Market Overview - On September 1, the A-share market experienced fluctuations, with the Shanghai Composite Index rising by 0.12%, the Shenzhen Component Index by 0.11%, and the ChiNext Index by 0.55% [1][2] - The total trading volume for the market reached 1.85 trillion yuan, slightly lower than the previous day, with over 3,100 stocks rising [2] Precious Metals Sector - The precious metals sector saw significant gains, with gold, jewelry, cobalt, and small metal stocks becoming active [5][6] - Notable stocks that hit the daily limit included Haixing Co., Jintong Co., Shengda Resources, and Western Gold, among others [6] - The rise in precious metals was attributed to increased attractiveness due to expectations of a Federal Reserve rate cut, alongside geopolitical risks and trade tensions [7][8] Innovative Pharmaceuticals Sector - The innovative pharmaceutical sector was notably active, with stocks like Maiwei Biotech hitting the daily limit, alongside others such as Baihua Pharmaceutical and First Pharmaceutical [8][9] - Maiwei Biotech announced the approval of its two monoclonal antibody injection products in Pakistan, marking its first overseas registration [13] - The company also entered into a licensing agreement with CALICO LIFESCIENCES LLC, receiving an upfront payment of $25 million and potential milestone payments totaling up to $571 million [13] Stock Performance Highlights - Maiwei Biotech's stock price increased by 20% to 57.60 yuan, with a trading volume of 24.39 million shares [10][11] - Other notable performers in the pharmaceutical sector included Baijia Shenzhou and WuXi AppTec, both seeing significant gains [14]

此次通过审核，证明迈威生物的生产体系具备满足国际高标准的能力，为产品持续出海提供了核心竞争 力。 哥伦比亚是拉美市场战略国家之一，人口约 5,000 万，拥有严格的药品监管体系，审评标准高度参照 FDA、EMA 及 WHO 等国际权威组织机构，在南美洲认可度较高。迈威生物此前已就两款地舒单抗注 射液在哥伦比亚市场达成战略合作。此次，哥伦比亚审计官对泰康生物的厂房设施、质量体系、生产、 仓储、检测和放行等全流程环节开展了为期 5 天的深度检查，并对审计过程和审计结果给出了高度评价 和肯定。 迈威生物董事、高级副总裁、董秘胡会国表示："哥伦比亚 GMP 检查体系近年来是公认的新兴市场最 严格的监管体系之一，此次以'零缺陷'结果当场通过 GMP 现场检查，是迈威生物在质量管理体系与生 产能力方面所获的又一国际认可，也为产品后续在更多国家的商业化打下了坚实基础，将进一步提升产 品在更多患者中的可及性。" 在哥伦比亚 INVIMA 的 GMP 现场检查中，迈威生物子公司泰康生物的表现亮眼：审计官对两款地舒单 抗注射液9MW0311（Prolia® 生物类似药，国内商品名：迈利舒®）和 9MW0321（Xgeva® 生物 ...