HYBIO(300199)
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一周医药速览(06.23-06.27)
Cai Jing Wang· 2025-06-27 08:43
Group 1 - Xiansheng Pharmaceutical announced that its insomnia treatment drug Daridorexant (brand name: Kewiko®) has been approved for marketing in China, enhancing patient access and supporting long-term use [1] - HAP Pharmaceutical entered a global strategic collaboration with Otsuka Pharmaceutical to develop a BCMAxCD3 bispecific T-cell engager, receiving an upfront payment of $47 million and potential additional payments up to $623 million based on future milestones [1] - Baotai announced a licensing agreement with Stein for the commercialization rights of BAT2406 (Dupilumab) in Latin America, with total upfront and milestone payments potentially reaching $10 million [1] Group 2 - David Medical received a medical device registration certificate for its electric stretcher, which offers significant advantages over traditional manual devices, improving operational efficiency and reducing the burden on healthcare personnel [2] - Hanyu Pharmaceutical's subsidiary received approval for the listing of its active pharmaceutical ingredient Acetate Degarelix, which is used to treat advanced prostate cancer [3] - China Traditional Chinese Medicine reported that its innovative TCM drug Yushudapin's registration application has been accepted, showing significant efficacy in improving early symptoms of depressive disorders [4]
细胞免疫治疗概念下跌1.41%,5股主力资金净流出超5000万元
Zheng Quan Shi Bao Wang· 2025-06-26 09:12
Market Performance - The cell immunotherapy sector declined by 1.41%, ranking among the top losers in the concept sector as of the market close on June 26 [1] - Notable declines were observed in companies such as Rongchang Biologics, Yuyuan Pharmaceutical, and Huahai Pharmaceutical, while ST Xiangxue, Shutai Shen, and Tailin Biologics saw gains of 4.19%, 1.71%, and 1.42% respectively [1] Capital Flow - The cell immunotherapy sector experienced a net outflow of 796 million yuan, with 43 stocks facing net outflows, and 5 stocks seeing outflows exceeding 50 million yuan [1] - Rongchang Biologics led the outflow with 110 million yuan, followed by Hengrui Medicine, Huahai Pharmaceutical, and Yuyuan Pharmaceutical with outflows of 104 million yuan, 75 million yuan, and 70 million yuan respectively [1] Top Gainers and Losers - The top gainers in the cell immunotherapy sector included ST Xiangxue, Shutai Shen, and Tailin Biologics, while the largest losers were Rongchang Biologics, Hengrui Medicine, and Huahai Pharmaceutical [1][3] - The trading volume for Rongchang Biologics was notably high, with a turnover rate of 14.96% and a significant drop of 18.36% in stock price [2][3]
翰宇药业(300199) - 关于全资子公司原料药获得上市申请批准通知书的公告
2025-06-25 10:30
本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假 记载、误导性陈述或重大遗漏。 近日,深圳翰宇药业股份有限公司(以下简称"公司"或"翰宇药业")全 资子公司翰宇药业(武汉)有限公司(以下简称"翰宇武汉")醋酸地加瑞克原 料药收到国家药品监督管理局签发的《化学原料药上市申请批准通知书》(受理 号:CYHS2360753),现将相关情况公告如下: 证券代码:300199 证券简称:翰宇药业 公告编号:2025-033 深圳翰宇药业股份有限公司 关于全资子公司原料药 获得上市申请批准通知书的公告 一、原料药登记信息 1、通用名称:醋酸地加瑞克 2、登记号:Y20230000914 3、包装规格:1g/袋、5g/袋、10g/袋、20g/袋、100g/袋、400g/袋。 4、生产企业:翰宇药业(武汉)有限公司 二、药品的其他情况 地加瑞克是促性腺激素释放激素(GnRH)受体拮抗剂,可逆的与垂体GnRH 受体结合,因而降低促性腺激素和睾丸素释放,可用于治疗晚期前列腺癌患者。 三、对公司的影响 本次醋酸地加瑞克原料药获得上市批准,标志着翰宇武汉取得该原料药国内 市场销售资格,拓宽了原料药产品管线,进一步推 ...
“高位股”震荡,A股调整
新华网财经· 2025-06-19 04:37
Market Overview - A-share market experienced a "high-low switch" with strong sectors like innovative drugs, controllable nuclear fusion, and digital currency facing adjustments, while previously weak humanoid robot sector rebounded significantly [1][2] - High-position stocks faced significant fluctuations, with companies like Changshan Pharmaceutical and Yong'an Pharmaceutical hitting the daily limit down, contributing to a 1.98% drop in the micro-cap stock index [2] Index Performance - As of the morning close, the Shanghai Composite Index fell by 0.86% to 3359.78, the Shenzhen Component Index decreased by 1.01% to 10072.42, and the ChiNext Index dropped by 1.1% to 2032.19 [3] Innovative Drug Sector - The innovative drug sector saw a pullback, with Changshan Pharmaceutical hitting a 20% daily limit down and other stocks like Hanyu Pharmaceutical also experiencing significant declines [5][6] - Despite the current adjustments, institutions remain optimistic about the innovative drug sector's investment opportunities in the second half of the year, citing supportive policies and improving fundamentals [8] Solid-State Battery Sector - The solid-state battery sector showed strong performance in the morning, with stocks like Haike Xinyuan and others experiencing significant gains [10] - Key factors driving the solid-state battery sector include policy support, breakthroughs in research by leading battery manufacturers, continuous optimization of equipment, and unexpected commercial progress [11][12][13]
【帮主郑重午评】创业板半日跌超1%!4600只股下跌背后藏着这些信号
Sou Hu Cai Jing· 2025-06-19 04:02
Market Overview - The three major indices experienced a decline, with the ChiNext Index dropping by 1.1% and over 4600 stocks in the market showing negative performance [1][3] - The Shanghai Composite Index fell by 0.86%, the Shenzhen Component Index decreased by 1.01%, and the North China 50 Index also saw a nearly 1% drop, with trading volume exceeding 800 billion, an increase of over 40 billion compared to the previous day [3] Economic Factors - Recent macroeconomic data has shown signs of pressure, leading to hesitance in market recovery expectations [3] - Popular sectors such as AI and weight-loss drugs are experiencing corrections, prompting funds to shift towards defensive sectors [3] - External market instability has also contributed to negative sentiment in the domestic market [3] Sector Performance - Solid-state batteries, PCB, and oil sectors saw gains, with stocks like Nord and Xiangtan Electric achieving limit-up [3] - The solid-state battery sector is gaining attention due to recent technological breakthroughs and a reasonable valuation after previous adjustments in the new energy sector [3] - The oil sector's rise may be linked to geopolitical tensions in the Middle East, particularly the potential for U.S. actions against Iran, leading to short-term oil price volatility [3] Declining Sectors - The nuclear fusion, military, and weight-loss drug sectors faced significant declines, with Changshan Pharmaceutical hitting the limit down and Hanyu Pharmaceutical dropping over 10% [4] - The military sector's adjustment is attributed to a lack of new catalysts, leading to fund withdrawals [4] - The nuclear power sector saw stocks like Hezhan Intelligent and China Nuclear Technology hitting the limit down, possibly due to negative news from specific companies [4] Investment Strategy - In a broad market decline, it is essential to maintain a calm mindset and focus on identifying quality stocks [4] - Long-term investors should prioritize company fundamentals and industry prospects over short-term price fluctuations [4] - The solid-state battery sector is highlighted as a promising long-term investment, while caution is advised in the weight-loss drug sector due to speculative trading [4]
翰宇药业(300199) - 关于2025年度向金融机构申请综合授信及担保额度的进展公告
2025-06-16 09:15
深圳翰宇药业股份有限公司 关于2025年度向金融机构申请综合授信 及担保额度的进展公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假 记载、误导性陈述或重大遗漏。 特别风险提示: 截至本公告披露日,公司及控股子公司累计对外提供担保总额占最近一期经 审计净资产125.64%、对资产负债率超过70%的单位担保金额占公司最近一期经 审计净资产69.99%;公司及子公司无对合并报表范围外的对外担保事项,也不存 在逾期担保。敬请广大投资者注意风险。 一、授信及担保审议程序 证券代码:300199 证券简称:翰宇药业 公告编号:2025-032 深圳翰宇药业股份有限公司(以下简称"公司"或"翰宇药业")于2025年2月 28日召开第六届董事会第二次会议、2025年3月17日召开2025年第一次临时股东 大会,审议通过了《关于2025年度申请综合授信及担保额度的议案》,同意公司 及子公司2025年度向金融机构申请综合授信及担保额度总计不超过3.5亿元。其 中:公司为子公司、子公司之间提供综合授信及担保额度5,000万元;子公司为本 公司提供综合授信及担保额度不超过30,000万元。该授信自2025年3 ...
翰宇药业(300199) - 关于独立董事取得培训证明的公告
2025-06-16 09:15
证券代码:300199 证券简称:翰宇药业 公告编号:2025-031 深圳翰宇药业股份有限公司 根据《上市公司独立董事管理办法》《深圳证券交易所自律监管指引第2号 ——创业板上市公司规范运作》等相关规定,许立勇先生已书面承诺参加最近一 次独立董事培训并取得深圳证券交易所认可的独立董事资格证书。 近日,公司收到许立勇先生的通知,其已按照相关规定参加了深圳证券交易 所举办的上市公司独立董事培训,并取得了由深圳证券交易所创业企业培训中心 颁发的《上市公司独立董事培训证明》。 特此公告。 深圳翰宇药业股份有限公司董事会 2025年6月17日 关于独立董事取得培训证明的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假 记载、误导性陈述或重大遗漏。 深圳翰宇药业股份有限公司(以下简称"公司"或"翰宇药业")因第五届 董事会任期已届满,按照相关法律程序进行了董事会换届选举。2024年12月19日, 公司召开2024年第四次临时股东大会,审议通过了《提名许立勇先生为第六届董 事会独立董事候选人》,会议选举许立勇先生为公司第六届董事会独立董事,任 期自股东大会审议通过之日起三年。 ...
翰宇药业制剂矩阵:三靶点减肥创新药及近20种制剂面向全球
Zheng Quan Shi Bao Wang· 2025-06-16 05:57
Core Insights - Hanyu Pharmaceutical (300199) has recently conducted investor research, discussing the progress of the HY3003 new drug project, its layout in the innovative drug field, and overseas market expansion [1][2] Group 1: HY3003 New Drug Project - The HY3003 project has completed preclinical candidate compound screening and raw material process development, officially entering the raw material pilot scale-up phase, which validates the producibility of the molecular structure for subsequent IND application and clinical transformation [1] - HY3003 is a GLP-1R/GIPR/GCGR receptor agonist developed using AI peptide chip technology, aimed at weight loss indications [1] - The project employs a multi-formulation parallel development strategy, including weekly, ultra-long-acting monthly, and oral formulations, with the ultra-long-acting formulation designed to reduce dosing frequency and improve medication adherence [1] Group 2: siRNA and Other Drug Developments - The company is also developing siRNA drugs such as Inclisiran and Zilebesiran for treating high cholesterol and hypertension, as well as Pegcetacoplan for treating geographic atrophy [1] Group 3: Overseas Market Expansion - Currently, the company's raw materials are sold to over 20 countries and regions, with formulations licensed in over 90 countries and regions [2] - The company has signed cooperation agreements for the semaglutide injection (weekly formulation) and oral tablets in markets including China, Brazil, Egypt, Mexico, Eurasian Union, GCC member countries, and North Africa [2] - The company has completed the enrollment of all participants in the Phase III clinical trial for semaglutide injection as of January this year, with plans to submit for approval in China by 2026, followed by the US and other global markets [2] Group 4: Future Pipeline - Hanyu Pharmaceutical has a rich pipeline of peptide and small nucleic acid formulations, planning to launch no less than 20 formulations over the next 10 years, including innovative drugs, micro-innovative drugs, and ANDA [2]
翰宇药业HY3003项目进入原料药中试阶段 三靶点减重新药加速推进
Zheng Quan Ri Bao· 2025-06-13 07:45
Group 1 - The core viewpoint of the article highlights the collaboration between Shenzhen Hanyu Pharmaceutical Co., Ltd. and Zhuhai Carbon Cloud Peptide Pharmaceutical Technology Co., Ltd. on the HY3003 project, which has successfully completed preclinical candidate screening and raw material process development, entering the raw material pilot scale-up phase [2][3] - The HY3003 project is a GLP-1R/GIPR/GCGR tri-target receptor agonist for weight loss, utilizing AI peptide chip technology for high-throughput screening [2] - The project employs a parallel development strategy for multiple dosage forms, including weekly, ultra-long-acting monthly, and oral formulations [2] Group 2 - The management of Hanyu Pharmaceutical emphasizes the complementary strengths in technology and resources between the two companies, with Carbon Cloud Peptide possessing silicon-based peptide chip technology and AI algorithms, while Hanyu has extensive experience in peptide drug synthesis, purification, formulation development, and clinical translation [3] - A strategic cooperation was established in October 2024, followed by a joint development agreement in May 2025, aiming to incubate China's first tri-target peptide weight loss innovative drug [3] - Hanyu Pharmaceutical's Wuhan raw material production base passed FDA inspection with "zero defects" in November 2024, and the production line for Glatiramer Acetate Injection also successfully passed FDA inspection in 2025, with both products expected to launch in the U.S. market soon [3]
翰宇药业:司美格鲁肽注射液项目已进入剂量维持期 预计2026年中国申报上市
news flash· 2025-06-12 11:52
Core Insights - Hanyu Pharmaceutical has entered the dosage maintenance phase for its Semaglutide injection project, with plans to apply for market approval in China by 2026 [1] Company Developments - The company is developing HY3003, a GLP-1R/GIPR/GCGR receptor agonist for weight loss, utilizing AI peptide chip technology for candidate selection [1] - Hanyu has completed preclinical candidate screening and raw material process development, now moving into the raw material pilot scale-up phase [1] - In addition to the weight loss drug, the company is also working on an innovative drug, HY3000 nasal spray, aimed at preventing coronavirus infections, which is currently in Phase III clinical trials [1] Collaborations and Innovations - Hanyu is collaborating with China National Pharmaceutical Group on the research and commercialization of Cannabidiol (CBD) innovative drugs, integrating peptide and small nucleic acid drug technologies [1] - The company has completed enrollment of all participants in the Phase III clinical trial for Semaglutide injection as of January this year and is currently in the follow-up phase [1]