注射用帕瑞昔布钠

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四川汇宇制药股份有限公司关于自愿披露公司产品获得境外上市许可的公告
Shang Hai Zheng Quan Bao· 2025-08-13 18:41
Group 1 - The company has received overseas marketing approvals for its products, injection paracetamol sodium and injection pemetrexed disodium, from the Dutch Medicines and Healthcare Products Regulatory Agency and the Saudi Food and Drug Authority [1][2] - Injection paracetamol sodium is indicated for the treatment of short-term postoperative pain in adults and has been approved in multiple countries including the UK and the Netherlands, with a registration application submitted in Germany [1] - Injection pemetrexed disodium is used in combination with cisplatin for the first-line treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic lung cancer, and has received approvals in 14 countries including China, the UK, and Germany, with applications submitted in 10 additional countries [2] Group 2 - The approvals for injection paracetamol sodium and injection pemetrexed disodium enhance the company's product pipeline in international markets, improve brand image, and support the sustainable development of international business [3] - The company has initiated preparations for the sales of these products, but the future revenue generation remains uncertain due to factors such as competition and the effectiveness of business promotion [3]
汇宇制药: 关于自愿披露公司产品获得境外上市许可的公告
Zheng Quan Zhi Xing· 2025-08-13 16:12
Core Viewpoint - Sichuan Huiyu Pharmaceutical Co., Ltd. has received marketing approvals for its products, injectable Parecoxib Sodium and injectable Pemetrexed Disodium, from regulatory authorities in the Netherlands and Saudi Arabia, enhancing its international market presence and product pipeline [1][2]. Group 1: Product Approval Details - Injectable Parecoxib Sodium is indicated for the treatment of short-term postoperative pain in adults and has received marketing approval in the UK and the Netherlands, with a registration application submitted in Germany [1]. - Injectable Pemetrexed Disodium is used in combination with cisplatin for the first-line treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic lung cancer, and it is also suitable for maintenance therapy in locally advanced or metastatic non-small cell lung cancer [1][2]. Group 2: International Market Expansion - The company has successfully registered injectable Pemetrexed Disodium in 14 countries, including China, the UK, Germany, Finland, and Saudi Arabia, and has submitted registration applications in an additional 10 countries and regions [2]. - The approvals for injectable Parecoxib Sodium and injectable Pemetrexed Disodium are expected to enrich the company's product pipeline in international markets, enhance brand image, and support sustainable development in international business [2].
汇宇制药:产品获得境外上市许可
Zheng Quan Ri Bao Wang· 2025-08-13 13:12
Core Viewpoint - Seacross Pharma (Europe) Ltd. and Seacross Pharmaceuticals Ltd., subsidiaries of the company, have received marketing approvals for their products, injectable Parecoxib Sodium and injectable Pemetrexed Disodium, from the Dutch Medicines and Medical Devices Authority and the Saudi Food and Drug Authority respectively [1] Summary by Categories - **Regulatory Approvals** - The company’s subsidiaries have obtained marketing licenses for injectable Parecoxib Sodium and injectable Pemetrexed Disodium [1] - Approvals were granted by the Dutch Medicines and Medical Devices Authority and the Saudi Food and Drug Authority [1]
8月13日晚间重要公告一览
Xi Niu Cai Jing· 2025-08-13 10:20
Group 1 - Kaizhong Precision plans to invest up to 250 million yuan to establish a subsidiary and build a production base in Thailand, focusing on overseas connector and precision component business [1] - Longbo Technology reported a 60.18% year-on-year increase in net profit for the first half of 2025, with revenue of 122 million yuan, up 18.03% [2] - Dingyang Technology achieved a net profit of 76.88 million yuan in the first half of 2025, a year-on-year increase of 31.54%, with revenue of 279 million yuan, up 24.61% [4] Group 2 - Heng Rui Pharmaceutical received approval for clinical trials of two drugs, SHR-A2102 and Adebeli monoclonal antibody injection [6] - Maolai Optical plans to use up to 100 million yuan of idle funds for entrusted wealth management to improve fund utilization efficiency [8] - Shiji Information signed a major contract with MGM Grand, providing a next-generation cloud-based hotel information management system [7] Group 3 - Yunnan Germanium's subsidiary received a government subsidy of 6.8 million yuan related to revenue [9] - Jizhi Co. received a warning letter from the Zhejiang Securities Regulatory Bureau for failing to disclose significant government subsidies [10] - Dongfang Precision reported a net profit of approximately 397 million yuan for the first half of 2025, a year-on-year increase of 142.52% [11] Group 4 - Aolaide expects a net profit decrease of 68.41% to 72.77% for the first half of 2025, with revenue projected between 270 million and 290 million yuan [12] - Feilong Co. used 111 million yuan of idle funds for cash management through structured deposit products [13] - Anhui Construction won two major projects with a total investment exceeding 6.6 billion yuan [15] Group 5 - Yunnan Germanium's subsidiary received a government subsidy of 6.8 million yuan related to revenue [9] - Jizhi Co. received a warning letter from the Zhejiang Securities Regulatory Bureau for failing to disclose significant government subsidies [10] - Dongfang Precision reported a net profit of approximately 397 million yuan for the first half of 2025, a year-on-year increase of 142.52% [11] Group 6 - China Medical's subsidiary received approval for the listing of fumaric acid volnora raw materials [20] - Huayuan Vaccine's subsidiary received approval for clinical trials of Hib vaccine [29] - Ganfeng Lithium plans to integrate lithium salt lake projects in Argentina and provide financial support of up to 130 million USD [41]
汇宇制药(688553.SH):公司产品获得境外上市许可
Ge Long Hui· 2025-08-13 09:15
Core Viewpoint - The company has received marketing approvals for its injectable drugs in the Netherlands and Saudi Arabia, enhancing its international market presence and product pipeline [1] Group 1: Product Approvals - The company's subsidiary Seacross Pharma (Europe) Ltd. and Seacross Pharmaceuticals Ltd. have recently obtained marketing licenses from the Dutch Medicines and Health Products Regulatory Authority and the Saudi Food and Drug Authority for injectable Parecoxib Sodium [1] - Injectable Parecoxib Sodium is indicated for the treatment of short-term postoperative pain in adults, which expands the company's product offerings in the pain management segment [1] - Injectable Pemetrexed Disodium, another product, is approved for use in chemotherapy for unresectable malignant pleural mesothelioma and locally advanced or metastatic lung cancer, enhancing the company's oncology portfolio [1] Group 2: Market Expansion - The approvals for injectable Parecoxib Sodium and injectable Pemetrexed Disodium are expected to enrich the company's international product pipeline, improve its brand image, and facilitate the continuous expansion of its international business [1]
汇宇制药:两产品获荷兰、沙特上市许可
Xin Lang Cai Jing· 2025-08-13 08:11
Core Viewpoint - Sichuan Huiyu Pharmaceutical Co., Ltd. announced that its subsidiary has received marketing approvals for injectable Parecoxib Sodium and injectable Pemetrexed Disodium from the drug regulatory authorities in the Netherlands and Saudi Arabia respectively [1] Group 1: Product Approvals - Injectable Parecoxib Sodium is indicated for short-term pain management in adults post-surgery and has already been approved in the UK and the Netherlands, with an application submitted in Germany [1] - Injectable Pemetrexed Disodium is used for the treatment of related cancers and has been approved in 14 countries, with applications submitted in 10 additional countries and regions [1] Group 2: Strategic Implications - The recent approvals are expected to enrich the international pipeline and enhance the brand image of the company [1] - However, future sales remain uncertain, and the short-term impact on performance is not expected to be significant [1]
汇宇制药:公司产品注射用帕瑞昔布钠、注射用培美曲塞二钠获得荷兰和沙特阿拉伯上市许可
Mei Ri Jing Ji Xin Wen· 2025-08-13 08:01
Core Viewpoint - The company has received marketing approvals for its products from regulatory authorities in the Netherlands and Saudi Arabia, enhancing its international market presence and product pipeline [1] Group 1: Product Approvals - Seacross Pharma (Europe) Ltd. and Seacross Pharmaceuticals Ltd., subsidiaries of the company, have obtained marketing licenses for injectable Parecoxib Sodium and injectable Pemetrexed Disodium [1] - Injectable Parecoxib Sodium is indicated for the treatment of short-term postoperative pain in adults [1] - Injectable Pemetrexed Disodium, in combination with Cisplatin, is approved for first-line treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic lung cancer (primarily non-squamous) [1] Group 2: Market Impact - The approvals are expected to enrich the company's product pipeline in international markets [1] - These developments will enhance the company's brand image and facilitate the continuous expansion of its international business [1]
汇宇制药:注射用帕瑞昔布钠、注射用培美曲塞二钠获境外上市许可
Zhi Tong Cai Jing· 2025-08-13 08:01
Core Viewpoint - The company has received marketing approvals for its injectable products, Parecoxib Sodium and Pemetrexed Disodium, from regulatory authorities in the Netherlands and Saudi Arabia, enhancing its international market presence and brand image [1] Group 1 - The company's subsidiary, Seacross Pharma (Europe) Ltd., and Seacross Pharmaceuticals Ltd. have obtained marketing licenses for injectable Parecoxib Sodium and Pemetrexed Disodium [1] - The approvals from the Dutch Medicines and Health Products Regulatory Authority and the Saudi Health Products Regulatory Authority signify a strategic expansion into international markets [1] - The successful launch of these products is expected to enrich the company's product pipeline and support sustainable development in international markets [1]
汇宇制药:公司两款产品获得境外上市许可
Zheng Quan Shi Bao Wang· 2025-08-13 08:01
Core Viewpoint - The company, Huyou Pharmaceutical (688553), announced that its subsidiaries, Seacross Pharma (Europe) Ltd. and Seacross Pharmaceuticals Ltd., have received marketing approvals for their products, injectable Parecoxib Sodium and injectable Pemetrexed Disodium, from the Dutch Medicines and Healthcare Products Regulatory Agency and the Saudi Arabian Health Products Regulatory Authority [1]. Group 1 - The company has successfully obtained marketing licenses for two injectable products [1] - The approvals were granted by regulatory authorities in the Netherlands and Saudi Arabia [1] - This development may enhance the company's market presence in Europe and the Middle East [1]
汇宇制药(688553.SH):注射用帕瑞昔布钠、注射用培美曲塞二钠获境外上市许可
智通财经网· 2025-08-13 07:59
Core Viewpoint - The company has received marketing approvals for its injectable products, Parecoxib Sodium and Pemetrexed Disodium, from regulatory authorities in the Netherlands and Saudi Arabia, enhancing its international market presence and product pipeline [1] Group 1: Regulatory Approvals - The company's subsidiary, Seacross Pharma (Europe) Ltd., and Seacross Pharmaceuticals Ltd. have obtained marketing licenses for injectable Parecoxib Sodium and injectable Pemetrexed Disodium from the Dutch Medicines and Medical Devices Authority and the Saudi Food and Drug Authority [1] Group 2: Market Impact - The approvals are expected to enrich the company's product pipeline in international markets, improve its brand image, and facilitate the ongoing expansion of its international business [1] - The developments lay a solid foundation for the sustainable growth of the company in international markets [1]