HUALAN BIOLOGICAL(002007)
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华兰生物:关于收到药物临床试验批准通知书的公告
Zheng Quan Ri Bao· 2026-02-03 13:13
Core Viewpoint - On February 3, 2026, the company announced that it received the Clinical Trial Approval Notification from the National Medical Products Administration for its drug, Recombinant Exendin-4-Fc Fusion Protein Injection [2] Group 1 - The approval notification number is 2026LP00310 [2] - The drug is intended for clinical trials, indicating progress in the company's research and development efforts [2]
华兰生物重组Exendin-4-Fc融合蛋白注射液临床试验获批
Zheng Quan Ri Bao Wang· 2026-02-03 13:13
Core Viewpoint - The announcement indicates that Hualan Biological has received approval from the National Medical Products Administration for clinical trials of its recombinant Exendin-4-Fc fusion protein injection (HL08) for use in overweight or obese adults, expanding its application beyond type 2 diabetes management [1] Group 1 - Hualan Biological's HL08 has been approved for clinical trials to improve weight control in obese patients, in addition to its original indication for blood sugar control in type 2 diabetes patients [1] - The approval allows the company to officially conduct clinical research to further verify the safety and efficacy of HL08, laying the groundwork for future registration and market launch [1] - This new indication enhances the company's biopharmaceutical product pipeline and optimizes its product structure [1]
2月3日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-03 10:11
Group 1 - Fulin Precision's subsidiary Jiangxi Shenghua invested 270 million yuan to establish a joint venture for a 500,000-ton ferrous oxalate project, with a total investment of 1.5 billion yuan expected to be completed by September 30, 2026 [1] - Xuguang Electronics plans to raise up to 1 billion yuan through a private placement to fund high-voltage vacuum arc extinguishing chamber expansion and other projects [2] - Minexplosion Optoelectronics intends to acquire 100% equity of Xiazhi Precision, with the transaction subject to shareholder and regulatory approvals [3] Group 2 - Shangluo Electronics' controlling shareholder plans to reduce his stake by up to 3% due to personal financial needs [4] - Babi Food reported a 1.3% decline in net profit for 2025, despite an 11.22% increase in revenue [5] - Pengding Holdings' subsidiary acquired industrial land in Huai'an for 66.14 million yuan [6] Group 3 - Zhuoyue New Energy's net profit for 2025 increased by 14.16%, despite a 17.43% decline in revenue [7] - Zhongyuan Media's net profit grew by 30.99% in 2025, with revenue decreasing by 5.13% [8] - Huangshan Tourism plans to invest approximately 530 million yuan in a hotel project with a 24-month construction period [9] Group 4 - *ST Jinling's restructuring plan was approved by the court, which may improve the company's financial situation [11] - Jichuan Pharmaceutical's subsidiary paid 80 million yuan for exclusive commercialization rights of a drug [12] - Pilin Bio's subsidiary received a notice for the acceptance of a drug supplement application [13] Group 5 - Nepe Mining terminated its investment in Swiss Veritas Resources AG due to changes in conditions [14] - Jinhui Wine announced a cash dividend of 0.20 yuan per share for the first three quarters of 2025 [15] - Hualan Biological's clinical trial for a new drug received approval for an additional indication [16] Group 6 - Industrial Fulian reported a total of 247 million yuan spent on share buybacks as of January 31, 2026 [17] - Yitong Century was pre-selected for a 107 million yuan project with China Tower [18] - Wanfeng Co. noted uncertainty in future price changes for disperse dyes [19] Group 7 - Bibet's clinical trial application for a new drug was approved by the National Medical Products Administration [21] - Chengbang Co. signed new project contracts worth 40.03 million yuan in Q4 2025 [22] - *ST Hengji received a court ruling for a performance compensation of 175 million yuan [23] Group 8 - Jihua Group is planning a change in control, leading to continued stock suspension [24] - Ningbo Port expects a container throughput of 5.03 million TEUs in January 2026, a 9.5% increase [25] - Hengli Petrochemical's actual controller increased his stake by 3.3 million shares [26] Group 9 - Hongfuhan signed a sales contract worth 480 million yuan with Guangdong Quanxiang [27] - All New Good's shareholder lifted a judicial freeze on 4.36% of the company's shares [28] - Changchun High-tech's subsidiary's clinical trial application for a new drug was accepted [29] Group 10 - Xingqi Eye Medicine's clinical trial for a new drug entered the first/second phase [31] - Hanma Technology reported a 140.04% increase in new energy heavy truck production in January 2026 [32] - Hengfeng Paper plans to invest 349 million yuan in a new green printing project [33] Group 11 - Zhifei Biological's mRNA vaccine for shingles received clinical trial approval [34] - Yutong Bus reported a 15.35% decrease in production in January 2026 [35] - StarNet Ruijie plans to sign a lease contract with an affiliate for a total rent of up to 110 million yuan [36] Group 12 - Hacheng Bonda's director completed a 0.97% share reduction [37] - Hendi Pharmaceutical's application for a new drug was approved [38] - Xinhua Medical's subsidiary received a medical device registration certificate [40] Group 13 - Yaokang Bio reported a 31.49% increase in net profit for 2025 [41] - Gaotie Electric reported a 14.02% increase in net profit for 2025 [42]
华兰生物(002007) - 关于收到药物临床试验批准通知书的公告
2026-02-03 09:00
证券代码:002007 证券简称:华兰生物 公告编号:2026-003 注册分类:治疗用生物制品 1 类 申请类型:新药 华兰生物工程股份有限公司 关于收到药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整,没 有虚假记载、误导性陈述或重大遗漏。 2026 年 2 月 2 日,华兰生物工程股份有限公司(以下简称"公司")收到 国家药品监督管理局下发的《药物临床试验批准通知书》(通知书编号:2026L P00310)。现将相关情况公告如下: 一、药物基本情况 药物名称:重组 Exendin-4-Fc 融合蛋白注射液(以下简称"HL08") 三、对公司的影响及风险提示 本次 HL08 新增适应症临床试验获批,标志着药物可正式开展对应临床研究, 进一步验证安全性与有效性,为后续注册上市奠定基础,同时丰富公司生物药产 品管线,优化产品结构。 药品研发具有周期长、环节多、风险高的特点,本品后续尚需完成全部临床 试验、生产申报、国家药监局审批等环节,各环节结果均存在不确定性;同时面 临临床数据与进度不及预期、市场竞争激烈、行业政策及技术迭代变化等风险, 可能影响最终研发成果与市场表现。 ...
华兰生物:重组Exendin-4-Fc融合蛋白注射液获准开展临试
Zhi Tong Cai Jing· 2026-02-03 09:00
Core Viewpoint - The company Hualan Biological (002007.SZ) has received approval from the National Medical Products Administration for clinical trials of a new drug, HL08, which is aimed at improving weight control in obese patients in addition to its original indication for type 2 diabetes management [1] Group 1 - The drug HL08 is a recombinant Exendin-4-Fc fusion protein injection [1] - The original indication for HL08 was to improve blood glucose control in patients with type 2 diabetes [1] - The newly approved indication expands its use to include weight control in obese patients [1]
华兰生物(002007.SZ):重组Exendin-4-Fc融合蛋白注射液获准开展临试
智通财经网· 2026-02-03 08:57
Core Viewpoint - The company Hualan Biological (002007.SZ) has received approval from the National Medical Products Administration for a new drug clinical trial, expanding the indications for its drug HL08 to include weight control in obese patients in addition to its original indication for improving blood glucose control in type 2 diabetes patients [1] Group 1 - The drug HL08 is a recombinant Exendin-4-Fc fusion protein injection [1] - The original indication for HL08 was to improve blood glucose control in patients with type 2 diabetes [1] - The newly approved indication aims to assist in weight control for obese patients [1]
华兰生物(002007.SZ):HL08收到药物临床试验批准通知书
Ge Long Hui A P P· 2026-02-03 08:57
Core Viewpoint - The company, Hualan Biological (002007.SZ), has received approval from the National Medical Products Administration for its drug, HL08, a new generation GLP-1 receptor agonist developed in-house [1] Group 1: Drug Development - HL08 is a recombinant Exendin-4-Fc fusion protein injection [1] - The active ingredient of HL08 is a recombinant Exendin-4-Fc fusion protein, which combines Exendin-4 with the Fc fragment of IgG2 antibody [1] - The drug significantly extends the biological half-life while retaining the natural physiological functions of Exendin-4, enhancing medication convenience and therapeutic efficacy [1]
华兰生物:HL08新增适应症临床试验获批
Ge Long Hui A P P· 2026-02-03 08:57
Core Viewpoint - The company has received approval from the National Medical Products Administration for a new drug, HL08, which is a recombinant Exendin-4-Fc fusion protein injection aimed at treating type 2 diabetes and obesity [1] Group 1: Drug Approval Details - The approval notification was issued on February 2, 2026, under the notification number 2026LP00310 [1] - HL08 is classified as a Class 1 therapeutic biological product and is categorized as a new drug [1] Group 2: Drug Characteristics - HL08 is a next-generation GLP-1 receptor agonist developed by the company [1] - The active ingredient is a recombinant Exendin-4-Fc fusion protein, which combines Exendin-4 with the Fc fragment of IgG2 antibody [1] - This fusion significantly extends the biological half-life of the drug, enhancing convenience and sustained efficacy in treatment [1] Group 3: Indications - The original approved indication for HL08 was to improve blood glucose control in patients with type 2 diabetes [1] - An additional indication has been approved for improving weight control in obese patients [1]
华兰疫苗:公司与华兰生物在研发、生产、供应链及合规经验等方面具备良好协同基础
Zheng Quan Ri Bao· 2026-02-02 08:40
Core Viewpoint - The company, Hualan Vaccine, emphasizes its strong collaboration with its controlling shareholder, Hualan Biological, in various aspects such as biopharmaceutical research and development, production quality system construction, supply chain management, and compliance experience [1] Group 1 - The company and Hualan Biological are committed to building and managing the "Hualan" brand, which has been recognized as a well-known trademark in China, indicating good market recognition and brand reputation [1] - Some vaccine products from the company have complementary clinical applications with related immunological products from Hualan Biological, such as rabies vaccine and tetanus vaccine, which can be used in conjunction with corresponding human immunoglobulin to achieve synergistic effects of active and passive immunity [1]
武汉病毒所发现尼帕有效药物!生物疫苗回调,沃森生物、智飞生物跌超6%!生物医药ETF汇添富(159839)收跌超2%,再获超5400万份净申购!
Sou Hu Cai Jing· 2026-01-27 09:32
Group 1 - The core viewpoint of the news highlights a recent pullback in the biopharmaceutical sector, with the Huatai-PineBridge Biopharmaceutical ETF (159839) declining by 2.08% while maintaining high trading volume, with nearly 600 million yuan in transactions for the day [1][4] - The ETF has seen continuous inflows, with a net subscription of over 54 million shares today and a total of over 73 million yuan in the last 10 days [1] - The ETF tracks the Guozheng Biopharmaceutical Index, which includes sectors such as CXO, vaccines, chemical drugs, blood products, and medical aesthetics, with the vaccine sector currently accounting for 15.1% of the index [6] Group 2 - A significant research breakthrough was reported by the Wuhan Institute of Virology, confirming that the oral nucleoside drug VV116 shows significant antiviral activity against the Nipah virus, providing new hope for the prevention and treatment of this high-mortality emerging infectious disease [3] - The biopharmaceutical ETF's major component stocks mostly experienced declines, with Watson Bio and Zhi Fei Bio dropping over 6%, while Sanofi Biopharma saw an increase of over 10% [4][5] - The latest performance forecast from Sanofi Biopharma indicates an expected net profit of approximately 2.9 billion yuan for 2025, representing a year-on-year growth of 311.35% [4] Group 3 - Data from Guoxin Securities indicates a decrease in pharmaceutical holdings among funds, with the overall pharmaceutical holding ratio at 7.97%, down by 1.71 percentage points from the previous quarter [7] - The largest sub-sector in pharmaceutical holdings is chemical preparations and other biological products, while the internet pharmacy and other biological products saw the most significant decline in holdings [9] - The JPM 2026 conference highlighted the acceleration of internationalization among Chinese pharmaceutical companies, with significant technological breakthroughs in areas such as ADC and GLP-1, leading to increased global competitiveness [10][11]