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A股减肥药概念股集体上涨;智飞生物上半年净利润亏损约6亿元
Mei Ri Jing Ji Xin Wen· 2025-08-18 23:13
Group 1: Weight Loss Drug Sector - A-share weight loss drug concept stocks collectively rose, with Hanyu Pharmaceutical increasing over 14% and Jinkai Biotechnology rising over 12% following the FDA's accelerated approval of Novo Nordisk's Wegovy for treating non-alcoholic steatohepatitis in adults [1] - The competition in the GLP-1 weight loss drug sector is intensifying, expanding from weight loss efficacy to related complications like fatty liver disease, indicating a broad market potential [1] Group 2: Shenyuan Biological - Shenyuan Biological's stock experienced two consecutive trading limit increases, but the company clarified that its main business is veterinary biological products, while its innovative drug pipeline, including HIV monoclonal antibodies, is operated independently by a joint venture [2] - Investors are advised to be cautious of stock price fluctuations that may deviate from the company's fundamentals [2] Group 3: Maiwei Biological - Maiwei Biological announced that its ADC innovative drug 7MW4911 received FDA approval to conduct clinical trials for advanced colorectal cancer and other gastrointestinal tumors, marking a significant step in its international drug innovation efforts [3] - The ADC field is highly competitive, and investors should closely monitor the subsequent clinical data for 7MW4911 [3] Group 4: Zhifei Biological - Zhifei Biological reported a net loss of 597 million yuan for the first half of 2025, with revenue declining by 73.06% year-on-year to 4.919 billion yuan, and no cash dividends or stock bonuses planned [4] - The vaccine industry is under pressure due to vaccine hesitancy, fluctuating demand, and intensified competition, making it challenging for Zhifei Biological to reverse its performance difficulties in the short term [4] Group 5: Aimeike - Aimeike's revenue for the first half of 2025 was 1.299 billion yuan, down 21.59% year-on-year, with a net profit decline of 29.57% to 789 million yuan [5] - The company plans to distribute a cash dividend of 12 yuan per 10 shares, and its acquisition of South Korea's REGEN is expected to strengthen its position in the medical beauty injection market amid increasing competition and differentiated consumer demand [5]
上证早知道|支持AI与机器人产业,广东大动作!暑期档票房,突破百亿元!公募发行,热度攀升
Group 1 - Guangdong Provincial Department of Industry and Information Technology and the Provincial Department of Finance recently issued the "Implementation Rules for Fund Management Related to the Innovative Development of Artificial Intelligence and Robotics Industry," which provides funding support for national-level manufacturing innovation centers, with subsidies not exceeding 40% of the total cost of newly purchased R&D equipment, capped at 50 million yuan per project [6] - The total box office for the summer movie season (June to August) in 2025 has exceeded 10 billion yuan, with films such as "Nanjing Photo Studio," "Wang Wang Mountain Little Monster," and "Lychee of Chang'an" ranking in the top three [6] - According to IDC, the global smartphone market shipped 297 million units in Q2 2025, a year-on-year increase of 1.4%, with Huawei regaining the top position in the Chinese market after four years [6] Group 2 - The short drama sector is experiencing rapid expansion, with over 2,300 vertical screen micro-short drama crews received in Hengdian Film and Television City in the first seven months of this year, surpassing the total for 2024 [11] - The market size for micro-short dramas is expected to reach 68 billion yuan by 2025 and potentially exceed 100 billion yuan by 2027, driven by the increasing popularity across all age groups [11][12] - The competition in the industry is becoming more concentrated, with the "Hongguo" free short drama app reaching 173 million monthly active users by March 2025, a year-on-year increase of 220% [12] Group 3 - The public fund issuance market is heating up, with 45 new funds starting fundraising from August 18 to August 24, 2025, representing a week-on-week increase of 36.36% [23] - Active equity funds increased their stock positions to 85.84% as of August 15, 2025, with increases in technology, finance, and new energy sectors, while reducing positions in manufacturing and consumer sectors [24]
迈威生物注射用7MW4911临床试验申请获FDA许可
Bei Jing Shang Bao· 2025-08-18 09:07
Core Viewpoint - Maiwei Biotech has received FDA approval for the clinical trial application of its innovative antibody-drug conjugate (ADC) 7MW4911, which targets cadherin 17 (CDH17) using its proprietary IDDC technology platform [1] Company Summary - The company announced the receipt of a Clinical Research Continuation Notification from the FDA on August 18, indicating that the clinical trial for 7MW4911 can proceed [1] - 7MW4911 is developed based on the company's own intellectual property rights and represents a significant advancement in targeted cancer therapy [1]
迈威生物(688062.SH):注射用7MW4911临床试验申请获FDA许可
智通财经网· 2025-08-18 08:37
Group 1 - The core point of the article is that Maiwei Biotech (688062.SH) has received a Clinical Study Continuation Notification from the FDA, allowing the clinical trial application for the injectable 7MW4911 to proceed [1] - The clinical trial will focus on the safety, pharmacokinetics, and efficacy of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors [1]
迈威生物:注射用7MW4911临床试验申请获FDA许可
Xin Lang Cai Jing· 2025-08-18 08:31
近日,迈威(上海)生物科技股份有限公司收到美国食品药品监督管理局(FDA)签发的《临床研究继 续进行通知书》,注射用7MW4911临床试验申请正式获FDA许可。该药品是基于公司自主知识产权的 IDDC™抗体偶联技术平台开发的靶向钙黏蛋白(CDH17)的创新抗体偶联药物(ADC)。 ...
迈威生物(688062.SH):注射用7MW4911临床试验申请获得FDA许可
Ge Long Hui A P P· 2025-08-18 08:31
Core Viewpoint - Maiwei Biotech (688062.SH) has received FDA approval for its clinical trial application for the injectable drug 7MW4911, which is an innovative antibody-drug conjugate (ADC) targeting CDH17, a promising therapeutic target in various cancers [1] Company Summary - The FDA issued a "Study May Proceed Notification" for 7MW4911, allowing the clinical trial to commence [1] - 7MW4911 is developed based on the company's proprietary IDDC? antibody conjugation technology platform [1] - CDH17 is validated as a potential therapeutic target across multiple cancer types, showing significant overexpression in colorectal, gastric, and pancreatic cancers, which is associated with tumor invasion, metastasis, and poor prognosis [1] Industry Summary - CDH17 is expressed exclusively in the basolateral membrane of intestinal epithelial cells in normal tissues, making it an ideal target for precision intervention in gastrointestinal malignancies [1]
迈威生物: 迈威生物自愿披露关于注射用7MW4911临床试验申请获得国家药品监督管理局和美国FDA受理的公告
Zheng Quan Zhi Xing· 2025-07-31 16:15
证券代码:688062 证券简称:迈威生物 公告编号:2025-038 迈威(上海)生物科技股份有限公司 获得国家药品监督管理局和美国 FDA 受理的公告 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、准确性和完整性依法承担法律责任。 重要内容提示: 近日,迈威(上海)生物科技股份有限公司(以下简称"迈威生物"或"公 司")收到:1)国家药品监督管理局(NMPA)签发的《受理通知书》,注射用 出具的 IND Acknowledgement Letter,确认已收到公司就注射用 7MW4911 递交 的 IND 申请。由于药品的研发周期长、审批环节多,容易受到一些不确定性因 素的影响,敬请广大投资者谨慎决策,注意防范投资风险。现将相关情况公告如 下: 一、药品基本情况 (一)国家药品监督管理局受理情况 药品名称:注射用 7MW4911 申请事项:境内生产药品注册临床试验 受理号:CXSL2500640 自愿披露关于注射用 7MW4911 临床试验申请 申请人:迈威(上海)生物科技股份有限公司 二、药品的其他相关情况 向钙黏蛋白 17(CDH17)的创新抗体 ...
迈威生物:关于注射用7MW4911临床试验申请获得国家药品监督管理局和美国FDA受理的公告
Zheng Quan Ri Bao· 2025-07-31 13:42
证券日报网讯 7月31日晚间,迈威生物发布公告称,近日,公司收到:国家药品监督管理局(NMPA) 签发的《受理通知书》,注射用7MW4911的临床试验申请已获正式受理;美国食品药品监督管理局 (FDA)出具的INDAcknowledgementLetter,确认已收到公司就注射用7MW4911递交的IND申请。 (文章来源:证券日报) ...
7月31日晚间重要公告一览
Xi Niu Cai Jing· 2025-07-31 10:18
Group 1 - Jiejia Weichuang expects a net profit of 1.7 billion to 1.96 billion yuan for the first half of 2025, representing a year-on-year increase of 38.65% to 59.85% [1] - Micron Biotech's CS231295 clinical trial application has been approved by the FDA for treating advanced solid tumors [1] - Sinopec anticipates a net profit of 20.1 billion to 21.6 billion yuan for the first half of 2025, a decrease of 39.5% to 43.7% year-on-year [2] Group 2 - High Energy Environment has obtained a loan commitment letter from a financial institution for share repurchase [2] - Electric Power Investment Energy received a warning letter from the Inner Mongolia Securities Regulatory Bureau for inadequate disclosure in its semi-annual report [3] - Zhejiang University Net New won a bid for an intelligent engineering project worth 94.2712 million yuan [5] Group 3 - Daodaoquan reported a net profit of 181 million yuan for the first half of 2025, a year-on-year increase of 563.15% [8] - New Light Optoelectronics expects a net loss of 19 million to 23 million yuan for the first half of 2025 [9] - Aihua Pharmaceutical's two probiotic powder registration applications have been accepted [10] Group 4 - Xinhui Electric's subsidiary signed a product sales framework contract for commercial and household robots [11] - Baida Precision Engineering's subsidiary obtained 134,500 square meters of industrial land use rights [12] - Haiyang Technology's chief engineer resigned for personal reasons [13] Group 5 - Tianhe Magnetic Materials received a project filing notice for a 12,000-ton magnetic material deep processing project [22] - Wanlima is the pre-selected unit for a procurement project worth 43.835 million yuan from China Southern Airlines [24] - Yipin Hong's subsidiaries obtained two drug registration certificates [25] Group 6 - Zhejiang Jiaoke's subsidiary signed new construction projects worth 4.783 billion yuan in the second quarter [27] - Shenglan Co. received approval for issuing convertible bonds [29] - Jimi Technology expects a net profit of 88.6622 million yuan for the first half of 2025, a year-on-year increase of 2062.33% [31] Group 7 - Dingtong Technology reported a net profit of 115 million yuan for the first half of 2025, a year-on-year increase of 134.06% [32] - Huaheng Biological is planning to list on the Hong Kong Stock Exchange [34] - Yuntian Lihui submitted an application for H-share issuance and listing on the Hong Kong Stock Exchange [36] Group 8 - Nanchip Technology expects a net profit of 108.8 million to 133.1 million yuan for the first half of 2025, a decrease of 35.09% to 47.03% year-on-year [43] - Anglikang's Mesobam injection has received a drug registration certificate [44] - Jida Zhengyuan's shareholder plans to reduce their stake by up to 0.998% [45]
迈威生物注射用7MW4911临床试验申请获受理
Zhi Tong Cai Jing· 2025-07-31 08:05
Core Viewpoint - The company has received formal acceptance of its clinical trial application for the injectable 7MW4911 from the National Medical Products Administration (NMPA) and an IND Acknowledgement Letter from the FDA, indicating progress in its drug development pipeline [1] Group 1 - The injectable 7MW4911 is an innovative antibody-drug conjugate (ADC) targeting cadherin 17 (CDH17) developed based on the company's proprietary IDDC antibody conjugation technology platform [1] - The acceptance of the clinical trial application by NMPA marks a significant milestone for the company in advancing its drug candidate [1] - The receipt of the IND Acknowledgement Letter from the FDA confirms that the company has submitted its IND application for 7MW4911, facilitating its entry into the U.S. market [1]