Anselamimab

目录一、BD 与投融资二、临床与研发进展三、商业化合作与业绩四、会议预告 一、BD 与投融资 本窗口（8/26 全天 + 8/27 10:00 前）未见新的日本药企授权、合作、并购或投融资交易，此类动态暂无新增。 二、临床与研发进展 1. 中外製薬（Chugai，东证 4519）vamikibart 向日本 MHLW 提交上市申请 中外製薬 8/25 宣布已向日本厚生劳动省（MHLW）提交抗 IL-6 单克隆抗体 vamikibart 的上市申请，用于非感染性葡萄膜炎相关的葡萄膜炎性黄斑水肿（UME）。vamikibart（研发代号 RG6179 / RO7200220，由 Roche/Genentech 开发）为玻璃体内注射制剂，通过抑制白细胞介素-6（IL-6）这一眼部炎症关键细胞因子发挥抗炎作用；此前已于 6/23 获日本孤儿药资格，申报基于全球 III 期 MEERKAT 与 SANDCAT 研究。若获批，将成为日本首个用于该适应症的"抗 IL-6 抗体"疗法，提供非类固醇的局部眼部治疗选择。 值得关注：UME 现有治疗以皮质类固醇为主、长期安全性受限；IL-6 通路是眼科抗炎的新兴机制（同类机制在糖尿病黄斑水肿 DME 也在探索），Chugai 作为 Roche 日本主体主导开发，体现其在眼科炎症领域的差异化布局。 2. Belite Bio（NASDAQ: BLTE）tinlarebant 推进日本申报布局 PHARMA JAPAN 8/26 报道，美国临床阶段公司 Belite Bio 的口服疗法 tinlarebant（LBS-008）正借日本 Sakigake（先驱审查）资格加速本土路径。tinlarebant 为 RBP4（视黄醇结合蛋白 4）口服抑制剂，通过降低血液 RBP4 水平、减少维生素 A（视黄醇）进入视网膜，从而减少毒性产物（双视黄醇 bisretinoid）在眼内累积，用于治疗青少年 Stargardt 病（STGD1，ABCA4 基因突变所致的遗传性黄斑变性）及地图样萎缩（GA，晚期干性 AMD）；全球 III 期 DRAGON 研究（12–20 岁）已达主要终点，显著减缓病灶生长约 35%。公司计划 2026 上半年向 FDA 报 NDA，并在日本开展 DRAGON II（含 15 例日本受试者）以满足 PMDA 要求。 值得关注：STGD1 目前全球无获批疗法，tinlarebant 有望成为首个；日本 Sakigake 通道或使其较早可及。Belite Bio 为专注退行性视网膜疾病的美国临床阶段生物制药公司，官网 belitebio.com。 三、商业化合作与业绩 1. Biocon / Sandoz pegfilgrastim 生物类似药获日本 MHLW 批准 Biocon Biologics（印度）8/25 宣布其 pegfilgrastim 生物类似药获日本 MHLW 营销批准；该药为安进 Neulasta 的生物类似药，用于降低化疗所致中性粒细胞减少症（一种白细胞缺乏）的发生风险。产品由 Biocon 开发生产，日本市场由 Sandoz K.K.（诺华分拆的仿制药/生物类似药巨头日本法人）独家推广、销售与分销。 值得关注：日本肿瘤支持治疗（onco-supportive）生物类似药竞争升温；Neulasta 全球销售峰值曾超 50 亿美元，仿制药入场有望压低医疗成本、提升可及性，Sandoz 在日本 biosimilar 版图再下一城。 2. 日本 MHLW 专家分科会 8/26 审议 6 个新分子实体 + Leqembi SC PHARMA JAPAN 报道，日本 MHLW 专家分科会于 8/26 审议一批新药及新增适应症，包括：小野制药（Ono）的 Xcopri（cenobamate，钠通道抑制 + GABA_A 增强，抗癫痫，用于难治性部分性发作）、Lundbeck 的 Vyepti（eptinezumab，抗 CGRP 受体单抗，偏头痛预防）、Viatris 的 Wakix（pitolisant，H3 受体拮抗剂/反向激动剂，发作性睡病）、Alexion 的 gefurulimab 与 anselamimab、礼来（Lilly）的超长效胰岛素 efsitora alfa；另涵盖卫材/Biogen 的 Leqembi SC（lecanemab 皮下制剂，抗 β-淀粉样蛋白（Aβ）单抗，阿尔茨海默病）及 Uplizna（inebilizumab）更广标签。 值得关注：Leqembi SC 若获准，将把阿尔茨海默病给药从数小时 IV 输液缩短为皮下注射，大幅提升日本患者门诊可及性；Xcopri 为小野制药在日本补强癫痫治疗线（cenobamate 美国已上市、疗效突出但需监测不良反应）。 四、会议预告第85回日本癌学会 JCA2026 —— 9/24–26，京都・国立京都国際会館；日本最大级癌症学术与转化会议。インターフェックスWeek大阪 / 再生医療EXPO大阪 —— 9/30–10/2，インテックス大阪；制药制造技术与再生医疗商业化展示。BioJapan 2026 —— 10/7–9，パシフィコ横浜；日本最大级医药 BD/投融资对接会（partnering 为核心）。第64回日本癌治療学会 JSCO2026 —— 10/22–24，神戸；临床肿瘤治疗学会。BMB2026 —— 12/1–4，パシフィコ横浜；日本分子生物学会年会（含药物研发相关议题）。

Total net revenue increased 14% to $18.7 million for second quarter of 2026 compared to second quarter of 2025 Partnered programs continue to advance with Crystalys Therapeutics announcing its $130 million Series B financing to support the late-stage global development and commercialization preparation for dotinurad, and royalties generated from the launches of ZYCUBO® and UNLOXCYT™ MIAMI, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2026. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “The second quarter of 2026 reflected continued momentum across our portfolio and further progress in unlocking long-term shareholder value. Our subsidiary Urica Therapeutics, Inc.’s (“Urica”) equity position in Crystalys Therapeutics, Inc. (“Crystalys”) was strengthened by Crystalys' $130 million Series B financing, which will support the late-stage global development and commercialization preparation for dotinurad, a next-generation oral URAT1 inhibitor for gout, on which Urica is entitled to a 3% royalty on future net sales. Journey Medical also continues to scale Emrosi®, securing a third major GPO contract that expanded payer access to over 150 million commercial lives. Coming off the momentum of ZYCUBO®'s approval and the $205 million PRV sale in the first quarter, we enter the second half of 2026 with a favorable cash balance that positions us to continue executing on our pipeline and business development priorities.” Dr. Rosenwald added, “We continued to see encouraging clinical progress this quarter on our partnered programs. AstraZeneca reported additional prespecified subgroup analyses for anselamimab (formerly CAEL-101) showing a 62% improvement in survival and a 71% reduction in cardiovascular hospitalizations among kappa predominant light chain isotype patients in the CARES program, and indicated that it plans to submit these findings to regulatory authorities. Crystalys also continues to advance dotinurad's two global Phase 3 trials while initiating a new Phase 2 study in difficult-to-treat gout, broadening the program's potential patient population. With a diversified portfolio spanning commercial, late-stage, and development-stage programs, including royalties, milestones and equity, and a strengthened balance sheet following the ZYCUBO® PRV monetization, we believe Fortress is well positioned to advance strategic initiatives and drive long-term value for our shareholders.” Recent Corporate Highlights1: Commercial Portfolio Updates Clinical Updates Financial Results: About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income. The company has a portfolio of multiple marketed prescription pharmaceutical products and programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Fortress’ portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress’ model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Nationwide Children’s Hospital, Columbia University, Dana-Farber Cancer Center and Sentynl Therapeutics. For more information, visit www.fortressbiotech.com. Forward-Looking Statements Statements in this press release that are not descriptions of historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. The words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include risks relating to: our growth strategy, financing and strategic agreements and relationships; our need for substantial additional funds and uncertainties relating to financings; uncertainty related to the timing and amounts expected to be realized from future milestone, contingent value right, royalty or similar future revenue streams, if at all; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of product candidates under development; the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products for which we receive regulatory approval or receive royalties or other distributions from third parties; our ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Company Contact: Jaclyn Jaffe Fortress Biotech, Inc. (781) 652-4500 ir@fortressbiotech.com Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 tplohoros@6degreespr.com ___________________________ 1 This press release references products being developed or commercialized by Fortress, by Fortress’ private or public subsidiaries (referred to herein as “subsidiaries” or “partner companies”) and by entities with whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as “partners”). The words “we”, “us” and “our” may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context. Released August 13, 2026