Core Viewpoint - Huahai Pharmaceutical's subsidiary has received FDA approval for a new drug application for Dicyclomine Hydrochloride Tablets, which is expected to enhance its market presence in the U.S. [1] Group 1: Company Developments - The subsidiary, Pulinsitong Pharmaceutical Co., Ltd., has successfully obtained approval for the abbreviated new drug application (ANDA) from the U.S. FDA [1] - The drug is primarily used for treating functional gastrointestinal disorders and was developed by ALLERGAN SALES LLC, first launched in the U.S. in 1984 [1] - The company has invested approximately 7 million RMB in research and development for this project [1] Group 2: Market Impact - The expected sales revenue for the drug in the U.S. market in 2024 is approximately 17.6 million USD [1] - The approval allows the company to sell the product in the U.S. market, which is anticipated to expand its sales and strengthen its product supply chain [1] - This development is expected to enrich the company's product portfolio and enhance its market competitiveness [1]

Core Viewpoint - Fuyuan Pharmaceutical (601089.SH) has received a drug registration certificate from the National Medical Products Administration for Levothyroxine Sodium Tablets (100μg), allowing the production of this medication [1] Group 1: Product Approval - The Levothyroxine Sodium Tablets were developed by Merck and were first approved for sale in France in June 1980 [1] - The drug was approved for domestic sale in China in July 1997 by the National Medical Products Administration [1] Group 2: Indications - Levothyroxine Sodium Tablets are indicated for the treatment of non-toxic goiter (with normal thyroid function) [1] - The medication is used to prevent the recurrence of goiter after thyroidectomy [1] - It serves as a replacement therapy for hypothyroidism [1] - The drug is also an adjunct treatment for hyperthyroidism when using antithyroid medications [1] - It is indicated for suppression therapy after thyroid cancer surgery [1] - The tablets are used in thyroid suppression tests [1]

Core Viewpoint - The approval of the drug "Drospirenone and Ethinyl Estradiol Tablets" by the National Medical Products Administration marks a significant milestone for the company, allowing it to sell this product in the domestic market, which will positively impact its product line and overall business performance [1]. Group 1 - The company’s subsidiary, Wuhan Jiulong Renfu Pharmaceutical Co., Ltd., has received the drug registration certificate for Drospirenone and Ethinyl Estradiol Tablets [1]. - The approval indicates that the company is now qualified to market this drug in China, enhancing its product offerings [1]. - The company plans to arrange for the production and market launch of the drug based on market demand [1].

Core Viewpoint - Changchun High New's subsidiary Brillian Pharma INC. has received FDA approval for the freeze-dried powder of Amlodipine Besylate oral solution, indicating a significant advancement in its product portfolio and potential market expansion [1] Group 1: Product Approval - The FDA has approved the freeze-dried powder of Amlodipine Besylate oral solution for marketing [1] - The product is indicated for hypertension in patients aged 6 and older, as well as for chronic stable angina and vasospastic angina in adults [1] - The approval supports the treatment of coronary heart disease confirmed by angiography [1]

Core Viewpoint - Changchun High New's subsidiary, Brillian Pharma INC., has received FDA approval for its Amlodipine Besylate Oral Solution Lyophilized Powder, indicating a significant advancement in its product portfolio and potential market opportunities in the hypertension and chronic stable angina treatment sectors [1] Group 1: Product Approval - The FDA has approved the Amlodipine Besylate Oral Solution Lyophilized Powder for use in patients aged 6 and above, as well as adults [1] - The product is indicated for the treatment of hypertension and chronic stable angina, including vasospastic angina and coronary heart disease confirmed by angiography [1]

Core Viewpoint - The company announced that its subsidiary, Meitheal Pharmaceuticals, Inc., received FDA approval for the production site transfer of Etoposide Injection in multiple dosages, which is expected to positively impact the company's operational performance [1] Group 1: FDA Approval - The FDA issued a production site transfer approval letter for Etoposide Injection (100mg/5mL, 500mg/25mL, and 1g/50mL) under ANDA number 074529 [1] - The approved production will take place at the subsidiary, Jianjin Pharmaceutical Co., Ltd. [1] Group 2: Financial Impact - The company has invested approximately 2.1561 million yuan in the research and development of Etoposide Injection [1] - The newly approved product is expected to be launched in the U.S. market soon, which may have a positive effect on the company's financial performance [1]

Core Viewpoint - The approval of Celecoxib by the National Medical Products Administration enhances the company's market competitiveness and is expected to positively impact its operating performance [1] Company Summary - The company has received the approval notice for the marketing application of Celecoxib from the National Medical Products Administration [1] - Cumulative investment in the research and development of this drug amounts to approximately RMB 14.899 million [1] - The approval of Celecoxib is seen as a significant boost for the company's market position [1]