药品研发

Search documents
联邦制药(03933.HK):UBT251已授权给诺和诺德 动保/胰岛素稳健增长
Ge Long Hui· 2025-05-22 01:55
Core Viewpoint - The company, Lianbang Pharmaceutical, has shown significant progress in its drug development, particularly in weight loss and insulin products, while maintaining a stable growth outlook in its antibiotic and animal health segments [1][2][3] Group 1: Weight Loss Drug Development - UBT251 has achieved authorization, and the clinical trial results for UBT251 in China show a 15.1% average weight loss from baseline at the highest dose after 12 weeks, compared to a 1.5% increase in the placebo group [1] - The safety profile of UBT251 is similar to other gut incretin products, with the most common adverse events being gastrointestinal reactions, mostly mild to moderate [1] - The company has granted overseas rights for UBT251 to Novo Nordisk, receiving an upfront payment of $200 million and potential milestone payments of up to $1.8 billion, along with tiered sales royalties based on annual net sales in overseas regions [1] Group 2: Insulin Business Outlook - The company has successfully won bids in all six procurement groups for insulin, with all selected products classified as Class A, indicating a stable growth outlook for its insulin business [2] - The company’s self-production costs are controllable, which supports the expectation of stable growth in the insulin segment [2] Group 3: Animal Health and Antibiotics - The company anticipates that 19 animal health formulations will be launched by 2025, with over 10 formulations expected to be approved annually from 2026 to 2028, indicating a strong pipeline and growth potential in the animal health market [2] - The company has established itself as a leader in the penicillin industry, with a market share of around 50% in both penicillin industrial salt and 6-APA, benefiting from vertical integration and process iteration [2] - The antibiotic business is expected to remain stable, despite some anticipated fluctuations in demand starting in Q4 2024, due to the execution of centralized procurement for piperacillin-tazobactam sodium [2] Group 4: Financial Projections and Valuation - The company’s projected total revenue for 2025-2027 is estimated at 145.24 billion, 139.87 billion, and 145.80 billion yuan, with year-on-year growth rates of 5.56%, -3.70%, and 4.23% respectively [2] - The projected net profit attributable to the parent company for the same period is 29.07 billion, 25.57 billion, and 27.62 billion yuan [2] - The company is valued using a comparable company valuation method, with a target market capitalization of 34.102 billion HKD and a target price of 18.77 HKD per share, reflecting a buy rating [3]
上海复星医药(集团)股份有限公司 关于控股子公司药品临床试验进展的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-05-17 04:59
本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性承担法律责任。 一、概况 近日,上海复星医药(集团)股份有限公司(以下简称"本公司")控股子公司上海复宏汉霖生物技术股 份有限公司及其控股子公司自主研发的伊匹木单抗生物类似药HLX13(重组抗CTLA-4全人单克隆抗体 注射液,以下简称"HLX13")一线治疗不可切除的晚期肝细胞癌(HCC)患者于中国境内启动I/III期临 床试验。 二、HLX13的基本信息及研究情况 HLX13为本集团(即本公司及控股子公司/单位,下同)自主研发的伊匹木单抗生物类似药,拟用于治 疗黑色素瘤、肾细胞癌、结直肠癌、肝细胞癌、非小细胞肺癌、恶性胸膜间皮瘤及食管鳞状细胞癌。 截至2025年4月,本集团现阶段针对HLX13累计研发投入约为人民币1.04亿元(未经审计)。 特此公告。 上海复星医药(集团)股份有限公司 董事会 二零二五年五月十六日 (1 由IQVIA提供,IQVIA是全球医药健康产业专业信息和战略咨询服务提供商。) 根据IQVIA MIDASTM最新数据1,2024年,伊匹木单抗制剂于全球范围内的销售额约为 ...
未名医药(002581) - 2025年5月15日投资者关系活动记录表
2025-05-16 11:03
6、公司最近有分红计划吗? 证券代码:002581 证券简称:未名医药 山东未名生物医药股份有限公司投资者关系活动记录表 编号:2025-001 | | □特定对象调研□分析师会议 | | --- | --- | | 投资者关系活动 | □媒体采访□业绩说明会 | | 类别 | □新闻发布会□路演活动 | | | □现场参观 | | | 年山东辖区上市公司投资者网上集体接待日活动 ☑其他 2025 | | 参与单位名称及 | 通过"全景路演"网站(http://rs.p5w.net)、"全景财经"微信 | | 人员姓名 | 公众号、全景路演 APP 方式参与"2025 年山东辖区上市公司投 | | | 资者网上集体接待日"活动的广大投资者。 | | 时间 | 2025 年 5 月 15 日(周四)下午 15:00-16:30 | | 地点 | 全景网"投资者关系互动平台"(https://ir.p5w.net) | | 上市公司接待人 | 董事长、总经理岳家霖先生、副总经理徐隽雄先生、财务总监周 | | 员姓名 | 婷女士、董事会秘书史晓如女士 | | | 公司就投资者在本次说明会中提出的问题进行了回复: | ...
双鹭药业(002038) - 002038双鹭药业投资者关系管理信息20250514
2025-05-15 09:32
证券代码: 002038 证券简称:双鹭药业 北京双鹭药业股份有限公司投资者关系活动记录表 编号:2025-001 深圳市全景网络有限公司 公司研发的 GLP-1 周制剂和日制剂用于Ⅱ型糖尿病治疗及 体重管理目前已完成临床研究,正在进行申报前的准备。 3、DT678 临床查询为主动终止,具体原因是什么? 2025 年一季度报告利润 4597 多万,扣非后为 2100 万,董秘解释:首 药控股和星昊医药两项一季度对利润影响-11065 万元,如何理 解? DT678 优先的临床研究方案将于近期启动。首药控股和星昊 医药由于股价波动,去年一季度与今年一季度相比公司持股市值 下降 11065 万元。 4、目前公司的产品基本仿制药为主,但看目前的业绩,卖 得越多,并不攒钱,看趋势还可能会亏损,后续规划是什么,是 否有计划引进新的高管,寻找新的思路。 企业要发展就需要不断推出有竞争力的产品,不断引进和培 养优秀的技术和管理人才,您说的很对,多家竞争的仿制药利润 微薄,需要企业不断开发有竞争力的产品,采取差异化的竞争策 略。公司新推出的益生元益生菌压片糖果也是公司寻找新的利润 增长点的一次尝试。该含片含有的凝结魏茨曼氏菌 ...
诺诚健华(688428):1Q25业绩略好于预期,全年奥布替尼收入指引上调5%
SPDB International· 2025-05-14 12:58
Investment Rating - The report maintains a "Buy" rating for the Hong Kong stock and a "Hold" rating for the A-share, with target prices set at HKD 11.7 and CNY 19.6 respectively [5][12]. Core Insights - The company's Q1 2025 performance slightly exceeded expectations, with total revenue reaching RMB 381 million, representing a year-on-year increase of 129.9% and a quarter-on-quarter increase of 22.3% [2][3]. - The revenue from the drug Oubatinib was RMB 311 million, showing a year-on-year growth of 89.2% and a quarter-on-quarter growth of 1.2% [2][3]. - The management has raised the full-year revenue growth guidance for Oubatinib from 30% to 35% year-on-year, driven by strong sales in exclusive indications and market share gains [3][12]. Financial Performance Summary - Q1 2025 net profit attributable to shareholders was RMB 17.97 million, which is an improvement compared to previous losses, primarily due to better-than-expected revenue and lower sales and administrative expenses [2][3]. - The gross margin for product sales improved to 88.4%, up from 85.3% in Q1 2024 and 87% in Q4 2024 [2][3]. - The company expects significant contributions from the MZL indication to Oubatinib's overall revenue, increasing from 30% in 2024 to 50% in 2025 [3][12]. Research and Development Progress - The company is advancing two TYK2 inhibitors, with CP-332 in Phase III clinical trials for AD and CP-448 in Phase III for psoriasis, both expected to complete patient enrollment in 2025 [4][12]. - Key upcoming R&D catalysts include new indication approvals and important data readouts for Oubatinib and other drugs [4][12]. Market Expectations - The current market capitalization is approximately HKD 20.066 billion, with a recent average trading volume of HKD 121 million over the past three months [5][12]. - The stock price has ranged between HKD 4.2 and HKD 11.0 over the past 52 weeks, with the current price at HKD 9.5, indicating a potential upside of 23% to the target price [5][12].
Aquestive(AQST) - 2025 Q1 - Earnings Call Transcript
2025-05-13 13:00
Aquestive Therapeutics (AQST) Q1 2025 Earnings Call May 13, 2025 08:00 AM ET Speaker0 Good day, and thank you for standing by. Welcome to the Aquestive Therapeutics first quarter twenty twenty five earnings conference call. At this time, all participants are in a listen only mode. After the speakers' presentation, there'll be a question and answer session. Please be advised today's conference is being recorded. I would now like to turn the conference over to your host today, Brian Korb. Please go ahead. Spe ...
莎普爱思:获得左氧氟沙星滴眼液药品补充申请批准
news flash· 2025-05-09 07:34
莎普爱思(603168)公告,公司近日收到国家药品监督管理局核发的左氧氟沙星滴眼液《药品补充申请 批准通知书》。该药品适应菌种包括葡萄球菌属、链球菌属等,适应症为眼睑炎、结膜炎等。公司已取 得该药品的《药品注册证书》,并累计研发投入约为593.05万元。获得批准通知书有助于提升该产品的 市场竞争力。 ...
誉衡药业(002437) - 002437誉衡药业投资者关系管理信息20250508
2025-05-08 11:06
证券代码: 002437 证券简称:誉衡药业 哈尔滨誉衡药业股份有限公司投资者关系活动记录表 | | | | | | 2025-002 | | --- | --- | --- | | | 特定对象调研 分析师会议 √ □ | | | 投资者关系活动 | □ 媒体采访 □ | 业绩说明会 | | 类别 | □ 新闻发布会 □ 路演活动 | | | | □ 现场参观 | | | | □ 其他 (请文字说明其他活动内容) | | | 参与单位名称及 | 惠升基金管理有限责任公司 张政 | | | 人员姓名 | | | | 时间 | 年 月 日 2025 5 8 15:30~16:40 | | | 形式 | √现场 口网上 口电话会议 | | | 上市公司接待人 | 董事、副总经理、董事会秘书:刘月寅 | | | 员姓名 | 证券事务高级经理:王孟云 | | | | 问题 1:与第一三共的合作情况及后续是否还有其他合作 | | | | 计划? | | | | 回复: | | | | 公司与第一三共已有近十年的合作关系,公司专业化推广能 | | | | 力获得了第一三共的高度认可,双方合作关系不断巩固与加深,合 | | ...
千金药业2024年净利润下滑28% 研发及药材成本导致毛利承压
Xi Niu Cai Jing· 2025-05-06 08:39
2024年,千金药业研发投入为2.35亿元,占营收6.46%。中药方面,经典名方桃红四物颗粒提交注册,妇科千金胶囊启动巴基斯坦等国际市场申报;化药方 面,14个仿制药提交注册,碳酸锂片通过一致性评价,地屈孕酮片10个月完成申报;拟每10股派发现金红利3.6元(含税)。 财报披露,2024年千金药业业绩变动原因主要为主动收缩低毛利药品批发零售业务,其次为研发投入大幅增加及中药材成本上涨导致毛利率承压,其中中药 生产毛利率下降3.11个百分点至64.12%。 2024年,千金药业货币资金从19.98亿元降至13.44亿元,主要因增加一年期以上定期存款;短期借款同比减少79%至0.12亿元,长期借款清零;期末净资产 达24.62亿元,同比增长3.04%。 | 营业收入 | 3, 629, 804, 4 | 3, 798, 485, | -4. 44 | 4, 026, 278, 59 | 4, 026, 2 | | --- | --- | --- | --- | --- | --- | | | 92. 14 | 330. 31 | | 3.25 | 25 | | 归属于上市公司股 | 230, 756, 619 | ...
津药药业:“原料药+制剂”一体化,产品矩阵持续丰富
Quan Jing Wang· 2025-04-30 10:12
双轨并行策略,加速新药上市进程 津药药业通过"创新线"与"仿制线" 双轨并行的策略持续强化研发实力,在近期药品审评中展现出强劲 动能。根据公开资料显示,公司注射用甲泼尼龙琥珀酸钠、乳酸钠林格注射液、氯化钾注射液等10个品 种共11个品规获得《药品补充申请批准通知书》,通过一致性评价,其中子公司津药和平为国内盐酸甲 氧氯普胺注射液通过一致性评价的首家企业;倍他米松磷酸钠注射液、间苯三酚注射液、吸入用乙酰半 胱氨酸溶液、吸入用复方异丙托溴铵溶液、盐酸溴己新注射液共5个品种获得《药品注册证书》,完善 了公司制剂产品群,产品矩阵不断扩充。 部分品种市场表现亮眼,前景广阔 津药药业是国内领先的甾体激素类药物生产企业之一,也是全球领先的氨基酸原料药制造商,其在2024 年度被认定为天津市先进智能工厂、企业重点实验室,彰显了其在行业内的领先地位与示范效应。 多元产品矩阵,覆盖广泛治疗领域 目前,公司主要产品丰富,拥有70余个原料药品种,包括地塞米松系列、泼尼松系列、甲泼尼龙系列、 倍他米松系列、氨基酸等,以及注射剂、软膏剂、乳膏剂、硬胶囊剂、丸剂、冻干粉针剂、吸入制剂、 片剂等10余个剂型药品,能够满足不同患者的治疗需求。 ...