VEGF×补体）/IBI324（VEGF×Ang-2）/RC28-E（VEGFxFGF）   IBI302（VEGF×补体）     IBI302是一款VEGF×补体双抗，通过融合 VEGF Trap 与 complement receptor 1（CR1）结构域，既抑制 VEGF 介导的血管生成与渗漏，又干预补体活化介导的炎症通路。在一项多中心 II 期 nAMD 研究中，其在改善 BCVA、缩减视网膜厚度及潜在延长给药间隔方面与标准抗 VEGF 药物非劣效，并显示有望抑制黄斑萎缩的趋势。目前 III 期 STAR 试验正在推进中。此策略在全球范围内尚属领先且接近注册阶段。  备注：非头对头比较    IBI324（VEGF×Ang-2）    信达与合作伙伴Ollin Biosciences开发的IBI324（靶点VEGF×Ang-2）利用VHH结构提供了更高的摩尔效价，对Ang-2的结合力显著强于目前的SoC，在JADE研究中展现了极快的视网膜干燥速度。    备注：Roche 2025Q4报告从管线移除了RG6120，虽然RG6120和Vabysmo（已上市）的双靶点一样，但Vabysmo是标准的intrvitreal注射，RG6120可能更偏向工程化探索。 RC28-E（VEGF*FGF）     荣昌生物自主研发的双靶点融合蛋白药物，同时靶向VEGF和成纤维细胞生长因子（FGF）。其分子设计使其既能阻断 VEGF 与其受体结合，又能阻断 FGF 与受体的结合，从而在抗新生血管、抗渗漏及抗纤维化等病理通路上发挥协同效应。RC28-E 主要通过玻璃体内注射给药，用于湿性年龄相关性黄斑变性（wAMD）、糖尿病性黄斑水肿（DME）及糖尿病视网膜病变（DR）等适应症的治疗开发。    2025 年在 ARVO 会议公布的Ⅱ期临床数据显示，在 DME 患者中 RC28-E 能显著改善最佳矫正视力（BCVA）并降低中心视网膜厚度（CST），耐受性良好。基于随后开展的多中心 III 期随机对照研究，RC28-E 的中国 生物制品上市许可申请（BLA）已于 2025 年下半年获中国药监中心受理（针对 DME 适应症），并计划于 2026 年中提交 wAMD 适应症的 BLA，显示其临床开发进展已进入关键注册阶段。参天制药已获得大中华区及东南亚部分国家/地区的开发与商业化权利，以加速该药的全球布局。三、2026年全球眼科市场主要玩家矩阵 • 跨国巨头（MNC）梯队：以罗氏（Roche）、再生元（Regeneron）和艾伯维（AbbVie）为首，凭借成熟的抗VEGF药物（靶点VEGF）布局和全球商业化能力占据主导地位。 • 领军Biotech梯队： • Annexon（核心资产ANX007，靶点C1q）； • EyePoint（核心资产DURAVYU，靶点VEGF）； • Kodiak Sciences（核心资产KSI-101，靶点VEGF×IL-6；KSI-501，靶点VEGF×IL-6），依托ABC生物偶联平台布局多靶点管线； • Oculis（核心资产Privosegtor，靶点SGK pathway），在细分创新领域形成技术壁垒。 • 中国创新力量：以信达生物（IBI302，靶点VEGF×补体；IBI324，靶点VEGF×Ang-2；IBI311，靶点IGF-1R）、明慧医药（MHB018A，靶点IGF-1R）和橙帆医药（OLN102，靶点TSHR×IGF-1R）为代表，在双抗、纳米抗体、多靶点阻断等领域实现差异化突破。四、重点管线数据透视  • ANX007 (靶点C1q，C1q抑制剂)：ARCHER II数据显示，每月给药组（EM）在中心凹亚型中，BCVA损失超过15个字母的比例仅为7.7%，而对照组为27.6%。 • Privosegtor (SGK激活剂)：ACUITY研究中，3mg/kg/day剂量组实现了平均18个字母的视力改善相比对照组，且有效降低了神经丝轻链（NfL）水平。 • KSI-101（靶点VEGF×IL-6）：APEX研究（Phase 1b）随访至第20周数据显示，单次注射后CST下降达157微米，5mg和10mg剂量组超90% MESI患者达到完全无积液状态，超50%患者视力提升≥15个字母；目前Phase 3 PEAK/PINNACLE研究招募加速。 • OCU400（靶点NR2E）：两年的随访中，9名可评估患者中有100%实现了视功能稳定或改善，LDNA改善>lux。 五、眼科新药开发核心信息（部分代表) 六、第四增长曲线：基于组织稳态与神经再生的新药候选 随着抗VEGF药物（靶点VEGF）、双靶点药物（如KSI-101，靶点VEGF×IL-6）与补体抑制类药物（如ANX007，靶点C1q）路径逐步进入边际收益递减区间，眼科创新正在出现一条尚未被充分定价、但已具备明确证据基础的“第四增长曲线”。其共同特征在于：并非以短期解剖学改善为核心，而是尝试在细胞存活、神经功能或组织稳态层面改变疾病长期结局。 6.1 已进入临床/人体试验阶段的新 Modality 1. OpRegen（靶点无明确单一靶点，RPE细胞替代疗法） • 生物学机制：通过移植分化成熟的异体RPE细胞，直接替代GA导致的失能细胞，从源头恢复视网膜支持系统。 • 现有证据等级：已完成Phase 1/2a研究；CTS 2025公布的36个月数据显示，在广泛覆盖病灶的患者中，BCVA平均增益达+9个字母，且OCT证实了视网膜外层结构的持续稳定。 • 未来3-5年读出窗口：目前正在进行的Phase 2a GAlette研究（NCT05626114）将验证功能改善信号在更大样本中的可重复性。 2. BI 1584862（靶点无明确单一靶点，口服磷脂调节剂） • 生物学机制：针对GA相关的炎症反应并旨在保护视网膜血管功能。作为一种口服小分子，它能同时干预双眼病灶，极大降低患者的治疗负担。 • 活跃度：2026年将是Phase 2 JADE研究的关键节点，结果将决定其是否进入全球Phase 3注册临床。 3. RNAi（以OLX10212为代表，靶点为驱动AMD病理进展的炎症因子相关mRNA） • 生物学机制：通过序列特异性沉默靶mRNA，下调驱动AMD病理进展的炎症因子（如IL-6、TNF-α等）。 • 现状：已进入Phase 1临床试验，玻璃体内给药的安全性和耐受性获得初步验证。6.2 Pre-IND/具备强临床前证据的新靶点 1. SARM1 / NMNAT2（靶点SARM1/NMNAT2，程序性轴突死亡通路） • 生物学机制：SARM1是轴突退行的核心执行分子。该通路在视网膜神经节细胞与光感受器退行中被多次验证。 • 当前活跃度：核心资产如Nura Bio的SARM1抑制剂NB-4746（靶点SARM1）目前处于临床1期阶段（主要适应症为肌萎缩侧索硬化、多发性硬化等）。由于其具备广谱神经保护潜力，眼科适应症（如青光眼、GA）的IND推进备受行业关注。 2. Ferroptosis（靶点无明确单一靶点，铁死亡通路） • 生物学机制：由铁依赖脂质过氧化驱动的细胞死亡方式。RPE与光感受器对该过程高度敏感，被认为是GA与糖尿病视网膜病变（DR）中的重要终末病理通路。七、2026年眼科上市成功率 (PoS) 资产排序分析 本部分根据2026年1月的最新监管状态、临床进度及机制验证程度，对核心资产的上市成功率（Probability of Success, PoS）进行排序：7.1 确定性 Tier 1：商业化与医保阶段（PoS: 100%） 1. IBI311 (SYCUME) / SYCUME®（靶点IGF-1R） • 状态：2025年中国获批，2026年1月1日正式执行医保目录（NRDL）。 • 分析：成功率已定格。作为国内首个获批的IGF-1R单抗，其商业化路径已完全打通。7.2 高确定性 Tier 2：后期关键临床阶段（PoS: 85%-95%） 2. OCU400（靶点NR2E，修饰基因疗法） • 状态：计划2026年上半年启动滚动BLA提交。 • 分析：极高。2年随访数据的稳健性及“突变无关”机制的逻辑自洽，显著降低了传统突变特异性基因疗法的机制风险。 3. MHB018A（靶点IGF-1R，皮下IGF-1R单抗） • 状态：中国Phase 3正在收集顶线数据，FDA已清关全球Phase 3。 • 分析：极高。IGF-1R靶点已获全球验证。MHB018A通过VHH技术改进给药方式，属于高PoS的成熟机制改良资产。7.3 验证路径 Tier 3：机制已验证或 BTD 认定资产（PoS: 70%-85%） 4. IBI324 / OLN324（靶点VEGF×Ang-2，VEGF×Ang-2双抗） • 状态：JADE Phase 1b随机头对头研究证明其解剖改善优于市场领军者Vabysmo，计划2026年启动全球Phase 3。 • 分析：机制已验证（Mechanism Validated）。VEGF×Ang-2组合已有成药先例。IBI324的PoS源于其纳米抗体结构实现的更高结合效价，开发风险显著低于纯新机制资产。 5. IBI302（靶点VEGF×补体） • 状态：多中心 II 期 nAMD 研究显示在改善 BCVA、缩减视网膜厚度及潜在延长给药间隔方面与标准抗VEGF药物非劣效，显示有望抑制黄斑萎缩趋势；III 期 STAR 注册性研究正在推进中。 • 分析：机制已验证（Mechanism Validated），结合VEGF Trap与CR1结构域实现双机制协同；临床注册进展及早期疗效稳定性使PoS在Tier 3合理定位。 6. Privosegtor / OCS-05（SGK激活剂） • 状态：2026年1月获FDA突破性疗法认定（BTD），启动PIONEER注册性研究。 • 分析：高。FDA的BTD认定提升了监管成功的确定性，且Phase 2提供的RNFL稳定数据提供了罕见的量化证据。 7.4 验证进行中 Tier 4：注册临床验证中（PoS: 50%-70%） 7. ANX007（靶点C1q）/ KSI-101（靶点VEGF×IL-6） • 状态：全球多中心Phase 3注册性临床进行中，2026年下半年读出顶线数据。 • 分析：中高。成功率取决于Phase 3大样本人群中Phase 2惊艳数据的复现程度。7.5 探索 Tier 5：早期临床或颠覆性 Modality（PoS: <50%） 8. BI 1584862（靶点无明确单一靶点，口服磷脂调节剂） • 分析：潜在大黑马。虽然处于Phase 2，但其“口服制剂”对GA管理的便捷性具有颠覆性意义，由于其口服、双眼同时干预的特性，具备潜在的差异化监管吸引力。 9. OpRegen（靶点无明确单一靶点，RPE细胞替代疗法）/ RNAi（以OLX10212为代表，靶点为驱动AMD病理进展的炎症因子相关mRNA） • 分析：探索性。OpRegen虽然表现出病灶逆转潜力，但手术复杂性是其商业化落地的最大变数。八、报告总结：2026年眼科研发的黄金法则 2026年的眼科研发已正式进入“四维集成”的新周期。成功的冠军资产必须在以下四个维度展现深度交织的能力： 1. 多靶点协同 (Multispecific Synergism)：破解单一靶点逃逸机制； 2. 长效化平台 (Longevity Platforms)：降低治疗负担，提升依从性； 3. 机制上游化与神经功能保护 (Upstream Neuro-Protection)：从源头干预病理进程； 4. 给药范式无创化 (Invasive-to-Convenient Transition)：优化患者治疗体验。 从抗VEGF时代的单一靶点突破，到如今多维度、跨模态的创新协同，眼科新药开发正站在技术主权重构的关键节点。中国创新力量与全球巨头的同场竞技，将持续推动治疗范式的迭代升级，为全球眼科患者带来更长效、更安全、更便捷的治疗选择。参考文献 1. ASND_JPM 2026_Press Release - Final - 2.20pm - Ascendis Pharma, accessed January 23, 2026, https://investors.ascendispharma.com/static-files/9fd7239c-9fe9-4a1e-b6bd-4fab1475814a 2. Ascendis Pharma Provides Business and Strategic Roadmap Update at 44th Annual J.P. Morgan Healthcare Conference | Nasdaq, accessed January 23, 2026, https://www.nasdaq.com/press-release/ascendis-pharma-provides-business-and-strategic-roadmap-update-44th-annual-jp-morgan 3. Minghui Pharmaceutical Announces FDA clearance of IND to Initiate …, accessed January 23, 2026, https://www.prnewswire.com/news-releases/minghui-pharmaceutical-announces-fda-clearance-of-ind-to-initiate-global-phase–trials-of-mhb018a-a-subcutaneous-single-domain-igf-1r-antibody-in-thyroid-eye-disease-302642063.html 4. US FDA clears Minghui Pharma’s IND application to begin global phase ? trials of MHB018A, a subcutaneous single-domain IGF-1R antibody, in thyroid eye disease - Pharmabiz.com, accessed January 23, 2026, https://www.pharmabiz.com/NewsDetails.aspx?aid=183058&sid=2 5. Oculis to Showcase Transformative Late-stage Pipeline in Neuro-ophthalmology and Ophthalmology at the 2026 J.P. Morgan Healthcare Conference, accessed January 23, 2026, https://investors.oculis.com/news-releases/news-release-details/oculis-showcase-transformative-late-stage-pipeline-neuro/ 6. Oculis Announces U.S. FDA Breakthrough Therapy Designation Granted to Privosegtor for Treatment of Optic Neuritis, accessed January 23, 2026, https://investors.oculis.com/news-releases/news-release-details/oculis-announces-us-fda-breakthrough-therapy-designation-granted/ 7. Follow-up data for Kodiak’s KSI-101 from the APEX study showed continued strengthening of clinical effect (≥90% of patients achieving absence of intraretinal and subretinal fluid) through week 20 in macular edema secondary to inflammation (MESI), accessed January 23, 2026, https://ir.kodiak.com/news-releases/news-release-details/follow-data-kodiaks-ksi-101-apex-study-showed-continued/ 8. New data for Kodiak’s KSI-101 from the APEX study reinforce its clinically meaningful vision gains and rapid retinal drying in macular edema secondary to inflammation (MESI), accessed January 23, 2026, https://ir.kodiak.com/news-releases/news-release-details/new-data-kodiaks-ksi-101-apex-study-reinforce-its-clinically/ 9. Innovent Biologics’ New Drug for Thyroid Eye Disease Granted Priority Review in China, accessed January 23, 2026, https://biopharmaapac.com/news/92/4785/innovent-biologics-new-drug-for-thyroid-eye-disease-granted-priority-review-in-china.html 10. Ophthalmology pipeline watch: Key trial results and PDUFA dates for Q1 2026, accessed January 23, 2026, https://www.ophthalmologytimes.com/view/ophthalmology-pipeline-watch-key-trial-results-and-pdufa-dates-for-q1-2026 11. Ocugen Reports Positive Two-Year Safety and Efficacy Results for OCU400 in Phase 1/2 Clinical Trial for Retinitis Pigmentosa | Nasdaq, accessed January 23, 2026, https://www.nasdaq.com/articles/ocugen-reports-positive-two-year-safety-and-efficacy-results-ocu400-phase-1-2-clinical 12. Ocugen’s Retinitis Pigmentosa Gene Therapy OCU400 Sustains or Improves Visual Function in 2-Year Follow-Up Data | CGTlive®, accessed January 23, 2026, https://www.cgtlive.com/view/ocugen-retinitis-pigmentosa-gene-therapy-ocu400-sustains-improves-visual-function-2-year-follow-up-data 13. ARCHER Study Supports ≥15-Letter Loss as Meaningful Endpoint in Dry AMD With GA, accessed January 23, 2026, https://retinalphysician.com/news/2025/archer-study-analysis/ 14. Innovent’s Partner Ollin Biosciences Announces Positive Topline Data with Superior Outcomes from a Randomized Head-to-Head Study of IBI324 Compared to Faricimab (Vabysmo®) in Diabetic Macular Edema and Wet Age-Related Macular Degeneration - PR Newswire, accessed January 23, 2026, https://www.prnewswire.com/news-releases/innovents-partner-ollin-biosciences-announces-positive-topline-data-with-superior-outcomes-from-a-randomized-head-to-head-study-of-ibi324-compared-to-faricimab-vabysmo-in-diabetic-macular-edema-and-wet-age-related-macular-dege-302655894.html 15. Ollin Biosciences Announces Positive Topline Data with Superior Outcomes from a Randomized Head-to-Head Study of OLN324 Compared to Faricimab (Vabysmo) in Diabetic Macular Edema and Wet Age-Related Macular Degeneration - FirstWord Pharma, accessed January 23, 2026, https://firstwordpharma.com/story/7048697 16. Retinitis Pigmentosa: Updated Treatment Options for 2026 - Eye Health Institute, accessed January 23, 2026, https://www.eyehealthinstitute.com/retinitis-pigmentosa-updated-treatment-options-2026 17. Kodiak Sciences Announces Recent Business Highlights and Third Quarter 2025 Financial Results, accessed January 23, 2026, https://ir.kodiak.com/news-releases/news-release-details/kodiak-sciences-announces-recent-business-highlights-and-third-0/ 18. IGF-1R Inhibitor IBI311 for the Treatment of Active Thyroid Eye Disease in Chinese Patients: The RESTORE-1 Randomized Clinical Trial - PubMed, accessed January 23, 2026, https://pubmed.ncbi.nlm.nih.gov/41066129/ 19. Innovent Announces First Patient Dosed in the Phase 3 Clinical Study (STAR) of Efdamrofusp Alfa (IBI302), a First-in-class Ophthalmic Anti-VEGF and Anti-Complement Bispecific Fusion Protein for the Treatment of Neovascular Age-related Macular Degeneration - PR Newswire, accessed January 23, 2026, https://www.prnewswire.com/news-releases/innovent-announces-first-patient-dosed-in-the-phase-3-clinical-study-star-of-efdamrofusp-alfa-ibi302-a-first-in-class-ophthalmic-anti-vegf-and-anti-complement-bispecific-fusion-protein-for-the-treatment-of-neovascular-age-rel-301950190.html 20. Minghui Pharma Secures FDA IND Clearance to Launch Global Phase 3 Trials of MHB018A in Thyroid Eye Disease - BioPharma BoardRoom, accessed January 23, 2026, https://www.biopharmaboardroom.com/news/56/4127/minghui-pharma-secures-fda-ind-clearance-to-launch-global-phase-3-trials-of-mhb018a-in-thyroid-eye-disease.html