Aflibercept

点击蓝字 关注我们 本 期 看 点 近日，绿叶制药集团控股子公司博安生物宣布，其自主研发的阿柏西普眼内注射溶液（商品名：博优景®）正式获得中国国家药监局批准上市。这是继2023年12月齐鲁制药的阿柏西普生物类似药获批后，国内第二个获批的同类产品。 包括新生血管性年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）在内的眼底疾病是严重的致盲性眼病。随着我国老龄化进程加快和糖尿病患病率上升，眼底疾病患者群体不断扩大，抗VEGF药物市场需求持续增长。 本期内容 01 生物类似药加速上市，原研药市场受冲击 02 信达生物双靶点创新药，临床优势显著 03 从康柏西普到IBI302，信达创始人的眼科情结 04 总结与展望 【01 生物类似药加速上市，原研药市场受冲击】 阿柏西普作为眼底病治疗的一线用药，原研药艾力雅®由再生元和拜耳共同开发，长期占据市场主导地位。然而，随着专利悬崖逼近，国产生物类似药纷纷布局，市场格局正在重塑。 齐鲁制药 2023年12月18日，齐鲁制药的阿柏西普生物类似药也获得国家药品监督管理局批准上市。阿柏西普是一种完全人源化的融合蛋白，通过抑制VEGF-A、VEGF-B和胎盘生长因子（PLGF）介导的信号通路，抑制血管增生和降低血管渗透性，广泛用于治疗新生血管性年龄相关性黄斑变性（湿性AMD）、视网膜静脉阻塞、糖尿病性黄斑水肿等眼底疾病。 齐鲁制药在阿柏西普生物类似药的研发中，充分发挥其在生物制剂领域的技术优势，确保产品在质量、疗效和安全性方面达到与原研药相当的水平，为患者提供更多可及的治疗选择。 博安生物 近日，博安生物的阿柏西普生物类似药“博优景®”获国家药监局批准，用于治疗湿性年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）。这是继齐鲁制药之后国内第二款获批的阿柏西普生物类似药。 研究显示，博优景®在质量、有效性和安全性方面与原研药高度相似，无临床意义上的差异。III期临床试验证实，其视力改善效果与原研药相当，且起效迅速、疗效持久。 博安生物已与欧康维视合作，由后者负责该产品在中国大陆的独家推广。同时，公司也积极布局海外市场，授权科兴医药在部分区域独家销售。 02 信达生物双靶点创新药，临床优势显著 在生物类似药抢占市场的同时，信达生物带来了更具创新性的治疗方案。2025年5月，信达生物公布了其全球首创VEGFR–CR1双靶药依莫芙普（IBI302）的II期临床数据。 研究结果显示，IBI302在132例nAMD患者中，视力改善效果非劣于阿柏西普，且超过80%患者可实现12周给药间隔，优于阿柏西普的8周方案。在抑制黄斑萎缩等解剖学指标上，IBI302也展现出显著优势。 IBI302作为一种重组人血管内皮生长因子受体和人补体受体1融合蛋白，具有双靶点作用机制，不仅抑制血管增生，还能调节补体系统，有望实现更全面的治疗效果。 信达生物已启动IBI302的III期全球多中心注册性研究，预计2026年可获得一线上市申请数据。同时，公司正在探索IBI302治疗糖尿病性黄斑水肿等其他眼底疾病的潜力。 【03 从康柏西普到IBI302，信达创始人的眼科情结】 信达生物在眼科领域的布局，与创始人俞德超博士的从业经历密切相关。俞德超曾主导康弘药业抗VEGF药物康柏西普的研发，该药于2013年获批上市，成为中国首个获批的抗VEGF融合蛋白药物。 后因专利与销售纠纷，俞德超离开康弘药业，于2011年创立信达生物。公司凭借PD-1抑制剂信迪利单抗在肿瘤免疫治疗领域快速崛起，如今又通过IBI302重返眼科赛道。 康柏西普作为国产明星产品，通过降价进入医保，年治疗费用显著低于阿柏西普，大大提升了患者可及性。如今，面对信达IBI302等创新疗法的挑战，康弘药业也需要继续寻求突破。 俞德超的“回归”，为中国眼底病治疗领域增添了新的变数。从康柏西普到IBI302，中国眼科创新药研发完成了从追随者到潜在引领者的转变。 04 总结与展望 随着生物类似药和创新药陆续进入市场，中国眼底病治疗领域正从“三国鼎立”走向“多强争霸”的局面。原研药、生物类似药、国产创新药同台竞技，最终受益的将是广大患者。 价格方面，生物类似药的上市将进一步拉低眼底病治疗的年费用，减轻患者经济负担。而创新药则通过更好的疗效和更长的给药间隔，提升治疗便利性和生活质量。 医保政策也将成为影响市场竞争的关键因素。随着更多药物纳入医保目录，眼底病治疗的可及性将大幅提高。 未来三到五年，中国眼底病治疗市场将经历快速变革。企业需要综合考虑产品疗效、价格策略、市场推广和医保准入等多重因素，才能在激烈竞争中脱颖而出。 ★

Created with Canva Dreamlab † Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected. One way or another, companies derailed by quality problems at a Novo Nordisk plant are edging toward solutions. An FDA reinspection of the facility offers Novo’s partners one path forward. Yet having suffered complete response letters due to the quality problems, Regeneron and Scholar Rock have already advanced efforts to end their reliance on the facility. The Bloomington, Indiana, site is one of three former Catalent facilities that Novo acquired for $11 billion last year as it tried to keep up with demand for its GLP-1 drugs. As a contract development and manufacturing organization (CDMO), Catalent had used the facility to provide fill/finish services to biopharma companies. Regeneron has received a series of complete response letters (CRLs) starting in 2023 because FDA inspectors found problems at the Indiana site. Scholar Rock received a CRL linked to the facility in September. The impact could be more widespread than those publicly disclosed rejections suggest. On an earnings call in late October, Regeneron CEO Leonard Schleifer said “the biggest companies in the world have had the same issue” at this and other fillers but kept quiet about the CRLs. With CRLs delaying approvals and the plant receiving an Official Action Indicated (OAI) classification in October, indicating an unacceptable state of compliance, Regeneron and Scholar Rock have stepped up efforts to craft paths to market that do not rely on the Indiana facility. On an earnings call in November, Scholar Rock CEO David Hallal said his team “accelerated our timelines for an additional vialer” after the OAI classification. While the biotech began looking into adding another U.S.-based fill/finish facility after Novo bought the Catalent facility, it pulled forward its plans in response to the OAI classification and CRL for its drug candidate apitegromab in spinal muscular atrophy (SMA). Manufacturing Violations at Novo’s Indiana Plant ‘Unacceptable,’ FDA Says Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could pose a problem for clients, including Regeneron and Scholar Rock. October 14, 2025 · 2 min read · Tristan Manalac Scholar Rock has secured commercial fill/finish capacity, a task Hallal said can be a lengthy process, from early 2026. The new provider successfully completed recent site inspections. Tech transfer is underway, the CEO said, and the team is aiming to include the site in an approval filing in 2026. BMO analysts raised the probability of success for apitegromab in SMA to 80% in response to the update. “As we have seen throughout 2025, the more biotech manufacturers can plan for unforeseen CMC issues, the less likely they are to face challenges with FDA approvals,” the analysts said. “Scholar Rock’s expedited transfer for this second fill finish acknowledges this reality and could provide comfort for investors who still are wary of another Catalent site reinspection.” The biotech took the actions despite Novo progressing toward a reinspection of the facility. Hallal said Novo representatives joined Scholar Rock at a meeting with the FDA in November and “detailed the progress they have made in implementing their remediation plan at the Bloomington facility.” The Novo team affirmed that they expect the facility to be ready for reinspection by the end of this year, Hallal said. Regeneron Brings Fill/Finish In-House Regeneron’s push to insulate itself from unforeseen CMC issues includes the construction of an in-house fill/finish plant. Schleifer said on the October call that the site is “ready to go, and we expect it to come online during the coming year.” A Regeneron spokesperson told BioSpace via email that the CEO was referring to a facility in Rensselaer, New York, that the company included in the $7 billion investment it unveiled in April. The spokesperson declined to answer questions about how many fill/finish lines will be active when the plant opens or about Regeneron’s plans for adding more lines over time. Schleifer was more forthcoming at a Morgan Stanley event in September, telling attendees that the facility will start with one line. Regeneron plans to take back some of the Dupixent filling that is currently handled by its partner Sanofi, he said, and over time, he expects to set up four lines to handle the company’s internal filling needs. While Regeneron is now on the cusp of lessening its reliance on third parties, analysts have questioned the company’s recent vulnerability to problems at CDMO partners. Schleifer addressed this concern on the October call, telling analysts that the company recognized it would “be more ideal if we could have our own filling” and explaining that efforts to add capacity were “delayed dramatically during COVID.” Adding back-up third-party sites has been a slow process too. “We’ve been working on backups for quite a long time now,” Schleifer said, explaining that “the FDA is very finicky about showing where you’re going to make the product, literally what equipment it’s going to touch. Then you have to do stability testing and . . . quality testing—all that for a given filler. That takes quite a bit of time, quite a bit of resources.” The time required to add fillers looked set to trigger another CRL for Eylea HD vials. Regeneron CFO Christopher Fenimore said at a Jefferies event on Nov. 17 that “if there is no compliant filler on the BLA, and really the only one that it could be at this point is Catalent, we would expect to get a CRL.” Two days later, however, Regeneron said the FDA had approved Eylea HD in macular edema after retinal vein occlusion and for monthly dosing across approved indications. In response to BioSpace ’s question about what changed between Fenimore’s comments and the FDA approval, a Regeneron spokesperson declined to elaborate beyond the press release announcing the approval. The press release lacks information on the production of Eylea HD, although it notes that Regeneron is still working with the ex-Catalent site to resolve issues that prevented the approval of a prefilled syringe product. BMO Capital Markets analysts said in a note to investors that the “approval comes as a welcome surprise as regulatory issues are starting to show signs of improvement.” Another test of whether Regeneron’s regulatory issues are improving is coming up, with the company planning to re approval of a prefilled Eylea HD syringe in January. The timing is tied to validating a new third-party filler. Manufacturing Novo-Acquired Catalent Plant Plagued by Unresolved Pest, Contamination Issues, FDA Finds Among the problems cited were cat hair, bacterial contamination and instrument defects. August 22, 2025 · 2 min read · Tristan Manalac Novo Contends With FDA Rejection While Regeneron and Scholar Rock can pivot away from the Indiana site, Novo’s $11 billion investment in the facility and two other plants gives the Danish drugmaker tighter ties. The Catalent purchase contributed to a 39% increase in cost of goods sold at Novo in the third quarter. Novo revealed a CRL for a multidose version of Wegovy in November. Asked via email if issues at the Indiana site were a factor in the CRL, a Novo spokesperson referred BioSpace to the company’s third-quarter earnings call. David Moore, executive vice president of U.S. operations at Novo, answered a question about the CRL on the earnings call without commenting on manufacturing. The company said in its third-quarter earnings report that the CRL provided “recommendations related to the co-existence of the multi-dose pen with the single-dose pen already on the market.” Novo added that it was addressing FDA’s feedback and would continue to engage with the agency on the application.