Core Viewpoint - South Korean pharmaceutical company Celltrion plans to invest up to 700 billion Korean won ($478.17 million) to expand capacity at its U.S. factory in response to U.S. tariffs and rising demand [1] Company Summary - Celltrion is responding to U.S. tariffs by increasing its manufacturing capacity in the United States [1] - The investment of 700 billion Korean won is aimed at meeting the growing demand for its products [1] Industry Summary - The pharmaceutical industry is experiencing rising demand, prompting companies like Celltrion to expand their production capabilities [1] - U.S. tariffs are influencing foreign pharmaceutical companies to invest in local manufacturing to mitigate costs [1]

Core Viewpoint - Celltrion, Inc. has received FDA designation for its biosimilars STOBOCLO® and OSENVELT® as interchangeable with the reference products PROLIA® and XGEVA®, respectively, for all approved indications, enhancing patient access and treatment options in the U.S. market [1][5]. Group 1: Product Information - STOBOCLO® (denosumab-bmwo) is indicated for treating postmenopausal women with osteoporosis at high risk for fracture, increasing bone mass in men with osteoporosis, and treating glucocorticoid-induced osteoporosis [4][6]. - OSENVELT® (denosumab-bmwo) is indicated for preventing skeletal-related events in patients with multiple myeloma and bone metastases, treating unresectable giant cell tumor of bone, and managing hypercalcemia of malignancy [17][21]. Group 2: Regulatory Designation - The FDA's interchangeability designation allows STOBOCLO and OSENVELT to be substituted for their reference products at pharmacies without consulting the prescriber, subject to state laws [3][5]. - The designations were based on comprehensive clinical data, including Phase III trial results demonstrating efficacy, safety, and pharmacokinetics in postmenopausal women with osteoporosis [3][5]. Group 3: Market Impact - The interchangeability designations are expected to reinforce confidence among healthcare providers, facilitating a smoother transition to these biosimilars and potentially leading to cost savings for patients and the U.S. healthcare system [3][5]. - STOBOCLO and OSENVELT were introduced to the U.S. market in July 2025, with STOBOCLO available in a 60 mg/mL injection and OSENVELT in a 120 mg/1.7 mL (70 mg/mL) injection [3][4].

Group 1 - The UK Competition and Markets Authority (CMA) confirmed Google's "strategic market position" in the search services sector, allowing for potential targeted interventions to ensure effective competition [1] - SeaTech's management attributed the decline in gross margin to an increase in customized service revenue, driven by new overseas content review business and state-owned enterprises adopting an "AI+" strategy [1] - Xiaomi Group-W received a net inflow of HKD 933 million from southbound funds, ranking first among net purchases [2] Group 2 - Malaysia warned that the cancellation of tariff exemptions on semiconductor exports to the US could harm its competitiveness and supply chain [2] - ZhiYuan Robotics plans to go public in Hong Kong next year, targeting a valuation between USD 5.1 billion and USD 6.4 billion [2] - SoftBank is negotiating a USD 5 billion margin loan using Arm's stock as collateral, intended for additional investment in OpenAI [2] Group 3 - CATL's intelligent chassis subsidiary completed its first round of financing, raising over CNY 2 billion and achieving a valuation exceeding CNY 10 billion, becoming the first unicorn in the intelligent chassis sector [3] - The financing will support the mass production of CATL's Rock chassis model and the development of the next-generation technology [3] Group 4 - The financing balance of the two stock exchanges increased by CNY 50.709 billion, with the Shanghai Stock Exchange reporting CNY 1.23325 trillion and the Shenzhen Stock Exchange CNY 1.18843 trillion [4] Group 5 - Celltrion's biosimilar Eydenzelt has been approved by the FDA for treating wet age-related macular degeneration and other eye diseases [6] Group 6 - The Federal Reserve's Daly indicated that a weak labor market and slowing inflation justify recent interest rate cuts, suggesting potential for further reductions [6] - A UK trading platform warned investors against including cryptocurrencies in their portfolios following the lifting of a ban on retail investors [6] Group 7 - Elon Musk and four former Twitter executives reached a settlement over severance pay claims, totaling USD 12.8 million [7] - The settlement follows a lawsuit related to mass layoffs after Musk's acquisition of Twitter [7] Group 8 - The US and Argentina established a USD 20 billion currency swap framework to address Argentina's liquidity crisis [8] - Global financial regulators plan to enhance monitoring of risks associated with the increasing use of artificial intelligence in the financial sector [8] - The China Securities Regulatory Commission is investigating *ST Yuancheng for serious financial fraud, proposing significant fines and potential delisting [8]

Representative imageCompanies without existing US manufacturing plants could face the full impact, triggering declines across major drugmakers in South Korea, Japan, and Hong Kong.In South Korea, Samsung Biologics fell 1.6%, while SK Biopharmaceuticals slid 2.6%. Celltrion, which recently acquired ImClone Systems from Eli Lilly in the United States for $330 million, rose 1.3% after recouping earlier losses.In Japan, Sumitomo Pharma tumbled 4.3%, Otsuka Holdings dropped 3.5%, and Daiichi Sankyo lost 1.6%. Ta ...

人工智能攻关"揭榜挂帅" 加速AI+制造专项行动 从工业和信息化部获悉，我国将启动新一轮人工智能赋能新型工业化"揭榜挂帅"行动。新一轮人工智能赋能 新型工业化"揭榜挂帅"希望通过机制创新，在新型工业化重点行业遴选技术难度大、应用前景广、推广价值 高的关键场景，开展联合创新、协同攻关，打造一批可复制、可推广的人工智能赋能新型工业化新标杆。通 过突破关键核心技术，加强通用大模型和行业大模型的研发布局，加快建设工业领域高质量数据集，促进人 工智能在工业领域深度融合。工业和信息化部相关负责人表示，将实施人工智能+制造专项行动，发布实施 制造业企业人工智能应用指南，常态化开展人工智能赋能新型工业化深度行活动。 阿里巴巴宣布与英伟达开展合作 在2025阿里云栖大会上，阿里巴巴正式宣布与英伟达开展Physical AI合作。合作覆盖了Physical AI的实践的 各个方面，包括数据的合成处理，模型的训练，环境仿真强化学习以及模型验证测试等。 湖北：到2027年全省算力总规模达到25EFLOPS 9月24日，在杭州云栖大会上，原力无限发布了首款人形机器人——AstroDroid AD-01。据介绍，AD-01身高 170c ...

Policy Developments - The National Healthcare Security Administration (NHSA) has initiated a pilot program for real-world comprehensive value assessment of medical insurance, aiming to establish a value-oriented evaluation system by the end of 2027 [1] Drug and Device Approvals - Hengrui Medicine's application for a new indication of Adebeli monoclonal antibody injection has been accepted by the National Medical Products Administration (NMPA) for treating operable non-small cell lung cancer [2] - Yuan Da Pharmaceutical's new specification of Treprostinil injection has been approved, enhancing treatment options for pulmonary arterial hypertension (PAH) patients [3] - China National Pharmaceutical's Lincomycin injection has passed the consistency evaluation for generic drugs, with projected sales of approximately 0.77 million in 2024 [4] - Dongfang Ocean's subsidiary has received medical device registration for a fat-soluble vitamin testing kit, expanding its clinical testing product line [5] Capital Market Activities - Celltrion plans to invest nearly $330 million to acquire a biologics manufacturing facility from Eli Lilly in New Jersey, with additional investments expected for expansion [7] - Amgen Pharmaceuticals intends to raise up to 1.033 billion for daily R&D and operational expenses through a private placement [8] Industry Events - Novo Nordisk's oral GLP-1 weight loss drug, Semaglutide, has shown a 16.6% average weight reduction in a 64-week trial, marking a significant milestone in obesity treatment [9] - The Central China Center for Drug and Medical Device Review has been established to enhance the efficiency of drug and medical device evaluations in the central region [10] Company Developments - Yabao Pharmaceutical has terminated the clinical development of SY-009 capsules, resulting in a full impairment of 55.793 million in capitalized costs [11] - Merck has signed a new memorandum with Siemens to accelerate the use of artificial intelligence in drug development [12] - Baicheng Pharmaceutical's executives plan to reduce their shareholdings due to personal financial needs [13][14] - Tsinghua Pharmaceutical's president and vice president have resigned, with no further roles in the company [15]

Group 1 - Spot gold prices reached a new high of $3,790 per ounce, driven by optimistic expectations regarding the Federal Reserve's continued interest rate cuts [1] - The "Seven Sisters" of technology stocks mostly rose in pre-market trading, with Tesla up 0.60%, Meta and Amazon up 0.40%, and Microsoft up 0.23% [1] - Chinese concept stocks mostly declined in pre-market trading, with Pinduoduo down 0.5%, Li Auto down over 1%, JD.com and Bilibili down over 2%, and Baidu down over 3% [1] Group 2 - Citigroup predicts that TSMC will remain a major foundry for NVIDIA and Intel, with expected revenue growth of 50% from NVIDIA and 20% from Intel by 2026 [2] - NVIDIA emphasized that its investment in OpenAI, which could reach up to $100 billion, will not affect its supply to other clients [2] - The KraneShares CSI China Internet ETF (KWEB) has seen continuous inflows for six weeks, totaling $599 million, marking the longest inflow period since February [2] Group 3 - South Korean biopharmaceutical company Celltrion plans to acquire Eli Lilly's biomanufacturing facility in New Jersey for nearly $330 million [3] - WeRide was officially included in the Nasdaq Golden Dragon China Index [3]

每经编辑｜何小桃 郑雨航 ① 【三大期指涨跌互现】道指期货涨0.10%、标普500指数期货跌0.02%、纳指期货涨0.01%。 ② 【科技股"七姐妹"盘前多数上涨】科技股"七姐妹"盘前多数上涨，特斯拉涨0.60%，Meta、亚马逊涨0.40%，微软涨0.23%，苹果、谷歌涨0.10%，英伟 达跌0.40%。 ⑨ 【文远知行被纳入纳斯达克中国金龙指数】9月22日，文远知行WeRide（Nasdaq：WRD）被正式纳入纳斯达克中国金龙指数HXC（Nasdaq Golden Dragon China Index）。 ⑩ 北京时间21:45，美国9月Markit制造业PMI初值发布。 编辑|何小桃 郑雨航 杜恒峰 校对|段炼 ③ 【中概股盘前多数下跌】中概股盘前多数下跌，拼多多跌0.5%，理想汽车跌超1%，京东、哔哩哔哩跌超2%，百度跌超3%。 ④ 【金价突破3790美元续创新高】9月23日，现货黄金上涨超1%，触及3790美元/盎司，刷新历史纪录高位。消息面上，投资者对于美联储将继续降息的 乐观预期继续推动金价上涨。 ⑤ 【花旗：预计台积电仍将是英伟达和英特尔的主要代工方】台积电盘前涨超3%。花旗分析师报告表示，在 ...

Group 1: E-commerce and Logistics - AliExpress has expanded its overseas management service to cover 30 countries, with over 50% of transaction volume in large items like furniture and appliances coming from this service [1] - The service enhancement includes the launch of official logistics in some countries to improve the last-mile delivery experience ahead of the Double 11 shopping festival [1] Group 2: Investment and Development - McDonald's China plans to invest over 400 million RMB in talent training and development over the next three years, focusing on upgrading its Hamburger University [2] - The investment aims to incorporate AI tools for personalized learning paths and virtual mentorship, enhancing the training of nearly 10,000 students annually [2] - Celltrion intends to invest approximately 1 billion USD to acquire and expand a biopharmaceutical plant in the U.S. to mitigate tariff risks [5] Group 3: Corporate Actions and Financing - Jiangsu Port Container Group's registered capital has increased from approximately 1.61 billion RMB to about 2.02 billion RMB, marking a 25% increase [6] - Noitom Robotics has completed an angel round financing of several tens of millions, with a Pre-A round currently underway [7] - Zhejiang Biyi has established a new manufacturing technology company with a registered capital of 10 million RMB, focusing on home appliance development and sales [8] Group 4: Trade Agreements - The EU and Indonesia have signed a free trade agreement after nine years of negotiations, which will eliminate over 98% of tariffs, benefiting labor-intensive and emerging industries [2] - The agreement is expected to save EU exporters over 600 million euros annually in tariffs on goods exported to Indonesia [2] Group 5: New Ventures - Guoshou (Nanjing) Health Management Co., Ltd. has been established with a registered capital of approximately 323 million RMB, focusing on health consulting and elderly care services [9] - Hefei Huanliu Technology Co., Ltd. has been set up with a registered capital of 2 million RMB, specializing in AI software development [10]

④ 【金价突破3790美元续创新高】9月23日，现货黄金上涨超1%，触及3790美元/盎司，刷新历史纪录 高位。消息面上，投资者对于美联储将继续降息的乐观预期继续推动金价上涨。 ⑤ 【花旗：预计台积电仍将是英伟达和英特尔的主要代工方】台积电盘前涨超3%。花旗分析师报告表 示，在英伟达和英特尔合作后，台积电可能仍将是这两家公司的主要代工方。英伟达8月份证实，台积 电正为其下一代Rubin架构生产六款新芯片。花旗分析师预测，到2026年，台积电来自英伟达的收入将 增长50%，来自英特尔的收入将增长20%。 ⑥ 【英伟达：投资OpenAI不会影响公司对其他客户的供应】英伟达与OpenAI在本周一宣布达成合作， 将一起建设大型数据中心，英伟达还将对OpenAI最高投资1000亿美元，这引发市场对英伟达公司未来 方向的担忧，对此，英伟达在周一晚些时候的声明中强调，对OpenAI投资不会改变公司重点，也不会 影响对其他客户的供应。 每经编辑：郑雨航 ① 【三大期指涨跌互现】道指期货涨0.10%、标普500指数期货跌0.02%、纳指期货涨0.01%。 ② 【科技股"七姐妹"盘前多数上涨】科技股"七姐妹"盘前多数上涨，特斯拉 ...