Core Viewpoint - The company has successfully completed Phase II clinical trials for its innovative drug UBT251 injection in overweight/obese patients in China, demonstrating significant weight loss and safety profile [1][2]. Group 1: Clinical Trial Details - The Phase II clinical study involved 205 participants with obesity (BMI ≥ 28.0 kg/m²) or overweight patients with at least one weight-related comorbidity (24.0 kg/m² ≤ BMI < 28.0 kg/m²) [1]. - Participants were randomly assigned in a 1:1:1:1 ratio to receive UBT251 injection at doses of 2 mg, 4 mg, or 6 mg, or a placebo, administered once weekly for 24 weeks [1]. - The primary endpoint was the percentage change in weight from baseline after 24 weeks of treatment [1]. Group 2: Results and Efficacy - After 24 weeks, the UBT251 treatment groups achieved a maximum average weight reduction of -19.7% (-17.5 kg), compared to -2.0% (-1.6 kg) in the placebo group [2]. - Significant improvements were also observed in secondary endpoints, including waist circumference, blood glucose, blood pressure, and blood lipids, all showing better results than the placebo [2]. Group 3: Safety and Next Steps - The overall safety and tolerability of UBT251 were good, with no participants dropping out due to adverse events, which were similar to those of comparable drugs and mostly mild to moderate gastrointestinal reactions [2]. - The successful Phase II results support the progression to Phase III clinical trials for UBT251 in overweight/obese patients in China [2].

截至本公告日，在新加坡境内该药品主要有BAYER，TEVA和INTEGA等其他6家获批厂商，BAYER为 主要销售商。 IQVIA数据库显示，2024年新加坡市场利伐沙班片三个规格(10mg、15mg、20mg)销售总额为800万美 元。 本次利伐沙班片3个规格(10mg、15mg、20mg)获得新加坡食品药品监督管理局的药品注册批文，标志着 该药品已具备在新加坡上市销售的资格，对公司拓展海外市场带来积极影响，并积累宝贵的经验。 智通财经APP讯，上海医药(02607)发布公告，近日，上海医药集团股份有限公司(以下简称"上海医 药"或"公司")下属常州制药厂有限公司(以下简称"常州制药厂")生产的利伐沙班片(以下简称"该药品")收 到新加坡食品药品监督管理局(HSA)颁发的药品注册证书，该药品获得批准上市。 利伐沙班片主要用于降低非瓣膜性房颤患者卒中和全身性栓塞的风险;用于治疗和预防深静脉血栓形成 (DVT);用于治疗肺栓塞(PE);用于预防急性病患者静脉血栓栓塞(VTE)等。利伐沙班片最早由BAYER和 JANSSEN联合研发并于2011年在美国上市。 2025年5月，常州制药厂的利伐沙班片获得美国食品药品 ...

同仁堂制药厂产品儿感清口服液、锁阳固精丸、人参健脾丸、大黄虫丸取得加拿大卫生部颁发的《产品 许可证(三类)》系产品上市许可。上述产品若拟在加拿大销售，后续还需根据加拿大卫生部法规要求， 完成包括但不限于对生产场地的加拿大生产质量体系认证等行政审批事项，该等审批可能存在一定不确 定性。本次获批事宜对公司近期经营业绩不会产生重大影响。 同仁堂（600085）(600085.SH)发布公告，公司分支机构北京同仁堂股份有限公司同仁堂制药厂(以下简 称同仁堂制药厂)收到加拿大卫生部核准签发的《产品许可证(三类)》，同仁堂制药厂产品儿感清口服 液、锁阳固精丸、人参健脾丸、大黄虫丸获得加拿大产品注册。 ...

凤凰网财经讯 港股2月24日收盘走低，恒生指数收报26590.32点，跌491.59点，跌幅1.82%；恒生科技指 数收报5270.7点，跌114.65点，跌幅2.13%。 恒生指数成分股中万洲国际、恒基地产、华润啤酒涨幅居前，中国生物制药、翰森制药、中国人寿跌幅 靠前。恒生科技指数成分股中华虹半导体、联想集团、小鹏汽车-W涨幅居前，金蝶国际、商汤-W、腾 讯音乐-SW跌幅靠前。 ...

华海药业公告称，近日收到国家药监局核准签发的马来酸曲美布汀片的《药品注册证书》，批准文号为 国药准字H20263372。该药品用于改善胃肠道运动功能紊乱症状和肠易激综合征，2025年国内市场销售 金额预计约3.4亿元。截至目前，公司在该药品研发上已投入约1010万元。获批产品可视同通过一致性 评价，将丰富产品线、提升竞争力，但生产和销售易受政策、市场等因素影响。 ...

Group 1 - The core point of the article is that Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of Trimebutine Maleate Tablets [1] - Trimebutine Maleate Tablets are indicated for the improvement of symptoms related to gastrointestinal motility disorders, including loss of appetite, nausea, vomiting, belching, abdominal distension, borborygmi, abdominal pain, diarrhea, and constipation, as well as for irritable bowel syndrome [1]

智通财经APP讯，葵花药业(002737.SZ)公告，公司子公司于近日收到国家药品监督管理局下发的关于复 方聚乙二醇(3350)电解质口服溶液获批注册的药品注册证书。相关适应症为：治疗慢性便秘、粪便嵌 塞。 ...

Core Insights - The strategic collaboration between Xianweida Biotech and Pfizer China focuses on the commercialization of Enoglutide injection, the first cAMP biased GLP-1 receptor agonist approved for adult type 2 diabetes treatment in China [1][2] - Pfizer will hold exclusive commercialization rights for Enoglutide in mainland China, while Xianweida will act as the marketing authorization holder (MAH) responsible for R&D, registration, production, and supply [1] - The agreement includes potential payments to Xianweida totaling up to $495 million, which encompasses upfront payments and milestone payments related to registration and sales [1] Clinical Efficacy - Enoglutide has demonstrated superior efficacy and safety in multiple clinical studies, with an average weight reduction of 15.1% in the Chinese population after adjusting for the placebo group [1] - 92.8% of patients achieved clinically significant weight loss, and over 80% of patients met blood sugar targets (HbA1c <7.0%) [1] Strategic Vision - The CEO of Xianweida, Dr. Pan Hai, expressed optimism about integrating Xianweida's innovative scientific achievements with Pfizer China's commercial capabilities to advance the commercialization of Enoglutide [2] - The collaboration aims to leverage the "Weight Management Year" as a significant opportunity to provide diverse and high-quality treatment options for patients with obesity and metabolic diseases in China [2]

利伐沙班片主要用于降低非瓣膜性房颤患者卒中和全身性栓塞的风险；用于治疗和预防深静脉血栓形成 （DVT）；用于治疗肺栓塞（PE）；用于预防急性病患者静脉血栓栓塞（VTE）等。 格隆汇2月24日丨上海医药(601607.SH)公布，公司下属常州制药厂有限公司（简称"常州制药厂"）生产 的利伐沙班片（简称"该药品"）收到新加坡食品药品监督管理局（HSA）颁发的药品注册证书，该药品 获得批准上市。 ...

上海医药(601607.SH)公告称，公司下属常州制药厂有限公司生产的利伐沙班片收到新加坡食品药品监 督管理局颁发的药品注册证书，该药品获得批准上市。该药品主要用于降低非瓣膜性房颤患者卒中和全 身性栓塞的风险；用于治疗和预防深静脉血栓形成（DVT）；用于治疗肺栓塞（PE）；用于预防急性 病患者静脉血栓栓塞（VTE）等。截至公告日，公司针对该药品在东南亚市场（即泰国、新加坡、马来 西亚及菲律宾）上市另投入的研发费用约人民币324.82万元。 ...