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]