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AUSTIN, Texas, Nov. 20, 2025 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: As late-stage biotech pipelines mature, fair-value remeasurements under U.S. Generally Accepted Accounting Principles (GAAP) are emerging as critical indicators of tangible scientific and commercial progress. These revaluations provide a financial bridge between laboratory breakthroughs and shareholder value, offering investors a clearer picture of how innovation becomes measurable enterprise worth. Oncotelic Therapeutics Inc. (OTCQB: OTLC) (profile) exemplifies this shift as the company prepares for a significant fair-value remeasurement of its 45% stake in joint venture (JV) entity GMP Bio, driven by a new independent valuation https://nnw.fm/5K7hg indicating a potential step-up in asset value. This key shift strengthens Oncotelic Therapeutics position in the oncology space as the company works to make a difference, along with other innovative leaders such as IO Biotech Inc. (NASDAQ: IOBT), Novartis AG (NYSE: NVS), Bicara Therapeutics Inc. (NASDAQ: BCAX) and Pfizer Inc. (NYSE: PFE) The JV’s newly estimated valuation of approximately $1.7 billion has added value to the partnership.With 45% ownership in GMP Bio, Oncotelic’s proportional implied asset value stands at approximately $765 million. The valuation is closely tied to progress in the Oncotelic’s Deciparticle(TM) nanomedicine platform, including Sapu-003, injectible Everolimus (Afinitor(R))Fair-value remeasurement under U.S. GAAP has become increasingly relevant for development-stage biopharmaceutical companies.Taken together, the valuation step-up, maturing clinical programs and forthcoming fair-value remeasurement illustrate a company moving from scientific promise to financial recognition. Click here to view the custom infographic of the Oncotelic Therapeutics editorial. New Valuation Signals Evolving Market Confidence Oncotelic and GMP announced their venture in 2022, but the JV’s newly estimated valuation of approximately $1.7 billion, based on an independent third-party analysis conducted by Frost & Sullivan (Hong Kong), has added value to the partnership. The valuation reflects continued research and development (R&D) advances in clinical programs governed by GMP Bio, including development of OT-101, an RNA therapeutic candidate targeting TGF-β for oncology indications. According to the company, based on Oncotelic’s 45% ownership interest, this valuation represents an illustrative potential value to the company of approximately $765 million; the valuation is nonbinding, forward looking and does not represent fair value under U.S. GAAP. “This represents one of the most significant milestones in Oncotelic’s history,” said Oncotelic CEO Dr. Vuong Trieu. “The independent valuation recognizes the multiyear scientific and clinical progress achieved through our GMP Bio joint venture and affirms the long-term potential of OT-101 and our Deciparticle nanomedicine platform.” Pipeline Milestones The company recently outlined additional meaningful progress in clinical development and regulatory strategy across its pipeline, reinforcing a trend toward late-stage maturation. Oncotelic’s pipeline includes multiple late-stage programs targeting oncology and rare diseases, with several drug candidates achieving significant key milestones. Those milestones include the following: OT-101 (TGF-β inhibitor): Phase 3 for pancreatic cancerOXi4503 (vascular disrupting agent): Phase 2 acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), advancing toward pivotal phase 3 designCA4P/Fosbretabulin: Late-stage oncology asset currently under repositioningAL-101 (intranasal apomorphine): phase 2 for Parkinson’s disease and sexual dysfunctionsAL-102 (oligonucleotide antisense via intrathecal injection): Discovery stage for Alzheimer’s diseasePediatric rare disease programs: Targeting orphan indications with the potential to generate Priority Review Vouchers (PRVs)Nanomedicine Deciparticle pipeline: Advancing multiple 505(b)(2) drug candidates into clinical testing, leveraging the 505(b)(2) pathway—a faster and more cost-efficient route to market approval compared to a full New Drug Application (NDA). “OTLC has achieved steady progress across multiple programs, strengthening our position as a late-stage biotech with broad value creation potential,” said Oncotelic chair and CEO Dr. Vuong Trieu. “Our pipeline addresses multibillion-dollar markets with high unmet medical need.” The growing market credibility of nanomedicine Deciparticle technologies further contextualizes this valuation. Global nanomedicine revenue is projected to exceed $350 billion by 2032, driven by oncology applications, improved therapeutic index and targeted delivery methodologies. This expanding economic footprint underscores why platforms such as GMP Bio’s Deciparticle(TM) nanomedicine engine may command substantially greater valuation premiums as clinical translation advances. This valuation milestone illustrates how capital markets are beginning to quantify and price biotech innovation earlier in the drug-development lifecycle, narrowing the traditional gap between scientific progress and accounting recognition. Strategic Stake with Transformational Potential With 45% ownership in GMP Bio, Oncotelic’s proportional implied asset value stands at approximately $765 million. This illustrative estimate does not yet represent U.S. GAAP-recognized value, but it sets the stage for a substantial potential balance-sheet expansion when the company completes an ASC-compliant valuation process. “If the forthcoming ASC-compliant valuation supports a carrying value materially higher than the amount currently reflected on balance sheet, Oncotelic may recognize an increase in the reported value of its minority interest in GMP Bio in future reporting periods,” the company stated. “Any such adjustment would be recorded in accordance with U.S. GAAP fair-value measurement standards and could result in a meaningful increase to total assets and shareholders’ equity. The magnitude and timing of any accounting impact will depend entirely on the conclusions of the independent valuation and applicable accounting guidance.” The importance of minority-interest remeasurement has expanded as joint venture and platform-licensing models become more common in biotech. For investors, such metrics provide an improved lens for comparing therapeutic enterprise value relative to peers in immuno-oncology, RNA therapeutics, and advanced drug delivery. Advancing Nanomedicine from Trials to Markets The valuation is closely tied to progress in the Oncotelic’s Deciparticle nanomedicine platform, including Sapu-003, an intravenous reformulation of oral everolimus (Afinitor) designed for full bioavailability and improved tumor penetration. The company recently confirmed advancement toward first-in-human clinical trial evaluation in Australia for metastatic breast cancer. The technology aims to address the well-documented challenges of targeted drug delivery, as nanoparticles have demonstrated capacity to overcome systemic and cellular barriers that limit therapeutic efficacy. “Nanoparticles have transformed contemporary medicine by improving bioavailability, targeting and drug release mechanisms,” reported Science Direct. “Traditional drug delivery methods typically exhibit minimal therapeutic efficacy due to rapid elimination, inadequate solubility and systemic toxicity. The distinctive physicochemical characteristics of nanoparticles provide targeted drug distribution to specific areas, reducing harmful consequences.” The company previously announced that Sapu-003 will deliver full bioavailability relative to oral everolimus, which is currently marketed as Afinitor for multiple cancers indications. Beyond Sapu-003, GMP Bio and Oncotelic plan expanded clinical development for OT-101 in pancreatic and other solid tumors, with potential biomarker-driven selection strategies. As nanomedicine approaches commercial inflection, platforms with robust IP protection and scalable manufacturing infrastructure, such as GMP-certified facilities, may benefit from accelerated licensing and co-development demand. Accounting That Reflects Real Progress Fair-value remeasurement under U.S. GAAP has become increasingly relevant for development-stage biopharmaceutical companies, particularly those relying on joint ventures and IP licensing rather than wholly owned pipelines. The Accounting Standards Codification governing fair-value reporting (ASC 820) permits changes in fair value to be recognized when supported by credible independent valuation evidence, subject to audit and reporting requirements. The recent revaluation may create a clearer alignment between scientific progress and enterprise valuation, addressing long-standing investor challenges in measuring early-stage biotech asset appreciation. Unlike traditional milestone-driven accounting, fair-value recognition enables investors to assess relative progress across candidates, modalities and clinical development stages. This approach supports an evolution toward more transparent biotechnology finance where value attribution more closely matches real-world medical and regulatory progression. Patent-Backed Platform Built for Scaling Taken together, the valuation step-up, maturing clinical programs and forthcoming fair-value remeasurement illustrate a company moving from scientific promise to financial recognition. And perhaps the most compelling signal of long-term potential lies not only in what has been built so far, but in what this platform can enable next, particularly as Oncotelic prepares to leverage its technology and intellectual property across additional partnerships. The company’s CEO, Dr. Vuong Trieu, holds 75 issued patents and filed more than 500 total patent applications. IP assets form the cornerstone of potential future collaborations, licensing models and joint venture structures. IP-anchored nanomedicine platforms have historically drawn significant partner interest, with notable precedent-setting transactions in lipid nanoparticle delivery, such as mRNA vaccine platforms, and antibody-drug conjugates. Oncotelic’s structure allows for selective codevelopment strategies, enabling shared risk while maintaining economic exposure to platform-driven therapeutic opportunities. With GMP Bio reportedly assessing a potential Hong Kong Stock Exchange IPO in late 2026, the company may benefit from expanded access to capital markets that have shown increasing appetite for advanced oncology and drug-delivery technologies. Oncotelic’s anticipated fair-value remeasurement for its GMP Bio stake is more than an accounting development; it represents a broader shift in how public markets measure the value of biotech innovation. As the JV’s valuation reaches a potential $1.7 billion, these adjustments may offer investors a clearer financial link between bench-side invention and real commercial potential. With a maturing nanomedicine pipeline, expanding intellectual-property estate, and increasing clinical momentum, Oncotelic stands as an example of how scientific progress, financial reporting transparency and shareholder value creation can converge. Advances in Oncology Research Accelerate New Treatment Paths New developments in cancer research are driving momentum across the oncology landscape, with novel immunotherapies, next-generation cell therapies and late-stage clinical results offering promising signs for patients and clinicians. Recent data presentations, regulatory milestones and trial initiations highlight the expanding potential of targeted treatments designed to address both solid tumors and complex immune-related diseases. IO Biotech Inc. presented new preclinical data for its next vaccine candidate, IO112, and additional candidate, IO170, at the Society for Immunotherapy of Cancer’s 40th Annual Meeting. “This new data is extremely important for our development path as it points toward more potential indications for our novel, immune-modulatory therapeutic vaccines to treat patients with a range of cancers,” said IO Biotech CEO and president Mai-Britt Zocca. “We look forward to advancing our cancer immunotherapy pipeline and expect to file an Investigational New Drug Application for IO112, our next candidate expected to enter clinical development, in 2026.” Novartis AG announced positive results from KALUMA, a phase 3 study for new malaria treatment KLU156 (ganaplacide/lumefantrine, or GanLum). The novel nonartemisinin antimalarial, which was developed with Medicines for Malaria Venture, met the study’s primary endpoint of noninferiority to the current standard of care. The trial studied 1,688 adults and children across 34 sites in 12 African countries, with GanLum given as a sachet of granules once a day for three days. Additional analysis indicated the treatment was highly effective against mutant malaria parasites associated with partial drug resistance. Bicara Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab. The designation is for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. Pfizer Inc. and Astellas Pharma U.S. Inc. are reporting final overall survival results from its phase 3 EMBARK study. The study evaluated XTANDI(R) (enzalutamide), in combination with leuprolide and as monotherapy, in men with nonmetastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis. According to the report, XTANDI plus leuprolide reduced the risk of death by 40.3% compared to leuprolide alone, making this the first and only androgen receptor inhibitor-based regimen to demonstrate an OS benefit in nmHSPC with high-risk BCR. As innovation continues to advance, transformative oncology platforms are moving closer to delivering more personalized and effective treatment options. The progress reflected in new vaccine programs, cell therapy trials, regulatory designations and survival data underscores a rapidly evolving field focused on improving outcomes and reshaping standards of care for patients worldwide. For more information, visit Oncotelic Therapeutics Inc. 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前文内容，请点击以下链接: 天然产物衍生药物的临床开发与审批现状综述(2014-2025) 3. 感染性疾病领域天然产物衍生药物临床评估进展 天然产物（NPs）在新一代抗感染药物的研发中始终发挥着关键作用。然而，尽管临床需求紧迫且耐药性威胁日益加剧，大型制药公司却已缩减甚至放弃了抗感染药物的开发投入。 抗菌药物研发进展明显放缓，尤其针对革兰氏阴性菌（G-ve）的药物研发陷入停滞90–92，其中商业回报不足是导致这一领域萎缩的重要原因93–95。 目前，抗菌药物的创新重任主要落在： 中小型生物技术公司（部分公司如Achaogen、Tetraphase虽成功获批新抗生素却因收入不足而倒闭） 公私合作项目及非营利性倡议 与此同时，间接作用型抗菌药和生物制剂等非传统手段逐渐成为新的研发方向90,96–99，例如： 直接或间接作用的噬菌体、蛋白质、微生物及单克隆抗体（mAbs）； 通过毒力抑制、耐药性缓解、肠道菌群重建或增强宿主免疫力以清除感染的间接作用制剂。 相比之下： 抗真菌药物创新仍十分有限，近几十年来仅有少数新类别进入临床或获批49,100； 抗病毒药物研发因应对SARS-CoV-2等新发病毒威胁而较为活跃，但多数成果仍局限于特定病毒，广谱抗病毒药物的需求持续存在101； 抗寄生虫药物研发管线也相对薄弱，突破性疗法寥寥无几102,103。 本文在第3.1节（表4）中详述处于临床试验阶段的NP与NP-D类抗菌药物，并在第3.2节（表5）中讨论抗寄生虫、抗病毒及抗真菌候选药物。 表4 截至2024年12月31日处于临床试验阶段的NP和NP-D抗菌化合物（按年份排序） 注释说明： a 如果抗生素类别与先导化合物不同时标注 b 同时作为抗真菌药物进行临床试验（详见第3.3节） c 结构未公开 缩写词解释： ABSSSI：急性细菌性皮肤及皮肤结构感染 CABP：社区获得性细菌性肺炎 cUTI：复杂性尿路感染 PJI：假体周围关节感染 TB：结核病 表5 截至2024年12月31日处于临床试验阶段的NP和NP-D抗寄生虫、抗病毒和抗真菌化合物（按年份排序） 注释说明： a Q-格里菲辛为天然产物（NP），通过直接分离（I）工艺生产 b 反式藏红花素同时开展肿瘤学相关临床试验 c HRS9432由福建圣迪制药开发，江苏恒瑞医药参与 d PL-18同时具有抗菌活性研究缩写说明： NP：天然产物；NP-D：天然产物衍生物；SS：半合成；TS：全合成；I：直接分离 ARDS：急性呼吸窘迫综合征；COVID-19：2019冠状病毒病 3.1 抗菌药物 那氟霉素（Nafithromycin, 3.01，WCK 4873） 酮内酯类抗生素 III期临床试验完成 药物类别：酮内酯类抗生素，具有广谱抗菌活性104–106。 研发单位：印度Wockhardt Limited。 研发进展：在印度完成一项针对社区获得性细菌性肺炎（CABP）的III期临床试验（CTRI/2019/11/021964）107。2025年1月2日（略超出本综述截止日期），Wockhardt宣布那氟霉素在印度获批用于CABP治疗108。 抗菌肽药物开发（江苏普莱医药生物技术有限公司） 培西加南（Peceleganan, 3.02，PL-5, V681） 抗菌肽 III期临床试验完成 结构特征：26聚体α螺旋抗菌肽，为天蚕素A与蜂毒肽B的杂交肽109,110。 研发进展：完成一项针对皮肤伤口感染的III期临床试验（ChiCTR2100047202）111。正在开展另一项III期试验（ChiCTR2300071255）评估其伤口感染疗效。已向中国国家药品监督管理局（NMPA）提交伤口感染的上市申请。同时开展II期临床试验（NCT06189638）评估其对糖尿病足感染的治疗效果112。 PL-18（3.03） 抗菌肽 Ib/II期临床试验 结构特征：15聚体α螺旋抗菌肽，源自幽门螺杆菌核糖体蛋白L1（RpL1）的N端序列109,110,113。 研发进展：完成一项针对细菌性阴道病（栓剂给药）的I期临床试验（NCT05340790）。目前正在进行一项Ib/II期临床试验（CTR20232467），评估其对单纯性外阴阴道念珠菌病的疗效。 扎洛加南（Zaloganan, 3.04，PLG0206，WLBU2） 抗菌肽 I期临床试验完成 药物类别：24聚体抗菌肽（AMP），灵感来源于具有广谱抗菌活性的人源抗菌肽LL37114–117。 抗菌谱：对革兰阳性菌（G+ve）、革兰阴性菌（G-ve）及生物膜均有抑制作用。 研发进展：完成一项针对假体周围关节感染（PJI）的I期临床试验（NCT05137314），采用术中局部冲洗给药118。完成一项静脉给药的I期试验（ACTRN12618001920280）。CARB-X近期宣布支持开发3.04的缓释制剂，用于治疗骨折相关感染119。 HRS-8427（结构未公开） 头孢菌素衍生物 III期临床试验 药物类别：头孢地尔（cefiderocol, 2.23）衍生物120–122。 研发单位：江苏恒瑞医药。 研发进展：正在进行一项针对复杂性尿路感染（cUTI）的III期临床试验（NCT06569056）。头孢地尔（2.23，第2.1节）为一种通过整合铁载体增强细胞摄取的头孢菌素类抗生素，2019年首次获批用于cUTI治疗123,124。 贝那培南（Benapenem, 3.05） 碳青霉烯类 II/III期临床试验完成 药物类别：静脉用碳青霉烯类抗生素，结构与厄他培南相关。 研发进展：2020年5月在中国完成一项针对cUTI的II/III期临床试验（NCT04505683）125,126。上海医药集团于2021年获得授权，其2023年年报中将3.05列为在研项目127。 桑费曲南酯（Sanfetrinem cilexetil, 3.06，GV-104326） 三环碳青霉烯类 II期临床试验 药物类别：合成三环碳青霉烯类（三环类）抗生素的前体药物128,129。 研发历史：1990年代已完成针对呼吸道感染的II期临床试验，后因商业考量暂停开发130。2022年5月启动一项早期杀菌活性（EBA）II期试验（NCT05388448）131。 拓展方向：目前已有其他研究关注β-内酰胺类药物在结核病治疗中的重新定位132,133。 利福斯替尼唑（Rifasutenizol, 3.07，TNP-2198） 杂合分子 III期临床试验完成 药物类别：利福霉素-甲硝唑杂合分子134。 研发单位：天恩医药（TenNor）。 给药特性：口服给药，无全身性吸收。 研发进展：近期完成一项III期临床试验（NCT05857163），联合雷贝拉唑和阿莫西林用于治疗幽门螺杆菌感染患者135。 利法喹嗪酮（Rifaquizinone, 3.08，TNP-2092，CBR 2092） 杂合分子 II期临床试验完成 药物类别：利福霉素-喹啉嗪杂合分子（先导化合物ABT-719，具氟喹诺酮类特性）136–138。 研发单位：天恩医药（TenNor Therapeutics）。 适应症与进展： 静脉给药：已完成针对革兰阳性菌急性细菌性皮肤和皮肤结构感染（ABSSSI）的II期试验（NCT03964493）。已完成针对假体周围关节感染（PJI）的II期试验（NCT04294862）。计划开展上述两适应症的III期临床试验139。 口服给药：正在评估用于肝硬化肝性脑病（I/II期，NCT06135675）及腹泻型肠易激综合征（I期）的治疗。 作用机制：通过杂合结构双靶点作用——RNA聚合酶（利福霉素组分）及DNA旋转酶/拓扑异构酶IV（喹啉嗪酮组分）137。 乌普加南（Upleganan, 3.09，EVER206，SPR206） 多粘菌素类似物 I期临床试验完成 药物类别：多粘菌素类似物。 研发合作： 美国Spero Therapeutics 大中华区、韩国及部分东南亚地区：Everest Medicines 其他地区：辉瑞欧洲（Pfizer Europe） 适应症：多重耐药革兰阴性菌感染。 研发进展：已完成四项I期临床试验（NCT03792308、NCT04868292、NCT04865393、ChiCTR2200056692）140–142。计划开展II期临床试验。 MRX-8（结构未公开） 多粘菌素类似物 I期临床试验完成 药物类别：多粘菌素类似物，为通过极性酯键连接脂肪酸尾链形成的"软性"前体药物，水解后生成活性代谢物MRX-8039（3.14）143–145。 研发单位：MicuRx。 研发进展：已完成两项I期临床试验（NCT04649541、CRT20221866）147。专利US9971394中化合物34（3.15）为代表性实例146。 BRII-693（3.10，QPX-9003，F365） 合成多粘菌素衍生物 I期临床试验完成 药物类别：合成多粘菌素衍生物，由莫纳什大学研究人员发现148。 适应症：铜绿假单胞菌和鲍曼不动杆菌感染。 研发进展：Qpex制药（现为盐野义子公司）于2022年7月完成I期试验（NCT04808414）。全球开发权已授权给Brii Biosciences公司149。 ASK0912（3.11，多粘菌素S2，IMB-0912） 天然多粘菌素 I期临床试验进行中 药物类别：天然多粘菌素类抗生素。 安全性优势：与多粘菌素B和E相比，肾细胞毒性和急性毒性较低150。 临床前研究：在鲍曼不动杆菌小鼠模型中显示出良好的体内活性151。 研发单位：江苏奥赛康药业。 研发进展：已完成一项I期试验（CTR20222379）122,152。另一项I期试验（CTR20243311）正在进行中。 齐法环素（Zifanocycline, 3.12，KBP-7072） 四环素衍生物 I期临床试验完成 药物类别：氨甲基环素类四环素衍生物，为蛋白质合成抑制剂，具有广谱抗菌活性153–155。 研发单位：KBP BioSciences。 研发进展：已完成四项I期临床试验（最近一项为NCT05507463）。 EBC-1013（3.13） 非传统抗菌药 I期临床试验 药物来源：为替吉拉诺替酯（tigilanol tiglate, 3.14，第7.1节）的半合成衍生物156–158。 研发单位：QBiotics。 适应症与进展：正在开展I期临床试验（ACTRN12624000544572），评估其促进下肢静脉溃疡伤口愈合的潜力156。为目前唯一进入临床试验阶段的非传统NP-D类抗菌药物。同步开发用于犬、马等动物的急慢性伤口管理。 作用机制： 作用于细菌细胞壁，导致革兰阳性菌与革兰阴性菌细胞壁通透性增加 通过靶向胞外聚合物基质破坏已形成的生物膜 激活免疫细胞产生活性氧（ROS）156 临床前研究：在糖尿病慢性伤口小鼠模型中，3.13可提高宿主防御肽表达、调节细胞因子水平、激活免疫细胞并加速伤口愈合156。 RG6436（GGDC-0829，结构未公开） 芳基霉素衍生物 I期临床试验 药物类别：芳基霉素（arylomycin）衍生物159–161。 研发单位：基因泰克（罗氏）。 作用靶点：芳基霉素（如arylomycin A-C16, 3.15）为链霉菌来源的SPase抑制剂162,163。SPase（信号肽酶）通过水解分泌蛋白N端信号肽，对细菌生存和毒力至关重要164–166。RG6436特异性抑制大肠杆菌I型信号肽酶LepB167。 研发进展：正在开展I期临床试验（ISRCTN18049481），开发为静脉制剂用于复杂性尿路感染（cUTI）治疗。 相关候选药物：另一芳基霉素LepB抑制剂RG-6319（结构未公开）已完成两项I期试验（ISRCTN15259645、ISRCTN16073754），但后续开发已中止，资源集中于RG6436168。 3.2 抗寄生虫、抗病毒及抗真菌药物 依莫赛普（Emodepside, 3.16，BAY 44-4400） 抗寄生虫药 II期临床试验 药物类别：PF1022A的双吗啉衍生物。 研发单位：被忽视疾病药物研发计划组织（DNDi）。 应用背景：自2005年起与吡喹酮联用治疗猫、狗寄生性线虫感染169。 临床进展： 正在进行针对类圆线虫（Strongyloides stercoralis）的II期试验（NCT06373835） 盘尾丝虫病的II期试验（NCT05180461）170–172 已完成针对人鞭虫（Trichuris trichiura）、钩虫（NCT05017194）及单独钩虫感染（NCT05538767）的II期试验173 母体化合物PF1022A：1992年首次从Rosellinia属真菌中报道174，对鸡蛔虫有体内活性，但对细菌、酵母及其他真菌无体外活性175–177。 作用机制： 主要激活SLO-1钾通道178,179 与latrophilin受体相互作用180,181 导致虫体麻痹及GABA能传递调节182 格里菲辛（Griffithsin） 抗病毒蛋白 I期临床试验完成 药物来源：从新西兰红藻Griffithsia sp.中分离的121个氨基酸凝集素。 抗病毒谱：对HIV、2型单纯疱疹病毒及丙型肝炎病毒具有皮摩尔级抑制活性。 作用机制：通过结合病毒颗粒表面高甘露糖寡糖末端的甘露糖残基，引发聚糖交联，抑制病毒入侵185,186。 研发进展： 路易斯维尔大学开发了鼻喷剂型（Q-格里菲辛，含M78Q突变以提高氧化稳定性） 已完成两项用于COVID-19预防的I期试验（NCT05437029、NCT05122260）187 早期I期试验（NCT02875119）评估其与卡拉胶联用预防性传播感染的潜力，安全性良好188 生产优势：可通过重组表达系统生产183,184。 沙比沙布林（Sabizabulin, 3.17，VERU-111，ABI-231） 抗病毒/抗肿瘤 III期临床试验完成 药物类别：康普瑞汀A4（combretastatin A4, 3.18）结构启发类似物189。 研发单位：Veru Inc。 临床进展： 2022年中完成一项针对COVID-19高危急性呼吸窘迫综合征（ARDS）患者的III期试验（NCT04842747）；中期分析显示较安慰剂组绝对死亡率降低24.9%190 后续开发将取决于资金与合作临床需求 曾评估用于转移性去势抵抗性前列腺癌治疗191，但一项III期试验（NCT04844749）于2023年因战略原因中止 作用机制： 通过结合微管蛋白秋水仙碱位点破坏微管聚合，导致快速分裂细胞周期停滞与凋亡189 可干扰冠状病毒S蛋白分布，阻碍病毒颗粒胞内运输、组装与复制192,193 藏红花素（Transcrocetin, 3.19） 抗病毒/ARDS治疗 II期临床试验完成 药物来源：黄色脱辅基类胡萝卜素，源自栀子（Gardenia jasminoides）与藏红花（Crocus sativus）等植物194。 生物合成：通过玉米黄质酶切及醛基还原生成195–197。 临床进展： Leaf4Life开发的脂质体制剂（LEAF-4L6715）已完成COVID-19相关ARDS的I/II期试验（NCT04378920）198 一项III期试验（NCT06640777）已注册但尚未启动 其钠盐制剂由Diffusion Pharmaceuticals（现属CervoMed）开展COVID-19的II期试验（NCT04573322）200，但后续开发似已中止 作用机制：通过降低血浆粘度并改变水分子结构，增强氢键形成，促进氧扩散梯度下的氧输送效率194,199。 SF001（3.20，AM-2-19） 抗真菌药 I期临床试验 药物类别：两性霉素B的N-1,3-二羟丙基-2-酰胺衍生物201,202。 研发单位：Elion Therapeutics。 临床进展： 正在开展静脉制剂I期试验，评估治疗侵袭性曲霉病潜力 口服剂型亦在评估中 安全性优势：两性霉素B的人肾毒性与其胆固醇提取作用相关；3.20通过选择性增强麦角固醇提取能力，在小鼠及人原代肾细胞中显示肾脏保护特性203–205。 HRS9432（结构未公开） 抗真菌药 II期临床试验 药物类别：阿尼芬净（anidulafungin）衍生物121。 研发单位：福建新cadia制药。 临床进展：正在开展II期试验（NCT06194201），评估治疗念珠菌血症和/或侵袭性念珠菌病。 相关药物：其他棘白菌素类药物如瑞扎芬净（rezafungin, 2.35）已于2023年获批（第2节）48。 SCY-247（3.21） 抗真菌药 I期临床试验启动 药物类别：第二代Fungerp类抗真菌药49,206–208，为真菌来源三萜烯芬净（enfumafungin, 3.22）衍生物209。 研发单位：Scynexis。 临床进展：2024年12月宣布启动针对侵袭性真菌感染的I期试验（ACTRN12624001393549、ACTRN12624001392550）210。 同类首创新药：伊布雷沙芬净（ibrexafungerp, 2.30）作为首个Fungerp类药物于2021年获批（第2节）47,49。 待续 广州凯美科信息技术有限公司是一家以化学信息学软件为核心业务的企业。公司成立于2019年10月，竭诚为国内医药、化工、食品等领域用户提供高质量的化学信息学软件解决方案和技术服务。作为加拿大ACD/Labs公司在国内的合作伙伴，我们在化合物结构鉴定、化学信息管理、色谱方法开发、化合物成药性评价、药物分子设计、分子模拟等方面累积了丰富的服务经验，并且得到广泛好评。 产品包括(点击查看详情)： ✅ 化合物波谱解析系列   ✅ 化合物成药性预测 ✅ 化合物性质预测系列   ✅ 色谱方法开发系列 ✅ 实验室化学信息管理 —————————————————— ✅ 智能解析｜👉 [申请核磁/质谱解析软件演示]✅ 疑难攻坚｜📩 [提交疑难数据，获取专家支援]✅ 购买升级｜💼 [单位采购/版本更新/技术培训] 📢 联系我们：▔▔▔▔▔▔▔▔▔▔▔🧑 产品经理｜胡炽文📲 电话/微信｜18680221948📮 服务邮箱｜hcw@chemico.com.cn🌍 官网直达｜www.chemico.com.cn 扫码咨询