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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
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].