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].

Policy Developments - The National Medical Insurance Administration has initiated a pilot program for intelligent review of the entire process of medical insurance management, aiming to enhance the review capabilities and ensure the sustainable operation of medical insurance funds through the integration of AI technology [2]. Industry Developments - Chongqing has introduced measures to support high-quality development of innovative drugs, emphasizing the role of artificial intelligence in drug innovation and the establishment of a public service platform for "AI + pharmaceuticals" [3][4]. - Shanghai Pharmaceuticals has received FDA approval for its clopidogrel tablets, which are expected to generate approximately $1.284 billion in sales in the U.S. market in 2024, marking a significant opportunity for the company to expand its overseas market presence [6]. - NuoVation has obtained two medical device registration certificates for adenovirus antigen test kits, which are classified as Class III medical devices, indicating a step forward in the company's product offerings [7]. - Renfu Pharmaceutical has received approval for clinical trials of its HWH217 tablets, aimed at treating pulmonary arterial hypertension, with a total R&D investment of approximately 6 million yuan [8]. Capital Market - Pulsecare has successfully completed a financing round of over 100 million yuan, indicating strong investor interest in cardiovascular treatment technologies [10]. - Sunshine Nuohua has completed a share purchase plan by its associated company, acquiring 612,638 shares, which represents 0.55% of the total share capital, with an investment exceeding 28 million yuan [11]. Major Industry Events - The first batch of ovarian cancer treatment drugs has cleared customs in Beijing, marking a significant step in ensuring nationwide supply for this new treatment [13]. - Research from the Beijing Brain Science and Brain-like Research Institute has identified a new mechanism for treating depression, which could lead to the development of new antidepressant strategies with fewer side effects [14]. Regulatory Updates - Asia-Pacific Pharmaceutical has received a notification that its application for the consistency evaluation of diltiazem hydrochloride tablets has been rejected due to insufficient evidence supporting bioequivalence, indicating challenges in the drug development process [16].

Core Points - The company, Asia-Pacific Pharmaceutical (002370), received a notification from the National Medical Products Administration stating that its application for the consistency evaluation of Diltiazem Hydrochloride Tablets was not approved [2] - The reason for the disapproval was that the bioequivalence study submitted could not support a conclusion of bioequivalence [2] - The company plans to improve the relevant experimental research for the drug and will reapply for approval in the future [2] Company Impact - The disapproval of Diltiazem Hydrochloride Tablets is not expected to have a significant impact on the company's current performance [2]

Core Viewpoint - Recently, Asia-Pacific Pharmaceutical (002370) received a notification from the National Medical Products Administration stating that the application for the consistency evaluation of Diltiazem Hydrochloride Tablets was not approved due to the inability of the bioequivalence study to support a bioequivalence conclusion [1] Group 1 - The company submitted the consistency evaluation application for Diltiazem Hydrochloride Tablets in November 2024, which was accepted by the National Medical Products Administration [1] - The reason for the disapproval was that the bioequivalence study conducted in this application could not support the conclusion of bioequivalence [1] - The company stated that this disapproval will not have a significant impact on its current performance and plans to improve the relevant experimental research before reapplying [1]