Core Points - The announcement confirms that nine companies, including Heilongjiang Guoyao Tianjiang Pharmaceutical Co., Ltd., have passed the on-site inspections and comply with the Good Manufacturing Practice (GMP) requirements as per the Drug Administration Law and related regulations [3][4] Group 1: Compliance and Inspections - Heilongjiang Guoyao Tianjiang Pharmaceutical Co., Ltd. is noted for its production lines for traditional Chinese medicine pieces, including various processing methods [3] - Heilongjiang Songhua Pharmaceutical Technology Co., Ltd. has passed inspections for its freeze-dried powder injection production lines [3] - Harbin Dayang Pharmaceutical Co., Ltd. has been inspected for its solid dosage forms, including tablets and capsules [3] Group 2: Production Facilities - Heilongjiang Zhenbao Island Pharmaceutical Co., Ltd. has been recognized for its oral liquid production lines and related processing facilities [3] - Heilongjiang Yibai Pharmaceutical Co., Ltd. has been inspected for its solid dosage forms and extraction processes [3] - Heilongjiang Daxinganling Liwo Pharmaceutical Co., Ltd. has passed inspections for its raw material drug production lines [3]

Core Viewpoint - Unimed Pharmaceutical faces significant operational challenges due to regulatory issues with its subsidiary Tianjin Weiming Biopharmaceutical Co., which has been ordered to suspend production and sales due to non-compliance with drug production quality management standards [1][2]. Group 1: Regulatory Issues - Tianjin Weiming was found to have production practices that do not meet the 2010 revised Drug Production Quality Management Standards, leading to a suspension of production and sales [1]. - The company must complete rectification and inspection before resuming production, which could take up to three months [1]. - If production is not restored within three months, Unimed may face additional risk warnings and could be subject to special treatment (ST) [1]. Group 2: Financial Impact - Following the announcement, Unimed's stock price dropped by 9.95%, closing at 7.42 yuan per share, with a market capitalization of 4.895 billion yuan [1]. - In 2024, Tianjin Weiming generated revenue of 217 million yuan, accounting for 60.09% of Unimed's total revenue, but reported a net loss of 14.0037 million yuan [1][2]. - The recall of a specific batch of interferon α2b spray due to non-compliance resulted in a revenue reduction of 23.1672 million yuan for Unimed [2]. Group 3: Historical Performance - Unimed has experienced fluctuating performance, with five out of the last seven years resulting in losses, particularly since 2018 [3]. - The company has faced multiple operational setbacks, including the suspension of its subsidiary Weiming Tianyuan due to environmental regulations and significant revenue declines in its core products [3][4]. - The ongoing control disputes over Beijing Kexing have further complicated Unimed's operational stability and financial performance [4]. Group 4: Current Business Structure - Unimed's operations are heavily reliant on three key subsidiaries: Tianjin Weiming, Xiamen Weiming, and Beijing Kexing [5]. - The revenue from the previously significant product, nerve growth factor, has decreased to 139 million yuan, representing only 38.59% of total revenue in 2024 [5]. - With Tianjin Weiming's current regulatory issues, Unimed faces potential operational crises as it relies on this subsidiary for a substantial portion of its income [5].

Core Viewpoint - Unimed Pharmaceutical's subsidiary Tianjin Unimed has been suspended from production and sales due to non-compliance with drug production quality management standards, significantly impacting the company's operations and raising concerns about its internal controls and compliance management [1][2]. Group 1: Company Impact - Tianjin Unimed, a key subsidiary, accounted for 60.09% of Unimed Pharmaceutical's revenue in 2024, generating 217 million yuan [1]. - The suspension of production is expected to exacerbate Unimed Pharmaceutical's operational difficulties, with a projected revenue decline of 16.14% to 360 million yuan and a net loss of 137 million yuan in 2024, representing a 58.70% increase in losses [2]. - The company's stock price fell to the daily limit on April 25, reflecting investor concerns about the ongoing situation [2]. Group 2: Regulatory and Compliance Issues - The suspension was triggered by violations of the 2010 revised Drug Production Quality Management Standards, indicating serious quality management issues within the company [1]. - The company has established a special rectification team to address the root causes and develop a corrective action plan, although the timeline for resuming production remains uncertain [2]. - The incident serves as a warning for the entire industry regarding the importance of adhering to drug production quality standards to ensure patient safety [1].

Core Points - The Heilongjiang Provincial Drug Administration announced that 14 companies, including Heilongjiang Fuhua Pharmaceutical Group Co., Ltd., passed the GMP compliance inspection as per the requirements of the Drug Administration Law and the revised Drug Production Supervision and Administration Measures [2][3] Group 1: Compliance Inspection Results - Heilongjiang Fuhua Pharmaceutical Group Co., Ltd. was inspected on February 17, 2025, for its small-volume injection production line [2] - Heilongjiang Ruige Pharmaceutical Co., Ltd. was inspected on February 7, 2025, for its solid dosage form production line [2] - Harbin Tiandi Pharmaceutical Co., Ltd. was inspected on January 8, 2025, for its solid dosage and traditional Chinese medicine extraction production lines [2] - Lantai Pharmaceutical Co., Ltd. was inspected from January 17 to 22, 2025, for its solid dosage production area [2] - Heilongjiang Hasan Pharmaceutical Co., Ltd. was inspected on February 17, 2025, for its raw material drug production line [2] Group 2: Additional Inspections - Heilongjiang Yuheng Pharmaceutical Co., Ltd. was inspected from March 4 to 6, 2025, for its oral dosage and capsule production lines [2] - Heilongjiang Bujia Tang Pharmaceutical Co., Ltd. was inspected from February 6 to 9, 2025, for its solid dosage production line [2] - Heilongjiang Songhua River Pharmaceutical Technology Co., Ltd. was inspected from February 13 to 16, 2025, for its freeze-dried powder injection and extraction production lines [3] - Heilongjiang Tianlong Pharmaceutical Co., Ltd. was inspected from September 26 to 29, 2024, for its eye drop production line [3] - Heilongjiang Jinjiao Pharmaceutical Co., Ltd. was inspected on February 13, 2025, for its small-volume injection production line [3]