TQF3250胶囊
Search documents
速递|正大天晴减重降糖口服新药FDA获批临床!
GLP1减重宝典· 2025-12-05 04:54
整理 | GLP1减重宝典内容团队 12月1日,中国生物制药(1177.HK)自主研发的1类创新药 TQF3250 胶囊(口服小分子偏向型GLP-1受体激动剂)获得美国食品药品 监督管理局(FDA)批准开展临床试验,拟用于减重治疗。此前的11月17日,其针对超重及肥胖人群的临床试验申请已获中国国家药 品监督管理局(NMPA)受理。除减重外,TQF3250近期还取得了用于2型糖尿病治疗的临床试验许可,体现其在代谢疾病领域的应用 潜力。 全球超重与肥胖问题持续加剧,对公共健康体系形成高压。根据《世界肥胖地图2025》预测,全球成年人超重及肥胖比例将从2000年 的36%攀升至2030年的50%,涉及近30亿人口。在中国,这一趋势同样显著:截至2025年,41%的成年人BMI≥25kg/m²,9%达到肥胖 标准。预计到2030年,我国高BMI成年人数将增至5.15亿,男性和40至65岁人群的风险更为突出。肥胖带来的疾病负担持续扩大。 2021年,全球因肥胖相关疾病导致的成年人过早死亡约1600万,相关慢性非传染性疾病占全球整体疾病负担的27%。值得关注的是, 约55%的2型糖尿病过早死亡与肥胖密切相关,全球在肥胖管 ...
智通港股早知道 | 因大宗商品供应线路被扰乱 航运价格飙升467%
Zhi Tong Cai Jing· 2025-12-04 23:56
【今日头条】 航运价格飙升467% 因大宗商品供应线路被扰乱 12月3日,波罗的海干散货指数(BDI)报2845点,创下2023年12月6日以来新高水平,单日涨幅达9.42%, 为近两个月最大单日涨幅。值得注意的是,BDI已连续15个交易日上涨,过去一个月累计涨幅达46%, 显示出干散货航运市场的强劲复苏势头。 由于冲突、制裁和产量激增扰乱了全球供应线路,从能源到散装矿石等大宗商品的跨洋运费迈向罕见的 年底飙升。今年走主要航线运输原油的每日进账金额增幅最大,为467%,液化天然气和铁矿石等大宗 商品的运费则分别上涨了三倍多和一倍多。以往运费在年底会下降,因为这时期是需求淡季。船舶在海 上运输货物的时间越来越长,导致价格飙升,一些航运业高管预计,整体市场的紧张局面至少会持续到 明年年初。 集运市场也呈现回暖迹象。11月以来,亚欧航线迎来一轮涨价潮,包括达飞海运集团、赫伯罗特和地中 海航运在内的多家国际航运巨头相继发布涨价公告。涉及集运产业链相关港股:太平洋航运(02343)、 辽港股份(02880)、海丰国际(01308)、东方海外国际(00316)、中远海控(01919)。 美股三大指数涨跌不一 Meta(M ...
中国生物制药:TQF3250“口服偏向型GLP-1受体激动剂”临床试验申请获NMPA、FDA批准
Zhi Tong Cai Jing· 2025-12-04 14:32
中国生物制药(01177)发布公告,集团自主研发的创新药TQF3250胶囊"口服偏向型GLP-1受体激动剂"的 临床试验申请已获得中国国家药品监督管理局(NMPA)和美国食品药品监督管理局(FDA)的批准,拟用 于减重。 除减重适应症外,TQF3250用于治疗2型糖尿病的临床试验申请已获NMPA批准。代谢性疾病是集团聚 焦的核心治疗领域之一,集团将通过多元化的产品管线,为患者提供更丰富的治疗选择。 超重与肥胖已成为21世纪最严峻的公共卫生挑战之一。根据《世界肥胖地图2025》报告,全球成年人超 重及肥胖比例预计将从2000年的36%攀升至2030年的50%,受影响人口近30亿。在中国,这一趋势尤为 显著,2025年中国已有41%的成年人伴有高BMI(≥25kg/m ), 9%的成年人达到肥胖标准(BMI≥30kg/m )。预计到2030年,中国高BMI成年人数量将达5.15亿。 TQF3250是一款口服小分子偏向型GLP-1受体激动剂。与传统GLP-1药物相比,TQF3250通过选择性激 活cAMP偏向的GLP-1受体信号通路,促进胰岛素分泌,同时减少β-arrestin募集和受体内吞,从而延长 药效持续时间 ...
中国生物制药(01177.HK):减重药TQF3250"口服偏向型GLP-1受体激动剂"临床试验申请获NMPA、FDA批准
Ge Long Hui· 2025-12-04 09:33
TQF3250是一款口服小分子偏向型GLP-1受体激动剂。与传统GLP-1药物相比,TQF3250通过选择性激 活cAMP偏向的GLP-1受体信号通路,促进胰岛素分泌,同时减少β-arrestin募集和受体内吞,从而延长 药效持续时间。TQF3250凭借其独特的作用机制,有望实现更优的血糖与体重控制,且显着降低胃肠道 副作用。相较於主流GLP-1药物的注射剂型,其口服给药方式更能大幅提升患者用药便利性和长期治疗 依从性。 格隆汇12月4日丨中国生物制药(01177.HK)布,集团自主研发的创新药TQF3250胶囊「口服偏向型GLP-1 受体激动剂」的临床试验申请已获得中国国家药品监督管理局(NMPA)和美国食品药品监督管理局 (FDA)的批准,拟用于减重。 除减重适应症外,TQF3250用于治疗2型糖尿病的临床试验申请已获NMPA批准。代谢性疾病是集团聚 焦的核心治疗领域之一,集团将通过多元化的产品管线,为患者提供更丰富的治疗选择。 超重与肥胖已成为21世纪最严峻的公共卫生挑战之一。根据《世界肥胖地图2025》报告,全球成年人超 重及肥胖比例预计将从2000年的36%攀升至2030年的50%,受影响人口近30 ...
中国生物制药(01177):TQF3250胶囊“GLP-1受体激动剂”临床试验申请获NMPA受理
智通财经网· 2025-09-22 08:43
Core Insights - China Biopharmaceutical's self-developed innovative drug TQF3250, a GLP-1 receptor agonist, has received acceptance for clinical trial application from the National Medical Products Administration (NMPA) in China, aimed at treating type 2 diabetes [1][2] - TQF3250 is an oral small molecule GLP-1RA that selectively activates the cAMP-biased GLP-1R signaling pathway, effectively promoting insulin secretion while reducing β-inhibitory protein recruitment and receptor internalization, thereby extending the duration of drug efficacy [1] - Preclinical studies indicate that TQF3250 significantly improves glucose tolerance at doses as low as 1 mg/kg in mouse models, showing comparable efficacy to the similar drug Orforglipron [1] - In monkey models, TQF3250's no-observed-adverse-effect level (NOAEL) reached 24 mg/kg/day, with no significant cardiac or genetic toxicity risks identified, indicating good safety [1] Market Potential - Third-party statistics show that the global GLP-1RA market is expected to exceed $50 billion in 2024 and surpass $150 billion by 2031 [1] - The current GLP-1RA market is predominantly composed of injectable formulations, while TQF3250, as an oral capsule, presents multiple advantages: 1. Convenient administration, significantly enhancing patient compliance 2. Stability in storage, with the formulation showing stability for 24 months at 25ºC 3. Metabolic safety, primarily metabolized by CYP3A enzymes, resulting in low risk of drug interactions [1] Development Strategy - The company aims to accelerate the clinical development of TQF3250 to provide a more convenient and effective treatment option for patients with type 2 diabetes [2]
中国生物制药(01177.HK):TQF3250胶囊“GLP-1受体激动剂”临床试验申请获NMPA受理
Ge Long Hui· 2025-09-22 08:42
Core Viewpoint - China National Pharmaceutical Group (01177.HK) has received acceptance for the clinical trial application (IND) of its self-developed innovative drug TQF3250, a GLP-1 receptor agonist, from the National Medical Products Administration (NMPA) in China, aimed at treating type 2 diabetes [1]. Group 1 - TQF3250 is an oral small molecule GLP-1 receptor agonist that selectively activates the cAMP-biased GLP-1R signaling pathway [1]. - The drug effectively promotes insulin secretion while reducing the recruitment of β-inhibitory proteins and receptor internalization, thereby extending the duration of its efficacy [1].
中国生物制药:TQF3250胶囊“GLP-1受体激动剂”临床试验申请获NMPA受理
Zhi Tong Cai Jing· 2025-09-22 08:41
Core Viewpoint - China Biopharmaceutical (01177) has received acceptance for the clinical trial application (IND) of its self-developed innovative drug TQF3250, a GLP-1 receptor agonist, intended for the treatment of type 2 diabetes [1][2] Company Summary - TQF3250 is an oral small molecule GLP-1 receptor agonist that selectively activates the cAMP-biased GLP-1R signaling pathway, effectively promoting insulin secretion while reducing β-inhibitory protein recruitment and receptor internalization, thereby extending the duration of drug efficacy [1] - Preclinical studies indicate that TQF3250 significantly improves glucose tolerance in mouse models at doses as low as 1 mg/kg, showing comparable activity to the similar drug Orforglipron, demonstrating high efficacy in glucose reduction [1] - In monkey models, the no-observed-adverse-effect level (NOAEL) for TQF3250 reached 24 mg/kg/day, with no significant cardiac or genetic toxicity risks identified, indicating good safety [1] Industry Summary - Third-party statistics show that the global market for GLP-1 receptor agonists is expected to exceed $50 billion in 2024 and is projected to surpass $150 billion by 2031 [1] - The current GLP-1 receptor agonist market is predominantly composed of injectable formulations, while TQF3250, as an oral capsule formulation, presents multiple advantages: 1. Convenient administration, significantly enhancing patient compliance 2. Stable storage, with the formulation showing stability for 24 months at 25°C 3. Metabolic safety, primarily metabolized by CYP3A enzymes, resulting in low risk of drug interactions [1] - Currently, there is only one approved oral GLP-1 receptor agonist globally, and the company aims to accelerate the clinical development of TQF3250 to provide a more convenient and effective treatment option for type 2 diabetes patients [2]