更新于：2024-12-12

Trabedersen

更新于：2024-12-12

概要

研发状态

概要

基本信息

药物类型

ASO

别名

TGF-beta antisense、Trabedersen (INN/BAN)、A-12009 FREE ACID

+ [6]

靶点

TGF-β2

作用机制

TGF-β2抑制剂(转化生长因子β2抑制剂)

治疗领域

肿瘤神经系统疾病消化系统疾病+ [4]

在研适应症

黑色素瘤胰腺癌胰腺导管腺癌+ [5]

非在研适应症

结直肠癌新型冠状病毒感染多形性胶质母细胞瘤+ [5]

原研机构

Isarna Therapeutics GmbH

在研机构

Oncotelic Therapeutics, Inc.

Isarna Therapeutics GmbH

Oncotelic, Inc.

非在研机构

财团法人生物技术开发中心

Autotelic, Inc.

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评罕见儿科疾病 (美国)、孤儿药 (美国)

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序列信息

Sequence Code 29532696

来源: *****

关联

项与 Trabedersen 相关的临床试验

NCT05425576 / Not yet recruiting临床2期

Phase 2 Trial of TGF-β Inhibition (OT-101) With Anti-PD-1 (Pembrolizumab) in Patients With Malignant Pleural Mesothelioma (MPM) Failing to Achieve or Maintain Response to Checkpoint Inhibition

This is a study of OT-101, a TGF-b2 inhibitor in combination of pembrolizumab in patients with malignant pleural mesothelioma. Both efficacy assessment, and safety and tolerability of various dose of OT-101 in combination of pembrolizumab are evaluated.

开始日期2025-06-01

申办/合作机构

Oncotelic Therapeutics, Inc.

NCT06579196 / Not yet recruiting临床1/2期IIT

Evaluation of Trabedersen (OT-101) With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1

The goal of this clinical trial is to: 1) evaluate the safety and recommended dose of the drug OT-101/Trabedersen when combined with Pembrolizumab and 2) determine the efficacy of the combination therapy in adults with certain types of Non-Small Cell Lung Cancer. The main question(s) it aims to answer are:
* What medical problems to participants have when taking OT101 together with Pembrolizumab?
* What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy?
* Does the combination therapy delay progression or relapse of the participant's Non-Small Cell Lung Cancer?
Participants will:
* Receive intravenous OT-101/Trabedersen for 4 days once every 2 weeks. Clinic visits are required to receive and disconnect the infusion.
* Receive intravenous Pembrolizumab once every 6 weeks.

开始日期2025-01-01

申办/合作机构

University of Nebraska

NCT06079346 / Recruiting临床2/3期

A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer

The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.

开始日期2024-05-01

申办/合作机构

Oncotelic Therapeutics, Inc.

100 项与 Trabedersen 相关的临床结果

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100 项与 Trabedersen 相关的转化医学

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100 项与 Trabedersen 相关的专利（医药）

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项与 Trabedersen 相关的文献（医药）

2023-01-01·Methods in molecular biology (Clifton, N.J.)

Visualization of Differentiated Cells in 3D and 2D Intestinal Organoid Cultures.

Article

作者: Sato, Toshiro ; Sugimoto, Shinya ; Hanyu, Hikaru

The intestinal epithelium maintains self-renewal and differentiation capacities via coordination of key signaling pathways, including the Wnt, bone morphogenetic protein (BMP), epidermal growth factor (EGF), and Notch signaling pathways. Based on this understanding, a combination of stem cell niche factors, EGF, Noggin, and the Wnt agonist R-spondin was shown to enable the growth of mouse intestinal stem cells and the formation of organoids with indefinite self-renewal and full differentiation capacity. Two small-molecule inhibitors, including a p38 inhibitor and a TGF-beta inhibitor, were added to propagate cultured human intestinal epithelium but at the cost of differentiation capacity. There have been improvements in culture conditions to overcome these issues. Substitution of the EGF and a p38 inhibitor with insulin-like growth factor-1 (IGF-1) and fibroblast growth factor-2 (FGF-2) enabled multilineage differentiation. Monolayer culture with mechanical flow to the apical epithelium promoted the formation of villus-like structures with mature enterocyte gene expression. Here, we summarize our recent technological improvements in human intestinal organoid culture that will deepen the understanding of intestinal homeostasis and diseases.

2022-05-01·Matrix biology : journal of the International Society for Matrix Biology1区 · 生物学

Corneal fibroblast collagen type IV negative feedback modulation of TGF beta: A fibrosis modulating system likely active in other organs

1区 · 生物学

Review

作者: Sampaio, Lycia Pedral ; Hilgert, Guilherme S L ; Wilson, Steven E ; Shiju, Thomas M

Collagen type IV (COL IV) is a major component of basement membranes (BM) in all organs. It serves functions related to BM organization and modulates the passage of growth factors from one tissue compartment to another. COL IV binds transforming growth factor (TGF) beta-1 and TGF beta-2 and, therefore, is a major modulator of TGF beta pro-fibrotic functions. After fibrotic corneal injury, TGF beta enters into the stroma from the tears, epithelium, endothelium and/or aqueous humor and markedly upregulates COL IV production in corneal fibroblasts in the adjacent stroma far removed from BMs. It is hypothesized this non-BM stromal COL IV binds TGF beta-1 (and likely TGF beta-2) in competition with the binding of the growth factors to TGF beta cognate receptors and serves as a negative feedback regulatory pathway to mitigate the effects of TGF beta on stromal cells, including reducing the developmental transition of corneal fibroblasts and fibrocytes into myofibroblasts. Losartan, a known TGF beta signaling inhibitor, when applied topically to the cornea after fibrotic injury, alters this COL IV-TGF beta pathway by down-regulating COL IV production by corneal fibroblasts. Non-BM COL IV produced in response to injuries in other organs, including the lung, skin, liver, kidney, and gut, may participate in similar COL IV-TGF beta pathways and have an important role in controlling TGF beta pro-fibrotic effects in these organs.

2019-12-17·Current pharmaceutical design4区 · 医学

Therapeutic Potential of Targeting Transforming Growth Factor-beta in Colorectal Cancer: Rational and Progress

4区 · 医学

Review

作者: Hassanian, Seyed M ; Khorrami, Shadi ; Avan, Amir ; Gachpazan, Meysam ; Ferns, Gordon A ; Khazaei, Majid ; Kashani, Hoda

Background::

Colorectal cancer (CRC) is one of the most common types of cancer and is associated with an increasing rate of mortality. Transforming Growth Factor-Beta (TGF-β) is often upregulated in CRC, and appears to play an important role in regulating cell proliferation, migration, immune surveillance, apoptosis, cell differentiation, drug-resistance and many cellular processes that may be involved in CRC, and therefore underscores its potential value as a therapeutic target in the treatment of CRC. An increased expression of the TGF- β pathway has been associated with poor prognosis in several cancer types, including CRC.

Methods::

Here, we describe the critical role of the TGF-β pathway in CRC as well as the preclinical and clinical investigations on TGF-β inhibitors, with particular emphasis on recent findings with small-molecule inhibitors in CRC. Several TGF-β inhibitors (e.g., Trabedersen, Galunisertib, Gradalis, PF-03446962, NIS793) have been generated over the past decade for targeting this pathway.

Results::

There is accumulating evidence of the therapeutic potential of this and other TGF-β inhibitors for the treatment of other malignancies. These inhibitors might be used in combination with chemotherapy as well as with other biological agents, in order to overcome different resistance mechanisms. However, further studies are needed to identify determinants of the activity of TGF-β inhibitors, through the analysis of genetic and environmental alterations affecting TGF-β and parallel pro-cancer pathways.

Conclusion::

These studies will be critical to improving the efficacy and selectivity of current and future anticancer strategies targeting TGF-β.

项与 Trabedersen 相关的新闻（医药）

2024-11-09

·药渡

肿瘤微环境中的免疫抑制性细胞因子

来源：小药说药前言癌细胞表观遗传学和生长动力学的改变导致细胞外分泌多种细胞因子，这些细胞因子控制免疫细胞的活性，使其有利于肿瘤生长。其中，免疫调节细胞因子的分泌是招募免疫抑制细胞的主要因素。肿瘤微环境中的免疫调节细胞因子招募其他免疫抑制细胞，并负责效应免疫细胞的表型和功能转换，使其支持肿瘤的发展。表型转换的免疫细胞进一步提高免疫抑制细胞因子的水平，并使肿瘤环境抵抗抗肿瘤免疫细胞的活性。其中MDSCs、TAMs、Treg和Breg细胞是调节性细胞因子的主要来源。在广泛的免疫抑制细胞因子中，IL-10、TGF-β、IL-4和IL-35在多种癌症的肿瘤环境中占主导地位，主要负责免疫抑制。这些细胞因子改变先天性和适应性免疫细胞的命运，并调节癌细胞的生长和增殖能力。同时，免疫抑制细胞因子也改变了幼稚免疫细胞的表观基因组和转录网络，有利于免疫抑制细胞谱系的形成。此外，这些细胞因子可以直接作用于细胞毒性CD8+T细胞或自然杀伤（NK）细胞，并抑制其效应器功能和增殖。 IL-10 IL-10是一种多功能的免疫抑制细胞因子，具有免疫调节和血管生成功能。IL-10由癌细胞和几种免疫细胞分泌，包括髓系和淋巴细胞。已有证据表明IL-10具有促进肿瘤和抑制肿瘤的双重功能。一方面，IL-10通过下调癌细胞和APC上的MHC表达来抑制细胞毒性T细胞活化，从而阻止抗原特异性T细胞识别癌细胞。另一方面，高剂量的IL-10可增强CD8+T细胞的增殖及其细胞毒性活性。某些炎性细胞因子和条件可能会促进组织损伤和肿瘤发生，IL-10可以抑制这些炎症状态，从而防止随后的肿瘤发生。最近的研究表明，基于西妥昔单抗的IL-10融合蛋白（CmAb-IL10）通过阻止树突状细胞介导的肿瘤浸润性CD8+T细胞凋亡，显示出强大的抗肿瘤作用。CmAb-IL10与免疫检查点阻断剂的联合应用显示，晚期肿瘤小鼠的抗肿瘤免疫力得到明显改善。因此，有必要根据具体癌症类型和患者亚群的具体情况，通过抑制或促进IL-10通路来评估潜在的治疗干预。 TGF-β TGF-β作为一种免疫抑制细胞因子，通过不同的机制对免疫应答产生广泛的抑制作用。TGF-β降低Th1、Th2细胞和细胞毒性T淋巴细胞（CTL）的分化和功能，所有这些都提供重要的抗肿瘤反应。此外，TGF-β还通过调节Treg细胞的数量和功能，增强免疫耐受和肿瘤逃避。TGF-β通过抑制或刺激细胞增殖来调节免疫细胞的命运，从而影响胸腺和外周T细胞的发育。 TGF-β在TME中起着双重作用，这是由于肿瘤发展的不同阶段和基因改变背景决定的。在早期肿瘤中，TGF-β途径可诱导细胞凋亡并抑制包括癌细胞在内的细胞增殖。矛盾的是，在晚期，它通过调节基因组不稳定性、EMT、新生血管生成、免疫逃避和转移，具有促肿瘤作用。当促肿瘤功能压倒细胞中TGF-β信号的抗肿瘤作用时，它将以一致的方式作为肿瘤促进剂发挥作用。尽管有许多因素增加了TGF-β信号转导的复杂性，但在肿瘤治疗中TGF-β信号靶向药物显示出了强大的活性。这些特异性或非特异性药物包括靶向TGF-β受体的小分子、反义寡核苷酸、疫苗、中和抗体以及受体IgG-Fc融合蛋白。 Galunsertib（LY2157299）是第一个进入临床试验的小分子阻断剂，它抑制TGF-βRI激酶。在一项1/2期临床试验中，与安慰剂吉西他滨相比，Galunisertib联合吉西他滨治疗PAC患者的OS明显改善。TEW-7197是另一种TGF-βRI激酶抑制剂。 GC-1008（fresolimumab）是一种能中和TGF-β所有亚型的人源单克隆抗体。M7824（Bintrafusp-alfa）是一种由抗PD-L1的抗体和TGF-βRII分子的胞外段组成的双功能分子，可以“捕获”在TME中的TGF-β。ABBV-151影响TGF-β主动释放的复杂过程是另一种治疗干预手段。抗GARP抗体ABBV-151阻断其与LAP的结合显著减缓乳腺癌细胞系的肺转移。 Belagenpumatucel-L（Lucanix）是一种治疗性、基因修饰的异基因肿瘤细胞疫苗，用于NSCLC，抑制TGF-β2 mRNA的产生。虽然针对NSCLC的3期试验没有达到预定的临床终点，但额外的分析表明在患者亚群中取得了令人鼓舞的结果，在一线化疗结束后12周内随机使用Lucanix治疗的患者中，观察到OS的显著增加。Trabedersen（ap12009）是TGF-β2基因mRNA区域的反义互补物，通过下调TGF-β2 mRNA发挥抑制作用。在一项2期研究中，与标准化疗治疗相比，使用10 mM trabedersen治疗的复发/难治性晚期胶质瘤患者的2年生存率更高。 IL-4 IL-4主要作用于Th2细胞的谱系特异性分化和体液免疫反应的调节。除嗜碱性粒细胞和肥大细胞外，IL-4主要由Th2细胞通过自分泌信号分泌。IL-4在肿瘤微环境中发挥着多种作用，并具有免疫抑制和抗肿瘤活性。研究表明，在结肠癌和乳腺癌小鼠模型中，阻断IL-4可减少特定肿瘤微环境中免疫抑制M2表型和MDSCs的生成，并改善肿瘤特异性CD8+T细胞反应。此外，阻断IL-4可提高抗OX40免疫治疗的反应性。在非小细胞肺癌小鼠模型中进行的类似研究表明，阻断IL-4可通过肿瘤抗原特异性树突状细胞增加IL-12的生成，从而增强效应T细胞的浸润和增殖，并减轻肿瘤负担。此外，在间变性甲状腺癌（ATC）小鼠模型中，IL-4的缺失可增强抗肿瘤免疫和总体存活率，且无任何明显毒性。研究表明，IL-4是一个新的治疗靶点，阻断可以减少肿瘤诱导的免疫抑制，提高传统癌症治疗的疗效。因此，与其他免疫抑制性细胞因子类似，IL-4是肿瘤发生和转移的关键调节因子，可能单独或与当前有效治疗癌症患者的治疗方案相结合，是一个有吸引力的免疫治疗靶点。 IL-35 与IL-10、TGF-β和IL-4相比，IL-35是一种异二聚体且相对较新发现的细胞因子，属于IL-12家族细胞因子，由p35和EBi3亚单位组成。IL-35已被证明在良性和恶性肿瘤的发展中发挥重要作用，包括肝细胞癌、晚期乳腺癌、胰腺导管腺癌、非小细胞肺癌和前列腺癌。此前，已有研究证明IL-35主要由Tregs产生，近年来，肿瘤细胞中IL-35的表达逐渐得到证实。在体内，IL-35通过增强其他细胞因子的分泌，如IL-6和G-CSF（粒细胞集落刺激因子），促进肿瘤生长、进展和转移。IL-35还抑制多种细胞因子，包括IFN-γ，以实现促肿瘤效应。积累的数据表明，IL-35可以参与TME中恶性肿瘤细胞与周围免疫细胞之间的相互作用，诱导免疫抑制环境并限制有效抗肿瘤免疫反应的参与。随着多种IL-35+免疫细胞类型如M1 TAM和DC的发现和分离，目前的证据表明，肿瘤源性IL-35广泛参与不同细胞环境的促肿瘤特性，可能是通过抑制肿瘤浸润淋巴细胞（TIL）浸润和效应细胞增殖。总的来说，恶性肿瘤细胞以及周围基质细胞产生的IL-35有助于肿瘤微环境内的免疫抑制，从而支持肿瘤的持续生长和转移小结细胞因子在决定肿瘤发生命运的肿瘤免疫微环境中起着至关重要的作用。这些免疫抑制细胞因子限制抗肿瘤免疫细胞的增殖和效应功能，改变其可塑性，并将其转化为抑制表型。由于受限制的渗透或缺乏效应免疫细胞，导致免疫检查点抑制剂无法发挥最佳效果。因此，靶向或消耗这些细胞因子具有显著的临床益处。几种细胞因子在肿瘤发生中发挥免疫抑制作用，具体取决于肿瘤类型和肿瘤免疫环境。最近的多项研究显示，IL-10、TGF-β、IL-4和IL-35，这些细胞因子在限制抗肿瘤免疫和肿瘤生长进展中发挥重要作用。阻断IL-10、TGF-β、IL-4和IL-35等免疫抑制性细胞因子可能在使肿瘤对常规和免疫疗法敏感方面发挥显著的效果，从而激活抗肿瘤免疫，并控制肿瘤发生。参考文献： 1.Tumorpromoting roles of IL-10, TGF-β, IL-4, and IL-35: Its implications in cancerimmunotherapy. SAGE Open Med. 2022; 10: 20503121211069012. 2. Roles ofTGF-β signaling pathway in tumor microenvirionment andcancer therapy. Int Immunopharmacol. 2020 Oct 21;89(Pt B):107101. 3. IL-35 Regulatesthe Function of Immune Cells in Tumor Microenvironment. Front Immunol. 2021;12: 683332. 药渡媒体商务合作媒体公关 | 新闻&会议发稿张经理：18600036371（微信同号）点击下方“药渡“，关注更多精彩内容免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇

免疫疗法

2024-11-06

·GlobeNewswire-Health Care

ONCOTELIC CLINICAL PRESENTATIONS AT SITC 2024

AGOURA HILLS, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) announced today its presentation at SITC 2024. Dr. Cynthia Lee, VP of R&D will be presenting Sapu Bio pipeline of TGFB2 therapeutics. For additional information please go to: https://www.sitcancer.org/home. Dr. Lee has been leading our R&D programs for the past several years including the buildout of our GMP facility in San Diego. The presentations are: Abstract Number 198: TGFB2 mRNA levels prognostically interact with Interferon-alpha receptor activation of IRF9 and IFI27, and makers for tumor-associated macrophages impacting overall survival in PDAC. Authors Sanjive Qazi, Cynthia Lee, Vuong Trieu Abstract Number 218: Evaluating the prognostic impact of Transforming growth factor beta 2 mRNA levels, in conjunction with Interferon-gamma receptor activation of IRF5 and expression of CD276/B7-H3 in low-grade gliomas. Authors Sanjive Qazi, Anthony Maida, Vuong Trieu Abstract Number 1444: Meta-analysis comparing the incidence of serious adverse events, overall survival, and progression-free survival in PDAC patients harboring unresectable tumors treated with mFOLFIRINOX or FOLFIRINOX. Authors Vuong Trieu, Sanjive Qazi, Seymour Fein, Anthony Maida, Tenshang Joh About Oncotelic Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma (“DIPG” through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia (through OXi 4503). Oncotelic acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, 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, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. Oncotelic’s first in class TGFB2 therapeutic to treat pancreatic cancer and glioblastoma is being developed through its JV – Sapu Bio. Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future clinical trials, the reporting of clinical data for the Company’s product candidates and the potential use of the Company's product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and upon granting of approval by the regulatory agencies, the successful marketing of the products; building and the success of our nanoparticle platform and the related success of launching the platform, the development of the Company’s AI suite including but not limited to AI Chatbots, the public access to the Company’s AI suite, the success of the development of the AI suite or any other AI technologies and whether if any or portion thereof the Company’s AI suite or technologies will be commercialized and launched for sale. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements or may not occur at all. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, taking the Company or its affiliates through initial public offerings. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company's Annual Report on Form 10-K/A filed with the SEC on April 19, 2023 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether because of new information, future events, or otherwise. Contact Information: For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com

并购信使RNA

2024-11-01

·药智网

眼药新秀将产下百亿“金蛋”

在亿胜生物、兴齐眼药等这些老牌的国内眼药龙头面前，兆科眼科是年轻的后生。 2021年，兆科眼科携带25款眼科候选药以第二家眼药生物科技公司的身份成功登陆港交所，三年过去，虽然还未走出亏损泥潭，但兆科眼科依然在眼药赛道里辛勤耕耘，终于迎来了弯道超车的机会。 01 两年狂飙，猛攻“百亿首款药” 近日，兆科眼科宣布，旗下眼药候选物NVK002的III期临床试验（China CHAMP）取得积极的顶线结果，NVK002是一种用于控制儿童及青少年近视加深的试验性新型外用眼部溶液（采用了0.01%及0.02%的低剂量阿托品），这是继兴齐眼药的硫酸阿托品滴眼液之后，最受关注的一款阿托品近视防控在研新药。 2020年10月，兆科眼科从Nevakar手里引进了NVK002，拥有了NVK002在中国、韩国和东南亚地区开发和商业化的权益，之后便马不停蹄推进NVK002的研发，因为兆科眼科很清楚NVK002是所有候选物中最有可能成为“爆款”的产品。根据国家卫健委的最新数据，我国5岁以上人口中，近视患者已高达6亿，几乎是美国总人口的两倍，更令人担忧的是，青少年群体的近视率呈现逐年上升的趋势。调查显示，预计未来5-15岁群体近视患病率将达到77.42%，16-24岁群体甚至将高达94%。这一庞大且持续增长的目标人群，为近视防控市场提供了广阔的发展空间。据中金公司测算，2030年近视防控市场规模有望达约2100亿元，十年复合增速约13.7%。目前，近视矫正及预防措施主要包括框架眼镜、角膜接触镜、手术矫正以及药物治疗。药物治疗中的阿托品通过多种机制发挥作用，包括影响视网膜和后部巩膜的相关受体，以及通过胆碱能、G-蛋白等信号通路，在保持相对较好的近视控制效果的同时，不良反应较轻。目前阿托品滴眼液是唯一经过循证医学验证、能够有效延缓近视进展的药物，其显著的临床价值将颠覆过去以器械耗材为主的眼科市场。目前，低浓度阿托品(主要以0.01%为主)制剂产品已在新加坡、日本等近视发病率的较高国家上市，年平均使用成本约3000-4000元。若国内按照每年1500元成本(价格低于手术和角膜塑形镜成本的1/5)计算，阿托品制剂理论市场空间将高达1200亿元。千亿的近视防控蓝海市场，兴齐眼药捷足先登。今年3月，兴齐眼药0.01%硫酸阿托品滴眼液（SQ-729，商品名：美欧品）获NMPA批准上市，用于延缓儿童近视进展，成为国内首款上市的延缓儿童近视进展低浓度硫酸阿托品滴眼液。不出所料，美欧品上市之后兴齐眼药营收和净利大增，财报显示，兴齐眼药的滴眼剂业务在2024年上半年录得营收5.12亿元，同比增长62.97%，其中第二季度实现营收5.42亿元，环比增长54.89%，归母净利润1.35亿元，环比大增287.27%，主要就是美欧品火速“产奶”。目前，兴齐眼药正快速向全国铺设销售渠道，美欧品还在快速放量中，峰值远未到来，根据德邦证券相关数据，低浓度阿托品近视防控主要的儿童及青少年总数近1亿人，当前主流阿托品院内制剂的年费用约为3600元，预计美欧品能在上市的第3个完整年（2027年）达到销售峰值，达到101.8亿元。如今，兆科眼科经过两年的疯狂追赶，已经兵临城下，如若NVK-002顺利申报并获批上市，美欧品的市场独占期将被终结。 02 赛道拥挤，胜算大吗？除了兴齐眼药和兆科眼科，阿托品滴眼液的千亿市场外，还聚集了诸多玩家。德邦证券研究院数据显示，国内恒瑞医药、极目生物、参天制药、欧康维视等多家企业的相关产品已经进行到Ⅲ期临床阶段。图1 阿托品滴眼液部分在研情况图片来源：德邦研究院其中，恒瑞医药的HR19034滴眼液跑得较快，于2021年9月就已登记临床试验Ⅲ期，登记时间上领先兆科眼科2个月，该Ⅲ期试验为评估药物的有效性及安全性。治疗周期为144周（约3年），主要终点在内的多个临床终点设置在96周和48周，目前正在开展当中。另外，欧康维视的OT-101在2023年6月完成了III期国际多中心临床患者入组（2月份完成中国区入组），欧康维视设计了3+1的研究周期，临床预计2026H2或者2027年结束。 2023年11月，齐鲁制药也在Clinicaltrials.gov官网上登记了一项多中心、随机、开放、安慰剂对照的III期研究（NCT06151587），旨在评估不同浓度阿托品滴眼液（QLM3004）延缓儿童近视进展的疗效与安全性，预计将在2027年6月完成。国内不少企业的虎视眈眈，使得阿托品滴眼液赛道的竞争氛围拉满，作为第一家突围的企业，兴齐眼药也感受到压力，除推进美欧品快速放量，同时开发不同于美欧品的0.02%和0.04%硫酸阿托品滴眼液，近期，兴齐眼药宣布0.02%和0.04%硫酸阿托品滴眼液的III期临床已取得成功。显然，未来阿托品近视防控这个赛道竞争势必相当激烈，不过兆科眼科有取胜秘籍，因为NVK002的具有差异化优势，研究数据显示，NVK-002专有的剂型能够成功解决低浓度阿托品不稳定的问题，同时与美欧品目标年龄段仅为6-12岁、欧康维视生物的产品目标年龄段为3-15岁相比，NVK-002覆盖3至17岁儿童和青少年，是目前拥有最广泛的目标患者群体的一款阿托品滴眼液产品。此外，NVK-002所拥有的配方产品不含防腐剂，预计保存期至少为24个月，具备了更强的商业吸引力。如此看来，NVK-002颇有成为百亿级大单品的潜质。 03 结语当下，近视防控药物市场迎来黄金时代，随着首个产品上市及多个产品进入后期，国内阿托品滴眼液市场巨变的序幕已拉开，经过两年的狂奔，兆科眼科即将产下金蛋，催化业绩扭亏为盈指日可待。参考资料：《未来已来：市场潜力巨大，近视防控行业的黄金时代即将来临》大健康从业者联盟声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

财报上市批准临床3期医药出海

100 项与 Trabedersen 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
胰腺导管腺癌	临床3期	美国	Oncotelic Therapeutics, Inc.	2024-05-01
胰腺继发性恶性肿瘤	临床3期	美国	Oncotelic Therapeutics, Inc.	2024-05-01
黑色素瘤	临床3期	德国	Isarna Therapeutics GmbH	2016-08-29
胰腺癌	临床3期	德国	Isarna Therapeutics GmbH	2016-08-19
多形性胶质母细胞瘤	临床3期	美国	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床3期	阿根廷	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床3期	奥地利	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床3期	巴西	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床3期	加拿大	Isarna Therapeutics GmbH	2008-12-01
多形性胶质母细胞瘤	临床3期	法国	Isarna Therapeutics GmbH	2008-12-01

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04801017 (C001, Corporate Publications) 人工标引	临床2期	新型冠状病毒感染	32	Standard of Care+OT-101	夢齋齋繭積網憲艱獵顧(願廠簾窪鏇糧艱蓋廠憲) = 夢繭網夢夢網鑰鹽餘糧積蓋齋窪糧遞憲選獵廠 (構觸鑰襯憲醖憲廠衊網 ) 更多	积极	2021-11-23
NCT04801017 (C001, Corporate Publications) 人工标引	临床2期	新型冠状病毒感染	32	Standard of Care+Placebo	夢齋齋繭積網憲艱獵顧(願廠簾窪鏇糧艱蓋廠憲) = 願願鹹觸鏇顧製觸衊網積蓋齋窪糧遞憲選獵廠 (構觸鑰襯憲醖憲廠衊網 ) 更多	积极	2021-11-23
P-001 (AACR2016)	N/A	晚期胰腺腺癌三线	37	Trabedersen	觸鹽積壓遞觸衊繭鹹範(艱膚壓觸簾襯膚鏇製齋) = 壓壓壓夢衊餘廠膚繭鏇夢糧顧糧蓋襯鹽遞鏇齋 (遞憲遞網醖齋鑰繭蓋醖 ) 更多	积极	2016-07-15
P-001 (AACR2016)	N/A	晚期胰腺腺癌三线	37	Chemotherapy	艱糧簾糧餘齋遞淵築齋(壓顧襯淵築艱襯觸鑰蓋) = 鏇顧醖壓鏇齋襯蓋選簾願壓顧範網憲繭窪鹽構 (壓淵製衊窪範觸築範願 )	积极	2016-07-15
ASCO2012	临床1/2期	黑色素瘤 \| 结直肠癌 \| 胰腺癌	61	Trabedersen	齋鹹築簾顧獵齋醖齋窪(顧夢壓簾積獵選築夢醖) = 願鏇網齋醖夢壓齋鏇願醖廠鏇選膚鹹壓鑰壓壓 (艱壓襯鑰衊淵選蓋艱夢 ) 更多	-	2012-05-20
AACR2011	临床1/2期	肿瘤	33	Trabedersen	簾壓簾憲憲蓋壓顧窪選(憲遞壓簾憲願觸獵窪夢) = 觸鹹獵製窪築襯鑰鏇鏇製獵夢淵淵構醖衊襯艱 (築範顧築鹽製簾鏇鹹鑰 )	-	2011-04-15
ASCO2010	N/A	高级别胶质瘤	134	Trabedersen	觸廠夢願簾繭艱襯淵選(積廠構網獵夢獵築鹽鏇) = 積選鹽齋獵醖鹹醖選願齋鹽築構壓壓選選顧鬱 (簾醖窪壓襯壓選壓鹽鑰, 18.1 ~ ND)	-	2010-05-20
ASCO2010	N/A	高级别胶质瘤	134	Standard chemotherapy (TMZ/PCV)	觸廠夢願簾繭艱襯淵選(積廠構網獵夢獵築鹽鏇) = 憲齋鹽艱蓋襯醖膚夢繭齋鹽築構壓壓選選顧鬱 (簾醖窪壓襯壓選壓鹽鑰, 9.0 ~ 13.2)	-	2010-05-20
AP 12009-P001 (ASCO2008)	临床1/2期	黑色素瘤 \| 结直肠癌 \| 胰腺癌	17	AP 12009	淵窪鹹糧顧壓鑰積夢廠(艱襯壓鏇膚壓蓋築鏇壓) = 構顧鏇壓鏇襯網選鬱繭遞夢鹽憲觸艱襯獵蓋獵 (齋築獵憲遞鏇憲憲遞齋 ) 更多	-	2008-05-20
G004 (ASCO2008)	临床2期	星形细胞瘤	-	AP 12009 (10 μM)	衊築選襯鬱窪遞鬱鏇鑰(餘艱鏇簾壓獵願憲願襯) = 獵壓顧糧獵網網選積獵襯積鹹襯膚艱蓋壓糧衊 (鬱餘淵鹹膚鑰製窪鏇築 )	积极	2008-05-20
AP 12009-P001 (ASCO2007)	临床1/2期	黑色素瘤 \| 结直肠癌 \| 胰腺癌	17	AP 12009	觸淵遞糧繭鹹衊夢顧艱(襯獵選繭鑰網範艱鹽艱) = 繭觸製餘鏇鹽積繭糧鑰蓋壓築夢製選願鏇衊鏇 (鑰鏇淵築夢憲淵顧繭遞 )	积极	2007-06-20
ASCO2005	临床1/2期	胰腺癌	-	AP 12009	遞艱餘鹽廠餘鬱夢觸簾(製衊窪顧構衊鏇鏇窪夢) = 積鹹積糧範鏇範襯顧壓艱築積繭鏇顧鏇構觸廠 (網範觸網艱齋廠構糧夢 )	-	2005-06-01
ASCO2004	临床1/2期	高级别胶质瘤	24	AP 12009	壓鑰遞繭構襯觸製餘觸(範壓襯齋製觸鬱餘廠製) = In only 5 of the total 24 patients “possibly” related adverse events were observed, mostly of grade 1 or 2, one was classified as serious 餘窪淵廠鬱齋觸艱鑰選 (簾糧築願獵蓋憲製衊衊 )	积极	2004-07-15
ASCO2004	临床1/2期	高级别胶质瘤	24	Standard chemotherapy		积极	2004-07-15