排名前五的靶点	数量

fungal CYP51A1(真菌细胞色素P450家族成员51)	1
CAs(碳酸酐酶家族)	1
H1 receptor(组胺H1受体)	1
Bacterial DNA gyrase x GR x Top II	1
GR(糖皮质激素受体)	1

关联

项与 Taro Pharmaceutical Industries Ltd. 相关的药物

Dexamethasone/Levofloxacin

地塞米松/左氧氟沙星

靶点

Bacterial DNA gyrase x GR x Top II

作用机制

细菌DNA旋转酶复合体抑制剂 [+2]

在研机构

Taro Pharmaceutical Industries Ltd. [+5]

原研机构

NTC SRL

在研适应症

白内障 [+3]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

德国

首次获批日期2020-05-28

Loratadine

氯雷他定

靶点

H1 receptor

作用机制

H1 receptor拮抗剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期1993-04-12

Terconazole

特康唑

靶点

fungal CYP51A1

作用机制

fungal CYP51A1抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期1987-12-31

项与 Taro Pharmaceutical Industries Ltd. 相关的临床试验

NCT06305637 / Completed临床1期

A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ketoconazole Shampoo, 2% to Ketoconazole Shampoo, 2% (RS) and Both Active Treatments to a Placebo Control in the Treatment of Tinea Versicolor.

To demonstrate the efficacy, therapeutic equivalence and safety of Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A., Inc.) and Ketoconazole 2% Shampoo (Reference Standard) in the treatment of tinea versicolor.

开始日期2023-12-04

申办/合作机构

Taro Pharmaceuticals U.S.A., Inc.

CTRI/2023/10/058559 / Not yet recruitingN/A

A bioequivalence, multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Diclofenac diethylamine gel, 2.32% (Taro Pharmaceuticals U.S.A., Inc.) to Voltaren Emulgel Extra Strength, 2.32% (Canadian Reference Product) and both active treatments to a placebo control in the treatment of acute sprain of lateral ankle. - NIL

开始日期2023-10-21

申办/合作机构

Taro Pharmaceutical Industries Ltd.

NCT06063473 / Completed临床1期

A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) and to AKLIEF® Cream (Trifarotene 0.005%,Galderma) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris

开始日期2023-02-22

申办/合作机构

Taro Pharmaceuticals U.S.A., Inc.

100 项与 Taro Pharmaceutical Industries Ltd. 相关的临床结果

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0 项与 Taro Pharmaceutical Industries Ltd. 相关的专利（医药）

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项与 Taro Pharmaceutical Industries Ltd. 相关的文献（医药）

2020-04-01·Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学

Preclinical Evaluation of a Novel SHIP1 Phosphatase Activator for Inhibition of PI3K Signaling in Malignant B Cells

1区 · 医学

Article

作者: Lenz, Georg ; Stevenson, Freda K. ; Karydis, Laura ; Gebreselassie, Yohannes ; Carter, Matthew J. ; Packham, Graham ; Smith, Lindsay D. ; Williamson, Chris T. ; Valle-Argos, Beatriz ; Mackenzie, Lloyd ; Steele, Andrew J. ; Richter, Johanna ; Lemm, Elizabeth A. ; Forconi, Francesco ; Svaton, Michael ; Harwig, Curtis ; Cragg, Mark ; Helman, Karel ; Karolova, Jana ; Pettigrew, Jeremy ; Weston-Bell, Nicola J. ; Cross, Jennifer ; Klener, Pavel

Abstract:

Purpose::

PI3K signaling is a common feature of B-cell neoplasms, including chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL), and PI3K inhibitors have been introduced into the clinic. However, there remains a clear need to develop new strategies to target PI3K signaling. PI3K activity is countered by Src homology domain 2-containing inositol-5′-phosphatase 1 (SHIP1) and, here, we have characterized the activity of a novel SHIP1 activator, AQX-435, in preclinical models of B-cell malignancies.

Experimental Design::

In vitro activity of AQX-435 was evaluated using primary CLL cells and DLBCL-derived cell lines. In vivo activity of AQX-435, alone or in combination with the Bruton's tyrosine kinase (BTK) inhibitor ibrutinib, was assessed using DLBCL cell line and patient-derived xenograft models.

Results::

Pharmacologic activation of SHIP1 using AQX-435 was sufficient to inhibit anti–IgM-induced PI3K-mediated signaling, including induction of AKT phosphorylation and MYC expression, without effects on upstream SYK phosphorylation. AQX-435 also cooperated with the BTK inhibitor ibrutinib to enhance inhibition of anti–IgM-induced AKT phosphorylation. AQX-435 induced caspase-dependent apoptosis of CLL cells preferentially as compared with normal B cells, and overcame in vitro survival-promoting effects of microenvironmental stimuli. Finally, AQX-435 reduced AKT phosphorylation and growth of DLBCL in vivo and cooperated with ibrutinib for tumor growth inhibition.

Conclusions::

Our results using AQX-435 demonstrate that SHIP1 activation may be an effective novel therapeutic strategy for treatment of B-cell neoplasms, alone or in combination with ibrutinib.

2016-09-01·The Journal of urology1区 · 医学

A Phase II Study of the Efficacy and Safety of the Novel Oral SHIP1 Activator AQX-1125 in Subjects with Moderate to Severe Interstitial Cystitis/Bladder Pain Syndrome

1区 · 医学

Article

作者: Nickel, J. Curtis ; Davis, Edward ; Egerdie, Blair ; Shrewsbury, Stephen B. ; Evans, Robert ; Mackenzie, Lloyd

PURPOSE:

In this 6-week, randomized, double-blind, placebo controlled, multicenter trial we assessed the effect of the novel SHIP1 (SH2-containing inositol-5'-phosphatase 1) activator AQX-1125 on bladder pain and urinary symptoms in patients with interstitial cystitis/bladder pain syndrome.

MATERIALS AND METHODS:

Women with interstitial cystitis/bladder pain syndrome and a mean pain score of 5 or greater on an 11-point scale despite treatment were randomized to AQX-1125 or placebo orally once daily for 6 weeks. Average and maximum pain scores (daily) and urinary frequency (before visits) were recorded by e-diary and at clinic visits. The O'Leary-Sant ICSI (Interstitial Cystitis Symptom Index) and ICPI (Interstitial Cystitis Problem Index), BPIC-SS (Bladder Pain Interstitial Cystitis Symptom Score) and SF-12v2® questionnaires were administered. Safety was monitored through 6 weeks of treatment and 4 weeks of followup.

RESULTS:

A total of 37 patients received oral AQX-1125 and 32 received placebo. At 6 weeks average daily pain on an e-diary decreased by 2.4 points for AQX-1125 vs 1.4 for placebo (p = 0.061), while average pain at clinic decreased by 2.6 vs 1.1 (p = 0.008), maximum daily pain on e-diary diary decreased by 2.6 vs 1.4 (p = 0.030) and maximum pain at clinic decreased by 2.8 vs 1.1 (p = 0.028). AQX-1125 reduced ICSI by 3.8 points vs 1.4 for placebo (p = 0.005), ICPI by 3.6 points vs 1.6 (p = 0.014) and BPIC-SS by 8.8 points vs 4.0 (p = 0.011). Urinary frequency decreased on AQX-1125 by 3.6 voids per 24 hours vs 0.8 for placebo (p = 0.040). Adverse event rates were similar for AQX-1125 and placebo (51.4% and 78.1%, respectively). No serious adverse events were reported.

CONCLUSIONS:

Women with moderate to severe interstitial cystitis/bladder pain syndrome who were treated with the oral SHIP1 activator AQX-1125 reported significantly reduced bladder pain and improved urinary symptoms at 6 weeks. AQX-1125 was well tolerated. AQX-1125 may be a potential new treatment for interstitial cystitis/bladder pain syndrome. It warrants further investigation.

2015-04-01·Clinical and vaccine immunology : CVI

Protective Efficacy and Pharmacokinetics of Human/Mouse Chimeric Anti-Stx1 and Anti-Stx2 Antibodies in Mice

Article

作者: Carvalho, H M ; O'Brien, A D ; Melton-Celsa, Angela R ; Thuning-Roberson, Claire

ABSTRACT:

In the United States, Shiga toxin (Stx)-producingEscherichia coli(STEC) is the most frequent infectious cause of hemorrhagic colitis. Hemolytic uremic syndrome (HUS) is a serious sequela that may develop after STEC infection that can lead to renal failure and death in up to 10% of cases. STEC can produce one or more types of Stx, Stx1 and/or Stx2, and Stx1 and Stx2 are responsible for HUS-mediated kidney damage. We previously generated two monoclonal antibodies (MAbs) that neutralize the toxicity of Stx1 or Stx2. In this study, we evaluated the protective efficacy of human/mouse chimeric versions of those monoclonal antibodies, named cαStx1 and cαStx2. Mice given an otherwise lethal dose of Stx1 were protected from death when injected with cαStx1 either 1 h before or 1 h after toxin injection. Additionally, streptomycin-treated mice fed the mouse-lethal STEC strain B2F1 that produces the Stx2 variant Stx2d were protected when given a dose of 0.1 mg of cαStx2/kg of body weight administered up to 72 h post-oral bacterial challenge. Since many STEC strains produce both Stx1 and Stx2 and since either toxin may lead to the HUS, we also assessed the protective efficacy of the combined MAbs. We found that both antibodies were required to protect mice from the presence of both Stx1 and Stx2. Pharmacokinetic studies indicated that cαStx1 and cαStx2 had serum half-lives (t1/2) of about 50 and 145 h, respectively. We propose that cαStx1 and cαStx2, both of which have been tested for safety in humans, could be used therapeutically for prevention or treatment early in the development of HUS.

项与 Taro Pharmaceutical Industries Ltd. 相关的新闻（医药）

2024-07-03

·BiG生物创新社

2024年上半年：25家biotech被并购，自免领域拔得头筹

作者｜小鱼在药物开发过程中，商业交易与科学突破同样至关重要。很多当今“最赚钱”的药物，如Keytruda、Enbrel，都是通过并购才得以走到大众面前，获得今日的辉煌成就。或许在今年上半年的并购案中，也能出现“爆款”明星药品。 2024年上半年，已经有25家biotech被收购，整理如下（按时间排序）：从表格可见，在25个Biotech并购案中，并购金额最大三起为Vertex收购Alpine（ 49亿美元）、Gilead收购CymaBay（43亿美元）、诺华收购Morphosys（29亿美元）。6起并购案超过20亿美元，15起并购案超过10亿美元，分布在癌症、免疫疾病、罕见病、视网膜疾病、肝脏疾病领域。从中，我们能看到并购活动不仅集中在肿瘤和免疫疾病领域，还扩展到了肝脏疾病、眼科疾病以及罕见病等。其次，跨国药企重视新型药物技术，如双抗/三抗疗法、ADC药物、靶向放射性药物、RNA药物等。 01 6.8亿美元：默沙东收购Harpoon 1月8日，默沙东（MSD）公司宣布以6.8亿美元收购Harpoon Therapeutics。默沙东将获得一系列T细胞接合器在研疗法，包括处于1/2期临床开发阶段的HPN328，扩展其肿瘤学研发管线。 HPN328（此后称为MK-6070）是基于TriTAC平台构建的DLL3靶向T细胞结合器，通过靶向激活T细胞，对表达DLL3的肿瘤细胞进行杀伤。DLL3是一种抑制性Notch配体，在小细胞肺癌（SCLC）和神经内分泌肿瘤中高度表达。目前，HPN328正处于临床开发阶段，用于治疗SCLC/NEPC与其他神经内分泌肿瘤。其他候选药物包括HPN217，一种靶向B细胞成熟抗原（BCMA）的T细胞接合剂，目前处于一期临床开发阶段，用于治疗复发/难治性多发性骨髓瘤患者，以及几种临床前阶段候选药物，包括HPN601，一种条件激活的靶向上皮细胞粘附分子（EpCAM），用于治疗某些表达EpCAM的肿瘤患者。 02 20亿美元：强生收购Ambrx 1月8日，强生（Johnson & Johnson）宣布与Ambrx Biopharma达成最终协议，将斥资20亿美元收购Ambrx。此次收购，强生的重点是加速ARX517在晚期前列腺癌中的1/2期试验APEX01的进展，同时推进一系列新颖的候选产品。 ARX517由人源化的抗PSMA单抗与Ambrx专有的强效微管抑制剂AS269连接而成。在临床前研究中，ARX517的癌细胞杀伤有效载荷AS269通过单抗释放到癌细胞中时具有很强的细胞毒性。ARX517的位点特异性连接、稳定的共轭化学性质和不可裂解的连接体使ADC具有均匀的药物抗体比、类似单抗的生物物理特性和优异的稳定性。因此，Ambrx公司认为ARX517可以促进对肿瘤细胞的高度特异性杀伤，同时将脱靶毒性降至最低。ARX517有潜力成为“first-in-class”和“best-in-class”的抗PSMA ADC，以满足转移性去势抵抗性前列腺癌（mCRPC）患者的巨大未竟医疗需求。 03 2.5亿美元：诺华收购Calypso 1月8日，诺华宣布将以2.5亿美元收购Calypso生物技术公司(Calypso Biotech)，并支付高达1.75亿美元的开发里程碑付款。此次收购，诺华将获得Calypso唯一一个项目CALY-002。 CALY-002是一种潜在的同类最佳治疗抗体，可结合并中和IL-15。IL-15是一种广泛的、未开发的免疫轴，在许多慢性自身免疫性疾病中控制屏障功能和下游免疫级联反应。CALY-002目前正在Celiac病和嗜酸性粒细胞性食管炎患者的1b期试验中进行评估。 04 10亿美元：GSK收购Aiolos 1月9日，GSK宣布已与一家专注于解决呼吸和炎症性疾病公司Aiolos达成收购协议，GSK将支付后者10亿美元的预付款和高达4亿美元的成功监管里程碑付款。此次收购使GSK获得了Aiolos的候选药物AIO-001（SHR-1905），扩大了GSK的呼吸道疾病管线。 AIO-001是一种潜在“best-in-class”的长效抗胸腺基质淋巴细胞生成素（TSLP）单克隆抗体，由于其药效具差异性、半衰期长，每6个月只需给药1次。TSLP是经过临床验证的哮喘治疗靶点，无论患者的生物标志物状态如何。靶向TSLP通路解决了主要过敏性和炎症性反应的关键驱动因素。AIO-001目前处于二期临床阶段，用于治疗成年哮喘者，并有可能用于其他适应症，包括慢性鼻窦炎伴鼻息肉。 05 3.48亿美元：太阳制药收购Taro 1月17日，印度第一大仿制药巨头太阳制药（Sun Pharma）以3.48亿美元正式全资收购以色列老牌皮肤科仿制药公司Taro Pharmaceutical。此前，太阳制药已经拥有Taro 78.5%的股份。 Taro Pharmaceutical Industries 是一家以研究为基础的制药商，在纽约证券交易所上市。公司开发、生产、销售和分销高品质的仿制药、品牌处方药和非处方药产品。该公司拥有 200 多种产品，主要涉及皮肤科、镇痛药、胃药、中枢神经系统、心脏病等多个治疗领域。 06 17亿美元：赛诺菲收购Inhibrx 1月23日，赛诺菲宣布，其与临床阶段生物制药上市公司Inhibrx已达成一项最终协议，将以17美元的股权价值和1.96亿美元的或有价值权益收购Inhibrx，扩赛默飞的单域抗体领域。 INBRX-101是一种重组人AAT-Fc融合蛋白，由2个与人lgG4 Fc结构域连接的重组人AAT分子组成，进过优化，比pdAAT有更长的半衰期和更高的暴露量，防止因氧化而失去活性。目前INBRX-101正在开发用于治疗α-1抗胰蛋白酶缺乏症（AATD），于2022年3月获得FDA的“孤儿药”认定，2023年6月获FDA快速通道指定。Inhibrx临床在研的管线还有DR5激动剂、OX40激动剂。 07 29亿美元：诺华收购Morphosys 2月5日，诺华宣布与Morphosys达成全现金收购协议，收购对价27亿欧元，约合29亿美元。此次诺华收购的重点是Pelabresib——目前全球进展最快的BET抑制剂（Pelabresib），此次收购也将进一步强化诺华在肿瘤领域的布局。溴结构域和末端外结构域（BET）蛋白家族包括四种蛋白(BRD2,BRD3,BRD4和BRDT)，它们具有表观遗传修饰因子的功能，能够调控一系列异常致癌信号的基因表达途径。Pelabresib是一种BET抑制剂，它可以选择性地与BET蛋白结合，降低癌症中异常表达基因的表达，从而抑制肿瘤的发生发展。目前BET抑制剂已被证明可以靶向多种MF驱动机制，与JAKi联合治疗具有协同作用。pelabresib联合芦可替尼治疗初治骨髓纤维化患者三期研究达到主要终点。 08 43亿美元：吉利德收购CymaBay 2月12日，吉利德科学公司（Gilead Sciences）和CymaBay Therapeutics宣布达成最终协议，吉利德将以总金额43亿美元收购CymaBay。吉利德将获得Cymabay的核心管线PPARδ激动剂Seladelpar，以扩充其肝脏产品线。 Seladelpar为一在研、口服、潜在“first-in-class”的强效选择性过氧化物酶体增殖物活化受体（PPARδ）激动剂。PPARδ表达在肝脏的多种细胞类型中，对调控胆汁酸合成、炎症、纤维化过程的多种基因有调节作用。也在2月12日收购协议达成日，CymaBay宣布美国FDA接受seladelpar用于治疗原发性胆汁性肝硬化患者，包括其瘙痒症状（pruritus）的新药申请（NDA），并授予其优先审评资格，该药物的PDUFA目标日期为2024年8月14日。 09 0.9亿美元：诺华收购IFM Due 3月13日，诺华宣布将收购私人控股公司IFM Therapeutics的子公司IFM Due，IFM Due将获得9000万美元预付款，并有资格获得高达7.45亿美元的里程碑付款。根据收购协议，诺华将获得IFM Due的STING拮抗剂产品组合的全部权利。 IFM Due专注于针对cGAS-STING通路引发的先天免疫系统异常炎症反应开发小分子口服候选药物。cGAS-STING通路通过侦测细胞质内的DNA（细胞危险信号）并启动STING依赖性炎症反应而在先天免疫系统中发挥作用。由于突变或线粒体功能障碍等原因所导致该通路不正常的激活，会引起过度的干扰素/细胞因子信号传导，进而导致多种严重炎症疾病的发生。目前该抑制cGAS/STING途径的免疫疗法还在临床前阶段。 10 8亿美元：阿斯利康收购Amolyt 3月14日，阿斯利康宣布已达成最终协议，拟斥资10.5亿美元收购Amolyt Pharma，包括8亿美元的预付款以及2.5亿美元的特定里程碑付款。这次收购讲使AZ获得Amolyt研发项目Eneboparatide（AZP-3601）。 Eneboparatide是一种研究性治疗肽，旨在与甲状旁腺激素（PTH）受体的特定构型高亲和力结合，以在血液中产生持续稳定的钙水平，从而管理甲状旁腺功能减退症的症状，并通过恢复肾脏对钙的重吸收来限制尿钙排泄，预防肾功能的逐渐下降和慢性肾病的发展。Amolyt Pharma公司与5月2日宣布，Eneboparatide已获得FDA授予的快速通道指定，三期Calypso试验正在美国、欧洲、加拿大和英国的50多个中心进行。 11 24亿美元：阿斯利康收购Fusion 3月19日，阿斯利康宣布将斥资24亿美元，收购专注于开发新一代放射性偶联药物（RDC）的生物制药公司Fusion Pharmaceuticals。这次收购是阿斯利康在核药领域的又一次重大布局。 Fusion核心产品FPI-2265是一款针对前列腺特异性膜抗原（PSMA）的靶向药物，目前正处于二期临床开发阶段，用于治疗转移性去势抵抗性前列腺癌（mCRPC）。这一药物的研发，体现了核药在癌症治疗中的巨大潜力和独特优势。另一款临床在研产品为FPI-1434，靶向表达IGF-1R（IGF-1R是一种在许多肿瘤类型上过表达的受体）癌细胞并递送发射α的医用同位素，目前正处于一期临床开发阶段。 12 1.38亿美元：艾伯维收购Landos 3月25日，艾伯维宣布将收购Landos Biopharma，获得其炎症性肠病研发管线NX-13，艾伯维支付1.375亿美元现金，以及7500万美元里程碑付款。 NX-13是一款口服NLRX1激动剂，开发用于治疗溃疡性结肠炎和克罗恩病。NX-13可以通过胞外、胞内两种路径来减少炎症循环，发挥双重机制，具有抗炎作用并促进上皮修复的潜力。目前处于二期临床阶段，溃疡性结肠炎二期临床数据预计2024年四季度读出。 13 18亿美元：Genmab收购ProfoundBio 4月3日，Genmab和ProfoundBio（普方生物）共同宣布签署了一项确定性协议，Genmab将以18亿美元现金收购ProfoundBio。此次收购将使Genmab在全球范围内拥有三个临床开发候选药物的权利，包括rinatabart sesutecan（Rina-S），以及ProfoundBio的新型抗体-药物偶联物（ADC）技术平台。 Rina-S是一种新型的、下一代的、潜在的同类最佳Topo1 ADC，靶向叶酸受体α（FRα）。FRα在一系列实体瘤中过表达，在正常组织中表达有限，因此是ADC有吸引力的靶标。Rina-S由人FRα的单克隆抗体、一种新型可裂解亲水接头、拓扑异构酶1抑制剂有效载荷Exatecan组成。目前正在招募晚期实体瘤患者进行首次人体1/2期研究。此外，普方生物披露的在研药物还有靶向CD70的ADC、靶向PTK7的ADC、靶向EGFR和cMET的双特异性ADC等。 14 49亿美元：Vertex收购Alpine 4月10日，Vertex宣布，将斥资49亿美元收购Alpine immune science，收获该公司主打产品Povetacicept（ALPN-303），并扩大其肾脏和免疫系统疾病的业务。 Povetacicept是BAFF/APRIL双重拮抗剂，BAFF/APRIL可促进B细胞、T细胞和髓系细胞的活化、分化和存活，在多种自身免疫性疾病的发病机制中发挥关键作用，包括但不限于系统性红斑狼疮（SLE）和IgA肾病等。目前Povetacicept有3条临床管线：针对自身免疫性肾小球肾炎处于临床二期阶段、针对系统性红斑狼疮（SLE）处于临床一期阶段、针对自身免疫性血细胞减少症处于临床二期阶段。 15 7.5亿美元：Incyte收购Escient 4月23日，Incyte和Escient Pharmaceuticals宣布达成最终协议，Incyte同意以约7.5亿美元款项收购Escient，并收获该公司两款潜在FIC小分子疗法EP262和EP547，扩大其在炎症与自身免疫疾病领域的研发管线。 EP262是一种强效、高选择性、每日一次的小分子MRGPRX2拮抗剂，通过阻断MRGPRX2和肥大细胞颗粒释放，EP262有潜力治疗多种肥大细胞介导的疾病，包括特应性皮炎（AD）、慢性诱发性荨麻疹（CIndU）和慢性自发性荨麻疹（CSU），目前均处于临床一期阶段。EP547则是一种强效、高选择性MRGPRX4小分子拮抗剂，可阻断各种胆汁酸、胆红素和尿胆素激活MRGPRX4，有望成为治疗胆汁淤积性和尿毒症性瘙痒症的潜在有效疗法。 16 24亿美元：小野制药收购Deciphera 4月29日，小野制药（ONO Pharmaceutical）宣布以24亿美元收购Deciphera Pharmaceuticals，届时Deciphera将成为小野制药全资子公司。这一收购将增强小野制药的肿瘤学研发管线。 Deciphera公司擅长激酶药物发现和开发，其小分子抑制剂Qinlock已经在美国和其他40多个国家和地区获批上市，用于治疗经治胃肠间质瘤（GIST）患者。Deciphera还拥有CSF-1R抑制剂、ULK抑制剂、pan-RAF抑制剂、pan-KIT抑制剂、GCN2激活剂等多种研发管线，包括Vimseltinib、DCC-3116（一种ULK抑制剂）以及多个其他的肿瘤学候选药物。 17 10亿美元：诺华收购Mariana 5月2日，专注于开发新型放射性配体疗法（RLT）的生物技术公司Mariana Oncology宣布，诺华将以10亿美元的预付款和高达7.5亿美元的潜在里程碑付款收购该公司。次收购将Mariana Oncology的创新放射性药物管线和平台与诺华公司成熟的临床开发和商业化专业技术相结合。 Mariana 公司由Atlas Venture、Access Biotechnology和RA Capital Management于2021年创立，并从Deep Track Capital和Forbion等其他顶级投资者处筹集了额外资金。 Mariana Oncology公司已开发出一系列基于多肽的新型放射性药物，可用于治疗多种实体瘤癌症，并在生产能力、广泛的同位素供应链和新型配方方面进行了投资，以提高最终产品的保质期。公司的领先项目MC-339是一款RTL，专门针对小细胞肺癌。 18 8.5亿美元：强生收购Proteologix 5月16日，强生宣布以8.5亿美元收购专注于开发免疫介导疾病双特异性抗体的私营生物技术公司Proteologix，已签订最终协议，并有可能支付额外的里程碑付款。 Proteologix的研发管线中包括PX128，这是一种靶向IL-13和TSLP的双特异性抗体，准备进入针对中度至重度特应性皮炎（AD）和中度至重度哮喘的一期开发。另一款在研疗法PX130是一种靶向IL-13和IL-22的双特异性抗体，正在进行针对中度至重度AD的临床前开发。由于AD和哮喘都是异质性疾病，不同患者亚群的疾病由不同信号通路驱动，靶向多条信号通路有可能实现更好的疗效和疾病缓解。 PX128和PX130之外，此外收购还将为强生提供其他双特异性抗体研发项目，这些项目可应用于各种其他疾病，进一步增强公司在开发新型双特异性治疗方案方面的能力。 19 11.5亿美元：渤健收购HI-Bio 5月22日，Biogen（渤健）和免疫疗法公司Human Immunology Biosciences（HI-Bio）宣布，两家公司已达成收购协议。根据协议条款，渤健将向HI-Bio支付11.5亿美元的预付款。如果Felzartamab项目达成某些开发里程碑，HI-Bio还有资格获得高达6.5亿美元的额外款项，总交易款项可能高达18亿美元。 HI-Bio的主要资产Felzartamab（菲泽妥单抗）是一款靶向CD38的单抗，主要用于开发自免适应症。目前，Felzartamab用于原发性膜性肾病、抗体介导的排斥反应、IgA肾病等临床试验处于二期阶段，狼疮性肾炎处于临床一期阶段。除了Felzartamab外，HI-Bio的管线还包括izastobart/HIB210，这是一种C5aR1靶向抗体，目前处于临床一期试验阶段，具有用于治疗一系列补体介导疾病的潜力。HI-Bio还拥有处于发现阶段的肥大细胞靶向管线，该管线亦具有在多种免疫介导疾病中应用的潜力。 20 12.5亿美元：强生收购YJT 5月28日，强生宣布已与Numab therapeutics达成最终协议，将以约12.5亿美元的现金收购其全资子公司Yellow Jersey therapeutics（YJT），该公司将分拆给Numab的股东。将其新型、在研一流双特异性抗体NM26的全球权利收入囊下。 NM26是一种用于治疗特应性皮炎（AD）的同类首创双特异性抗体，靶点是AD中两种经临床验证的通路-IL-4Rα和IL-31，前者会引发Th2介导的皮肤炎症，后者会影响皮肤骚痒和随后的骚抓，从而使病情恶化。NM26除了有可能改变AD的治疗标准外，对其他涉及Th2炎症和骚痒的炎症性皮肤病也有疗效。 21 11亿美元：旭化成收购Calliditas 5月28日，日本公司旭化成注株式会社（Asahi Kasei）拟提出以118亿瑞典克朗（约合11亿美元）收购瑞典药企Calliditas Therapeutics，以扩大在肾脏和自身免疫性疾病领域的产品规模，并在欧洲建立业务，扩充研发管线。同日，Calliditas宣布已经接受旭化成的收购要约。该收购要约受到了Calliditas董事会的支持。 Calliditas在售产品是Nefecon（布地奈德肠溶胶囊）。作为全球第一款上市的IgA肾病疗法，Nefecon通过特殊的制作工艺，将布地奈德靶向释放于回肠末端的黏膜B细胞，胶囊溶解后，三层包衣微丸持续稳定释放布地奈德，高浓度覆盖整个靶区域，从而减少诱发IgA肾病的半乳糖缺陷的IgA1抗体产生，达到治疗IgA肾病的作用。目前，Calliditas主打在研药品为NOX1/4抑制剂Setanaxib（潜在FIC药物）。该产品用于治疗一系列纤维化罕见疾病和实体瘤，预计今年将有三项临床二期研究结果公布，分别针对原发性胆汁性胆管炎、特发性肺纤维化以及头颈部鳞状细胞癌。 22 13亿美元：默沙东收购EyeBio 5月29日，默沙东（MSD）和EyeBiotech Limited（EyeBio）联合宣布，两家公司已达成最终协议，默沙东将通过一家子公司以13亿美元的前付款和高达17亿美元的里程碑付款收购EyeBio公司。本次收购潜在总价值30亿美元。通过这一收购，默沙东将收获EyeBio的先导候选药物Restoret（EYE103），一种治疗糖尿病性黄斑水肿（DME）和新生血管性年龄相关性黄斑病变性（NVAMD）的新型晚期候选药物，以及一种针对视网膜疾病的临床前管线。 Restoret是一种四价、三特异性Wnt抗体，可以同时与受体LRP5和FZD4结合，激活Wnt信号通路。Wnt信号通路在恢复和维持血网膜屏障方面具有关键性作用。临床前研究显示，Restoret可持久减少DME和额NVAMD相关的视网膜血管渗漏。Restoret预计将于2024年下半年进入糖尿病性黄斑水肿关键研究。 23 0.5亿美元：GSK收购Elsie 6月7日，GSK宣布以5000万美元的款项收购了致力于开发寡核苷酸疗法的Elsie Biotechnologies公司。此次收购使GSK能够整合Elsie的寡核苷酸发现、合成和递送技术，以增强GSK平台的研发能力。 Elsie的发现平台是超高通量专有工艺，能够对寡核苷酸化学空间进行全面评估。通过应用专有编码技术，Elsie能够评估所有潜在的序列或化学修饰模式，旨在增强活性、降低毒性并改善寡核苷酸治疗候选药物的递送。此外，Elsie还采用专有的P（V）化学技术，包括一套新型试剂和工艺，通过精确的合成控制合成多种寡核苷酸疗法。 24 3.81亿美元：ANI收购Alimera 6月24日，仿制药公司ANI Pharmaceuticals（ANI）宣布以3.81亿美元收购Alimera Science。 Alimera 是一家全球性的专门从事用于治疗视网膜疾病处方药商业化开发的制药公司，因其两款主要产品而闻名：Iluvien是一种可注射的、非生物降解的氟轻松玻璃体内植入物，用于治疗糖尿病性黄斑水肿 (DME) ，以及慢性非感染性葡萄膜炎(NIU-PS)；Yutiq是一种氟轻松玻璃体内植入物，治疗NIU-PS。 25 2.5亿美元：艾伯维收购Celsius 6月27日，艾伯维（AbbVie）宣布以2.5亿美元款项收购Celsius Therapeutics。艾伯维将收获一款潜在“first-in-class”候选药物CEL383。 CEL383是一种针对TREM1的实验性抗体，已完成治疗炎症性肠病（IBD）的一期临床研究。TREM1已被确认为IBD中的关键致病基因，主要表达于炎性单核细胞和中性粒细胞上。在这些及其他细胞类型中，TREM1位于多个已知炎症通路的上游，能够放大炎症反应。CEL383已被证明可以抑制TREM1信号传导，降低炎症条件下具有高临床相关性的多种炎症介质的水平。写在最后 2024年上半年生物医药行业发生了25个并购案，其中我们不难看出交易集中在癌症（7起）和免疫系统疾病（11起）上，交易金额随着药物研发平台的含金量、管线的临床进展和临床重大成果而水涨船高。对于跨国制药巨头来说，并购重组能够获取优质资产，填补专利悬崖带来的销售缺口，并切入新兴赛道，重塑自己的产品管线和销售体系。对于Biotech企业来说，通过并购实现退出，这不仅为股东带来回报，也为Biotech的早期投资机构提供了退出渠道。同时，也意味着几乎不再面临资本市场的不确定性和资金链的挑战。如何促成并购案呢？上述成功的并购案例显示，具有创新技术平台和研发管线的企业更受青睐。如Elsie的寡核苷酸合成平台、Mariana的创新放射性药物管线和平台、Ambrx的非天然氨基酸的定点插入技术平台等。因此，面对市场寒冬，Biotech企业需要聚焦核心竞争力，对管线进行评估，避免局限于me-too或fast-follow药物。资料来源：公司官网、咨询类订阅号共建Biomedical创新生态圈！如何加入BiG会员？

并购抗体药物偶联物临床1期

2024-06-24

·BioSpace

Sun Pharma Completes Taro Merger

Combined entity is better positioned to compete in increasingly competitive generics industry MUMBAI, India and PRINCETON, N.J., June 24, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) today announced the successful completion of the merger of Taro Pharmaceutical Industries Ltd. (NYSE: TARO) ("Taro") with its subsidiary. As part of this merger, Sun Pharma acquired all outstanding ordinary shares of Taro other than the shares already held by Sun Pharma or its affiliates. As a result of the merger, Taro is now a private company and wholly-owned by Sun Pharma. Sun Pharma has been the majority shareholder of Taro since 2010. Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, said, "We are pleased with the successful completion of Taro merger process. This milestone marks a significant step forward for both organizations, allowing us to effectively leverage each other's strengths and capabilities. Together, we are excited about starting this new chapter and creating a more robust, successful future for the combined entity." About Sun Pharmaceutical Industries Limited (CIN – L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun Pharma's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Logo: Company Codes: Bombay:524715, Bombay:SUNPHARMA.BO, India:SUNPHARMA.NS

并购

2024-05-23

·BioSpace

Taro Shareholders Approve Merger with Sun Pharma

MUMBAI, India and NEW YORK, May 23, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries and/or associates referred as "Sun Pharma") and Taro Pharmaceutical Industries Ltd. (NYSE: TARO) ("Taro" or the "Company") today announced that the merger agreement between Taro and Sun Pharma was approved by the affirmative vote of Taro shareholders (including a vote of the majority of shares held by Taro shareholders unaffiliated with Sun Pharma) at an Extraordinary General Meeting and an Ordinary Class Meeting on May 22, 2024. The details of the merger agreement were announced on January 17, 2024. Dilip Shanghvi, Managing Director of Sun Pharma, said, "We are pleased with the approval by Taro's shareholders, which, subject to the remaining closing conditions, will enable Taro to merge with Sun. The combined entity will enable us to better serve the needs of patients, healthcare professionals and our customers around the world." Uday Baldota, Chief Executive Officer of Taro, said, "Throughout our fifteen-year relationship with Sun Pharma, Taro has benefited from their global scale and resources. This merger will further enable us to compete effectively in our products and markets." Upon completion of the merger, currently expected to close in approximately 35 days (subject to the satisfaction or waiver of certain closing conditions), Taro will become a privately held company wholly owned by Sun Pharma and soon after its shares will be de-listed from the NYSE. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050) Sun Pharma is a leading global specialty generics company with presence in Innovative products, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on "X" @SunPharma_Live About Taro Pharmaceutical Industries Ltd. (NYSE: TARO) Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products. For further information on Taro Pharmaceutical Industries Ltd., please visit the Company's website at Forward-Looking Statements This announcement contains forward-looking statements, including, but not limited to, the anticipated timing of closing the transaction. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Statements that are not historical or current facts, including statements about beliefs and expectations, are forward-looking statements. Forward-looking statements involve factors, risks and uncertainties that could cause actual results to differ materially from those expressed or implied in these forward-looking statements. Such factors, risks and uncertainties include the possibility that the merger will not occur on the timeline anticipated, or at all, if events arise that result in the termination of the Agreement, or if one or more of the various closing conditions to the merger are not satisfied or waived, or if the regulatory review process takes longer than anticipated and other risks and uncertainties discussed in documents filed with the SEC by the Company as well as the Schedule 13E-3 and the proxy statement filed by the Company. All information provided in this press release is as of the date of the press release, and the Company undertakes no duty to update such information, except as required under applicable law. Further information on these and other factors is included in filings the Company makes with the SEC from time to time, including the section titled "Risk Factors" in the Company's most recent Form 20-F, as well as the Form 6-K and Schedule 13E-3, including the amendments thereto (which include the proxy statement) filed by the Company. These documents are available (or will be available when filed) on the SEC Filings section of the Investor Relations section of the Company's website at: . Investor Relations Contacts Sun Pharmaceutical Industries Limited Investor Contact: Dr. Abhishek Sharma Tel: +91 22 4324 4324, Xtn 2929 Tel Direct: +91 22 4324 2929 Mobile: +91 98196 86016 E-mail: abhi.sharma@sunpharma.com Media Contact: Gaurav Chugh Tel: +91 22 4324 4324, Xtn 5373 Tel Direct: +91 22 4324 5373 Mobile: +91 98104 71414 E-mail: gaurav.chugh@sunpharma.com Media Contact (US): Janet Metz Mobile +1 609-389-3044 E mail: janet.metz@sunpharma.com Taro Pharmaceutical Industries Ltd. Contact: William J. Coote VP, CFO (914) 345-9001 William.Coote@taro.com View original content to download multimedia: SOURCE Sun Pharma Company Codes: Bloomberg:SUNP, Bombay:524715, India:SUNPHARMA, NYSE:TARO

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