以岭药业公告，近日，全资子公司以岭万洲国际制药有限公司向国家药品监督管理局药品审评中心申报 的苯胺洛芬注射液的上市许可申请，获得国家药品监督管理局的批准，取得药品注册证书。苯胺洛芬注 射液是以岭万洲首个获批上市的化药专利新药。苯胺洛芬是一种芳基烷酸类非甾体类镇痛抗炎药，在体 内分解为联苯乙酸，联苯乙酸镇痛的作用机制可能与其抑制前列腺素的合成有关。苯胺洛芬注射液主要 用于腹部开放与腹腔镜手术以及胸腔镜手术的术后镇痛。 ...

此次获批标志着甘李药业的甘精胰岛素注射液正式进入欧洲市场，将在欧盟（EU）、冰岛、列支敦士 登和挪威上市销售。 近日，甘李药业（603087）发布公告称，公司及其欧洲全资子公司宣布，由甘李药业自主研发的甘精胰 岛素注射液（欧盟商品名：Ondibta ，中国商品名：长秀霖 1），于近日获得欧盟委员会（EC）批准， 用于治疗成人、青少年和2岁及以上儿童的糖尿病。 ...

Core Viewpoint - The approval of the drug "Isopropamide Iodide Injection" by the National Medical Products Administration is a significant milestone for the company, enhancing its product pipeline and market competitiveness [2] Group 1: Company Developments - The subsidiary of the company, Jingfeng Pharmaceutical, received a drug registration certificate for Isopropamide Iodide Injection, an antihistamine used for skin and mucosal allergies and motion sickness [2] - The company has invested approximately 4.67 million yuan in the research and development of this drug [2] Group 2: Market Implications - The approval of this drug is expected to help the company expand its market share and enrich its injectable product line [2] - There are uncertainties regarding production and sales scale due to factors such as national policies and market environment [2]

Core Viewpoint - Yipinhong Pharmaceutical Group Co., Ltd. has received approval from the National Medical Products Administration for the sodium valproate injection concentrated solution, which is classified as a Category B product under the national medical insurance scheme [1][2]. Group 1 - The sodium valproate injection concentrated solution is registered as a Class 3 chemical drug, which is considered to have passed the consistency evaluation [1][2]. - The approval of this product enhances the company's portfolio in the pharmaceutical market, particularly in the area of medications covered by national insurance [1][2]. - The announcement regarding the registration certificate was made public through an official notice by the company [2][3].

Core Viewpoint - The company, Jianyou Co., Ltd. (603707.SH), has received ANDA approval from the US FDA for its propofol emulsion injection, which is expected to positively impact its operational performance [2]. Group 1: Product Approval - The US FDA has granted ANDA approval for propofol emulsion injection in three specifications: 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL [2]. - The reference product is held by FRESENIUS KABI USA LLC [2]. Group 2: Financial Investment - The company has invested approximately RMB 73.66 million in research and development for this product [2]. Group 3: Market Impact - The newly approved product is set to be launched in the US market soon, which is anticipated to have a positive effect on the company's business performance [2].

Core Viewpoint - The company announced that its subsidiary, Meitheal Pharmaceuticals, Inc., received approval from the U.S. FDA for the production of Acetate Octreotide Injection in various concentrations, which is expected to positively impact the company's financial performance [1] Group 1 - The FDA approval includes the production of Acetate Octreotide Injection at concentrations of 50 mcg/mL, 100 mcg/mL, and 500 mcg/mL [1] - The approved product will soon be launched in the U.S. market [1] - The production will take place at the Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. facility [1]

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]