帕妥珠单抗注射液是一款重组人源化抗HER2单克隆抗体注射液，患者每3周需使用一次。该产品通过特 异性结合HER2的细胞外二聚化结构域II，阻断HER2与HER2或其他HER家族成员之间的配体之间的二 聚化作用，从而阻断细胞周期并诱导凋亡。该产品还可介导抗体依赖细胞介导的细胞毒作用。本次申请 主要是基于一项III期等效性临床试验，入组患者为早期或局部晚期HER2阳性乳腺癌患者。临床试验结 果显示，该产品用于早期或局部晚期HER2阳性乳腺癌的新辅助治疗与原研参照药等效。同时，该产品 的安全性和耐受性良好，与原研参照药类似。 智通财经APP讯，新诺威(300765.SZ)发布公告，公司控股子公司石药集团巨石生物制药有限公司(简 称"巨石生物")于近日收到国家药品监督管理局核准签发的《受理通知书》，帕妥珠单抗注射液的上市 申请获得受理。 ...

格隆汇11月12日丨新诺威(300765.SZ)公布，控股子公司石药集团巨石生物制药有限公司（简称"巨石生 物"）于近日收到国家药品监督管理局核准签发的《受理通知书》，帕妥珠单抗注射液的上市申请获得 受理。帕妥珠单抗注射液是一款重组人源化抗HER2单克隆抗体注射液，患者每3周需使用一次。该产品 通过特异性结合HER2的细胞外二聚化结构域II，阻断HER2与HER2或其他HER家族成员之间的配体之 间的二聚化作用，从而阻断细胞周期并诱导凋亡。该产品还可介导抗体依赖细胞介导的细胞毒作用。 ...

关于控股子公司帕妥珠单抗注射液上市申请 获得受理的公告 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。 一、概述 石药创新制药股份有限公司（以下简称"公司"）的控股子公司石药集团巨石 生物制药有限公司（以下简称"巨石生物"）于近日收到国家药品监督管理局（以 下简称"国家药监局"）核准签发的《受理通知书》，帕妥珠单抗注射液的上市申 请获得受理。现将相关情况公告如下： 二、药品的基本信息 药品名称：帕妥珠单抗注射液 剂 型：注射剂 注册分类：治疗用生物制品 3.3 类 证券代码：300765 证券简称：新诺威 公告编号：2025-086 石药创新制药股份有限公司 受 理 号：CXSS2500123 申 请 人：石药集团巨石生物制药有限公司 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 三、药品的其他相关情况 帕妥珠单抗注射液是一款重组人源化抗 HER2 单克隆抗体注射液，患者每 3 周需使用一次。该产品通过特异性结合 HER2 的细胞外二聚化结构域 II，阻断 HER2 与 HER2 或其他 HER 家族成员之间的配体之间的 ...

Core Viewpoint - The article discusses the insider trading scandal involving Shiyao Group and its executive director Pan Weidong, who was fined 5 million yuan by the China Securities Regulatory Commission (CSRC) for insider trading related to a restructuring deal of its subsidiary, Xin Nuo Wei [4][5][39]. Group 1: Insider Trading Incident - Pan Weidong was fined 5 million yuan for insider trading, with a transaction amount close to 100 million yuan, which met the criteria for criminal prosecution [4][5]. - The insider trading was linked to a restructuring deal of Xin Nuo Wei, where Pan was aware of the insider information before it was publicly disclosed [5][11]. - The CSRC's investigation revealed that Pan had contact with other individuals involved in the insider trading, leading to additional penalties for them [11][12]. Group 2: Company Operations and Financial Performance - Despite the insider trading incident, Shiyao Group stated that its business operations remain normal and the penalty will not negatively impact its overall business [4][39]. - Shiyao Group's financial performance has shown a decline, with revenue in 2024 dropping to 29.01 billion yuan, a decrease of 9.56% year-on-year, and net profit falling by 25.9% [36]. - The company has been actively involved in mergers and acquisitions, including a failed 7.6 billion yuan acquisition of Shiyao Baike, which was terminated due to high valuation and performance uncertainties [17][22][39]. Group 3: Strategic Direction and Market Position - Shiyao Group is focusing on transitioning towards innovative drug development, with significant investments in research and development, amounting to 2.683 billion yuan in the first half of 2025 [37]. - The company has a pipeline of nearly 90 products in various clinical trial stages, indicating a commitment to expanding its innovative drug portfolio [37]. - The market remains skeptical about the company's ability to successfully transition to innovative drugs, especially in light of recent financial performance and insider trading issues [39].

Core Viewpoint - The article discusses the insider trading case involving Pan Weidong, the former chairman of XinNuoWei, and the termination of a significant asset restructuring deal with Shiyao Baike, highlighting the implications for both companies and the broader market context [1][2][9]. Group 1: Insider Trading Case - Pan Weidong was fined 5 million yuan by the China Securities Regulatory Commission (CSRC) for insider trading related to the proposed acquisition of Shiyao Baike [1][8]. - The investigation revealed that Pan bought 2.74258 million shares of XinNuoWei for approximately 99.99 million yuan before the public announcement of the restructuring [1][3]. - Other individuals involved in the insider trading, including Zhang Heming, Du Ying, and Zhen Hong, also faced penalties, with profits ranging from 150,000 to 790,000 yuan [3][8]. Group 2: Termination of Restructuring Deal - XinNuoWei announced in April 2024 the termination of its plan to acquire 100% of Shiyao Baike for 7.622 billion yuan, citing various market and strategic concerns [9][10]. - The acquisition was initially seen as a significant move, with a valuation that represented a 78.25% premium over Shiyao Baike's book value [9][10]. - The termination raised questions about the deal's valuation, strategic fit, and financial health, leading to skepticism in the market [10]. Group 3: Company Performance and Market Reaction - XinNuoWei has faced declining revenues and profits, reporting its first quarterly loss since going public, with a net profit of -24.05 million yuan in the first three quarters of 2025 [13]. - The company's stock price has experienced significant volatility, rising from 22 yuan in January 2023 to a peak of 63 yuan in June, before falling to 31.41 yuan by November 7, 2023 [13]. - XinNuoWei is also pursuing an IPO in Hong Kong, indicating a strategic shift amidst its financial challenges [13].

Group 1 - The State Council issued an implementation opinion focusing on the large-scale application of new scenarios, highlighting five key areas including new fields, industry transformation, and social governance [2] - The National Bureau of Statistics reported that the Consumer Price Index (CPI) rose by 0.2% year-on-year and month-on-month in October, while the core CPI increased by 1.2%, marking the sixth consecutive month of growth [3] - The Producer Price Index (PPI) decreased by 2.1% year-on-year in October, but the decline narrowed by 0.2 percentage points from the previous month, with a month-on-month increase of 0.1% [3] Group 2 - As of the end of October, China's foreign exchange reserves reached $3.343 trillion, an increase of $4.7 billion from September, marking the highest level since December 2015 [4] - The People's Bank of China has increased its gold reserves for 12 consecutive months, with the official gold reserves reaching 74.09 million ounces, up by 30,000 ounces from the previous month [4] Group 3 - The China Securities Regulatory Commission and the Ministry of Finance jointly released a revised management method for the securities settlement risk fund, effective from December 8, 2025, with differentiated adjustments to the contribution ratio [5] - The Ministry of Finance reported that since 2025, fiscal policy has become more proactive, focusing on stabilizing employment, enterprises, and market expectations [6] Group 4 - The Ministry of Commerce announced the suspension of certain export controls on dual-use items to the United States, effective immediately until November 27, 2026 [7] - Upcoming macroeconomic data for October, including industrial added value and fixed asset investment, is set to be released on November 14 [8] Group 5 - U.S. stock markets ended mixed, with the Nasdaq down 0.21% and the S&P 500 up 0.13%, marking the end of a three-week rally [9] - The China Securities Regulatory Commission approved IPO registrations for two companies, with new stock issuances scheduled for the week of November 10-14 [10] Group 6 - A total of 33 companies will have their restricted shares released this week, amounting to 1.407 billion shares with a total market value of approximately 24.715 billion yuan [12] - The companies with the highest market value of released shares include Youyan Silicon (9.991 billion yuan) and Xinnoway (4.948 billion yuan) [12]

Core Viewpoint - A total of 34 companies will have 1.407 billion shares released from restrictions next week, with a total market value of 24.733 billion yuan, representing an increase of 742 million yuan compared to the previous week [1] Group 1: Upcoming Unlocks - The peak unlock day is on Monday, November 10, with an unlock scale of 12.563 billion yuan, accounting for 50.79% of the total for the week [1] - The top three companies by unlock market value are Youyan Silicon (99.91 billion yuan), XinNuoWei (49.48 billion yuan), and Juxing Technology (32.97 billion yuan) [1] Group 2: Detailed Unlock List - Youyan Silicon: Unlock date on November 10, market value of 99.91 billion yuan, with 74,005.54 thousand shares, accounting for 59.32% of total shares [2] - XinNuoWei: Unlock date on November 14, market value of 49.48 billion yuan, with 15,752.05 thousand shares, accounting for 11.21% of total shares [4] - Juxing Technology: Unlock date on November 11, market value of 32.97 billion yuan, with 11,826.6 thousand shares, accounting for 76.22% of total shares [3]

Core Viewpoint - A total of 34 companies will have their restricted shares unlocked between November 10 and 14, with a combined market value exceeding 24.7 billion yuan based on the latest closing prices [2] Group 1: Unlocking Market Value - The peak unlocking date is November 10, with the highest market values for unlocked shares being: Youyan Silicon (688432.SH) at 9.991 billion yuan, Xinnowei (300765.SZ) at 4.948 billion yuan, and Juxing Technology (920111.BJ) at 3.297 billion yuan [2] Group 2: Unlocking Share Volume - The top three companies by the number of unlocked shares are: Youyan Silicon with 740 million shares, Xinnowei with 158 million shares, and Beibu Gulf Port (000582.SZ) with 156 million shares [2]

Economic Data Release - The National Bureau of Statistics will release October economic data on November 14, including industrial added value, fixed asset investment, and retail sales [2] - Financial data for October, such as M2, new loans, and social financing, is also expected to be released next week [3] Industry Conferences - A series of industry conferences will take place in November, including the 2025 China Robot Industry Development Conference from November 10 to 12, and the 12th China (Suzhou) Battery New Energy Industry International Summit Forum from November 11 to 13 [4] - Other notable events include the 2025 World Power Battery Conference, the 2025 Fourth China Nuclear Energy High-Quality Development Conference, and the 2025 6G Development Conference [4] Fuel Price Adjustment - A new round of domestic fuel price adjustments will begin on November 10 at 24:00, with an expected increase of 130 yuan per ton for gasoline and diesel based on the average crude oil price of 62.52 USD per barrel [5] Stock Unlocking - Over 24.7 billion yuan worth of restricted shares will be unlocked next week, with a peak unlocking date on November 10 [6] - The top three companies by unlocking market value are Youyan Silicon (99.91 million yuan), Xin Nuowei (49.48 million yuan), and Juxing Technology (32.97 million yuan) [6] New Stock Opportunities - Two new stocks will be issued next week: Nant Technology on November 11 and Hai'an Group on November 14 [9]

Core Viewpoint - New Nuo Wei's stock price has experienced significant fluctuations, with a year-to-date increase of 19.08% but a recent decline of 35.44% over the past 60 days, indicating potential volatility in the market [1]. Financial Performance - For the period from January to September 2025, New Nuo Wei reported a revenue of 1.593 billion yuan, reflecting a year-on-year growth of 7.71%. However, the net profit attributable to shareholders was a loss of 24.05 million yuan, a decrease of 117.26% compared to the previous year [2]. - Cumulatively, since its A-share listing, New Nuo Wei has distributed a total of 651 million yuan in dividends, with 500 million yuan distributed over the past three years [3]. Shareholder Structure - As of October 31, 2025, the number of shareholders for New Nuo Wei increased by 32.87% to 21,800, while the average number of circulating shares per person decreased by 24.74% to 57,116 shares [2]. - The top ten circulating shareholders include significant institutional investors, with Hong Kong Central Clearing Limited holding 17.7822 million shares, a decrease of 3.2169 million shares from the previous period [3].