亚太药业盐酸地尔硫片未通过一致性评价,公司已连亏6年

Core Viewpoint - Asia-Pacific Pharmaceutical received a notification from the National Medical Products Administration regarding the rejection of its application for the consistency evaluation of Diltiazem Hydrochloride Tablets, which may impact the company's recent strategic shift towards innovation following a change in control [2][6]. Company Overview - Asia-Pacific Pharmaceutical, established in 1989 and listed in 2010, primarily produces chemical generic drugs, with over 60% of its products being antibiotics [4]. - The company has faced a continuous decline in performance over the past six years, accumulating a net loss of over 2.5 billion yuan [4]. Financial Performance - From 2019 to 2024, the company's net profit excluding non-recurring items showed significant losses: 1.94 billion yuan, 143 million yuan, 239 million yuan, 117 million yuan, 68.94 million yuan, and 28.13 million yuan respectively [4]. - In the first half of 2025, the company reported revenue of 152 million yuan, a year-on-year decline of 31.48%, while the net profit attributable to shareholders increased by 1820.97% due to the sale of a subsidiary [4]. - The third quarter of 2025 showed a net profit of 97.2 million yuan, a year-on-year increase of 2909.49%, but the net profit excluding non-recurring items was a loss of 56.6 million yuan, indicating a worsening trend [5]. Product and Market Challenges - The company's product structure, heavily reliant on chemical generics, faces intense market competition and challenges due to delays in the consistency evaluation of generics, leading to weakened competitiveness [5]. - Currently, only 19 of the company's products have passed the consistency evaluation, and the ongoing pressures from centralized procurement and slowing demand for antibiotics have resulted in declining sales and prices [5]. Strategic Shift - In October 2023, Starry Holdings acquired a 14.62% stake in Asia-Pacific Pharmaceutical for 900 million yuan, marking a strategic shift from generic to innovative drug development, with plans to invest 700 million yuan in new research platforms [6]. - The recent failure of the consistency evaluation for Diltiazem Hydrochloride Tablets poses a setback to this transformation strategy [6].