二氟尼柳片
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浙江莎普爱思药业股份有限公司 关于获得二氟尼柳片《药品补充申请批准通知书》的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-01-15 23:46
Core Viewpoint - Zhejiang Shapuaisi Pharmaceutical Co., Ltd. has received approval for the supplementary application of Diflunisal tablets, which enhances the company's product line and market competitiveness [1][5]. Group 1: Drug Approval Details - Drug Name: Diflunisal Tablets [2][3] - Dosage Form: Tablet [2][3] - Specifications: 0.25g and 0.5g [2][3] - Registration Category: Chemical Drug [2][3] - License Holder and Manufacturer: Zhejiang Shapuaisi Pharmaceutical Co., Ltd. [2][3] - Approval Conclusion: The drug has passed the consistency evaluation of generic drug quality and efficacy [1][2]. Group 2: R&D Investment - The cumulative R&D investment for the Diflunisal tablet project is approximately 7.1492 million RMB [4]. Group 3: Market Impact - The approval of Diflunisal tablets is expected to enrich the company's product line and enhance the market competitiveness of this product [5].
莎普爱思:关于获得二氟尼柳片《药品补充申请批准通知书》的公告
Zheng Quan Ri Bao· 2026-01-15 12:43
Group 1 - The core point of the article is that the company, Shapais, has received approval from the National Medical Products Administration for the drug Diflunisal tablets, as indicated by the issuance of the Supplementary Application Approval Notice [2] Group 2 - The approval notice has the reference numbers 2026B00097 and 2026B00098, which are essential for tracking the regulatory process [2]
1月15日晚间重要公告一览
Xi Niu Cai Jing· 2026-01-15 10:25
Group 1 - Siyuan Electric reported a total operating revenue of 21.205 billion yuan for 2025, a year-on-year increase of 37.18%, with a net profit attributable to shareholders of 3.163 billion yuan, up 54.35% year-on-year [1] - VisiOn expects a negative net profit for 2025, indicating a loss in operating performance [2] - Chongqing Steel anticipates a net loss of 2.5 billion to 2.8 billion yuan for 2025, which is an improvement from a net loss of 3.196 billion yuan in the previous year [3] - Lianfa Co. forecasts a net profit of 280 million to 320 million yuan for 2025, representing a year-on-year growth of 38.92% to 58.77% [4] Group 2 - CICC announced that the audit work related to the absorption merger with Dongxing Securities and Xinda Securities has not yet been completed [5] - Dalong Real Estate's subsidiary won a project bid worth 763 million yuan [6] - Zhongchuang Zhiling plans to issue convertible bonds to raise no more than 4.35 billion yuan for various projects [7] - Jintong Co. intends to acquire a 24% stake in Jinsha Molybdenum for 1.731 billion yuan [8] Group 3 - Nami Technology expects a net profit of 128 million to 145 million yuan for 2025, an increase of 54.51% to 75.03% year-on-year [9] - China State Construction reported a new contract total of 4.5458 trillion yuan for 2025, a 1% increase year-on-year [12] - China Metallurgical Group's new contract amount for 2025 is expected to decrease by 10.8% to 1.1136 trillion yuan [13] Group 4 - Beiding Co. reported a net profit of 111 million yuan for 2025, a year-on-year increase of 59.05% [14] - Southwest Securities expects a net profit of 1.028 billion to 1.098 billion yuan for 2025, an increase of 47% to 57% [15] - China Eastern Airlines reported a 4.93% year-on-year increase in passenger capacity for December 2025 [20] Group 5 - *ST Aowei's stock may be delisted due to a closing price below par value [21] - Yilian Network expects a net profit of 2.542 billion to 2.648 billion yuan for 2025, a decrease of 0% to 4% year-on-year [22] - Huochen Co. anticipates a net profit of 420 million to 540 million yuan for 2025, recovering from a loss of 2 million yuan in the previous year [17] Group 6 - Guoli Electronics expects a net profit of 68 million to 80 million yuan for 2025, an increase of 124.89% to 164.57% [28] - Jinchuan Group forecasts a net profit of 11 billion to 12 billion yuan for 2025, a year-on-year increase of 73.57% to 89.34% [41] - Triangle Tire plans to invest 3.219 billion yuan in a new tire project in Cambodia [42]
莎普爱思:二氟尼柳片通过仿制药一致性评价
Zheng Quan Shi Bao Wang· 2026-01-15 08:14
Core Viewpoint - The company Shapais (603168) has received approval from the National Medical Products Administration for the drug Diflunisal, which is now considered to have passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The drug Diflunisal is indicated for the treatment of rheumatoid arthritis, osteoarthritis, and various mild to moderate pain [1]
莎普爱思(603168.SH):获得二氟尼柳片《药品补充申请批准通知书》
Ge Long Hui A P P· 2026-01-15 08:00
Core Viewpoint - The company, Zhejiang Shapuaisi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the supplementary application of Diflunisal tablets, indicating a significant advancement in its product portfolio [1]. Group 1: Product Approval - The company has obtained the approval notice for Diflunisal tablets, with notification numbers 2026B00097 and 2026B00098 [1]. - Diflunisal tablets have passed the consistency evaluation of generic drug quality and efficacy, which is crucial for market entry [1]. Group 2: Indications and Applications - The approved Diflunisal tablets are indicated for rheumatoid arthritis, osteoarthritis, and various mild to moderate pain conditions, expanding the therapeutic options available [1]. Group 3: R&D Investment - As of the date of the announcement, the total research and development investment for the Diflunisal tablet project amounts to approximately 7.1492 million RMB [1].
莎普爱思:二氟尼柳片通过仿制药质量和疗效一致性评价
Xin Lang Cai Jing· 2026-01-15 07:35
莎普爱思公告,近日,公司收到国家药品监督管理局核发的二氟尼柳片的《药品补充申请批准通知 书》。药品名称为二氟尼柳片,剂型为片剂,规格为0.25g和0.5g,注册分类为化学药品,上市许可持有 人和药品生产企业均为公司。审批结论为视同通过仿制药质量和疗效一致性评价。 ...