Core Viewpoint - ST Unimed (未名医药) reported a significant decline in profitability despite a revenue increase in Q3 2025, primarily due to the suspension of its core subsidiary, Tianjin Unimed, affecting its operations and stock status [1][3]. Financial Performance - In Q3 2025, ST Unimed achieved a revenue of 141 million yuan, marking a 35.94% year-on-year increase, but the cumulative revenue for the first three quarters fell by 32.62% to 212 million yuan [2][3]. - The net profit attributable to shareholders for the first three quarters was a loss of 68.81 million yuan, a drastic decline of 570.46% compared to a profit of 14.63 million yuan in the same period last year [2][3]. - The basic and diluted earnings per share were both -0.1043 yuan, reflecting a year-on-year decrease of 569.82% [2]. Operational Challenges - The operational difficulties stem from the suspension of Tianjin Unimed's production and sales since April 2025 due to regulatory compliance issues, which has severely impacted the company's revenue [3][5]. - Tianjin Unimed accounted for 60.09% of the company's total revenue in 2024, highlighting its critical role in ST Unimed's financial health [3]. Strategic Actions - ST Unimed has resolved historical equity issues with its wholly-owned subsidiary, Xiamen Unimed, by regaining 34% of its shares from Hangzhou Qiangxin Biotechnology Co., Ltd. through a settlement agreement [4]. - The company is actively seeking new growth opportunities, including a 45 million yuan investment in Sichuan Gukang Pharmaceutical Co., Ltd., acquiring a 51% stake and providing financial support of up to 55 million yuan [5].

Core Viewpoint - Junshi Biosciences (01877) announced that its wholly-owned subsidiary, Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., successfully passed an unannounced CGMP inspection by the FDA, indicating the company's high-quality manufacturing system continues to gain international recognition [1] Group 1: FDA Inspection - Suzhou Zhonghe underwent an unannounced CGMP inspection from June 16 to June 24, 2025, and received a favorable Establishment Inspection Report (EIR) from the FDA [1] - This marks the second successful FDA inspection for Suzhou Zhonghe since its first in 2023, reinforcing the company's commitment to quality [1] Group 2: Production Capacity and Certifications - As of the announcement date, the Suzhou Wujiang production facility has a fermentation capacity of 4,500 liters (9 x 500 liters) [1] - The facility has obtained GMP certifications and approvals from multiple countries and regions, including mainland China, Hong Kong, the USA, EU, UK, Australia, Singapore, India, Jordan, UAE, Kuwait, and Pakistan [1] Group 3: Market Implications - The successful FDA inspection is crucial for the company's strategy to expand in the US market, providing a solid foundation for ongoing commercial supply of Toripalimab [1] - This development is expected to have a positive impact on the company's production and operations [1]

此次是苏州众合继2023年首次通过FDA现场检查以来，第二次通过FDA现场检查，表明公司高质量生产 制造体系持续获得国际认可。截至本公告披露日，苏州吴江生产基地拥有4500升(9*500升)发酵能力， 已获得中国内地、中国香港、美国、欧盟、英国、澳大利亚、新加坡、印度、约旦、阿联酋、科威特、 巴基斯坦等多个国家和地区的GMP认证和批准，主要负责特瑞普利单抗海外市场的商业化供应。美国 市场是公司海外商业化战略的重要构成部分，本次通过FDA现场检查，为公司持续拓展美国市场提供了 坚实的保障，将对公司生产经营产生积极影响。 智通财经APP讯，君实生物(01877)发布公告，公司全资子公司苏州众合生物医药科技有限公司(以下简 称"苏州众合")于2025年6月16日至2025年6月24日期间接受了美国食品药品监督管理局(以下简称"FDA") 的CGMP(现行药品生产质量管理规范)飞行检查(UnannouncedInspection，指在日常期间不事先通知的检 查)。近日，苏州众合收到FDA签发的现场检查报告(EIR，EstablishmentInspectionReport)，该报告表明 苏州众合已通过本次CGMP现场 ...

此次是苏州众合继2023年首次通过FDA现场检查以来，第二次通过FDA现场检查，表明公司高质量生产 制造体系持续获得国际认可。 君实生物(688180.SH)发布公告，公司全资子公司苏州众合生物医药科技有限公司(简称"苏州众合")于 2025年6月16日至2025年6月24日期间接受了美国食品药品监督管理局(简称"FDA")的CGMP(现行药品生 产质量管理规范)飞行检查。近日，苏州众合收到FDA签发的现场检查报告(EIR)，该报告表明苏州众合 已通过本次CGMP现场检查。 ...

Core Viewpoint - 康龙化成's subsidiary, 康龙化成(绍兴)药业有限公司, successfully passed the FDA's cGMP pre-approval inspection, confirming compliance with U.S. drug quality standards [1] Group 1: Company Overview - 康龙化成's subsidiary, 康龙化成(绍兴), underwent a cGMP pre-approval inspection by the FDA from May 29 to June 4, 2025 [1] - The inspection covered various GMP systems including quality management, material management, production management, equipment facilities, packaging and labeling, and laboratory control [1] - 康龙绍兴 received a positive on-site inspection report from the FDA, confirming that its production facilities met the required quality standards [1]

Core Viewpoint - The company, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., a subsidiary of Baiyunshan (600332)(00874), has received a production license from the Guangdong Provincial Drug Administration, allowing it to produce drugs and renovate its small-volume injection production line, which is expected to optimize capacity and meet market demand [1]. Group 1 - The company has been granted a "Drug Production License" for commissioned drug production limited to registered products [1]. - The renovation of the small-volume injection production line and the solid oral dosage form workshop for cephalosporin production has passed the compliance inspection for drug production quality management standards [1]. - The new license and production capabilities are expected to enhance the company's production capacity to better satisfy market needs [1]. Group 2 - The impact of this license on the company's current performance is not expected to be significant [1].

Core Viewpoint - Shenzhen's pharmaceutical companies are facing challenges with the "upstairs" industrial development model due to regulatory approval standards for production facilities, prompting discussions on how to better support these enterprises [1][5]. Regulatory Standards - The Guangdong Provincial Drug Administration clarified that having an independent factory is not a prerequisite for obtaining a drug production license, except for specific high-risk drugs that require dedicated facilities [2][4]. - Approval is based on the compliance of production management, pollution control, ventilation, and transportation conditions with national standards, rather than the independence of the facility [2][4]. Cost Considerations - Pharmaceutical companies weigh the costs of rent and "upstairs" renovations when deciding on their production locations, considering factors like potential interference with neighbors [3]. - The cost of "renovation" in non-independent facilities can be significantly higher due to the need for additional measures to ensure safety and compliance with regulations [3]. Support for "Upstairs" Enterprises - The regulatory body aims to treat "upstairs" enterprises fairly and will not lower standards for their production facilities compared to independent ones, ensuring compliance with national requirements [4][5]. - The administration is exploring ways to better serve companies that choose the "upstairs" model, focusing on professional guidance and support for innovative products [5].

Core Viewpoint - ST诺泰 has received the PIC/S GMP certificate from Brazil's National Health Surveillance Agency, indicating compliance with international production quality management standards, which will enhance the company's ability to market its products overseas [1] Group 1: Regulatory Compliance - The company has successfully passed another overseas compliance inspection following approvals from the US FDA and South Korea's MFDS [1] - The certification covers the cGMP system at the company's Lianyungang factory, which includes the production of active pharmaceutical ingredients Semaglutide and Liraglutide [1] Group 2: Market Implications - This certification is expected to further promote the company's products in international markets, enhancing sales and marketing efforts [1]

Core Viewpoint - Sichuan Shuangma's subsidiary, Hubei Jianxiang Biopharmaceutical Co., Ltd., has received compliance certificates from the Hubei Provincial Drug Administration, indicating that its production line meets GMP standards equivalent to those of the EU and WHO [1] Group 1 - Hubei Jianxiang has obtained the "Notice of Compliance Inspection for Drug GMP" and "Certificate of Export of Raw Materials to the EU" from the Hubei Provincial Drug Administration [1] - The A101 production line for the raw material drug Liraglutide has passed the on-site inspection and complies with China's GMP requirements [1] - The GMP compliance is recognized as equivalent to the standards set by the EU, WHO, and ICH Q7 guidelines for raw material drug production [1]

Core Viewpoint - Sichuan Shuangma (000935.SZ) announced that its subsidiary Hubei Jianxiang Biopharmaceutical Co., Ltd. has received the GMP compliance inspection notice and EU export certificate from the Hubei Provincial Drug Administration, indicating compliance with international drug production quality management standards [1] Group 1 - Hubei Jianxiang's A101 workshop production line for the raw material drug Liraglutide has passed the on-site inspection by the Hubei Provincial Drug Administration [1] - The compliance with China's GMP standards is equivalent to the requirements set by the EU, World Health Organization, and ICH Q7 guidelines [1]