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桐晖药业是一家为医药研究提供专业服务的CRO公司
医药研发服务 Service Items
PyloriMed
Phase 2 ready for H Pylori eradication, GERD
H Pylori strongly linked to chronic active gastritis, peptic ulcer, atrophic gastritis, MALT lymphoma and gastric cancer .  
Eradication limited by antibiotic resistance, suboptimal acid suppression and pill burden leading to poor compliance.  
* Pylori Med’s novel CMA-PPI H. pylori eradication regimen combines long-duration pro-omeprazole with amoxicillin 
* Phase 2 ready with established CMC methods and more than sufficient intermediate for Phase 2 
Good market potential with 3 million prescriptions in US for PPI plus antibiotic in 2016.  
Huge Upside in nighttime acid breakthru GERD
新型CMA-PPI制剂
幽门螺旋杆菌根除综合解决方案。
目前研发进度已经到临床二期。
研究表明,幽门螺杆菌与慢性活动性胃炎、消化性溃疡、萎缩性胃炎、MALT淋巴瘤和胃癌密切相关。
但幽门螺杆菌的根除受限于抗生素耐药性,抑制胃酸不理想和药物负担等问题,效果不理想。
我们的新产品针对上述痛点,结合了长效的奥美拉唑和阿莫西林,为幽门螺杆菌的治疗提出了新型的治疗解决方案。
产品优势:
*已通过成熟的CMC方法,并提供了足够的中间体,为临床2期做好准备。
*良好的市场潜力,2016年在美国有300万张PPI加抗生素处方。
*对于GRED,夜间酸突破方面能带来巨大的好处。
ABCENTRA
Phase 2 Ab to oxLDL
Orticumab - Anti-inflammatory monoclonal antibodies targeting oxidized low-density lipoprotein (oxLDL).  
Preparing for Phase II 
*260 patients have been treated with excellent safety profile through 3 clinical trials.  
*Possible indications include:  atherosclerosis, psoriasis.
针对oxLDL的单克隆抗体:
Orticumab(奥替库单抗)-针对氧化的低密度脂蛋白(oxLDL)的抗炎单克隆抗体。
准备进行临床2期
*通过3项临床试验,对260例患者进行了安全性评估。
*可能的适应症包括:动脉粥样硬化,银屑病。
APTITUDE VISION
VEGF/ang2 bispecific aptamer for ophthalmology
Standard of care anti-VEGF has limited efficacy and frequent injections
*  Aptitude's aptamer has added efficacy from ang2 
*  And 10x greater VEGF potency and 100x greater ang2 potency than Roche Faricimab
*  And much longer duration
These combine to mean MUCH longer time over minimal effective concentration = LESS FREQUENT DOSING
眼科用VEGF / ang2双特异性抗体
抗VEGF的护理标准疗效有限且经常注射
* Aptitude的适体增加了ang2的功效
*与Roche Faricimab相比,VEGF效能高10倍,ang2效能高100倍
*持续时间更长
这些结合在一起意味着在最小有效浓度下需要更长的时间=更少的剂量
BridGene Biosciences
With a platform with covalent inhibitors to 5000 targets, BridGene can collaborate to 
*  identify a hit for a hard to drug-like hit target and provide information on selectivity to enable a rapid creation of a lead candidate
*  identify the targets of phenotypic screens
Two  covalent inhibitors programs ready for partnering
FGFR4 inhibitor for cancer:  
*  small molecule with oral bioavailability, 
*  efficacy and regression in HCC and Rhabdomyosarcoma models
*  great selectivity
*  inhibition of gatekeeper mutations
GMPS inhibitor for lupus and other autoimmune disorders: 
Novel immunosupressant
GMPS is downstream of IMPDH in purine synthesis where approved MPA (MMF) immunosuppressant acts 
* nM potency
* suppression of T cell activation and T cell growth
* In vivo effects
带有共价抑制剂的平台借助具有针对5000个靶标的共价抑制剂的平台,BridGene可以与
*确定难以被药物针对的目标,并提供有关选择性的信息,以快速创建潜在候选化合物
*确定表型筛选的目标
两个共价抑制剂计划准备合作
1. FGFR4癌症抑制剂:
*具有口服生物利用度的小分子,
*在HCC和横纹肌肉瘤模型中的疗效和消退
*极大的选择性 *抑制网守突变
2. GMPS狼疮和其他自身免疫性疾病的抑制剂:新型免疫抑制剂
GMPS在嘌呤合成中IMPDH的下游,其中批准的MPA(MMF)免疫抑制剂起作用
* nM有效剂量, 抑制T细胞活化和T细胞生长*体内作用
GLYCONEX
 A humanized IgG antibody GNX102 for cancer in Phase 1 in US and Taiwan.
*  Targeted to biantennary LeY to target many cancers with higher selectivity versus normal cells.
*  GNX102 showed great anti-tumor efficacy in human tumor xenograft models.
*  Pilot toxicology studies showed that GNX102 was well tolerated in tested rats, dogs, and Cynomolgus monkeys.
*  GNX102 showed superior safety profile in GLP tox studies in rat and Cynomolgus monkeys.
一种在美国和台湾用于1期临床治疗癌症的人源化IgG抗体GNX102。
*针对双天线LeY,以比正常细胞更高的选择性靶向许多癌症。
* GNX102在人类肿瘤异种移植模型中显示出出色的抗肿瘤功效。
*初步毒理学研究表明,GNX102在测试的大鼠,狗和食蟹猴中具有良好的耐受性。
* GNX102在大鼠和食蟹猴的GLP毒理研究中显示出优异的安全性。
LOKI THERAPEUTICS
Breakthrough cancer immunotherapy with antigens of childhood vaccination 
*  Activates and redirects pre-existing memory T cells created during childhood tetanus vaccination to solid tumors and metastases
*  Attenuated Listeria infects tumor homing MDSC to deliver the antigens to the tumors
*  Unlike many approaches where converting naive T cells to memory T cells is hard in older patients
*  Antigens very immunogenic and not subject to tumor mutagenesis
采用儿童接种抗原的突破性癌症免疫疗法
*激活并重定向在儿童破伤风疫苗接种过程中产生的先前存在的记忆T细胞,使其转移至实体瘤和转移灶
*减毒李斯特菌感染肿瘤归巢MDSC,将抗原传递给肿瘤
*与许多在老年患者中很难将幼稚T细胞转化为记忆T细胞的方法不同
*抗原具有很高的免疫原性,不会引起肿瘤诱变
EXTEND BIO
Peptide therapeutics with extended duration and subcutaneous bioavailability
*  Long-acting grelin derivative for cancer cachexia - a single dose reverses cachexia in animal models
* Long-acting PTH for hypoparathyroidism
具有更长持续时间和皮下生物利用度的多肽治疗剂
*长效Grelin衍生物可治疗癌症恶病质-单剂量可逆转动物模型中的恶病质
*长效甲状旁腺激素可治疗甲状旁腺功能低下
Sound Biologics
Pair of Abs from a single cell to be a single drug entity, allowing different isotypes and stoichiometries, for rapid product creation
*  In Phase 1:   PSB205:  PD1 and CTLA4 Abs from a single cell designed to have rapid clearance of the CTLA4 for optimal efficacy
*  Multiple IO candidates including PD1/x,  CD20/CD37 pair, Her2/Her2 pair
*  Also seeking partnerships on platform
一对来自单个细胞的抗体成为一个单一的药物实体,允许不同的同种型和化学计量比,以快速创建产品
*临床1期:PSB205:来自单个细胞的PD1和CTLA4抗体设计用于快速清除CTLA4,以实现最佳功效
*多个肿瘤免疫候选项目,包括PD1 / x,CD20 / CD37对,Her2 / Her2
*此平台寻求合作伙伴
Glyconex
well characterized biosimilar to denosumab for osteoporosis and bone metastases from multiple myeloma
* 200L scale with cell line
* Great comparability and stability
与地诺单抗相似的生物仿制药,用于治疗多发性骨髓瘤的骨质疏松和骨转移
* 200L规模细胞株
*出色的可比性和稳定性
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