Core Viewpoint - The approval of the ANDA for Methylene Blue Injection by the FDA marks a significant milestone for the company, enhancing its international product pipeline and supporting its globalization strategy [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Chengdu ShuoDe Pharmaceutical Co., Ltd., received notification from the FDA regarding the approval of the ANDA for Methylene Blue Injection [1] - The active ingredient of Methylene Blue Injection is Methylene Blue, indicated for the treatment of acquired methemoglobinemia in children and adults [1] Group 2: Product Commercialization - Methylene Blue Injection is the company's third formulation to enter the international market, with the raw material also registered with the FDA [1] - The company has signed an exclusive supply and distribution agreement with an international pharmaceutical company for the commercialization of Methylene Blue Injection in the U.S. [1] - Under the agreement, the international company will be responsible for the comprehensive commercialization operations in the U.S., while the company will focus on production and supply, receiving milestone payments, sales revenue, and a share of the sales profits [1]

登录新浪财经APP 搜索【信披】查看更多考评等级 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗 漏。 海南双成药业股份有限公司（以下简称"公司"）于近日收到美国食品和药品监督管理局（以下简 称"FDA"）的通知，公司向美国FDA提交的注射用硼替佐米简略新药申请（以下简称"ANDA"）已获得 美国FDA的批准。美国FDA对公司递交的注射用硼替佐米ANDA申报资料进行了全面技术审评，认定公 司的产品与原研药品生物等效和疗效等效（bioequivalent and therapeutically equivalent）。现将相关信息 公告如下： 一、药品基本情况 （1）与美法仑和泼尼松联合使用，适用于治疗既往未接受过治疗且不适合接受大剂量化疗的多发性骨 髓瘤患者。 （2）作为联合治疗的一部分，适用于65岁以下既往未接受过治疗的多发性骨髓瘤患者，用于高剂量化 疗联合自体干细胞挽救之前的诱导治疗。 （3）适用于至少接受过一次既往治疗且疾病进一步发展的多发性骨髓瘤患者。 （4）与利妥昔单抗、环磷酰胺、多柔比星和泼尼松联合使用，适用于既往未接受过治疗的套细胞淋巴 瘤成人患者的治 ...

《海南双成药业股份有限公司关于注射用硼替佐米ANDA获得美国FDA上市许可的公告》 截至2025年12月18日收盘，*ST双成（002693）报收于6.58元，较前一交易日下跌0.3%，最新总市值为 27.29亿元。该股当日开盘6.59元，最高6.79元，最低6.55元，成交额达3208.79万元，换手率为1.17%。 近日，海南双成药业股份有限公司发布公告称，其注射用硼替佐米ANDA已获美国FDA上市许可，认定 与原研药生物等效和疗效等效。公告显示，该产品此前已获中国国家药监局批准并通过一致性评价，亦 获得澳大利亚TGA上市许可。此次获批标志着公司产品达到国际水平，有助于提升国际影响力和经营 业绩，丰富国际销售产品线，推进国际化布局。公告同时提示，药品在海外市场销售可能受法规、政 策、市场环境及汇率波动等因素影响。 最新公告列表 以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成 投资建议。 ...

Core Viewpoint - Chengdu Yuandong Pharmaceutical Co., Ltd. announced that its wholly-owned subsidiary, Chengdu ShuoDe Pharmaceutical Co., Ltd., successfully passed the FDA's pre-approval inspections for its Naloxone nasal spray product with zero deficiencies [1][2]. Group 1: Inspection Details - The FDA inspections took place from May 6 to 9 and May 16 to 22, 2025, focusing on current Good Manufacturing Practices (cGMP) and BioResearch Monitoring (BIMO) [1]. - The inspections were conducted for the Naloxone nasal spray product, specifically on the nasal spray production line [1]. - The inspection concluded with a zero deficiency report (no 483), indicating compliance with FDA standards [1]. Group 2: Product and Company Impact - This inspection marks the second time ShuoDe Pharmaceutical has undergone an FDA inspection and the first for its nasal spray production line [1]. - The successful inspection is expected to expedite the approval process for the company's submitted Abbreviated New Drug Applications (ANDA) in the U.S. and support the implementation of its internationalization strategy [1].

Group 1 - The company’s subsidiary, Tianjin Pharmaceutical Co., Ltd., has received a registration certificate from the Ministry of Health of the Republic of Panama for its injectable drug, Methylprednisolone Sodium Succinate, allowing it to produce and sell the product in the Panamanian market [1][2] - The drug is a corticosteroid used for anti-inflammatory treatment, immunosuppressive therapy, treatment of blood diseases and tumors, and shock treatment [1] - The global market sales for Methylprednisolone injectable products were reported to be $526 million in 2023 and $521 million in 2024 according to the IQVIA database [1] Group 2 - The registration of the drug is expected to create new opportunities for the company’s formulation business in the Panamanian market and further promote its international strategic layout [2] - The timeline for the drug's sales in foreign markets, market size, and subsequent expansion progress remains uncertain, influenced by external market conditions and exchange rate fluctuations [2]

Core Viewpoint - Ganli Pharmaceutical's insulin product has received a positive opinion from the European Medicines Agency (EMA), marking a significant step for Chinese biopharmaceuticals in the international market [1] Group 1: Company Developments - Ganli Pharmaceutical's insulin injection, Lantus® SoloStar® biosimilar, is recommended for approval by the EMA for treating diabetes in adults, adolescents, and children aged 2 and above [1] - This is the first time a Chinese-developed insulin has received positive recognition from a European regulatory body, indicating a major milestone for the company's internationalization strategy [1] - The positive opinion from the EMA is seen as a "golden passport" for entering international markets, enhancing the company's credibility and paving the way for future product launches in Europe [1][2] Group 2: Market Context - The European diabetes patient population aged 20 to 79 has surpassed 65.6 million, with related medical expenditures nearing $200 billion, highlighting a strong demand for effective and cost-efficient treatment options [2] - Currently, the European insulin market is dominated by Sanofi, with projected sales of €819 million in 2024, indicating a significant opportunity for Ganli Pharmaceutical to alter the market landscape [2] Group 3: Financial Performance - In the first three quarters of 2025, Ganli Pharmaceutical reported domestic formulation revenue of 2.624 billion yuan, a year-on-year increase of 45.6%, reflecting a robust recovery in the domestic market [2] - The company's international business also showed strong performance, with overseas sales revenue reaching 353 million yuan, up 45.5% year-on-year, indicating a growing order scale [2] - The company has achieved a 32.6% growth rate in agreement volume for six insulin products in the upcoming national procurement in 2024, laying a solid foundation for performance recovery [2]

Core Viewpoint - The company is actively promoting its innovative drug, Anladiwei, for the treatment of influenza, with positive clinical trial results and plans for international market expansion [2][4]. Financial Performance - As of October 24, 2025, the company's stock closed at 17.96 yuan, down 2.55%, with a turnover rate of 5.9%, trading volume of 449,200 shares, and a transaction amount of 811 million yuan [1]. Product Development - Anladiwei is the world's first targeted drug for the PB2 subunit of the influenza A virus, showing rapid and effective treatment capabilities with low resistance [2]. - The drug has completed Phase III clinical trials, demonstrating significant efficacy against various influenza virus strains, including H1 and H3 subtypes [4]. Market Strategy - The company has established a commercialization partnership for Anladiwei in Macau and is exploring further international market opportunities [3][4]. - The company is monitoring disease dynamics and is prepared to enhance production and sales efforts [4]. Investor Engagement - The company has clarified that there are no current financing plans and emphasized adherence to disclosure obligations [2]. - The company is open to suggestions regarding marketing strategies to increase awareness of Anladiwei's efficacy [2]. Market Activity - On October 24, there was a net outflow of 132 million yuan from major funds, while retail investors saw a net inflow of 14 million yuan [5].

Core Viewpoint - The company is focusing on international market opportunities for its pharmaceuticals, specifically through a collaboration with Sinovac Biotech for the commercialization of Anglatavir tablets in Macau, which aims to enhance its brand presence overseas and support its international expansion efforts [1] Group 1 - The company has established a commercial partnership with Sinovac Biotech for Anglatavir tablets in Macau [1] - This collaboration is intended to create a brand radiating effect in international markets [1] - The company plans to explore further international market opportunities and accelerate its globalization efforts [1] Group 2 - The company is closely monitoring disease dynamics and is committed to effective drug production and sales [1]

Core Viewpoint - Tonghua Dongbao has received the drug registration certificate for insulin aspart injection from the Indonesian Food and Drug Authority, allowing the company to sell this product in Indonesia, which enhances its international market presence and competitiveness [1] Group 1: Product Information - Insulin aspart injection is a rapid-acting insulin analog that takes effect within 10-20 minutes after subcutaneous injection and lasts for 3-5 hours, primarily used to control postprandial blood sugar [1] - Insulin aspart is typically administered immediately before meals and can also be given right after meals if necessary, often in combination with long-acting insulin for comprehensive blood sugar management [1] Group 2: Strategic Implications - The approval of insulin aspart injection by the Indonesian authority signifies that Tonghua Dongbao is now permitted to market this product in Indonesia, which is beneficial for expanding the company's international product line [1] - This development is expected to enhance the company's brand image, facilitate the expansion of international business, accelerate its presence in emerging markets, and improve its competitiveness in the global market [1]

Core Viewpoint - The company and its subsidiaries have recently obtained drug marketing approvals in Denmark, Germany, Uzbekistan, and Bangladesh for several injectable medications, which will aid in expanding the product line and enhancing brand image in international markets [1] Group 1: Drug Approvals - The company has received marketing approvals for injectable paclitaxel, injectable cyclophosphamide, paclitaxel injection, injectable zoledronic acid solution, and injectable azacitidine [1] - These drugs have been registered in multiple countries, indicating a successful expansion strategy [1] Group 2: Market Preparation - The company has conducted preliminary preparations for the market launch of these products [1] - Future performance remains uncertain due to market competition and other influencing factors [1]