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桐暉藥業是一家為醫藥研究提供專業服務的CRO公司
醫藥研發服務 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制劑
幽門螺旋桿菌根除綜合解決方案。
目前研發進度已經到臨床二期。
研究表明,幽門螺桿菌與慢性活動性胃炎、消化性潰瘍、萎縮性胃炎、MALT淋巴瘤和胃癌密切相關。
但幽門螺桿菌的根除受限于抗生素耐藥性,抑制胃酸不理想和藥物負擔等問題,效果不理想。
我們的新產品針對上述痛點,結合了長效的奧美拉唑和阿莫西林,為幽門螺桿菌的治療提出了新型的治療解決方案。
產品優勢:
*已通過成熟的CMC方法,并提供了足夠的中間體,為臨床2期做好準備。
*良好的市場潛力,2016年在美國有300萬張PPI加抗生素處方。
*對于GRED,夜間酸突破方面能帶來巨大的好處。
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.
針對oxLDL的單克隆抗體:
Orticumab(奧替庫單抗)-針對氧化的低密度脂蛋白(oxLDL)的抗炎單克隆抗體。
準備進行臨床2期
*通過3項臨床試驗,對260例患者進行了安全性評估。
*可能的適應癥包括:動脈粥樣硬化,銀屑病。
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雙特異性抗體
抗VEGF的護理標準療效有限且經常注射
* Aptitude的適體增加了ang2的功效
*與Roche Faricimab相比,VEGF效能高10倍,ang2效能高100倍
*持續時間更長
這些結合在一起意味著在最小有效濃度下需要更長的時間=更少的劑量
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
帶有共價抑制劑的平臺借助具有針對5000個靶標的共價抑制劑的平臺,BridGene可以與
*確定難以被藥物針對的目標,并提供有關選擇性的信息,以快速創建潛在候選化合物
*確定表型篩選的目標
兩個共價抑制劑計劃準備合作
1. FGFR4癌癥抑制劑:
*具有口服生物利用度的小分子,
*在HCC和橫紋肌肉瘤模型中的療效和消退
*極大的選擇性 *抑制網守突變
2. GMPS狼瘡和其他自身免疫性疾病的抑制劑:新型免疫抑制劑
GMPS在嘌呤合成中IMPDH的下游,其中批準的MPA(MMF)免疫抑制劑起作用
* nM有效劑量, 抑制T細胞活化和T細胞生長*體內作用
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.
一種在美國和臺灣用于1期臨床治療癌癥的人源化IgG抗體GNX102。
*針對雙天線LeY,以比正常細胞更高的選擇性靶向許多癌癥。
* GNX102在人類腫瘤異種移植模型中顯示出出色的抗腫瘤功效。
*初步毒理學研究表明,GNX102在測試的大鼠,狗和食蟹猴中具有良好的耐受性。
* GNX102在大鼠和食蟹猴的GLP毒理研究中顯示出優異的安全性。
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
采用兒童接種抗原的突破性癌癥免疫療法
*激活并重定向在兒童破傷風疫苗接種過程中產生的先前存在的記憶T細胞,使其轉移至實體瘤和轉移灶
*減毒李斯特菌感染腫瘤歸巢MDSC,將抗原傳遞給腫瘤
*與許多在老年患者中很難將幼稚T細胞轉化為記憶T細胞的方法不同
*抗原具有很高的免疫原性,不會引起腫瘤誘變
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
具有更長持續時間和皮下生物利用度的多肽治療劑
*長效Grelin衍生物可治療癌癥惡病質-單劑量可逆轉動物模型中的惡病質
*長效甲狀旁腺激素可治療甲狀旁腺功能低下
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
一對來自單個細胞的抗體成為一個單一的藥物實體,允許不同的同種型和化學計量比,以快速創建產品
*臨床1期:PSB205:來自單個細胞的PD1和CTLA4抗體設計用于快速清除CTLA4,以實現最佳功效
*多個腫瘤免疫候選項目,包括PD1 / x,CD20 / CD37對,Her2 / Her2
*此平臺尋求合作伙伴
Glyconex
well characterized biosimilar to denosumab for osteoporosis and bone metastases from multiple myeloma
* 200L scale with cell line
* Great comparability and stability
與地諾單抗相似的生物仿制藥,用于治療多發性骨髓瘤的骨質疏松和骨轉移
* 200L規模細胞株
*出色的可比性和穩定性
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