创新药临床试验审评审批
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前8个月,江苏外贸进出口同比增长5.1% 央行:前8个月人民币存款增加20.5万亿元
Sou Hu Cai Jing· 2025-09-13 00:19
Industry Events - The 46th Wuxi (Taihu) International Smart Industrial Equipment Expo opened on September 12, attracting over 600 domestic and international enterprises with an exhibition area of 50,000 square meters [2] Equity Market - On September 12, the stock market experienced a pullback, with all three major indices closing lower. The total trading volume in the Shanghai and Shenzhen markets reached 2.52 trillion yuan, an increase of 832 billion yuan from the previous trading day. Over 3,300 stocks declined, with sectors like non-ferrous metals and storage chips gaining, while large financials and liquor sectors fell [2] Commodity Market - COMEX gold prices have risen nearly 39% this year. Morgan Stanley predicts that news of a Federal Reserve interest rate cut will further boost gold prices, with an expected increase of about 5% by 2025, potentially reaching $3,800 per ounce by year-end [3] Trade Statistics - In the first eight months of this year, Jiangsu Province's foreign trade import and export value reached 3.82 trillion yuan, a 5.1% increase year-on-year, which is 1.6 percentage points higher than the national average. Exports totaled 2.55 trillion yuan, up 9%, while imports decreased by 2% to 1.27 trillion yuan [4] Regulatory Developments - The State Administration for Market Regulation and 15 other departments released guidelines on September 12 to accelerate the digital development of quality certification services, focusing on key digital equipment and products [5] - The National Medical Products Administration announced on September 12 that clinical trial applications for innovative drugs meeting requirements will be reviewed within 30 working days. So far this year, 64 drugs have been included in the breakthrough therapy list [5] Corporate Innovations - JPMorgan expects the European Central Bank to cut interest rates in December, a shift from its previous forecast of October [6] - 361 Degrees is exploring the use of stablecoins for payment and settlement solutions for its product sales outside mainland China [6] - Ant Group launched the world's first trusted connection technology framework for smart glasses, aiming to create a secure and interactive ecosystem for AI glasses [6] - Apple updated its website on September 12, indicating that the iPhone Air will be released after further updates, with eSIM support and no physical SIM card [6]
国家药监局征求意见:纳入创新药临床试验审评审批30日通道的申请 应当为中药、化学药品、生物制品1类创新药
news flash· 2025-06-16 07:02
国家药监局征求意见:纳入创新药临床试验审评审批30日通道的申请 应当为中药、化学药品、生物制 品1类创新药 智通财经6月16日电,国家药监局综合司公开征求《关于优化创新药临床试验审评审批有关事项的公告 (征求意见稿)》意见,其中提出,纳入创新药临床试验审评审批30日通道的申请,应当为中药、化学 药品、生物制品1类创新药,能够按要求提交申报资料,并需满足以下条件之一:(一)国家支持的重 点创新药。获国家全链条支持创新药发展政策体系支持的具有明显临床价值的重点创新药品种。(二) 入选国家药品监督管理局药品审评中心儿童药星光计划、罕见病关爱计划的品种。(三)全球同步研发 品种。全球同步研发的Ⅰ期、Ⅱ期临床试验和III期国际多中心临床试验,以及中国主要研究者牵头开展 的国际多中心临床试验。 ...