Group 1 - The core point of the article is that Brother Technology's subsidiary, Zhejiang Brother Pharmaceutical Co., Ltd., has received a drug registration certificate for Iopamidol injection, which is now approved for market sale in China [1][3] - The Iopamidol injection is classified as a Class 4 chemical drug and has been included in the National Medical Insurance Class A directory and the seventh batch of national drug centralized procurement [1][3] - The domestic market size for Iopamidol is projected to be approximately 450 million yuan in 2024, indicating a significant market opportunity for the company [1] Group 2 - On September 22, Brother Technology's stock closed at 7.17 yuan, down 1.92%, with a turnover rate of 13.39% and a trading volume of 939,200 shares, amounting to a transaction value of 675 million yuan [1] - The net outflow of main funds on September 22 was 40.2 million yuan, while retail investors saw a net inflow of 48.0 million yuan [1][3] - The approval of the drug registration certificate is expected to enhance the company's product line in iodine contrast agents and improve its market competitiveness [1]

Core Viewpoint - Brother Technology (002562.SZ) announced that its wholly-owned subsidiary, Zhejiang Brother Pharmaceutical Co., Ltd., has received the drug registration certificate for Iohexol injection from the National Medical Products Administration, allowing for commercial sales in China [1] Group 1 - The Iohexol injection is primarily used for various types of imaging procedures, including cardiovascular, peripheral artery, venous, coronary, cerebral, urinary tract, spinal, and joint imaging, as well as CT enhancement [1] - The product is characterized by low viscosity and good safety, which are significant advantages in its application [1] - The approval for Iohexol injection marks a significant step for Brother Pharmaceutical in commercializing this product, enhancing its product line of iodine contrast agents and increasing its competitiveness in the contrast agent market [1]

Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received approval from the European Commission for its subsidiaries' biosimilar products BILDYOSR and BILPREVDAR, which are based on denosumab [2][3] - The approval allows these products to be marketed in all EU member states as well as Iceland, Liechtenstein, and Norway [2] Product Information - HLX14, the biosimilar denosumab, is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures, along with other indications aligned with the reference products Prolia and XGEVA [2] - The cumulative R&D investment for HLX14 is approximately RMB 323 million as of July 2025 [4] Market Impact - The approval in the EU follows a previous approval in the US, enhancing the company's international market presence [5] - The global sales of denosumab injection products are projected to be approximately USD 7.463 billion in 2024 [4] - Commercial rights for HLX14 outside of China were granted to Organon LLC in June 2022, allowing for milestone and sales commission rights following the EU approval [5]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the FDA marks a significant milestone for the company, enhancing its international market presence and product portfolio [1][2] Group 1: Product Approvals - The FDA has approved two products, BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL), for various indications related to osteoporosis and bone-related events in cancer patients [1] - BILDYOS is indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for patients undergoing specific cancer treatments [1] - BILPREVDA is indicated for preventing bone-related events in multiple myeloma and solid tumor patients, and for treating certain bone tumors [1] Group 2: Clinical Data and Comparisons - The FDA's approval was based on comprehensive reviews of comparative studies demonstrating the similarity of HLX14 (the active ingredient in BILDYOS) to its reference drug Prolia in terms of quality, safety, and efficacy [2] - The approval aligns with FDA guidelines on demonstrating biosimilarity to reference drugs, allowing HLX14 to be used for all indications approved for Prolia and XGEVA [2] Group 3: Market Impact - According to IQVIA data, the global sales of denosumab (the active ingredient in Prolia) are projected to be approximately $7.462 billion in 2024 [2] - With the approval of BILDYOS and BILPREVDA, the company has now achieved a total of six products approved for overseas markets, with three specifically approved in the U.S., indicating a deepening of its global commercialization efforts [2] - This approval is seen as a recognition from international markets, which will further advance the company's internationalization strategy and enhance the global influence of its products [2]

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]

苯磺酸氨氯地平口服溶液用冻干粉适用于6岁以上和成人高血压，以及成人慢性稳定性心绞痛，血管痉 挛性心绞痛，经血管造影证实的冠心病。 长春高新（000661）(000661.SZ)公告，公司控股子公司Brillian Pharma INC.(简称"倍利年")申报的苯磺 酸氨氯地平口服溶液用冻干粉已获美国食品药品监督管理局(FDA)批准上市。 ...

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]