A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Bel-sar (AU-011) With Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors

The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with choroidal metastasis from breast or lung primary tumors.

开始日期2024-10-25

申办/合作机构

Aura Biosciences, Inc.

NL-OMON56767

/ Suspended临床3期

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma - AU-011-301-MD2

开始日期2024-04-01

申办/合作机构

Aura Biosciences, Inc.

NL-OMON56772

/ Suspended临床3期

开始日期2024-04-01

申办/合作机构

Aura Biosciences, Inc.

100 项与 Aura Biosciences, Inc. 相关的临床结果

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0 项与 Aura Biosciences, Inc. 相关的专利（医药）

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项与 Aura Biosciences, Inc. 相关的文献（医药）

2025-02-01·Advances in ophthalmology practice and research

Targeting ocular malignancies using a novel light-activated virus-like drug conjugate

Review

作者: Jager, Martine J ; Ossendorp, Ferry A ; Pinos, Elisabet de Los ; Huis In't Veld, Ruben V ; Ma, Sen

Background:

Targeted therapy is a promising approach to improve the treatment of tumors, including ocular malignancies. Current therapies, such as radiotherapy and surgery, often lead to serious damage to vision or to loss of the eye. New approaches have examined nanoparticles for use as targeted delivery vehicles for drugs. A newly-developed virus-like drug conjugate is a promising nanoparticle with a defined target: the novel virus-like particle-photosensitizer conjugate Belzupacap sarotalocan (Bel-sar, previous name AU-011).

Main text:

In this review, we summarize the application of this novel light-activated virus-like particle conjugate in pre-clinical and clinical studies and discuss its potential to treat ocular malignancies, such as uveal melanoma and conjunctival melanoma. We furthermore discuss the combination with immunotherapy and its application on pigmented and non-pigmented tumors as well as its effect on macrophage polarization, which is important to achieve effective results in immunotherapy.

Conclusions:

Belzupacap sarotalocan (Bel-sar) is a promising targeted drug carrier that enhances tumor-specific delivery and minimizes off-target effects. Its photodynamic therapy effectively treats pigmented and non-pigmented tumors while inducing immunogenic cell death through DAMP exposure, triggering local and systemic immune responses. Combining Bel-sar PDT with immunotherapy improves efficacy in preclinical models, warranting further clinical investigation.

2024-11-04·INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE

Treatment of Conjunctival Melanoma Cell Lines With a Light-Activated Virus-Like Drug Conjugate Induces Immunogenic Cell Death

Article

作者: Jager, Martine J. ; Ossendorp, Ferry A. ; Ma, Sen ; de los Pinos, Elisabet ; Huis In't Veld, Ruben V.

Purpose:

Conjunctival melanoma (CJM) is a rare malignant ocular surface tumor, which often leads to local recurrences and metastases. In murine models of subcutaneous tumors, treatment with a novel virus-like drug conjugate (VDC; Bel-sar) showed a dual mechanism of action with direct tumor cell killing as well as stimulation of an antitumoral immune response. Bel-sar is currently being evaluated for the treatment of primary uveal melanoma and indeterminate nevi in a phase III clinical trial. We determined whether Bel-sar also has direct antitumor efficiency and a potential immunostimulatory capacity in CJM cells.

Methods:

Three human tumor-derived CJM lines were used. Bel-sar's subcellular and intracellular locations were determined with tracers. Following light activation of Bel-sar, cytotoxicity and exposure of damage-associated molecular patterns (DAMPs) were assessed. Treated tumor cells were co-cultured with THP-1 derived macrophages to assess tumor-cell phagocytosis.

Results:

Bel-sar was bound and internalized by CJM cells and subsequently found in the cell membrane, lysosome, Golgi apparatus, and mitochondria. Bel-sar activation induced near complete cell death with half-maximal inhibitory concentration (IC50) values between 30 pM and 60 pM. Finally, light-activated Bel-sar enhanced exposure of DAMPs, including calreticulin, heat shock protein 90, and stimulated phagocytosis by macrophages.

Conclusions:

Treatment with a novel VDC (Bel-sar) induced pro-immunogenic cell death in all three CJM cell lines. The in vitro cytotoxicity was accompanied by exposure of DAMPs, suggesting Bel-sar is a potential treatment for CJM by a dual mechanism of action. This dual mechanism may provide a targeted and direct killing of tumor cells and induce an immune response which might decrease local recurrences and metastasis.

2024-09-01·Drug Research

Cerebroprotective Potential of Andrographolide Nanoparticles: In silico and In vivo Investigations

Article

作者: Gajula, Somasekhar ; Dintakurthi, Prasanth Sree Naga Bala Krishna ; Rudrala, Lakshmi Charitha ; Sirisha Mulukuri, N.V. L. ; Singh, Gagandeep ; Pasala, Praveen Kumar ; Ayyappa Gouru, Sampath ; Rudrapal, Mithun ; Challa, Ranadheer Reddy ; Subramanyam, Sibbala

Abstract:

Ischemic stroke remains the leading cause of death and disability, while the main mechanisms of dominant neurological damage in stroke contain oxidative stress and inflammation. Docking studies revealed a binding energy of − 6.1 kcal/mol for AG, while the co-crystallized ligand (CCl) exhibited a binding energy of − 7.3 kcal/mol with NOS. AG demonstrated favourable hydrogen bond interactions with amino acids ASN A:354 and ARG A:388 and hydrophobic interactions with GLU A:377. Molecular dynamics simulations throughout 100 ns indicated a binding affinity of − 27.65±2.88 kcal/mol for AG, compared to − 18.01±4.02 kcal/mol for CCl. These findings suggest that AG possesses a superior binding affinity for NOS compared to CCl, thus complementing the stability of NOS at the docked site.AG has limited applications owing to its low bioavailability, poor water solubility, and high chemical and metabolic instability.The fabrication method was employed in the preparation of AGNP, SEM analysis confirmed spherical shape with size in 19.4±5 nm and investigated the neuroprotective effect in cerebral stroke rats induced by 30 min of carotid artery occlusion followed by 4 hr reperfusion, evaluated by infarction size, ROS/RNS via GSH, MPO, NO estimationand AchE activity, and monitoring EEG function. Cortex and hippocampal histology were compared between groups. AGNP treatment significantly decreased Infarction size and increased GSH levels (p<0.01**), decreased MPO (p<0.01**), NO (p<0.01**), AchE (p<0.01**), restored to normal EEG amplitude, minimizing unsynchronized polyspikes and histological data revealed that increased pyramidal cell layer thickness and decreased apoptotic neurons in hippocampus, cortex appeared normal neurons with central large vesicular nuclei, containing one or more nucleoli in compared to AG treatment. Based on brain biochemical, histopathology reports AGNP exhibited significant cerebroprotective activity compared to AG on ischemic rats.

109

项与 Aura Biosciences, Inc. 相关的新闻（医药）

2025-03-30

·药明康德

使多名患者癌细胞完全消失的创新偶联药物；最低剂量就让患者完全缓解的体内基因编辑疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点1. 用于治疗广泛期小细胞肺癌的溶瘤病毒免疫疗法Olvimulogene nanivacirepvec在一项早期临床试验中使71%患者的肿瘤得到控制。2. 在研病毒样颗粒偶联药物（VDC）bel-sar在治疗非肌层浸润性膀胱癌（NMIBC）患者的1期临床试验中使多名患者的肿瘤完全消失。3. iECURE公司公布了首个通过基因编辑，在肝脏细胞的DNA中插入整个基因的婴儿的完整数据。药明康德内容团队整理Olvimulogene nanivacirepvec：公布1b/2期临床试验数据Genelux公司和恒翼生物（Newsoara BioPharma）公布了其共同资助的溶瘤病毒免疫疗法Olvi-Vec用于治疗铂类复发或铂难治性广泛期小细胞肺癌的1b/2期临床试验结果。Olvi-Vec是Genelux公司专有的溶瘤病毒疫苗，经过改良以提高其安全性、肿瘤选择性和治疗潜力。临床前研究结果表明，Olvi-Vec具有在体外和体内感染并直接杀死多种肿瘤细胞的潜力。2021年9月，Genelux公司授予恒翼生物在大中华区开发和商业化Olvi-Vec的独家许可。此次公布的结果表明，在初始剂量递增队列中，Olvi-Vec的疾病控制率（DCR）达71%（5/7），其中有两名患者达到部分缓解（PR）。所有实现疾病控制的受试者均观察到所有靶病灶的缩小，其中1名患者的肿瘤缩小了约79%。低剂量组中有3名患者实现疾病稳定（SD），肿瘤缩小幅度在24%-29.2%之间。安全性方面，Olvi-Vec总体安全性和耐受性良好。Bel-sar（AU-011）：公布1期临床试验数据Aura Biosciences公司宣布，其在研病毒样颗粒偶联药物bel-sar在治疗非肌层浸润性膀胱癌患者的1期临床试验中获得积极早期数据。Bel-sar由靶向肿瘤表面表达的糖蛋白的病毒样颗粒（VLP）与可由光激活的细胞毒性药物偶联生成。它被设计为具有双重作用机制，既能诱导肿瘤细胞坏死，又能激发强大且持久的抗肿瘤免疫反应。该试验共纳入了15名患者，主要终点是评估bel-sar单独使用（n=5）和bel-sar结合光激活（n=10）局部给药的安全性和可行性。次要终点是评估生物活性及肿瘤微环境（TME）中的免疫介导变化。所有单独接受bel-sar的患者（n=5）均为中危NMIBC，治疗后没有患者出现临床完全缓解（CR）或肿瘤缩小。在接受bel-sar结合光激活治疗的5名中危疾病患者中，有4例表现出目标病灶的临床CR，在组织病理学评估中未检测到肿瘤细胞。在接受bel-sar结合光激活治疗的5名高危疾病患者中，有1例表现出临床CR，3例在膀胱镜检查中观察到肿瘤缩小。此外，在结合光激活治疗队列中，7名多发性肿瘤患者中有4名（57%）在至少一处非靶病灶中表现出临床CR，伴有CD8+和CD4+效应T细胞浸润。此外，bel-sar具有良好的安全性，仅在不到10%的患者中报告了1级药物相关不良事件。ECUR-506：公布1/2期临床试验中首例患儿的数据iECURE公司公布了其正在进行的1/2期研究OTC-HOPE中的首例患儿的积极数据，该研究旨在评估基因编辑疗法ECUR-506治疗新生儿发病的鸟氨酸氨甲酰转移酶（OTC）缺乏症的效果。ECUR-506依赖于使用两种携带不同有效载荷但具有相同衣壳的腺相关病毒（AAV）载体。一种携带ARCUS核酸酶，靶向已被充分研究的PCSK9基因位点进行基因编辑，另一种是供体载体，用于插入功能性OTC基因。在PCSK9位点的基因编辑为安全插入OTC基因提供了潜在路径，从而可能实现功能性基因的永久表达。此前的新闻稿表示，该患儿是首个通过基因编辑，在肝脏细胞的DNA中插入整个基因的婴儿，代表着体内基因编辑领域的重要里程碑。此次公布的结果表明，这名婴儿接受ECUR-506治疗后总体耐受性良好，在单次给药最低剂量的ECUR-506治疗后12周获得完全临床缓解。该患儿停止使用氨清除药物，且每日平均蛋白质摄入量增加至符合年龄标准的水平。缺乏OTC基因的患儿由于尿素生成受损，其血尿素氮（BUN）水平通常较低。观察到ECUR-506治疗后的平均BUN水平与治疗前的平均值相比明显更高，接近正常下限，表明该患儿的功能性OTC酶的活性可能增加。NBTXR3（JNJ-1900）：公布1期临床试验数据Nanobiotix公司公布了其潜在“first-in-class”的新型放射增敏剂NBTXR3的一项1期临床试验的积极数据，该研究旨在评估NBTXR3作为二线或后线（2L+）疗法，用于适合再接受放疗的局部晚期非小细胞肺癌（NSCLC）患者。NBTXR3由功能化二氧化铪（HfO2）纳米颗粒组成，经由一次性瘤内注射给药并通过放射疗法激活。它的物理作用机制为：旨在通过放疗激活，诱导被注射肿瘤内大量的肿瘤细胞死亡，随后触发适应性免疫反应和长期的抗癌记忆。得益于该物理作用机制，Nanobiotix公司认为NBTXR3可扩展到任何可以通过放疗治疗的实体肿瘤和任何联合治疗方案中，特别是与免疫检查点抑制剂联合。2023年，Nanobiotix宣布与强生旗下杨森公司（现名为强生创新制药）达成全球共同开发和商业化NBTXR3的许可协议。此次公布的研究结果显示，在12名适合再次放疗且既往治疗失败的局部晚期非小细胞肺癌患者中，NBTXR3的安全性良好，并确认了注射的可行性。对生存数据的初步审查显示，患者的12个月的局部无进展生存率（LPFS）为64%，12个月的总生存率（OS）为83%。截至目前，剂量递增部分已完成，扩展研究部分已有5/12名患者接受了注射。STM-01：1期临床试验完成首例患者给药Secretome Therapeutics公司宣布，其干细胞疗法STM-01用于治疗射血分数保留型心力衰竭（HFpEF）的1期临床试验已完成首例患者给药。新闻稿指出，这是全球首个针对HFpEF的同种异体、现货型干细胞疗法的临床研究。STM-01是一种新生儿心脏祖细胞（nCPC），具有减少纤维化和改善线粒体功能的能力，目前正在开发用于治疗HFpEF和扩张型心肌病（DCM）。在临床前研究中，STM-01显著降低了HFpEF中细胞和分子水平的炎症，从而改善心脏功能和运动耐量。VERVE-102：IND申请获得FDA许可Verve Therapeutics公司宣布，其体内碱基编辑药物VERVE-102的IND申请已获得美国FDA批准，用于治疗杂合子家族性高胆固醇血症（HeFH）和/或早发性冠状动脉疾病（CAD）患者。VERVE-102旨在使肝脏中的PCSK9基因永久失活，目前正被开发用于治疗杂合子家族性高胆固醇血症，其最终目的是用于治疗那些因低密度脂蛋白胆固醇（LDL-C）水平高而继续受到影响的动脉粥样硬化性心血管疾病（ASCVD）患者。▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] iECURE Announces Presentation of Full Data for the First Infant Dosed with ECUR-506 in OTC-HOPE Phase 1/2 Clinical Trial at the 2025 ACMG Annual Clinical Genetics Meeting. Retrieved March 28, 2025, from https://iecure.com/news/iecure-announces-presentation-of-full-data-for-the-first-infant-dosed-with-ecur-506-in-otc-hope-phase-1-2-clinical-trial-at-the-2025-acmg-annual-clinical-genetics-meeting/[2] Verve Therapeutics Announces Clearance of Investigational New Drug Application by the U.S. FDA for VERVE-102, an Investigational Gene Editing Medicine Designed to Durably Lower Cholesterol After a Single Dose. Retrieved March 28, 2025, from https://www.globenewswire.com/news-release/2025/03/24/3047698/0/en/Verve-Therapeutics-Announces-Clearance-of-Investigational-New-Drug-Application-by-the-U-S-FDA-for-VERVE-102-an-Investigational-Gene-Editing-Medicine-Designed-to-Durably-Lower-Chole.html[3] Positive Data from Phase 1 Trial of Bel-sar in Patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) Presented at the 40th Annual European Association of Urology Congress. Retrieved March 28, 2025, from https://www.globenewswire.com/news-release/2025/03/24/3047703/0/en/Positive-Data-from-Phase-1-Trial-of-Bel-sar-in-Patients-with-Non-Muscle-Invasive-Bladder-Cancer-NMIBC-Presented-at-the-40th-Annual-European-Association-of-Urology-Congress.html[4] Genelux and Newsoara Announce Positive Preliminary Phase 1b/2 Data of Olvi-Vec in Advanced Small-Cell Lung Cancer. Retrieved March 28, 2025, from https://www.globenewswire.com/news-release/2025/03/25/3048735/0/en/Genelux-and-Newsoara-Announce-Positive-Preliminary-Phase-1b-2-Data-of-Olvi-Vec-in-Advanced-Small-Cell-Lung-Cancer.html[5] Secretome Therapeutics Announces First Patient Dosed in Groundbreaking Phase 1 Study of STM-01 in Heart Failure with Preserved Ejection Fraction. Retrieved March 28, 2025, from https://secretometherapeutics.com/2025/03/secretome-therapeutics-announces-first-patient-dosed-in-groundbreaking-phase-1-study-of-stm-01-in-heart-failure-with-preserved-ejection-fraction/[6] Nanobiotix Announces First Data From the Completed Dose Escalation Part of a Phase 1 Study Evaluating NBTXR3 (JNJ-1900) as a 2L+ Therapy for Patients With Locally Advanced NSCLC. Retrieved March 28, 2025, from https://www.globenewswire.com/news-release/2025/03/27/3051020/0/en/Nanobiotix-Announces-First-Data-From-the-Completed-Dose-Escalation-Part-of-a-Phase-1-Study-Evaluating-NBTXR3-JNJ-1900-as-a-2L-Therapy-for-Patients-With-Locally-Advanced-NSCLC.html[7] Nouscom to Present Final Results from Successful Phase Ib/II Trial of NOUS-209 in People Living with Lynch Syndrome, Demonstrating Powerful Potential to Intercept Cancer in its Earliest Stages of Development. Retrieved March 28, 2025, from https://nouscom.com/2025/03/25/nouscom-to-present-final-results-from-successful-phase-ib-ii-trial-of-nous-209-in-people-living-with-lynch-syndrome-demonstrating-powerful-potential-to-intercept-cancer-in-its-earliest-stages-of-deve/[8] Calidi Biotherapeutics and City of Hope Provide Update on a Phase 1 Clinical Trial with CLD-101 Virotherapy in Patients with Recurrent High-Grade Glioma. Retrieved March 28, 2025, from https://www.globenewswire.com/news-release/2025/03/26/3049641/0/en/Calidi-Biotherapeutics-and-City-of-Hope-Provide-Update-on-a-Phase-1-Clinical-Trial-with-CLD-101-Virotherapy-in-Patients-with-Recurrent-High-Grade-Glioma.html[9] Helicore Biopharma Announces First Participant Dosed in Phase 1 Clinical Trial of HCR-188, a First-in-Class GIP Antagonist for the Treatment of Obesity. Retrieved March 28, 2025, from https://www.globenewswire.com/news-release/2025/03/25/3048810/0/en/Helicore-Biopharma-Announces-First-Participant-Dosed-in-Phase-1-Clinical-Trial-of-HCR-188-a-First-in-Class-GIP-Antagonist-for-the-Treatment-of-Obesity.html[10] Oncotelic Therapeutics Announces Successful Completion of Phase 1 Trial of OT-101 and IL-2, Highlights Findings at SWCR 2025 Conference. Retrieved March 28, 2025, from https://www.oncotelic.com/press-releases/?[11] Neuron23 to Present Phase 1 Healthy Volunteer Data of NEU-411, a Brain-penetrant LRRK2 Inhibitor, at AD/PD™ 2025. Retrieved March 28, 2025, from https://neuron23.com/neuron23-to-present-phase-1-healthy-volunteer-data-of-neu-411-a-brain-penetrant-lrrk2-inhibitor-at-ad-pd-2025/[12] Personalized Cancer Vaccine Proves Promising in a Phase 1 Trial at Mount Sinai. Retrieved March 28, 2025, from https://www.globenewswire.com/news-release/2025/03/21/3047122/0/en/Personalized-Cancer-Vaccine-Proves-Promising-in-a-Phase-1-Trial-at-Mount-Sinai.html[13] Entrada Therapeutics Receives Authorization in the United Kingdom to Initiate ELEVATE-45-201, a Phase 1/2 Multiple Ascending Dose Clinical Study of ENTR-601-45 in People Living with Duchenne Muscular Dystrophy Amenable to Exon 45 Skipping. Retrieved March 28, 2025, from https://www.globenewswire.com/news-release/2025/03/24/3047704/0/en/Entrada-Therapeutics-Receives-Authorization-in-the-United-Kingdom-to-Initiate-ELEVATE-45-201-a-Phase-1-2-Multiple-Ascending-Dose-Clinical-Study-of-ENTR-601-45-in-People-Living-with.html免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床1期免疫疗法临床结果疫苗基因疗法

2025-03-29

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医药企业跨界整合，宣告失败

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融圈监测显示：在去年2024年8月27日晚，上市公司双成药业（002693）发布公告，宣布公司正筹划通过重大资产置换、发行股份及支付现金的方式，收购宁波奥拉半导体股份有限公司（简称“奥拉股份”）的股权。双成药业计划将其现有的医药业务相关资产与负债置出给奥拉股份的实际控制人王成栋、Wang Yingpu及其关联方（包括香港奥拉投资有限公司、宁波双全创业投资合伙企业等），作为对价，双成药业将向这些股东发行新股并支付一定现金，以购买奥拉股份的股权。同时，为了补充重组所需的流动资金，双成药业还计划向不超过35名特定投资者发行股份，募集配套资金。有股民评论：简直是一场资本市场的闹剧。这种所谓的跨界并购也不是证监会所期待的吧。药融云数据，www.pharnexcloud.com；改名后为摩熵医药数据双成药业根据深圳证券交易所的相关规定，申请自8月28日起停牌。公司承诺将在不超过5个交易日内，披露详细的交易方案及后续安排。（也就是截止2024年9月3日收盘）本次重组的标的，奥拉股份此前申报了科创板IPO：2022年11月28日获上交所受理；2024年5月27日，公司及其保荐人最终决定撤回发行上市申请。奥拉股份由双成药业实控人实际控制，主营模拟芯片和数模混合芯片的研发、生产和销售。前身是成立于2010年的印度芯片设计公司Aura。双成药业2024年半年报：上半年实现营业收入约为9489.26万元，同比下降31.74%；归属净利润亏损1694.62万元。公司表示业绩下滑的原因主要包括国家集采政策的持续影响、主要产品销量下滑以及政府补助和理财收益的减少等。2023年，双成药业2023年实现营业收入约为2.36亿元，同比下降14.13%；对应实现的归属净利润约为-5074万元（同样亏损），上年同期为901.2万元。海南双成药业股份有限公司成立于2000年，于2012年上市，是一家老牌以化学合成多肽药品为特色的高科技企业。公司在化学合成多肽药物合成、纯化分析、活性测定、制剂工艺等方面形成了整套成熟的技术工艺体系。目前主要产品包括注射用胸腺法新、注射用生长抑素、注射用比伐芦定、依替巴肽注射液等。2025年3月10日晚，海南双成药业股份有限公司（双成药业，002693）发布《关于终止发行股份及支付现金购买资产并募集配套资金暨关联交易事项的公告》，决定终止收购宁波奥拉半导体股份有限公司100%股份，这场历时半年多的跨界并购宣告失败。去年中国证监会发布《关于深化上市公司并购重组市场改革的意见》的文件，积极支持上市公司围绕战略性新兴产业、未来产业等进行并购重组，包括开展基于转型升级等目标的跨行业并购。但是不是鼓励走所谓捷径解决自家问题。2025年1月18日，双成药业发布2024年度业绩预告，2024年公司扣除后营业收入为14000万元-18000万元（继续下滑），扣非净利润预计亏损5837万元-8337万元，同比下降141.79%-245.36%。但公司目前仍有38亿市值。参考：NMPA/CDE；药融云数据，www.pharnexcloud.com；改名后为摩熵医药数据；FDA/EMA/PMDA；http://www.shuangchengmed.com/plus/list.php?tid=3；相关公司公开披露；等等。植根上海、辐射全球,药融圈作为生物医药产业级战略平台,以"让智慧与人脉无界流动"为使命,构建覆盖药物研发、生产、流通、商业化的全产业链赋能体系。通过智能化云服务、精准资源链接、产业智库与生态社群四大核心引擎,打造中国医药价值流动的基础设施。在全球化与数字化双重浪潮下,药融圈正重新定义医药资源的流通范式--这里不仅是信息与人脉的枢纽站,更是催生产业变革的化学反应器。我们以中国为原点,编织全球医药智慧网络,让每一次精准链接都成为企业跨越式增长的催化剂。点点赞点分享点推荐

财报并购

2025-03-11

·健识局

新事 | 双成药业将出现退市风险

消息来的比较突然，3月10日，双成药业决定终止发行股份及支付现金购买宁波奥拉半导体股份有限公司100%股份的交易，并停止募集配套资金。双成药业主要产品注射用胸腺法新、注射用生长抑素、注射用比伐芦定均为仿制药产品，而标的公司奥拉股份是国内高性能去抖时钟芯片市场的第一把交椅。双成药业当初是想剥离医药资产，全面“跨界转型”切入半导体行业，是公司存亡的关键。但谁也没想，这场历时半年的跨界并购最后还是惨淡收尾。 3月11日，双成药业股价开盘即跌停，截至收盘，公司市值为51.55亿元，不及去年9月时的三分之一。要知道，2024年9月，双成药业股价受到该并购重组预案消息刺激，由每股4元低点一路飙涨，一度到40.98元最高点，翻了10余倍。重组告吹的同时，还将公司推向了退市的悬崖边。公司2024年业绩压力也很大，1月17日，双成药业发布业绩预告称，2024年预计营收仅为1.5亿-1.9亿元，净亏损5500万-8000万元。根据相关规定：上市公司年度利润总额、净利润、扣除非经常性损益后的净利润低为负值，且扣除后的营业收入低于3亿元的情形，其股票交易将在2024年年报披露后被实施退市风险警示。撰稿丨苗苗编辑丨江芸贾亭运营｜王苗嫦声明：健识局原创内容，未经许可请勿转载医药全渠道与医疗服务闭环：京东健康的“两手抓、两手硬” 谁会冒充国药控股去行骗？问题根源或许在这里新事 | 百利天恒拟再融资39亿，投向ADC

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