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].

Core Viewpoint - Asia-Pacific Pharmaceutical (亚太药业) faced a setback as its application for the consistency evaluation of Diltiazem Hydrochloride Tablets was rejected by the National Medical Products Administration (NMPA) just a month after a significant change in its controlling shareholder and a capital increase plan [1][2][4]. Group 1: Company Overview - Asia-Pacific Pharmaceutical was established in 1989 and primarily produces chemical generic drugs, with over 60% of its products being antibiotics [3]. - The company has been experiencing a decline in performance for six consecutive years, with a cumulative loss exceeding 2.5 billion yuan in net profit excluding non-recurring items from 2019 to 2024 [3][4]. Group 2: Financial Performance - In the first half of 2025, the company reported revenue of 152 million yuan, a year-on-year decrease of 31.48%, while the net profit attributable to shareholders increased by 1820.97% due to the sale of a subsidiary [3]. - The third-quarter report for 2025 indicated a net profit of 97.2 million yuan, a year-on-year increase of 2909.49%, but the net profit excluding non-recurring items showed a loss of 56.6 million yuan, reflecting a 150.47% increase in loss [4]. Group 3: 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 [4]. - As of now, only 19 of the company's products have passed the consistency evaluation, and the ongoing pressures from normalized centralized procurement and slowing demand for antibiotics have resulted in declining sales and prices [4]. Group 4: Strategic Shift - In October 2023, Starry Holdings acquired 14.62% of Asia-Pacific Pharmaceutical for 900 million yuan, marking a 45.68% premium, and initiated a 700 million yuan capital increase plan aimed at transitioning the company from generic to innovative drug development [4]. - The recent failure of the consistency evaluation for Diltiazem Hydrochloride Tablets poses a significant challenge to this strategic shift towards innovation [4].

Core Viewpoint - After resuming trading on October 14, Asia-Pacific Pharmaceutical (002370.SZ) experienced a significant stock price increase of 52.38% by November 6, driven primarily by the change in its controlling shareholder to Qiu Zhongxun, chairman of the pharmaceutical internet platform Yaodou Technology, which opens new growth opportunities for the company [1] Group 1: Traditional Business and Cash Flow - Asia-Pacific Pharmaceutical's injection of cefazolin sodium is expected to generate sales revenue of 13.6965 million yuan in 2024, accounting for 3.38% of the company's total revenue [2] - The collaboration with Yaodou Technology is anticipated to enhance sales channels and market penetration, thereby increasing market share and brand influence [2] - The company holds 114 approved drug formulations, providing a solid foundation for maintaining traditional business stability while transitioning to innovation-driven operations [2] Group 2: Innovation Drug Transformation - The company plans to raise 700 million yuan through a private placement, which will be fully allocated to new drug research and development, focusing on oncolytic virus drug platforms and long-acting complex formulations [4] - A project research committee has been established to monitor cutting-edge medical technology trends and clinical value, enhancing the company's R&D capabilities and core competitiveness [4] - The new controlling shareholder has signed a research cooperation intention letter with relevant CRO companies, aiming to integrate industrial capabilities and research resources to promote the commercialization of innovative drugs [4] Group 3: Industry Environment and Future Outlook - The national "14th Five-Year Plan" suggests promoting innovative drug industries as a core component of future economic growth, benefiting from substantial capital support [5] - From 2015 to 2024, the cumulative financing scale in China's innovative drug sector has exceeded 1.23 trillion yuan, injecting strong capital support for growth [6] - The Chinese pharmaceutical market is undergoing a historic shift from generics to innovation, with Asia-Pacific Pharmaceutical leveraging a dual strategy of "capital and innovation" to navigate this transition [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].

Corporate Announcements - China Aluminum announced the election of He Wenjian as chairman and the appointment of Zhang Ruizhong as general manager, with Zhang holding 147,100 shares of A-shares [4] - Jiangbolong reported that its self-developed main control chip deployment exceeded 100 million units by the end of Q3, with ongoing rapid growth [5] - Asia-Pacific Pharmaceutical received a notice of disapproval for the consistency evaluation application of Diltiazem Hydrochloride Tablets, which will not significantly impact current performance [6] - Fuxiang Pharmaceutical successfully passed the FDA's cGMP inspection, marking the third successful inspection, enhancing its qualification for international market supply [7] - Biaobang Co. terminated its control change planning due to failure to reach consensus on core terms, leading to stock resumption [8] - Jingjin Equipment announced the release of its actual controller and chairman from detention, allowing normal operations [9] - Sand Membrane reported that part of its fundraising account was frozen, amounting to 11.74 million yuan, related to a contract dispute [10] - Renfu Pharmaceutical's subsidiary received approval for clinical trials of HWH217 tablets for treating pulmonary arterial hypertension [12] - Wanye Enterprises will change its stock name to "Xian Dao Ji Dian" effective November 12 [13] - Huahai Pharmaceutical's subsidiary passed the FDA inspection, ensuring compliance with international standards [14] Performance Metrics - Daqin Railway reported a cargo transport volume of 32.51 million tons in October, a decrease of 4.7% year-on-year [19] - Jingji Agriculture announced sales of 233,300 pigs in October, generating revenue of 317 million yuan [20] - Baiyun Airport reported a passenger throughput of 7.64 million in October, a year-on-year increase of 12.04% [21] - Dongfeng Motor's total vehicle production decreased by 23.4% year-on-year in October, with significant declines in commercial vehicle categories [22] - Hongyang Real Estate reported a contract sales amount of 202 million yuan in October [23][24] Shareholding Changes - Xintonglian announced that a shareholder plans to reduce its stake by up to 3% [25] - Tonghua Dongbao conducted its first share buyback, acquiring 0.01% of its shares for 1.29 million yuan [26] - Guoci Materials plans to repurchase shares worth 100 million to 200 million yuan at a price not exceeding 30 yuan per share [27] - Xili Technology announced multiple shareholders plan to reduce their stakes [28] Major Contracts - Dayu Water announced a pre-bid win for a 310 million yuan water conservancy project in Hainan [29] - Zhongjian Technology signed a significant sales contract worth 563 million yuan [30] - Longjian Co. won a bid for a 441 million yuan project for road construction in Heilongjiang [31] - Chongqing Construction's subsidiary won a bid for a 781 million yuan project in Chongqing [32]

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]

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 application for the consistency evaluation was submitted in November 2024 and was accepted by the National Medical Products Administration [1] - The reason for the disapproval was that the bioequivalence study conducted 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 resubmitting the application [1]

Corporate Governance - China Aluminum announced the election of He Wenjian as chairman and the appointment of Zhang Ruizhong as general manager, effective immediately [3] - Jiang Guiting, the actual controller and chairman of Jingjin Equipment, has had his detention lifted, allowing him to resume his duties [8] - Biao Bang Co. has terminated its plans for a change in control, with stock resuming trading [7] Industry Developments - Jiangbolong reported that its self-developed main control chip deployment has exceeded 100 million units, with rapid growth expected [4] - Asia Pacific Pharmaceutical received a notice of disapproval for its consistency evaluation application for a drug, which will not significantly impact its current performance [5] - Fuxiang Pharmaceutical successfully passed a cGMP inspection by the FDA, marking its third successful inspection [6] - Huahai Pharmaceutical's subsidiary passed an FDA inspection, enhancing its international market capabilities [13] Financial Performance - Daqin Railway reported a cargo transport volume of 32.51 million tons in October 2025, a year-on-year decrease of 4.7% [18] - Jingji Zhino achieved sales revenue of 317 million yuan from selling 233,300 pigs in October 2025 [19] - Baiyun Airport reported a passenger throughput of 7.64 million in October 2025, a year-on-year increase of 12.04% [20] - Dongfeng Motor's total vehicle production in October 2025 was 6,536 units, a year-on-year decrease of 23.40% [21] - Hongyang Real Estate reported a contract sales amount of 202 million yuan in October 2025 [22] Shareholder Actions - Xintonglian announced that a shareholder plans to reduce its stake by up to 3% [24] - Tonghua Dongbao conducted its first share buyback, acquiring 143,500 shares for 1.29 million yuan [25] - Guoci Materials plans to repurchase shares worth 100 million to 200 million yuan at a price not exceeding 30 yuan per share [26] Project Wins - Dayu Water-saving announced a pre-bid win for a 310 million yuan water conservancy project in Hainan [28] - Zhongjian Technology signed a significant sales contract worth 563 million yuan [29] - Longjian Co. won a project bid worth 441 million yuan for road construction in Heilongjiang [30] - Chongqing Construction's subsidiary won a project bid worth 781 million yuan for a residential project in Chongqing [31]

Core Viewpoint - The company, Asia-Pacific Pharmaceutical (002370.SZ), has received a notification from the National Medical Products Administration stating that the application for the consistency evaluation of Diltiazem Hydrochloride Tablets has been rejected due to insufficient bioequivalence study results [1] Company Summary - The rejected application pertains to Diltiazem Hydrochloride Tablets, which are used for the treatment of angina pectoris and mild to moderate hypertension [1] - The reason for the rejection is that the bioequivalence study submitted does not support a conclusion of bioequivalence [1]