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一周内,石家庄四药6款重磅药物获批上市

  • 2026-05-13 22:00:10
一周内,石家庄四药6款重磅药物获批上市
5月伊始,石家庄四药迎来大爆发,继5月6日3款重磅药物获批上市,5月9日,又迎来3款药物获批上市。

2026年5月9日,据中国国家药品监督管理局(NMPA官网最新显示,石家庄四药有限公司申报的盐酸屈他维林片、磷酸奥司他韦胶囊、甲氧氯普胺片3款药物同日获批上市,视同过评。

1、盐酸屈他维林片:是一种亲肌性解痉药,能直接作用于平滑肌细胞。在临床上广泛应用于胆道疾病(如胆囊/胆管结石、胆囊/胆管炎等炎症)相关的平滑肌痉挛、泌尿系统疾病(如肾/输尿管结石、肾盂/膀胱炎等炎症)所致的平滑肌痉挛。

据相关数据统计,盐酸屈他维林片年中国三大终端六大市场销售规模持续扩容,2021-2024年均保持双位数增长,分别为22.91%19.71%18.06%23.22%
截至目前为止,盐酸屈他维林片仅有2家企业拥有生产批文,江苏联环药业是首仿和首家过评企业,石家庄四药为第3家获得盐酸屈他维林片生产批文,市场前景未来可期。
2、磷酸奥司他韦胶囊:作为一种神经氨酸酶抑制剂,主要用于成人和1岁及以上儿童的甲型和乙型流感治疗,以及成人和13岁及以上青少年的甲型和乙型流感预防。
磷酸奥司他韦是其活性代谢产物的药物前体,其活性代谢产物(奥司他韦羧酸盐)是强效选择性的流感病毒神经氨酸酶抑制剂。磷酸奥司他韦的活性代谢产物能够抑制甲型和乙型流感病毒的神经氨酸酶活性,从而抑制新形成的病毒颗粒从被感染细胞中释放,减少了甲型或乙型流感病毒的播散,有效发挥预防流感发生及缓解流感症状的作用。 
据相关数据统计显示,磷酸奥司他韦胶囊在2025年全终端医院市场的销售额已超13亿元,市场体量庞大。从竞争格局来看,该品种已成为兵家必争之地。截至目前,国内已有超过50家药企的磷酸奥司他韦胶囊获批上市,市场竞争异常激烈。
3、甲氧氯普胺片:是一款经典的胃肠动力药,广泛用于各种病因所致恶心、呕吐的对症治疗,胃食管反流病的短期治疗,以及糖尿病胃轻瘫症状的缓解。
甲氧氯普胺是一种多巴胺D2受体拮抗剂,属于苯甲酰胺衍生物,由法国Laboratoires Delagrange公司研发,1964年在法国首次上市。该药物通过拮抗中枢及外周多巴胺D2受体,并轻度阻断5-羟色胺5-HT3受体,发挥止吐和促进胃肠动力双重作用。其独特的药理特性使其在治疗恶心呕吐和胃肠动力障碍方面具有重要价值,成为临床应用广泛的多功能药物。
2026年5月6日,据中国国家药品监督管理局(NMPA官)网最新显示,石家庄四药有限公司申报的脂溶性维生素注射液()、甲磺酸多沙唑嗪缓释片、盐酸二甲双胍片3款药物同日获批上市,视同过评。

4、脂溶性维生素注射液():产品主要用11岁以下的儿童和婴儿,作为静脉营养的补充,以满足每日对脂溶性维生素 A、D2、E 和 K1的需求。维生素是一类在人体内含量极低的小分子有机物,人体自身不能合成或合成量甚少,必须从食物中获得。其在调节人体物质能量代谢和维持正常生理功能方面发挥关键性作用,是维持正常生理功能所必需营养物质。依据其溶解性可分为脂溶性及水溶性两大类,脂溶性维生素包括维生素A、维生素D、维生素E、维生素K。

据了解,目前市场上的脂溶性维生素制剂均为注射剂,包括了注射用脂溶性维生素(II)、脂溶性维生素注射液(II)、注射用脂溶性维生素(I)和脂溶性维生素注射液(I)。2026年3月13日,石家庄四药申报的脂溶性维生素注射液(II)获批上市,成为了该品种首个过评产品。据悉,脂溶性维生素注射液(II)主要用于满足成人及11岁以上儿童每日对脂溶性维生素A、维生素D2、维生素E、维生素K1的生理需要。

5、甲磺酸多沙唑嗪缓释片:甲磺酸多沙唑嗪是国内外治疗轻中度高血压的一线药物,也是治疗良性前列腺增生合并下尿路症状(BPH/LUTS)的一线用药。截至目前为止,除原研外,国内已有四川科伦药业、华润双鹤、合肥立方制药、石家庄四药等9家药企获得甲磺酸多沙唑嗪缓释片生产批文,形成原研1+国产9竞争格局。多年来,甲磺酸多沙唑嗪缓释片院内市场份额主要由原研辉瑞所占据。随着仿制药相继获批上市,国产替代原研加速。
据了解,甲磺酸多沙唑嗪原研企业为辉瑞制药,甲磺酸多沙唑嗪片于1990年在日本首次上市,1995年在美国获批,用于治疗良性前列腺增生。甲磺酸多沙唑嗪缓释片于2005年获FDA批准在美国上市,商品名为CARDURA XL。2009年,原研甲磺酸多沙唑嗪缓释片在国内获批上市。

6、盐酸二甲双胍片:是一种经典的双胍类口服降糖药,自20世纪50年代获批以来,因其疗效确切、安全性高且成本低廉,成为全球2型糖尿病一线治疗的基石药物。于1992年获批进入我国。盐酸二甲双胍的核心机制在于通过激活PRKAB1(AMPK通路),抑制肝脏糖异生,同时增强外周组织对葡萄糖的摄取和利用,从而显著降低血糖。该药物是唯一被证实可降低糖尿病患者死亡率的口服降糖药。

除降糖作用外,盐酸二甲双胍的潜在临床价值备受关注,研究显示其可能具有40余种跨领域益处。例如:在代谢方面,可改善多囊巢综合征、辅助减肥;在抗衰老领域,或能逆转生物年龄、延缓衰老;在炎症及器官保护方面,可能减轻骨关节炎疼痛、提供心血管保护、抗炎及改善肠道菌群;此外,还被探索用于防雾霾损伤、协助戒烟等。尽管这些潜质用途展现了“神药”特性,但多数仍处于研究阶段,需进一步证据支持其确切疗效和适用范围。

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  1. CONNECT:[ UseTime:0.001054s ] mysql:host=127.0.0.1;port=3306;dbname=nowww460;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.000822s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000312s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000235s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.000554s ]
  6. SELECT * FROM `set` [ RunTime:0.000242s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.000538s ]
  8. SELECT * FROM `article` WHERE `id` = 510166 LIMIT 1 [ RunTime:0.000402s ]
  9. UPDATE `article` SET `lasttime` = 1778693144 WHERE `id` = 510166 [ RunTime:0.009353s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 65 LIMIT 1 [ RunTime:0.000278s ]
  11. SELECT * FROM `article` WHERE `id` < 510166 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000504s ]
  12. SELECT * FROM `article` WHERE `id` > 510166 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.005486s ]
  13. SELECT * FROM `article` WHERE `id` < 510166 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.002384s ]
  14. SELECT * FROM `article` WHERE `id` < 510166 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.000699s ]
  15. SELECT * FROM `article` WHERE `id` < 510166 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.001338s ]
0.112765s