福元医药公告，近日，公司收到了国家药品监督管理局颁发的吡格列酮二甲双胍片（15mg/850mg） （规格：每片含盐酸吡格列酮15mg（以C₁₉H₂₀N₂O₃S计）和盐酸二甲双胍850mg）《药品注册证书》 （证书编号：2025S02764），批准该药品生产。 ...

Group 1 - The core point of the article is that Fuyuan Pharmaceutical has received the drug registration certificate for Arolol hydrochloride tablets (10mg) from the National Medical Products Administration, allowing the company to commence production of this medication [2] Group 2 - The approval of Arolol hydrochloride tablets signifies a potential expansion in Fuyuan Pharmaceutical's product offerings, which may enhance its market position in the pharmaceutical industry [2] - This development reflects the ongoing regulatory support for new drug approvals in the pharmaceutical sector, indicating a favorable environment for innovation and growth [2]

Core Viewpoint - Fuyuan Pharmaceutical (601089.SH) has received the Drug Registration Certificate for Arolol Hydrochloride Tablets (10mg) from the National Medical Products Administration, which will enhance the company's product line and market competitiveness [1] Group 1 - The drug is indicated for primary hypertension (mild to moderate), angina pectoris, tachyarrhythmia, and essential tremor [1] - The approval of the Drug Registration Certificate will further enrich the company's product offerings [1] - This development is expected to improve the company's market competitiveness [1]

关于盐酸阿罗洛尔片获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、 误导性陈述或者重大遗漏，并对其内容的真实性、准确性和完整性承 担法律责任。 近日，北京福元医药股份有限公司（以下简称"公司"）收到了 国家药品监督管理局（以下简称"国家药监局"）颁发的盐酸阿罗洛 尔片（规格：10mg）（以下简称"该药品"）《药品注册证书》（证 书编号：2025S02717），批准该药品生产。现将相关情况公告如下： | 药品名称 | 药品通用名称：盐酸阿罗洛尔片 | | --- | --- | | | 英文名/拉丁名：Arotinolol Hydrochloride Tablets | | 剂型 | 片剂 | | 注册分类 | 化学药品4类 | | 规格 | 10mg | | 药品批准文号 | 国药准字H20255323 | | 药品注册标准编号 | YBH21362025 | | 处方药/非处方药 | 处方药 | | 申请事项 | 药品注册（境内生产） | | 审批结论 | 根据《中华人民共和国药品管理法》及有关规 定，经审查，本品符合药品注册的有关要求， 批准注册，发给药品注册证书。质量标准 ...

Core Viewpoint - The company has received the drug registration certificate for Arolol hydrochloride tablets (10mg) from the National Medical Products Administration, allowing for production approval [1] Group 1: Drug Approval - The drug Arolol hydrochloride is indicated for primary hypertension, angina pectoris, tachyarrhythmias, and essential tremor [1] - The company received the acceptance notice for the application on March 26, 2024, and has recently obtained the approval from the National Medical Products Administration [1] - The approval of the drug registration certificate is considered equivalent to passing the consistency evaluation according to national policies [1] Group 2: R&D Investment - The total R&D investment for the drug Arolol hydrochloride has reached RMB 3.9707 million (unaudited) as of the date of the announcement [1]

Core Points - Fuyuan Pharmaceutical (601089) experienced a significant decline of 9.66% in its stock price, with a trading volume of 7.29 billion yuan and a turnover rate of 6.18% [2] - The stock was listed on the Shanghai Stock Exchange for a daily price deviation of -10.90%, with a net sell-off of 42.23 million yuan from brokerage seats [2] - The company reported a revenue of 1.634 billion yuan for the first half of the year, reflecting a year-on-year decrease of 1.30%, and a net profit of 268 million yuan, down 7.83% year-on-year [2] Trading Data - The top five brokerage seats accounted for a total transaction of 206 million yuan, with a buying amount of 82.08 million yuan and a selling amount of 124 million yuan, resulting in a net sell-off of 42.23 million yuan [2] - The largest buying brokerage was Founder Securities Co., Ltd. with a purchase amount of 23.62 million yuan, while the largest selling brokerage was Dongfang Securities Co., Ltd. with a selling amount of 27.07 million yuan [2] Fund Flow - The stock saw a net outflow of 232 million yuan from major funds, with a significant outflow of 222 million yuan from large orders and a net outflow of 9.91 million yuan from medium orders [2] - Over the past five days, the net inflow of major funds was 76.64 million yuan [2]

Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received the drug registration certificate for Amlodipine Benazepril Capsules, which will enhance the company's product line and market competitiveness [1][4]. Drug Registration Certificate Details - The drug is approved for production by the National Medical Products Administration, with the registration certificate number 2025S02582 [1]. - Amlodipine Benazepril Capsules are indicated for patients whose blood pressure is not adequately controlled by either Amlodipine or Benazepril alone, or for those requiring a switch from separate Amlodipine and Benazepril tablets [1]. R&D Investment - The company has invested a total of RMB 8.1616 million (approximately 1.1 million USD) in the research and development of this drug [2]. Market Situation of Similar Drugs - According to data from Minai Network, the sales revenue of Amlodipine Benazepril oral formulations in China is approximately RMB 1.12 billion (about 160 million USD) for 2024 [3]. - The sales distribution includes RMB 727 million (about 102 million USD) from urban public hospitals and county-level public hospitals, RMB 167 million (about 24 million USD) from urban community centers and township health clinics, and RMB 226 million (about 32 million USD) from urban pharmacies and online pharmacies [3]. Impact on the Company - The approval of the drug will enrich the company's product line and enhance its market competitiveness [4].

Core Viewpoint - The innovative drug concept stocks experienced a decline, with several companies seeing significant drops in their stock prices [1] Group 1: Stock Performance - Shuyou Shen and Qianyan Biology both fell over 10% [1] - Fuyuan Pharmaceutical hit the daily limit down [1] - Baihua Pharmaceutical, Asia-Pacific Pharmaceutical, Wanbangde, Bailitianheng, and Ruizhiyiyuan all dropped over 5% [1]

Group 1 - The A-share market experienced fluctuations in the innovative drug sector, with significant declines in several stocks [1] - Fuyuan Pharmaceutical hit the daily limit down, while Frontier Biotech dropped over 10% [1] - Other companies such as Baihua Pharmaceutical, Jimin Health, Shutaishen, and Bailitianheng saw declines exceeding 5% [1]

Group 1 - The innovative drug concept sector experienced fluctuations in early trading, with several companies facing significant declines [1] - Fuyuan Pharmaceutical hit the daily limit down, indicating a strong negative market reaction [1] - Frontier Biotech dropped over 10%, reflecting investor concerns in the sector [1] Group 2 - Other companies such as Baihua Pharmaceutical, Jimin Health, Shutaishen, Bailitianheng, and Chengdu Xian Dao also saw declines exceeding 5% [1]