公开资料显示，亚太药业成立于1989年，前身为浙江亚太制药厂，2010年在深交所上市。目前亚太药业 生产的制剂产品以化学仿制药为主，抗生素类占比超六成，如阿莫西林克拉维酸钾分散片、阿奇霉素分 散片、注射用阿奇霉素等。 11月6日，亚太药业发布公告，公司收到国家药监局下发的关于盐酸地尔硫片一致性评价的申请不予批 准的通知书。今年10月，亚太药业控股股东变更为星浩控股，实际控制人变更为邱中勋。距离新实控人 携7亿元定增资金入主尚不足一个月，此次一次性评价申请被拒，对亚太药业影响几何？ 后续将完善相关研究重新申报 资料显示，盐酸地尔硫片是一种钙离子通道阻滞剂，主要用于治疗心绞痛和轻、中度高血压。作为苯并 硫氮杂环类钙通道阻滞剂，其研发始于20世纪70年代初期，由法国化学家皮埃尔·蒙塔尼主导合成，最 初旨在寻找新型抗心律失常药物。1974年，该药物率先在日本上市，1979年登陆法国市场，1986年进入 美国市场后，凭借对心绞痛、轻中度原发性高血压的显著疗效，迅速成为全球常用心血管药物。 在国内，盐酸地尔硫片已被纳入国家医保目录，是一种成熟的心血管药物。国内主要生产企业众多，国 家药监局官网显示，目前盐酸地尔硫片共有1 ...

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].

亚太药业表示，本次盐酸地尔硫片不予批准不会对公司当期业绩产生重大影响，后续公司将完善该药品 的相关试验研究工作后重新申报申请。 （文章来源：北京商报） 北京商报讯（记者丁宁）11月6日晚间，亚太药业（002370）发布公告称，公司于近日收到国家药品监 督管理局下发的关于盐酸地尔硫片一致性评价的申请不予批准的通知书。 公告显示，公司于2024年11月向国家药品监督管理局递交该产品的一致性评价申请并予以受理。本次不 予批准的原因是本次申报BE研究不能支持生物等效性结论。 ...

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]