Core Viewpoint - Northeast Pharmaceutical (000597) announced that its wholly-owned subsidiary, Shenyang Shide Pharmaceutical Co., Ltd., received the Drug Registration Certificate from the National Medical Products Administration for L-Carnitine Oral Solution, which is approved for treating primary systemic carnitine deficiency and secondary carnitine deficiency due to congenital metabolic disorders [1] Group 1 - The drug L-Carnitine Oral Solution has the approval number H20253799 and is valid until March 31, 2030 [1] - The approval of L-Carnitine Oral Solution is expected to enrich the company's product pipeline [1] - This development enhances the company's market competitiveness and presents new market opportunities [1]

Group 1 - The company has received the drug registration certificate for heavy tartrate hydroxylamine injection from the National Medical Products Administration [1] - The drug is indicated for the prevention and treatment of acute hypotension during epidural anesthesia and other conditions [1] - The registration of this drug enhances the company's product variety and positively impacts the optimization of its product structure [1]

同和药业（300636）公告，公司近日收到韩国食品药品安全部颁发的美阿沙坦钾药品注册证书。生产商 名称为江西同和药业股份有限公司，生产商地址为江西省奉新高新技术产业园区，认证范围为美阿沙坦 钾原料药，证书编号为2025-A1-0844，签发日期为2025.04.14。美阿沙坦钾适用于治疗成人原发性高血 压。公司美阿沙坦钾产品获得韩国药品注册证书，标志着公司美阿沙坦钾原料药获得了韩国市场的准入 资格，将对公司进一步扩大国际市场业务起到积极作用。 ...

Core Viewpoint - Harbin Pharmaceutical Group Co., Ltd. has received approval from the National Medical Products Administration for the registration of Lactulose Oral Solution, which is used for the treatment and prevention of chronic or habitual constipation and hepatic encephalopathy [1] Company Summary - The Lactulose Oral Solution has a total of 60 domestic drug approval numbers and 5 import drug approval numbers as of the announcement date [1] - The annual sales revenue of Lactulose Oral Solution in China for 2023 is 1.769 billion yuan [1]

Core Viewpoint - Northeast Pharmaceutical (000597) announced that its subsidiary, Shenyang First Pharmaceutical Co., Ltd., received the drug registration certificate from the National Medical Products Administration for Levetiracetam Extended-Release Tablets, which is approved for use in patients aged 12 and above for adjunctive treatment of partial seizures in epilepsy [1] Summary by Category - **Product Approval** - The drug name is Levetiracetam Extended-Release Tablets, with the approval number Guoyao Zhunzi H20253711, valid until March 24, 2030 [1] - The medication is specifically indicated for patients aged 12 years and older who experience partial seizures as part of their epilepsy treatment [1]

Core Viewpoint - Beijing Shuanglu Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for Regorafenib tablets, enhancing its portfolio in the oncology sector [1][2]. Group 1: Drug Information - Drug Name: Regorafenib Tablets - Dosage Form: Tablets - Specification: 40mg - Registration Category: Class 4 Chemical Drug - Approval Number: National Drug Approval No. H20253676 - Approval Conclusion: The drug meets the registration requirements as per the relevant laws and regulations [1][2]. Group 2: Market and Application - Regorafenib is a multi-targeted tyrosine kinase inhibitor used for treating various advanced cancers, including: - Metastatic colorectal cancer (mCRC) in patients previously treated with fluorouracil, oxaliplatin, and irinotecan-based chemotherapy [2]. - Gastrointestinal stromal tumors (GIST) in patients previously treated with imatinib and sunitinib [2]. - Hepatocellular carcinoma (HCC) in patients previously treated with sorafenib [2]. - The original Regorafenib was developed by Bayer and Onyx, approved by the FDA in September 2012, and entered the Chinese market in March 2017 [2]. Group 3: Impact on the Company - The approval of Regorafenib will enrich the company's oncology product offerings, potentially increasing its market competitiveness [3].