Group 1 - The 2025 China International Service Trade Fair (CIFTIS) is being held from September 10 to September 14 in Beijing, with a significant participation rate of 53% from Fortune Global 500 and industry-leading companies in the health and sanitation services sector [1] - The international participation rate at the fair reached 49%, indicating a growing interest in collaboration between domestic and foreign medical enterprises [1] - Several multinational medical companies expressed optimism about the potential for Sino-foreign cooperation and their commitment to deepening their presence in the Chinese market [1] Group 2 - Philips showcased its new ElitionAI+ intelligent MRI and the Azurion ClarityIQ interventional imaging platform, which has been clinically validated on nearly 20,000 patients, achieving a 70% reduction in radiation dose during interventional procedures [2] - Johnson & Johnson celebrated its 40th anniversary in China by presenting several breakthrough innovative products, including the Impella CP with SmartAssist and the innovative drug Nikalizumab, which are making their debut at the fair [2] - Other notable products included Siemens' photon-counting CT and GE Healthcare's MRI equipment tailored for brain and heart treatment, demonstrating advanced technology and market influence [2] Group 3 - Six Fortune Global 500 companies, including GE Healthcare, Siemens Healthineers, and Johnson & Johnson, have consistently participated in the fair, highlighting their commitment to the Chinese market [3] - Philips has been operating in China for 40 years and plans to establish its China R&D headquarters in Beijing by 2025, reflecting its long-term commitment to the local market [4] - Johnson & Johnson noted that recent policies encouraging innovation in China have created a favorable environment for multinational companies, significantly accelerating the approval and market entry of innovative medical products [4][5] Group 4 - The reform of China's drug review system has allowed Johnson & Johnson to expedite the approval of seven innovative drugs and twelve indications in 2024, including the global first approval for certain indications of its products [5] - The increasing awareness of public health, advancements in medical technology, and reforms in China's healthcare system are driving rapid development in the health sector, providing a conducive environment for business growth [5] - Companies are committed to leveraging global innovations while aligning with local market needs, emphasizing their dedication to high-quality healthcare development in China [5]

此次参展，两款重磅产品首次亮相服贸会：一是心力衰竭治疗领域的Impella CP with SmartAssist介入式 左心室辅助泵；二是尼卡利单抗注射液，其在中国注册申请目标适应症为治疗特定抗体阳性的全身型重 症肌无力成人及12岁以上青少年患者。 经济观察网9月10日，强生公司携旗下医疗科技与创新制药两大业务板块参展2025年中国国际服务贸易 交易会，重点呈现数十款全球领先突破性创新产品、多治疗领域精准化医疗解决方案，以及融合全球产 研能力与中国临床智慧的本土化创新成果。 ...

Core Viewpoint - Beijing is implementing a series of innovative policies and achievements in the pharmaceutical regulatory field to promote high-quality industrial development, including the establishment of innovation service stations and streamlined approval processes for medical devices and drugs [1][3][4]. Group 1: Innovation Service Stations - Beijing has established the first provincial-level drug and medical device innovation service station in the country, along with a national-level medical device innovation service station, to accelerate the transformation of research results and promote the application of key innovative products [3]. - The Changping service station has served 1,373 enterprises and answered 2,185 inquiries, achieving a problem resolution rate of 97%. The average review time for the first registration of Class II medical devices has been reduced from the statutory 120 working days to 47 working days, a speed increase of approximately 61% [3]. Group 2: Support for Innovative Drug Production - In April, Beijing released 32 reform and innovation measures to support the high-quality development of innovative pharmaceuticals, including a pilot program for cross-border segmented production of biological products [4]. - The first approved product under this program is Johnson & Johnson's Nicaralizumab injection, which is notable for being the first imported biological product approved for segmented production in China, targeting rare diseases in patients aged 12 and above [4]. Group 3: Accelerated Drug and Medical Device Inspection - Beijing has achieved immediate inspection of urgently needed clinical drugs and medical devices, completing inspections for 9 varieties and 19 batches this year, with a total value of nearly $100 million [5]. - The Beijing Vaccine Inspection Center, set to be operational in November, will meet the annual inspection demand for 4,000 batches of vaccines, providing comprehensive technical support from research to production [5]. Group 4: Regulatory Reforms for Retail Pharmacies - New regulations for retail pharmacies in Beijing have been introduced, removing restrictions on the shareholding ratio of chain headquarters and allowing for the establishment of remote prescription centers to enhance pharmaceutical service capabilities [6]. - The regulatory body is also supporting the integration of resources among pharmaceutical wholesale enterprises to create a multi-warehouse collaborative logistics management model, significantly reducing operational costs for businesses [6]. Group 5: Future Directions - The Beijing Drug Administration plans to continue enhancing industrial innovation services, actively seeking pilot policies, and improving review and inspection efficiency to empower the high-quality development of the pharmaceutical and health industry in Beijing [6].

消息面上，据新京报，全国首个创新生物制品跨境分段生产试点项目获批。近日，强生制药有限公司的 尼卡利单抗注射液跨境分段生产试点获国家药监局批复同意。该品种的原液在国内生产，制剂和包装在 境外生产，是北京首个获批的生物制品分段生产试点，也是全国首个获批开展原液境内分段生产试点的 进口生物制品，同时也是首个用于治疗12岁及以上青少年和成人患者罕见病"全身型重症肌无力"的生物 制品，实现了"3项"首个突破。 东海证券表示，我国创新药具备研发成本低、效率高的优点，或成为BD交易首选，中国有望成为低成 本研发与生产中心，加速从"仿制跟随"向"创新主导"转型。大型跨国药企在更严格的定价体系下可能积 极寻求降低研发生产成本的路径，我国CXO产业链或将进一步巩固市场地位。 5月22日，港股市场小幅低开，相关ETF中，港股创新药ETF（159567）实现四连涨后盘中回调，截至 发稿跌1.15%，成交额达1.34亿元，成分股中，远大医药涨超2%，先声药业、亚盛医药-B、诺诚健华等 跟涨，三生制药跌超4%。 Wind金融终端数据显示，截至5月21日，港股创新药ETF（159567）年内涨幅达36.43%。 港股创新药ETF（1595 ...

Core Insights - Johnson & Johnson's Nikalizumab injection has received approval for cross-border segmented production, marking a significant milestone in China's biopharmaceutical industry [1][2] - This product is the first biopharmaceutical in Beijing to be approved for segmented production and the first imported biopharmaceutical to conduct domestic segmented production [1] - Nikalizumab is aimed at treating myasthenia gravis in patients aged 12 and above, with potential applications for other autoimmune diseases [1] Group 1 - The segmented production model involves producing the raw liquid domestically while conducting formulation and packaging abroad, aligning with national policies to enhance pharmaceutical innovation [1][2] - The approval is part of the broader initiative to support cross-border segmented production of pharmaceuticals, which is expected to accelerate the introduction of global innovative drugs in China [1][2] - The initiative is in line with the "New 32 Measures" aimed at fostering high-quality development in the pharmaceutical sector in Beijing [1][2] Group 2 - The Beijing Drug Administration played a crucial role in facilitating the application process for Johnson & Johnson, demonstrating proactive engagement with the company [2] - The approval process for Nikalizumab was classified as a Class 1 innovative drug, highlighting its significance in the market [2] - Johnson & Johnson plans to collaborate with regulatory bodies to explore the regulatory model for segmented production, aiming to set a precedent for innovation in the biopharmaceutical industry [2]