Hinova Pharmaceuticals (688302)

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海创药业创新药氘恩扎鲁胺软胶囊获批上市 成都天府国际生物城创新生态再结硕果
Di Yi Cai Jing· 2025-05-30 10:52
Group 1 - The National Medical Products Administration approved the listing of the innovative drug Deuteroenzalutamide capsules (brand name: Hainaanan®) developed by Haichuang Pharmaceutical, providing a new treatment option for adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after receiving abiraterone acetate and chemotherapy [1][4][6] - The approval marks a significant milestone for Haichuang Pharmaceutical, representing 12 years of innovative research and development, and is the first small molecule innovative drug approved in Chengdu Tianfu International Bio-city [2][3][4] - Deuteroenzalutamide is an androgen receptor (AR) inhibitor developed based on Haichuang's core deuterated drug platform and has received support from the National Major New Drug Creation Technology Major Project [4][6] Group 2 - Prostate cancer is the fifth most common cancer among men in China, with an increasing incidence rate. It is estimated that by 2024, there will be 160,000 new cases of mCRPC in China, rising to 176,000 by 2030 [6] - The launch of Deuteroenzalutamide fills a clinical gap as there were no approved AR inhibitors for this indication in China prior to its approval [6][11] - Haichuang Pharmaceutical plans to enhance academic promotion efforts to increase awareness of the product among doctors and patients, aiming to improve patient survival rates and quality of life [7][11] Group 3 - Chengdu Tianfu International Bio-city has established a complete biopharmaceutical ecosystem from research and development to industrialization, supporting the growth of innovative pharmaceutical companies [2][8] - The bio-city provides comprehensive lifecycle services for enterprises, including streamlined approval processes, financial and market activities, and shared facilities to reduce collaboration costs [8][10] - The bio-city has also implemented green energy solutions, such as distributed photovoltaic projects, to ensure stable energy supply for biopharmaceutical enterprises [10] Group 4 - Haichuang Pharmaceutical has six additional products in various stages of clinical trials and several in preclinical research, indicating a robust product pipeline [11] - The company emphasizes sustainable and healthy development, focusing on long-term strategic planning to benefit more patients with new drug developments [11][12] - Chengdu Tianfu International Bio-city aims to continue fostering high-level innovation and support the biopharmaceutical industry’s high-quality development through comprehensive policy guarantees and resource mobilization [12][13]
5月30日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-30 10:21
Group 1 - Huapei Power received a project intention letter from a domestic new energy vehicle company for a thermal management system PTC water heater, with an estimated sales amount of approximately 9 million yuan over a 5-year lifecycle starting from 2026 [1] - Antu Biotech obtained medical device registration certificates for products including "Cytomegalovirus IgM Antibody Test Kit" [1][2] - Yihong Technology adjusted the upper limit of its share repurchase price to 65.04 yuan per share, with a total repurchase amount of 6.9583 million yuan for 198,000 shares [2] Group 2 - Aihui Long received a medical device registration certificate for the Hepatitis B virus core antibody detection kit, valid until May 28, 2030 [2][3] - Quanxin Co. plans to engage in commodity futures hedging to mitigate raw material price fluctuations, with a maximum guarantee amount of 8 million yuan [3] - Jiahua Intelligent plans to lease idle assets in Dongguan for a total rental amount of approximately 6.3193 million yuan over 6 years [3] Group 3 - Qianjiang Biochemical announced the resignation of its chairman and a director, with a new chairman to be elected [4][5] - Aerospace Morning Light was suspended from participating in military procurement activities due to violations, with internal investigations underway [6] - Guang'an Aizhong intends to establish a fund with a total scale of 70.7 million yuan, focusing on distributed wind and solar power generation [7] Group 4 - Zhejiang Medicine plans to use up to 1 billion yuan of idle funds for entrusted wealth management, with a maximum investment period of 12 months [10] - Hengrui Medicine's subsidiary received approval for clinical trials of HRS9531 injection, aimed at treating type 2 diabetes patients [11] - Taiji Co. announced the purchase of 10 million yuan in wealth management products, with a minimum holding period of 6 months [12] Group 5 - Hong Kong-listed company Huichuang Pharmaceutical received approval for the clinical trial of a spray for treating primary premature ejaculation [26][27] - Haichuang Pharmaceutical's new drug application for a prostate cancer treatment was approved by the National Medical Products Administration [28] - Zhuhai Guanyu was selected as a designated supplier for low-voltage lithium batteries by SAIC Volkswagen [29] Group 6 - Huayi Technology opened a tax refund service for overseas travelers, enhancing its retail offerings [32] - Baobian Electric plans to transfer 90% of its subsidiary's shares for 137 million yuan [33] - Yiwei Communication intends to invest 100 million yuan to establish a wholly-owned subsidiary to enhance its strategic layout [34]
A股弱势震荡,北证50指数逆势飘红半日涨0.25%
Mei Ri Jing Ji Xin Wen· 2025-05-30 04:32
Market Overview - On May 30, the last trading day before the Dragon Boat Festival, the market opened lower and experienced weak fluctuations, with the North Stock 50 index rising by 0.25% while the Shanghai Composite Index fell by 0.31% to 3353.07 points [1] - The total trading volume of A-shares for the half day was 771.57 billion yuan [1] Monetary Policy - The People's Bank of China announced a 7-day reverse repurchase operation of 291.1 billion yuan at a fixed rate of 1.40%, with a net injection of 148.6 billion yuan for the day [1] Industry Developments - The China Securities Association is formulating a special evaluation method for securities companies, focusing on contributions to key areas such as technology finance, green finance, and digital finance [1] Pharmaceutical Sector Performance - The pharmaceutical sector saw significant gains, with stocks like Ruizhi Pharmaceutical and Huana Pharmaceutical hitting a 20% limit up, while other related sectors such as CRO and brain-computer interface also experienced upward trends [2] Sector Performance Data - The top performing sectors included: - Chicken: +2.55% - Innovative Drugs: +2.52% - Pork: +2.47% - Immune Therapy: +1.94% - COVID-19 Drug Concept: +1.94% [3] Investment Outlook for Innovative Drugs - The investment value of innovative drugs is viewed positively due to ongoing supportive policies, improving payment conditions, and upgrading research capabilities of supply-side enterprises [4] - Companies with strong innovation capabilities and rich product pipelines are expected to benefit in the long term from the continuous promotion of bulk purchasing of drugs and consumables [4] Company Profiles - **Huana Pharmaceutical**: A high-tech enterprise focused on the R&D, production, and sales of chemical drugs and traditional Chinese medicine, with a promising antidepressant drug ZG001 [7] - **Kexing Pharmaceutical**: An innovative biopharmaceutical company engaged in the R&D and sales of recombinant protein drugs and micro-ecological preparations, with a strong international presence [7] - **Guanhao Biological**: Actively advancing the application for a human genetic resource sample library to support innovation in drug development and health services [7] - **Haichuang Pharmaceutical**: An international innovative drug company focusing on cancer and metabolic diseases, utilizing PROTAC technology for drug development [8]
海创药业前列腺癌药物获批 首个商业化产品能带领公司扭亏吗?
Mei Ri Jing Ji Xin Wen· 2025-05-29 13:29
Core Viewpoint - Hecotech Pharmaceuticals has received approval for its core product, Deutetrabenazine capsules, marking the company's first commercialized product after years of operating with zero drug revenue [2][3]. Group 1: Product Approval and Market Potential - Deutetrabenazine capsules are approved for treating metastatic castration-resistant prostate cancer (mCRPC) in adult patients who have not previously received novel androgen receptor inhibitors [3]. - The drug is the first deuterated mechanism innovation in the prostate cancer field and the first domestic innovative drug approved for this indication [3]. - According to GLOBOCAN 2022, there were 1.467 million new prostate cancer cases globally in 2022, with 134,000 new cases reported in China [3]. Group 2: Company Financials and Historical Context - Prior to the approval of Deutetrabenazine, Hecotech Pharmaceuticals had maintained a "zero drug revenue" status, resulting in cumulative losses of 1.703 billion yuan from 2019 to 2024 [4]. - The company is accelerating its commercialization process and has established a GMP-compliant R&D production base in Chengdu, along with a professional marketing team [4]. Group 3: Competitive Landscape - Deutetrabenazine is a deuterated version of enzalutamide, which was originally developed by Astellas and Medivation and has generated over $4 billion in global sales by 2019 [5]. - Enzalutamide's sales reached $5.67 billion in 2024, making it a significant revenue source for Astellas [5]. - Several domestic companies have developed generic versions of enzalutamide, with competition expected to intensify as the patent expires in 2026 [5].
海创药业(688302) - 自愿披露关于氘恩扎鲁胺软胶囊新药上市申请获得批准的公告
2025-05-29 10:31
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、准确性和完整性依法承担法律责任。 重要内容提示: 近日,海创药业股份有限公司(以下简称"公司")从国家药品监督管理 局(以下简称"NMPA")网站查询获悉,公司自主研发的 1 类新药海纳安®(通 用名:氘恩扎鲁胺软胶囊)获得国家药监局批准上市,用于治疗接受醋酸阿比 特龙及化疗后出现疾病进展,且既往未接受新型雄激素受体抑制剂的转移性去 势抵抗性前列腺癌(mCRPC)成人患者。根据公开资料查询,氘恩扎鲁胺软胶囊 是国内第一款针对该类患者人群获得批准上市的创新药物。 现将相关情况公告如下: 证券代码:688302 证券简称:海创药业 公告编号:2025-030 海创药业股份有限公司 自愿披露关于氘恩扎鲁胺软胶囊新药上市申请 获得批准的公告 氘恩扎鲁胺软胶囊(曾用名:HC-1119 软胶囊)是公司自主研发的、用于治 疗转移性去势抵抗性前列腺癌(mCRPC)的 1 类新药,是第二代雄激素受体(AR) 抑制剂,获得国家重大新药创制科技重大专项支持。氘恩扎鲁胺(HC-1119)中 国Ⅲ期临床研究达到主要终点,数据显示,相较 ...
创新药概念股走势低迷 三生国健等多股跌超5%
news flash· 2025-05-28 06:20
Group 1 - The innovative drug concept stocks are experiencing a downturn, with several companies seeing declines of over 5% [1] - Notable companies affected include Sanofi, Haisun Pharmaceutical, Huisheng Biological, Rejing Biological, Haichuang Pharmaceutical, and Ruizhi Pharmaceutical [1] - Other companies such as Saiseng Pharmaceutical and Hasan Union are also following the downward trend [1]
海创药业: 关于召开2025年第一季度业绩说明会的公告
Zheng Quan Zhi Xing· 2025-05-26 10:13
证券代码:688302 证券简称:海创药业 公告编号:2025-029 海创药业股份有限公司 关于召开 2025 年第一季度业绩说明会的公告 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。 重要内容提示: ? 会议召开时间:2025 年 6 月 4 日(星期三)15:00-16:00 ? 会议召开地点:上海证券交易所上证路演中心(网址: https://roadshow.sseinfo.com/) ? 会议召开方式:上证路演中心网络文字互动 ? 投资者可于 2025 年 5 月 27 日(星期二)至 6 月 3 日(星期二) 公司邮箱 ir@hinovapharma.com 进行提问。公司将在说明会上对投资 者普遍关注的问题进行回答。 海创药业股份有限公司(以下简称"公司")已于 2025 年 4 月 地了解公司 2025 年第一季度经营成果、财务状况,公司计划于 2025 年 6 月 4 日(星期三)15:00-16:00 举行 2025 年第一季度业绩说明 会,就投资者关心的问题进行交流。 一、说明会类型 本次投资者说明会 ...
海创药业(688302) - 关于召开2025年第一季度业绩说明会的公告
2025-05-26 09:45
证券代码:688302 证券简称:海创药业 公告编号:2025-029 海创药业股份有限公司 重要内容提示: 投资者可于 2025 年 5 月 27 日(星期二)至 6 月 3 日(星期二) 16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通过 公司邮箱 ir@hinovapharma.com 进行提问。公司将在说明会上对投资 者普遍关注的问题进行回答。 海创药业股份有限公司(以下简称"公司")已于 2025 年 4 月 26 日发布公司 2025 年第一季度报告,为便于广大投资者更全面深入 地了解公司 2025 年第一季度经营成果、财务状况,公司计划于 2025 年 6 月 4 日(星期三)15:00-16:00 举行 2025 年第一季度业绩说明 会,就投资者关心的问题进行交流。 一、说明会类型 本次投资者说明会以网络文字互动形式召开,公司将针对 2025 年第一季度的经营成果及财务指标的具体情况与投资者进行互动交 会议召开时间:2025 年 6 月 4 日(星期三)15:00-16:00 会 议 召 开 地 点 : 上 海 证 券 交 易 所 上 证 路 演 中 心 ( 网 址 : htt ...
创新药概念延续强势 舒泰神20CM涨停
news flash· 2025-05-21 01:44
智通财经5月21日电,舒泰神20CM涨停,此前三生国健3连板,赛升药业、海创药业、海辰药业、诺思 格、君实生物等跟涨。消息面上,港股创新药企三生制药公告称,其与辉瑞公司就前者自主研发的PD- 1/VEGF双特异性抗体SSGJ-707签订了独家许可协议。本次协议中12.5亿美元的首付款再次刷新了国产 创新药出海首付款金额纪录。 创新药概念延续强势 舒泰神20CM涨停 ...
海创药业(688302) - 中信证券股份有限公司关于海创药业股份有限公司2024年度持续督导跟踪报告
2025-05-14 10:02
关于海创药业股份有限公司 2024 年度持续督导跟踪报告 中信证券股份有限公司 一、持续督导工作情况 1、保荐人制定了持续督导工作制度,制定了相应的工作计划,明确了现场检查 的工作要求。 2、保荐人已与公司签订承销及保荐协议,该协议已明确了双方在持续督导期间 的权利义务,并报上海证券交易所备案。 3、本持续督导期间,保荐人通过与公司的日常沟通、对上市公司培训等方式开 展持续督导工作,并于 2025 年 4 月 21 日至 4 月 24 日对公司进行了现场检查。 4、本持续督导期间,保荐人根据相关法规和规范性文件的要求履行持续督导职 责,具体内容包括: (1)查阅公司章程、三会议事规则等公司治理制度、三会会议材料; 中信证券股份有限公司(以下简称"中信证券"或"保荐人")作为海创 药业股份有限公司(以下简称"海创药业"或"公司"或"上市公司")首次 公开发行股票并在科创板上市的保荐人,根据《证券发行上市保荐业务管理办 法》《上海证券交易所科创板股票上市规则》等相关规定,中信证券履行持续 督导职责,并出具本持续督导本年度跟踪报告。 (2)查阅公司内部审计和内控管理等内部控制制度,查阅了公司 2024 年度内 部控 ...