A Retrospective Study on the Efficacy and Safety of Oral NEPA Capsules in Preventing Nausea and Vomiting in Nasopharyngeal Carcinoma Patients after Cisplatin Chemotherapy

开始日期2024-10-01

申办/合作机构

广东医科大学附属医院

ITMCTR2024000498

/ RecruitingN/AIIT

Randomized controlled clinical trial of acupoint application combined with NEPA in preventing chemotherapy-induced nausea and vomiting

开始日期2024-08-01

申办/合作机构-

NCT06417567

/ RecruitingN/AIIT

The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study

The rapid progress of multiple antiemetic regimens ensures that patients can receive full dose chemotherapy, however, there are still a large number of unmet clinical needs in patient evaluation and treatment. Due to the fact that patients with liver, gallbladder, and pancreatic diseases undergoing surgery are still in the stage of nausea and vomiting, the actual incidence of delayed nausea and vomiting may be underestimated. The long-term effective control of nausea and vomiting by Nitopitan Palonosetron capsules may improve the quality of life of patients during and after treatment, and ultimately improve clinical outcomes

开始日期2024-05-15

申办/合作机构

天津市肿瘤研究所

100 项与奈妥匹坦帕洛诺司琼相关的临床结果

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100 项与奈妥匹坦帕洛诺司琼相关的转化医学

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100 项与奈妥匹坦帕洛诺司琼相关的专利（医药）

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项与奈妥匹坦帕洛诺司琼相关的文献（医药）

2025-04-01·ARCHIVES OF GERONTOLOGY AND GERIATRICS

Comparison of non-exercise physical activity and exercise habits for preventing frailty among community-dwelling older adults: A 7-year follow-up from the Kashiwa cohort study

Article

作者: Iijima, Katsuya ; Lyu, Weida ; Yoshizawa, Yasuyo ; Son, Bo-Kyung ; Tanaka, Tomoki

BACKGROUND:

Engagement in non-exercise physical activities (NEPA) has a significant correlation with health. This study aimed to compare the impact of moderate-to-vigorous-intensity NEPA and exercise habit (EH) on frailty among community-dwelling older adults.

METHODS:

This study utilized data from the Kashiwa cohort study in Japan, with baseline assessments in 2014 with a 7-year follow ups (4.0 [2.0-7.0]). A total of 1,288 participants were included. Frailty was assessed using the Cardiovascular Health Study Index, NEPA through the Global Physical Activity Questionnaire, and EH via self-reported exercise engagement at each follow-up examination. Generalized estimating equations (GEE) and Cox regression analyses were used to estimate associations between NEPA, EH, and frailty.

RESULTS:

Compared to participants with no NEPA nor EH, those with NEPA only, with EH only, and with both showed significantly lower adjusted odds ratio (95 %CI) of frailty: 0.29 (0.16-0.52), 0.21 (0.11-0.41) and 0.21 (0.12-0.36). NEPA and EH at baseline were predictor variables for new-onset frailty during the 7-year follow-up period, with adjusted hazard ratios (95 % CI) of 0.55 (0.33-0.92) for NEPA only, 0.51 (0.29-0.90) for EH only, and 0.42 (0.25-0.70) for both. No significant differences were observed between the associations of NEPA and EH with frailty.

CONCLUSIONS:

NEPA is associated with lower frailty risk in older adults, with a similar but non-additive effect to that of EH. These findings highlight the importance of NEPA for frailty prevention, particularly for those not engaged in formal exercise programs.

2025-02-06·ONCOLOGIST

Comparative effectiveness of netupitant-palonosetron plus dexamethasone versus aprepitant-based regimens in mitigating chemotherapy-induced nausea and vomiting: a meta-analysis of randomized controlled trials

Review

作者: Gautama, Made Satya Nugraha ; Chang, Chia-Lun ; Luo, Wun-Ting ; Huang, Tsai-Wei

Abstract:

Background:

Despite guidelines for managing chemotherapy-induced nausea and vomiting (CINV), there remains a need to clarify the optimal use of neurokinin-1 (NK1) receptor antagonists. Comparing the effectiveness of NEPA (netupitant-palonosetron) plus dexamethasone with other NK1 antagonist-based regimens combined with a 5HT3 receptor antagonist and dexamethasone is crucial for informed decision-making and improving patient outcomes.

Methods:

We conducted a systematic review of the literature to assess randomized controlled trials (RCTs) comparing the efficacy, safety, and cost-effectiveness of NEPA plus dexamethasone and other NK1 antagonist-based regimens combined with a 5HT3 receptor antagonist and dexamethasone. PubMed, Embase, and the Cochrane Library databases were systematically searched, with the latest update performed in December 2023. Data on patient demographics, chemotherapy regimen characteristics, and outcomes were extracted for meta-analysis using a random-effects model.

Results:

Seven RCTs were analyzed. NEPA plus dexamethasone showed superior efficacy in achieving complete response in the overall (risk ratio [RR], 1.15; 95% CI, 1.02--1.30) and delayed phases (RR, 1.20; 95% CI, 1.03-1.41) of chemotherapy. It was more effective in controlling nausea (overall phase RR, 1.20; 95% CI, 1.05-1.36; delayed phase RR, 1.21; 95% CI, 1.05-1.40) and reducing rescue therapy use (overall phase RR, 1.45; 95% CI, 1.07-1.95; delayed phase RR, 1.75; 95% CI, 1.10-2.78). Adverse event rates were comparable (RR, 1.03; 95% CI, 0.96-1.10). Subgroup analysis indicated NEPA’s particular efficacy in patients receiving moderately emetogenic chemotherapy (RR, 1.31; 95% CI, 1.07-1.60).

Conclusion:

NEPA plus dexamethasone regimens exhibit superior efficacy in preventing CINV, supporting their preferential inclusion in prophylactic treatment protocols. Its effective symptom control, safety profile, and cost-effectiveness endorse NEPA-based regimens as a beneficial option in CINV management.

2024-10-01·MEDICINE & SCIENCE IN SPORTS & EXERCISE

Acute Vigorous Exercise Decreases Subsequent Nonexercise Physical Activity and Body Temperature Linked to Weight Gain

Article

作者: NISHIJIMA, TAKESHI ; SAMESHIMA, KAZUKI ; Funabashi, Daisuke ; SAGAYAMA, HIROYUKI ; MATSUI, TAKASHI ; FUNABASHI, DAISUKE ; DOBASHI, SHOHEI ; Matsui, Takashi

ABSTRACT:

Purpose:

Exercise benefits the body and mind, but its weight loss effect is less than generally expected. Although this phenomenon is likely due to an exercise intensity–dependent decrease in non-exercise physical activity (NEPA), resulting in a decrease in non-exercise activity thermogenesis, the underlying mechanisms and effects of exercise intensity remain unknown. Here we show that acute vigorous exercise decreases subsequent NEPA and body temperature (BT) in association with body weight gain.

Methods:

Adult male C57BL/6J mice were categorized into three groups: sedentary, moderate exercise, and vigorous exercise, with exercise groups undergoing a 30-min treadmill session. Using an intraperitoneally implanted activity monitor, NEPA and BT were monitored for 2 d before and 3 d after exercise. The daily synchrony between NEPA and BT was evaluated using a cross-correlation function. Plasma corticosterone was also detected 6 and 24 h after exercise.

Results:

Notably, only the vigorous exercise group exhibited a decline in both NEPA and BT, resulting in body weight gain the following day, despite no observed changes in food intake. Furthermore, vigorous exercise induces a distinct delay in the daily dynamics of NEPA compared with BT. A positive correlation was observed between plasma corticosterone levels and changes in NEPA levels before and after exercise across all exercise groups.

Conclusions:

Our findings provide evidence for vigorous exercise–specific reduction in subsequent NEPA, BT, and their synchrony linked to weight gain, likely due to the disturbed circadian rhythm of corticosterone. This is an initial investigation redefining the significance of exercise intensity in beneficial effects beyond the energy expenditure of the exercise itself.

项与奈妥匹坦帕洛诺司琼相关的新闻（医药）

2025-03-26

·PRNewswire

Fosun Pharma Announces 2024 Annual Results

Accelerates Globalization of Innovative Products with Operating Cash Flow Surging 31.13% YoY SHANGHAI, March 25, 2025 /PRNewswire/ -- On March 25, 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"or "the Group"; Stock Code: 600196.SH, 02196.HK), a leading global pharmaceutical and healthcare company driven by innovation, announced its annual results for the year ended 31 December 2024 ("the Reporting Period"). In 2024, Fosun Pharma further focused on the business development of innovative drugs and high-value devices, achieving operating revenue of RMB41.07 billion and net profit attributable to shareholders of RMB2.77 billion, representing an increase of 16.08% YoY. Fosun Pharma continuously optimize supply chain management to enhance operational efficiency, recording an operating cash flow of RMB4.48 billion with an increase of 31.13% YoY, surpassing the growth rate of operating profit. In addition, Fosun Pharma continues to advance lean management across quality enhancement, cost control, efficiency improvement, cycle management, and innovation R&D, driving operational efficiency and expanding profitability. During the Reporting Period, the gross margin minus the selling and distribution expense ratio improved by 2.45 percentage points YoY; and, excluding the impact of newly acquired enterprises during the Reporting Period and the same period last year, administrative expenses declined by RMB355 million. Fosun Pharma always takes innovation as a core driving force in its development. Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. During the Reporting Period, Fosun Pharma continuously optimized its innovative R&D system while maintaining stable R&D investment, focusing on key pipeline strengths and enhancing efficiency through system integration. In 2024, Fosun Pharma's total R&D expenditure amounted to RMB5.55 billion, with R&D expenses totaling RMB3.64 billion. The R&D expenditure in the pharmaceutical manufacturing segment amounted to RMB4.91 billion, accounting for 16.98% of pharmaceutical business revenue. There are over 80 major pipeline projects on innovative drugs and biosimilars (calculated by indications). In addition, during the Reporting Period, the pharmaceutical manufacturing segment of Fosun Pharma submitted 220 patent applications, including 3 American patent applications, 18 PCT applications, and Fosun Pharma has obtained 66 licensed invention patents authorization. Accelerating Innovation Transformation and the Internationalization of Innovative Products Focusing on unmet clinical needs, Fosun Pharma continuous to push forward its innovation transformation and the development and commercialization of innovative products, expanding into regulatory markets such as the U.S. and the EU. During the Reporting Period, 7 innovative products/biosimilars with a total of 16 indications independently developed and licensed-in by Fosun Pharma were approved for launch, and 8 innovative products/biosimilars had entered the pre-launch approval/critical clinical stage. Fosun Pharma also had 18 innovative products/biosimilar projects (calculated by indications) initiated clinical trials. In the field of lung cancer, Fosun Pharma has developed a comprehensive layout in innovative drugs and precision diagnostics and treatment to benefit patients globally. Fosun Pharma's self-developed innovative anti-PD-1 monoclonal antibody, Han Si Zhuang (Serplulimab Injection), is the world's first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), and it remains the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC. During the Reporting Period, Han Si Zhuang also received approval in Chinese mainland for the treatment of non-squamous non-small cell lung cancer (nsNSCLC), and this also marked its third indication in the field of lung cancer, further expanding its reach. To date, Han Si Zhuang has been approved for marketing in over 30 countries and regions, including China, the European Union, and several Southeast Asian nations, benefiting more than 100,000 patients. In addition, to help more lung cancer patients obtain early diagnosis and treatment in a more minimally invasive way, the Ion Bronchial Navigation Operation Control System (Ion System) of Intuitive Fosun, Fosun Pharma's associated company, received NMPA approval in March 2024 and has been commercially deployed. In high-incidence cancers such as breast and gastric cancers, Fosun Pharma's self-developed monoclonal antibody(mAb) biosimilar Han Qu You (Trastuzumab Injection) has been approved for launch in over 50 countries and regions, including China, the European Union, the U.S., Canada and Australia, and has been included in the health insurance directories in countries such as China, UK, France, and Germany. To date, Han Qu You has benefited over 240,000 patients. The HER2-targeted innovative monoclonal antibody HLX22 for gastric cancer treatment and the novel endocrine therapy HLX78 (lasofoxifene) for breast cancer are currently under international multi-center Phase III clinical trials. Additionally, the biosimilar candidate HLX11 (pertuzumab) has had its new drug applications submitted and accepted in both China and the U.S., injecting new momentum into global expansion. In addition, Fosun Pharma is also advancing the development of rare disease drugs. Its self-developed MEK1/2 selective inhibitor Luvometinib tablets, (Project Code: FCN-159), has had its new drug applications for two indications—treatment of adult dendritic cell and histiocytic tumors, and treatment of plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1) in children aged 2 years and older—accepted by the NMPA and placed in the priority review process . In the non-oncology field, during the Reporting Period, Fosun Pharma's self-developed and licensed-in rabies vaccine (Vero cell) for human use (freeze dried), Pu Rui Ni (Pretomanid Tablets), Han Da Yuan (Adalimumab Injection) received approval for four new indications, and Su ke Xin (Avatrombopag Malate Tablets) was approved for its second indication in China; meanwhile, the new drug applications for a biosimilar of denosumab HLX14 under development were accepted by the European Medicines Agency (EMA), Health Canada and the FDA, respectively. Continuously Enhancing Global Operations and Bilateral Licensing Cooperation Fosun Pharma continues to uphold the internationalization strategy in multiple dimensions, such as innovative R&D, licensing, manufacturing and operations as well as commercialization. In 2024, overseas revenue reached RMB11.30 billion, accounting for 27.51% of total revenue. During the reporting period, Fosun Pharma continues to promote the building of production system with international quality standard, laying a solid foundation for the overseas distribution of preparations. As of the end of 2024, all production lines of the domestic subsidiaries under the pharmaceutical manufacturing segment of Fosun Pharma obtained domestic GMP certifications and 10 production lines had passed GMP certification in major regulatory markets such as the U.S. and the EU. Fosun Pharma's pharmaceuticals and medical devices businesses now primarily cover major overseas markets, including the United States, Europe, Africa, India, and Southeast Asia, with an overseas commercialization team of over 1,000 employees. In the U.S., Fosun Pharma's in-house generic drug team has continued to grow, establishing partnerships with major distributors and group purchasing organizations (GPOs) to drive the sales of formulation products. Meanwhile, Fosun Pharma has established its innovative drug team in the U.S. and is preparing for the commercialization of its anti-PD-1 monoclonal antibody (mAb), serplulimab injection. In Europe, Gland Pharma has built localized manufacturing capabilities through its subsidiary, Cenexi. Sisram Medical has expanded its global direct sales offices to 12, with its marketing network now covering over 110 countries and regions. The share of direct sales revenue has further increased to 87%. Meanwhile, Breas Medical's marketing network has expanded across key mature markets, including Europe, the United States, Japan, and Australia. In emerging markets, Fosun Pharma's sales network in Africa now covers over 40 countries and regions. The company continues to advance the Côte d'Ivoire park project to establish localized pharmaceutical manufacturing and supply in Africa. In February 2025, Fosun Pharma launched a new pharmaceutical and medical device sales platform in Nanning, gradually enhancing its registration and commercialization capabilities in Southeast Asia to expand its presence in the region. Fosun Pharma is also actively expanding into the Middle East market. During the reporting period, Henlius, a subsidiary of Fosun Pharma, entered into a strategic partnership with SVAX to establish a joint venture in Saudi Arabia. This collaboration aims to enhance the accessibility of innovative and high-value products in the MENAT region (Middle East, North Africa, and Turkey). Fosun Pharma continues to strengthen its global licensing collaboration, further enhancing its international influence and competitiveness. On the out-licensing front, Henlius, a subsidiary of Fosun Pharma has forged deep partnerships with over 20 leading global biopharmaceutical companies, including Accord, Abbott, Eurofarma, KGbio, Organon, and Dr. Reddy's, to jointly expand global markets. These collaborations comprehensively cover major biologics markets in Europe and the U.S., as well as numerous emerging markets. To date, its approved biologics have benefited more than 750,000 patients worldwide. Fosun Pharma continues to expand its product pipeline in core therapeutic areas through strategic global collaborations. Licensed-in products such as the antiemetic Akynzeo® (netupitant/palonosetron capsules), long-lasting recombinant human granulocyte colony-stimulating factor product (Pei Jin) and the drug for heart failure and hypertension treatment (Yi Xin Tan) have been included in the National Medical Insurance Drugs Catalogue, benefiting a wide range of patients. Fosun Pharma has obtained exclusive development and commercialization rights for Tenapanor Hydrochloride Tablets (Wan Ti Le), a first-in-class phosphate-lowering drug with a novel mechanism. In February 2025, the drug received approval from the National Medical Products Administration (NMPA) in China for the treatment of hyperphosphatemia in adult dialysis patients with chronic kidney disease (CKD). This approval marks a new era of multi-mechanism phosphate control, bringing new hope to dialysis patients with hyperphosphatemia. During the reporting period, Fosun Pharma's licensed product Daxxify® (DaxibotulinumtoxinA-lanm) became the first of its kind approved in China. The product received NMPA approval for the improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. Accelerating Localization of Innovative Products in China to Achieve High-quality Development As a global innovation-driven pharmaceutical and healthcare company, Fosun Pharma actively introduces internationally advanced technologies and products to the Chinese market, benefiting patients and customers. During the reporting period, Fosun-Insightec, a joint venture established with Insightec in China, successfully achieved sales of magneticresonance image guided focused ultrasound brain therapy system ("MRgFUS brain therapy system") for brain treatment. Additionally, the headquarters and industrial base of Intuitive Fosun, an associated company, was officially inaugurated in the Zhangjiang International Medical Park in Shanghai. This facility integrates R&D, manufacturing, and training, further accelerating the localization of the da Vinci Robotic surgical systems in China. To further enhance its leading position in tumor immunotherapy, Fosun Pharma increased its stake in its cell therapy platform, Fosun Kairos, to 100% during the reporting period. The company will continue to collaborate with Kite Pharma to advance the development and commercialization of its licensed products, Axi-Cel (marketed as Yi Kai Da ) and Brexu-Cel (investigational project FKC889), in Chinese mainland, Hong Kong S.A.R and Macao S.A.R. Yi Kai Da became the first in China to introduce an innovative outcome-based payment model. As of the end of 2024, Yi Kai Da has benefited over 800 lymphoma patients, been included in more than 110 provincial and municipal government-backed insurance programs and over 80 commercial insurance plans, and has been registered in more than 180 treatment centers across 28 provinces and municipalities nationwide. While maintaining steady operations, Fosun Pharma remains committed to its corporate social responsibilities. In 2024, the company received multiple domestic and international accolades for its significant progress in ESG, including recognition as one of China's ESG Listed Company Pioneer 100, Deloitte's China Best Managed Companies, Charity Star, and Forbes 2024 China ESG 50 list. Additionally, Fosun Pharma's MSCI ESG rating remained at A. "Fosun Pharma will continue to adhere to innovation-driven and global development strategies, actively embrace AI, concentrate resources on core businesses, and persistently advance lean management and enhance operational efficiency." Wu Yifang, Chairman of Fosun Pharma said, "We aim to grow in tandem with China's biopharmaceutical industry and stride into a new phase of high-quality development. Upholding our mission to 'create better health for families worldwide', we will maintain a patient-centric approach, address unmet clinical needs, deepen innovation transformation and global expansion, and strive to become a global leader in healthcare innovation and integration." About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; SSE: 600196, HKEX: 02196) is a leading innovation-driven global healthcare company operating in the fields of pharmaceuticals, medical devices & diagnostics, and healthcare services. Through its strategic alliance with Sinopharm Group Co., Ltd., Fosun Pharma further extends its capabilities in pharmaceutical commerce. Over the past 30 years since its establishment, Fosun Pharma has maintained deep roots in China while strategically expanding its global presence. The company has been actively implementing its "4IN" strategy -Innovation, Internationalization, Intelligentization, and Integration, with core business operations now spanning major overseas markets including the United States, Europe, Africa, India, and Southeast Asia. At present, Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. This multidimensional approach accelerates the translation of innovative therapies into clinical practice, systematically addressing critical unmet medical needs worldwide. Looking ahead, Fosun Pharma remains anchored in its core values of "Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership". By advancing its global innovation engine and operational excellence, the company strives to be a global leader to integrate pharmaceutical and healthcare innovations, creating better health for families worldwide. SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床3期疫苗引进/卖出

2025-03-25

·复星医药

复星医药发布2024年报：加快创新产品国际化，经营现金流同比增长31.13%

（2025年3月25日，中国上海）3月25日，创新驱动的全球化医药健康产业集团复星医药（“本集团”，股票代码：600196.SH；02196.HK）发布2024年度（报告期）业绩报告。 2024年，复星医药进一步聚焦创新药和高值器械业务发展，推进产品结构和策略转型，实现营业收入410.67亿元，归母净利润27.70亿元，同比增加16.08%；实现经营现金流44.77亿元，同比增长31.13%，高于当期经营性利润的增速, 同时通过资产结构优化和严格控制资本性支出等多项措施，实现自由现金流的提升。此外，复星医药在质量提升、成本控制、效率提升、周期管理、创新研发等环节持续推进精益管理，推动运营效率和盈利空间的提升。报告期内，毛利率减销售费用率同比提升2.45个百分点，剔除新并购企业的影响，管理费用下降3.55亿元。创新是复星医药发展的核心驱动力。复星医药已形成自主研发、合作开发、许可引进、产业投资等模式相结合的开放式、全球化的药品创新研发体系，聚焦肿瘤（实体瘤、血液瘤）、免疫炎症等核心治疗领域，重点强化抗体/ADC、细胞治疗、小分子等核心技术平台，并与产业基金合作布局核药、RNA、基因治疗、AI药物研发等前沿技术。报告期内，复星医药在保持研发强度基本稳定的情况下，持续优化创新研发体系，聚焦优势管线，通过整合研发体系提升效率。2024年，复星医药研发投入共计55.54亿元，其中，研发费用36.44亿元；制药业务研发投入人民币49.10亿元，占制药业务收入的16.98%。按适应症计，主要在研创新药、生物类似药项目超过80项。报告期内，复星医药制药板块专利申请达220项，其中包括美国专利申请3项、PCT申请18项；获得发明专利授权66项。 01 推进创新转型加快创新产品国际化围绕未被满足的临床需求，复星医药持续推进创新转型和创新产品的开发落地，进一步拓展美国、欧盟等法规市场。报告期内，复星医药自主研发及许可引进的 7 个创新药/生物类似药共 16 项适应症获批上市，8 个创新药/生物类似药进入上市前审批/关键临床阶段，共有 18 项创新药/生物类似药项目（按适应症计算）获批开展临床试验。针对全球头号癌症杀手“肺癌”，复星医药已形成创新药及精准诊疗的全方位布局，惠及全球患者。复星医药自主研发的创新药抗PD-1单抗汉斯状（斯鲁利单抗注射液）是全球首个获批一线治疗广泛期小细胞肺癌（ES-SCLC）的抗PD-1单抗，也是首个且唯一在欧盟获批上市用于ES-SCLC治疗的抗PD-1单抗。报告期内，汉斯状于中国境内新增获批一线治疗非鳞状非小细胞肺癌（nsNSCLC）适应症，这是该药品在肺癌领域获批的第三项适应症，进一步拓展覆盖人群。目前，汉斯状已在中国、欧洲和东南亚等30多个国家获批上市，惠及超过10万名患者。为帮助更多肺癌患者通过更微创的方式获得早期的诊断和治疗，联营公司直观复星的Ion 支气管导航操作控制系统（“Ion 系统”）于2024年3月获国家药监局批准上市并实现商业化装机。在乳腺癌、胃癌等高发癌症领域，复星医药自主研发的单抗生物类似药汉曲优（注射用曲妥珠单抗）已成功在中国、欧盟、美国、加拿大、澳大利亚等50个多家和地区获批上市，并进入中国、英国、法国和德国等多个国家的医保目录。截至目前，汉曲优已惠及超过24万名患者。针对胃癌治疗的靶向HER2创新型单抗HLX22及新型乳腺癌内分泌疗法HLX78（拉索昔芬片）均处于国际多中心III期临床试验阶段。在研帕妥珠单抗生物类似药HLX11的上市申请在中国和美国获受理，为全球化发展注入新动能。此外，复星医药还关注罕见病药物研发，自主研发的 MEK1/2 选择性抑制剂芦沃美替尼片（项目代号：FCN-159）两项适应症（治疗成人树突状细胞和组织细胞肿瘤、治疗2岁及2岁以上儿童1型神经纤维瘤病（NF1）相关的丛状神经纤维瘤（PN））的上市注册申请先后获国家药监局受理，且均被纳入优先审评程序。在非肿瘤领域，报告期内，复星医药自主研发的冻干人用狂犬病疫苗（Vero 细胞）、汉达远（阿达木单抗注射液）4 项新增适应症、及许可引进普瑞尼（普托马尼片）、苏可欣（马来酸阿伐曲泊帕片）第二项适应症于中国境内获批；复星医药在研地舒单抗生物类似药 HLX14的上市申请相继获得欧洲药品管理局、加拿大卫生部（Health Canada）和美国FDA受理。 02 持续提升全球运营能力加强全球化双向许可合作复星医药在创新研发、许可合作、生产运营及商业化等多维度持续践行国际化战略，2024年，复星医药海外收入112.97亿元，占营收比重27.51%。报告期内，复星医药持续推进生产体系的国际质量标准认证，进一步夯实制剂出海基础。截至2024年末，复星医药制药板块国内控股子公司所有商业化生产线均已通过国内GMP认证，并已有10条生产线通过美国、欧盟等主流法规市场GMP认证。目前，复星医药制药与医疗器械业务已主要覆盖美国、欧洲、非洲、印度和东南亚等海外市场，海外商业化团队超1,000人。在美国，复星医药的仿制药自营团队日趋成熟，与各大分销商及集团采购组织（GPO）均建立合作关系，推进制剂产品销售。与此同时，复星医药已组建美国创新药团队，并开展创新药抗PD-1单抗斯鲁利单抗注射液的商业化筹备工作。在欧洲，Gland Pharma通过控股子公司Cenexi构建欧洲本土化制造能力。复锐医疗科技（Sisram）全球直销办公室拓展至12个，营销网络已覆盖全球超过110个国家和地区，直销收入占比进一步提升至87%。博毅雅（Breas）的营销网络也已覆盖欧洲、美国、日本和澳大利亚等成熟市场。在新兴市场，复星医药在非洲市场的销售网络已覆盖超过40个国家和地区，并持续推动科特迪瓦园区项目建设以实现非洲本地化药品制造和供应。2025年2月，复星医药新设南宁药械销售平台，逐步推进东南亚注册和商业化能力建设，以拓展当地市场。复星医药还积极拓展中东市场，报告期内，控股子公司复宏汉霖与SVAX达成战略合作，双方拟于沙特阿拉伯新设合资公司，共同提升创新和高价值产品在MENAT地区（中东、北非、土耳其）的可及性。复星医药持续加强全球化的双向许可合作，国际影响力和竞争力不断提升。在对外许可方面，控股子公司复宏汉霖已与Accord、Abbott、Eurofarma、KGbio、Organon及Dr.Reddy's等20多家国际一流的生物制药企业建立深度合作，共同拓展全球市场，全面覆盖欧美主流生物药市场和众多新兴市场，已上市的生物药累计惠及超过75万名全球患者。复星医药还通过全球合作不断丰富核心领域的产品管线，包括止吐药奥康泽（奈妥匹坦帕洛诺司琼胶囊）、长效重组人粒细胞集落刺激因子产品珮金（拓培非格司亭注射液）、心衰和高血压治疗药物一心坦（沙库巴曲缬沙坦钠片）等许可引进产品已纳入国家医保目录，惠及广大患者。复星医药获独家开发和商业化许可的全新机制降磷First-in-class创新药万缇乐（盐酸替那帕诺片）用于治疗CKD成人透析患者的适应症也已于2025年2月在中国获批，将为透析高磷血症患者带来新的治疗希望。报告期内，获许可产品DAXXIFY（达希斐）成为首款于中国境内获批上市的Daxibotulinumtoxin A肉毒杆菌毒素产品，旨在改善中度至重度眉间纹及治疗成人颈部肌张力障碍。 03 加速创新产品中国本土化迈向高质量发展作为一家植根中国的全球化医药集团，复星医药积极将国际领先技术和产品引入中国市场，惠及中国广大患者与客户。报告期内，与Insightec在中国成立的合资公司复星医视特已实现“磁波刀”脑部治疗系统的销售；联营公司直观复星总部产业基地在上海张江国际医学园区落成启用，该基地集研发、生产和培训于一体，将进一步加速达芬奇手术系统的国产化进程。为进一步巩固在肿瘤免疫治疗领域的优势地位，报告期内，复星医药增持细胞治疗平台复星凯瑞股权至100%，并将与Kite Pharma继续推进既有许可产品Axi-Cel（即已上市产品“奕凯达”）及Brexu-Cel（即在研项目FKC889）在中国境内及港澳地区的开发和商业化合作。奕凯达在国内率先推出按疗效价值支付的创新方案，截至2024年末，奕凯达已累计惠及超过800位淋巴瘤患者，已被纳入超过110款省市惠民保和超过80项商业保险，备案的治疗中心覆盖全国超28个省市、数量超过180家。复星医药在坚持企业稳健经营的同时坚守责任担当，2024年，复星医药凭借在ESG领域的显著进展先后荣获中国ESG上市公司先锋100，中国卓越管理公司、慈善之星、福布斯2024中国ESG 50榜单等多项国内国际荣誉，MSCI ESG评级维持A。吴以芳复星医药董事长 “ 复星医药将继续坚持创新驱动与全球化发展，积极拥抱AI，集中资源聚焦核心业务，持续推进精益管理与运营效率的提升，与中国生物医药产业同频共振，迈向高质量发展新阶段。我们将秉持让每个家庭乐享健康的使命，始终以患者为中心，解决未被满足的临床需求，深化创新转型与全球化布局，致力于成为全球领先的医疗创新整合者。 ” 关于复星医药上海复星医药（集团）股份有限公司（“复星医药”，股票代码：600196.SH，02196.HK）成立于1994年，是一家创新驱动的全球化医药健康产业集团，直接运营的业务包括制药、医疗器械与医学诊断、医疗健康服务，并通过联营公司国药控股覆盖到医药商业领域。创立30多年来，复星医药植根中国，布局全球，积极践行“4IN”（创新 Innovation、国际化 Internationalization、智能化 Intelligentization、整合 Integration）的战略，核心业务已主要覆盖美国、欧洲、非洲、印度和东南亚等海外市场。目前，复星医药已形成开放式、全球化的药品创新研发体系，聚焦肿瘤（实体瘤、血液瘤）、免疫炎症等核心治疗领域，重点强化抗体/ADC、细胞治疗、小分子核心技术平台，并与产业基金合作布局核药、RNA、基因治疗、AI药物研发等前沿技术，持续推进创新转型与创新产品的开发落地，解决未被满足的临床需求。面向未来，复星医药始终秉持“关爱生命、不断创新、精益求精、合作共赢”的核心价值观，以“让每个家庭乐享健康”为使命，持续提升创新研发和全球运营能力，致力于成为全球领先的医疗创新整合者。

抗体药物偶联物生物类似药财报基因疗法细胞疗法

2025-02-12

·信狐药迅

元宵快乐！来来来，上班了！中山康方IL-17古莫奇单抗提交上市申请|新受理（1.20-2.9）

本周药品注册受理数据，分门别类呈现，一目了然。(1.20-2.9）新药上市申请药品名称企业注册分类受理号法赞雷生片江苏海岸药业有限公司1CXHS2500011法赞雷生片江苏海岸药业有限公司1CXHS2500010LJ01003长春澜江医药科技有限公司2.2CXHS2500009LJ01003长春澜江医药科技有限公司2.2CXHS2500008BCM857博志研新泰州药物技术有限公司2.2CXHS2500015BCM857博志研新泰州药物技术有限公司2.2CXHS2500014洛索洛芬钠滴眼液润尔眼科药物(广州)有限公司2.2;2.4CXHS2500016海博麦布阿托伐他汀钙片瀚晖制药有限公司2.3CXHS2500013海博麦布阿托伐他汀钙片瀚晖制药有限公司2.3CXHS2500012重组带状疱疹疫苗(CHO细胞)绿竹生物制药(珠海市)有限公司1.2CXSS2500027冻干人用狂犬病疫苗(无血清Vero细胞)科兴(成都)生物制品有限公司2.2CXSS2500017舒地胰岛素注射液江苏恒瑞医药股份有限公司1CXSS2500011舒地胰岛素注射液江苏恒瑞医药股份有限公司1CXSS2500010伏欣奇拜单抗注射液长春金赛药业有限责任公司1CXSS2500015古莫奇单抗注射液中山康方生物医药有限公司1CXSS2500020古莫奇单抗注射液中山康方生物医药有限公司1CXSS2500021 新药临床申请药品名称企业注册分类受理号硫酸心舒帕莎片山东齐都药业有限公司1CXHL2500102硫酸心舒帕莎片山东齐都药业有限公司1CXHL2500101FY101注射液北京福元医药股份有限公司1CXHL2500100HBW-012336胶囊成都海博为药业有限公司1CXHL2500099HRS-1167片江苏恒瑞医药股份有限公司1CXHL2500111HRS-1167片江苏恒瑞医药股份有限公司1CXHL2500110HRS-1167片江苏恒瑞医药股份有限公司1CXHL2500109TQB3912片正大天晴药业集团股份有限公司1CXHL2500108TQB3912片正大天晴药业集团股份有限公司1CXHL2500107BIOS-0618片杭州百诚医药科技股份有限公司1CXHL2500104BIOS-0618片杭州百诚医药科技股份有限公司1CXHL2500103INS018_055片英矽智能科技(上海)有限公司1CXHL2500120HX9428片福建海西新药创制股份有限公司1CXHL2500117HX9428片福建海西新药创制股份有限公司1CXHL2500116AC699片冰洲石生物科技(上海)有限公司1CXHL2500145ABP-671片杭州新元素药业有限公司1CXHL2500144ABP-671片杭州新元素药业有限公司1CXHL2500143AC699片冰洲石生物科技(上海)有限公司1CXHL2500142ABP-671片杭州新元素药业有限公司1CXHL2500141ABP-671片杭州新元素药业有限公司1CXHL2500140ABP-671片杭州新元素药业有限公司1CXHL2500139TQB3019胶囊正大天晴药业集团股份有限公司1CXHL2500138TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2500137TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2500136SNK-2726注射液施能康医药科技(苏州)有限公司1CXHL2500135TT-9701片1CXHL2500129TT-9701片1CXHL2500128INR102注射液云核医药(天津)有限公司1CXHL2500121伊匹乌肽滴眼液温州益承睛湛生物科技有限公司1CXHL2500146HRS-9813胶囊广东恒瑞医药有限公司1CXHL2500147HS-20118片江苏豪森药业集团有限公司1CXHL2500153HS-20118片江苏豪森药业集团有限公司1CXHL2500152HS-20118片江苏豪森药业集团有限公司1CXHL2500151SK-09片广州康臣药业有限公司1CXHL2500150SK-09片广州康臣药业有限公司1CXHL2500149HRS9531注射液福建盛迪医药有限公司1CXHL2500157HRS9531注射液福建盛迪医药有限公司1CXHL2500156HRS9531注射液福建盛迪医药有限公司1CXHL2500155UA026片祐森健恒生物医药(上海)有限公司1CXHL2500176UA026片祐森健恒生物医药(上海)有限公司1CXHL2500175HRS-5635注射液福建盛迪医药有限公司1CXHL2500174SYH2068注射液石药集团中诺药业(石家庄)有限公司1CXHL2500173注射用BH259珠海贝海生物技术有限公司1CXHL2500168FNX010片成都凡诺西生物医药科技有限公司1CXHL2500167FNX010片成都凡诺西生物医药科技有限公司1CXHL2500166HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500165HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500164HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500163HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500162HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500161HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500160HS-10529片江苏豪森药业集团有限公司1CXHL2500182HS-10529片江苏豪森药业集团有限公司1CXHL2500181TJ0113胶囊杭州天玑济世生物科技有限公司1CXHL2500180HIF-117胶囊沈阳三生制药有限责任公司1CXHL2500179HIF-117胶囊沈阳三生制药有限责任公司1CXHL2500178HIF-117胶囊沈阳三生制药有限责任公司1CXHL2500177CMC-2310口溶膜复星医药(徐州)有限公司2.2CXHL2500113CMC-2310口溶膜复星医药(徐州)有限公司2.2CXHL2500112BCM995上海云晟研新生物科技有限公司2.2CXHL25001051640A干混悬剂微多安药业(山东)有限公司2.2CXHL2500115双环醇缓释片海南广升誉制药有限公司2.2CXHL2500119注射用WE010上海宝龙药业股份有限公司2.2CXHL2500133OLP-210片深圳奥礼生物科技有限公司2.2CXHL2500132OLP-210片深圳奥礼生物科技有限公司2.2CXHL2500131OLP-210片深圳奥礼生物科技有限公司2.2CXHL2500130司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500127司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500126司美格鲁肽注射液2.2CXHL2500125司美格鲁肽注射液2.2CXHL2500124儿童专用维生素D3口服冻干片2.2CXHL2500123儿童专用维生素D3口服冻干片2.2CXHL2500122DM2065贴北京德默高科医药技术有限公司2.2CXHL2500148YHAX北京阳光诺和药物研究股份有限公司2.2CXHL2500158AQF直服颗粒深圳珐玛易药品科技有限公司2.2CXHL2500169TTYP01片上海澳宗生物科技有限公司2.2CXHL2500159KEM2111凝胶贴膏深圳珐玛易药品科技有限公司2.2;2.4CXHL2500172KEM2111凝胶贴膏深圳珐玛易药品科技有限公司2.2;2.4CXHL2500171KEM2111凝胶贴膏深圳珐玛易药品科技有限公司2.2;2.4CXHL2500170LH-2103胶囊江苏联环药业股份有限公司2.3CXHL2500114HK241雾化吸入溶液南京华盖制药有限公司2.4CXHL2500106注射用多西他赛(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500118注射用西罗莫司(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500134TAP-1503 乳膏上海泽德曼医药科技有限公司2.4CXHL2500154YKYY026注射液杭州天龙药业有限公司1.2CXSL2500058AFN1204注射液合肥阿法纳生物科技有限公司1.2CXSL2500074AFN1213注射液合肥阿法纳生物科技有限公司1.2CXSL2500101YKYY025注射液杭州天龙药业有限公司1.2CXSL250013020价肺炎球菌多糖结合疫苗云南沃森生物技术股份有限公司2.2CXSL2500061注射用7MW3711迈威(上海)生物科技股份有限公司1CXSL2500057XS228细胞注射液士泽生物医药(苏州)有限公司1CXSL2500055BBM-D101注射液信中医药科技(北京)有限公司1CXSL2500060依苏帕格鲁肽α注射液广州银诺医药集团股份有限公司1CXSL2500070依苏帕格鲁肽α注射液广州银诺医药集团股份有限公司1CXSL2500069依苏帕格鲁肽α注射液广州银诺医药集团股份有限公司1CXSL2500068SHR-4658注射液上海恒瑞医药有限公司1CXSL2500067XS411细胞注射液士泽生物医药(苏州)有限公司1CXSL2500066IBR854细胞注射液英百瑞(杭州)生物医药有限公司1CXSL2500065IBR854细胞注射液英百瑞(杭州)生物医药有限公司1CXSL2500064异体人再生胰岛注射液(E-islet 01)智新浩正(上海)医药科技有限公司1CXSL2500063注射用TQB2922正大天晴药业集团南京顺欣制药有限公司1CXSL2500062BNT324映恩生物制药(苏州)有限公司1CXSL2500073BNT327百欧恩泰(上海)医药有限公司1CXSL2500072TriCellPr-AC07人脐带间充质干细胞注射液奥辰生物(云南)有限公司1CXSL2500071HiCM388注射液艾尔普再生医学科技(深圳)有限公司1CXSL2500077UTAA09注射液博生吉医药科技(苏州)有限公司1CXSL2500075FT-017注射液芳拓生物科技(上海)有限公司1CXSL2500078RY_SW01细胞注射液江苏睿源生物技术有限公司1CXSL2500082RGL-270注射液广州瑞领医药有限公司1CXSL2500080注射用DR30206浙江道尔生物科技有限公司1CXSL2500079注射用ASKG915江苏奥赛康生物医药有限公司1CXSL2500092JMT601注射液上海津曼特生物科技有限公司1CXSL2500091PT217凡恩世制药(北京)有限公司1CXSL2500090SHR-1819注射液广东恒瑞医药有限公司1CXSL2500086注射用QLS31905齐鲁制药有限公司1CXSL2500084ADG126注射液天演药业(苏州)有限公司1CXSL2500089人羊膜间充质干细胞注射液源品细胞生物科技集团有限公司1CXSL2500087注射用ZG005苏州泽璟生物制药股份有限公司1CXSL2500083人自体多克隆调节性T细胞注射液上海赛尔欣生物医疗科技有限公司1CXSL2500094重组抗人EGFR抗体/IL-10双特异Fc融合蛋白注射液施慧达药业集团(吉林)有限公司1CXSL2500098注射用SIM0686上海先祥医药科技有限公司1CXSL2500097BNT327百欧恩泰(上海)医药有限公司1CXSL2500096BNT326百欧恩泰(上海)医药有限公司1CXSL2500095AK139注射液中山康方生物医药有限公司1CXSL2500100AK139注射液中山康方生物医药有限公司1CXSL2500099注射用BL-M09D1成都百利多特生物药业有限责任公司1CXSL2500103注射用KH815成都康弘生物科技有限公司1CXSL2500104注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500117注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500120注射用BL-M11D1成都百利多特生物药业有限责任公司1CXSL2500105注射用RC108荣昌生物制药(烟台)股份有限公司1CXSL2500108注射用LBL-024南京维立志博生物科技股份有限公司1CXSL2500107SHR-4849注射液苏州盛迪亚生物医药有限公司1CXSL2500111注射用LBL-024南京维立志博生物科技股份有限公司1CXSL2500112LBL-007注射液南京维立志博生物科技股份有限公司1CXSL2500113注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500114注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500119XS228细胞注射液士泽生物医药(苏州)有限公司1CXSL2500121注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500116注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500118注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500115注射用LBL-024南京维立志博生物科技股份有限公司1CXSL2500106注射用ZG006苏州泽璟生物制药股份有限公司1CXSL2500122人牙囊间充质干细胞注射液成都世联康健生物科技有限公司1CXSL2500129注射用KJ103上海宝济药业股份有限公司1CXSL2500128DNTH103注射液元羿生物科技(上海)有限公司1CXSL2500124IBI3020信达生物医药科技(杭州)有限公司1CXSL2500123NCR201注射液中盛溯源(广州)生物科技有限公司1CXSL2500126HWS116注射液武汉人福创新药物研发中心有限公司1CXSL2500125纳基奥仑赛注射液广东合源生物医药有限公司2.2CXSL2500076阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500081阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500093QL2107注射液齐鲁制药有限公司2.2CXSL2500085SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500088卡度尼利单抗注射液康方药业有限公司2.2CXSL2500102SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500110阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500109DJ-01注射剂苏州德进生物制药有限公司2.4CXSL2500059 仿制药申请药品名称企业注册分类受理号富马酸酮替芬口服溶液辽宁海一制药有限公司3CYHS2500385枸橼酸西地那非干混悬剂山东朗诺制药有限公司3CYHS2500378吡格列酮二甲双胍片烟台正方制药有限公司3CYHS2500376阿齐沙坦氨氯地平片江西施美药业股份有限公司3CYHS2500375依帕司他片沈阳永大制药股份有限公司3CYHS2500372硫酸特布他林口服溶液成都医路融曜药物科技有限公司3CYHS2500371复合磷酸氢钾注射液赤峰源生药业有限公司3CYHS2500370微量元素注射液4-II合肥市未来药物开发有限公司3CYHS2500368盐酸丁螺环酮片北京诚济制药股份有限公司3CYHS2500367黄体酮注射液上海惠永制药有限公司3CYHS2500365磷酸奥司他韦颗粒柏士顿(海南)医疗科技有限公司3CYHS2500364硫代硫酸钠注射液赤峰源生药业有限公司3CYHS2500363氨己烯酸口服溶液用散上海奥科远制药有限公司3CYHS2500416注射用雷替曲塞四川百利药业有限责任公司3CYHS2500415坎地氢噻片华益药业科技(安徽)有限公司3CYHS2500414盐酸左沙丁胺醇雾化吸入溶液复星医药(徐州)有限公司3CYHS2500413硫酸妥布霉素注射液华夏生生药业(北京)有限公司3CYHS2500412硫代硫酸钠注射液甘正(海南)生物药业有限公司3CYHS2500410吡格列酮二甲双胍片(15mg/500mg)宁波美舒医药科技有限公司3CYHS2500407吡拉西坦注射液北京四环科宝制药股份有限公司3CYHS2500406舒必利注射液海南卓科制药有限公司3CYHS2500405舒必利注射液海南卓科制药有限公司3CYHS2500404坎地氢噻片海南药谷云生物科技有限公司3CYHS2500403苯磺酸氨氯地平口服溶液湖南科伦制药有限公司3CYHS2500402苯磺酸氨氯地平口服溶液湖南科伦制药有限公司3CYHS2500401倍他米松磷酸钠注射液陕西顿斯制药有限公司3CYHS2500399铝镁匹林片(II)苏州特瑞药业股份有限公司3CYHS2500398头孢地尼干混悬剂苏州第三制药厂有限责任公司3CYHS2500396头孢地尼干混悬剂苏州第三制药厂有限责任公司3CYHS2500395注射用硫酸多黏菌素B桂林南药股份有限公司3CYHS2500394氯化钾注射液石家庄四药有限公司3CYHS2500440氯化钙注射液广东君康药业有限公司3CYHS2500439聚普瑞锌口腔崩解片海南金瑞宝医药科技有限公司3CYHS2500438盐酸肾上腺素注射液江苏润恒制药有限公司3CYHS2500435硝普钠注射液中润药业有限公司3CYHS2500433利多卡因喷雾剂重庆香雪医药有限公司3CYHS2500430利多卡因喷雾剂重庆香雪医药有限公司3CYHS2500429盐酸纳美芬注射液中山万汉制药有限公司3CYHS2500421左氧氟沙星注射液海南斯达制药有限公司3CYHS2500444左氧氟沙星注射液海南斯达制药有限公司3CYHS2500443普瑞巴林口崩片北京星昊盈盛药业有限公司3CYHS2500442头孢克肟胶囊南京瑞捷医药科技有限公司3CYHS2500468己酮可可碱注射液楚雄和创药业有限责任公司3CYHS2500467铝镁匹林片(II)福建省闽东力捷迅药业股份有限公司3CYHS2500461氯化钾颗粒南京黄龙生物科技有限公司3CYHS2500460左氧氟沙星注射液成都华宇制药有限公司3CYHS2500459左氧氟沙星注射液成都华宇制药有限公司3CYHS2500458氯化钾颗粒南京黄龙生物科技有限公司3CYHS2500457盐酸多巴胺注射液郑州维先医药科技有限公司3CYHS2500451盐酸拉贝洛尔注射液上海朝晖药业有限公司3CYHS2500448盐酸拉贝洛尔注射液上海朝晖药业有限公司3CYHS2500447利塞膦酸钠片北京福元医药股份有限公司3CYHS2500475盐酸溴己新注射液福安药业集团宁波天衡制药有限公司3CYHS2500493奥美拉唑碳酸氢钠干混悬剂(I)安徽四环科宝制药有限公司3CYHS2500492奥美拉唑碳酸氢钠干混悬剂(Ⅱ)安徽四环科宝制药有限公司3CYHS2500491布立西坦口服溶液江西科睿药业有限公司3CYHS2500486对乙酰氨基酚注射液北京柏雅联合药物研究所有限公司3CYHS2500485生理氯化钠溶液海南爱科制药有限公司3CYHS2500484生理氯化钠溶液海南爱科制药有限公司3CYHS2500483碳酸氢钠注射液安徽新世纪药业有限公司3CYHS2500481盐酸利多卡因注射液河北冀辉医药科技有限公司3CYHS2500494多种微量元素注射液(Ⅳ)北京柏雅联合药物研究所有限公司3CYHS2500521琥珀酸多西拉敏片南京济群医药科技股份有限公司3CYHS2500515琥珀酸多西拉敏片南京济群医药科技股份有限公司3CYHS2500514布瑞哌唑口腔崩解片南京海纳制药有限公司3CYHS2500513布瑞哌唑口腔崩解片南京海纳制药有限公司3CYHS2500512布瑞哌唑口腔崩解片南京海纳制药有限公司3CYHS2500511秋水仙碱片浙江浙北药业有限公司3CYHS2500508洛索洛芬钠口服溶液吉林省辉南长龙生化药业股份有限公司3CYHS2500506乙酰半胱氨酸片广东泰来润至医药科技有限公司3CYHS2500502氨溴特罗口服溶液吉林省益浦生物科技有限公司3CYHS2500499骨化三醇口服溶液湖北欣泽霏药业有限公司3CYHS2500498盐酸溴己新口服溶液湖南九典制药股份有限公司3CYHS2500497氯化钾口服溶液南京恒道医药科技股份有限公司3CYHS2500535氯化钾口服溶液合肥华威药业有限公司3CYHS2500533色甘酸钠滴眼液武汉新瑞医药科技有限公司3CYHS2500545醋酸钙口服溶液华益药业科技(安徽)有限公司3CYHS2500553缩宫素注射液苏州天马医药集团天吉生物制药有限公司3CYHS2500550碳酸氢钠/葡萄糖2mmol/l钾电解质血滤置换液成都青山利康药业股份有限公司3CYHS2500549阿仑膦酸钠口服溶液河北仁合益康药业有限公司3CYHS2500547磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙)成都青山利康药业股份有限公司3CYHS2500563布美他尼注射液山东方明药业集团股份有限公司3CYHS2500562乙酰半胱氨酸注射液江苏润恒制药有限公司3CYHS2500560盐酸丙卡特罗颗粒浙江百代医药科技有限公司3CYHS2500579硝普钠注射液海南爱科制药有限公司3CYHS2500578盐酸纳美芬注射液朗天药业(湖北)有限公司3CYHS2500576复方聚乙二醇(3350)电解质散河南福森药业有限公司3CYHS2500569坎地氢噻片福建大谱生物医药有限公司3CYHS2500568硫酸特布他林口服溶液苏州华健瑞达医药技术有限公司3CYHS2500567盐酸拉贝洛尔片山东华铂凯盛生物科技有限公司3CYHS2500583盐酸拉贝洛尔片山东华铂凯盛生物科技有限公司3CYHS2500582倍他米松磷酸钠注射液上海锦帝九州药业(安阳)有限公司3CYHS2500612重酒石酸去甲肾上腺素注射液江苏润恒制药有限公司3CYHS2500607重酒石酸去甲肾上腺素注射液江苏润恒制药有限公司3CYHS2500606乙酰半胱氨酸口服液安徽茂康药业有限公司3CYHS2500605米诺地尔搽剂北京京丰制药(山东)有限公司3CYHS2500598米诺地尔搽剂北京京丰制药(山东)有限公司3CYHS2500597盐酸溴己新注射液湖南赛隆药业(长沙)有限公司3CYHS2500595吸入用盐酸丙卡特罗溶液海南斯达制药有限公司3CYHS2500594吸入用盐酸丙卡特罗溶液海南斯达制药有限公司3CYHS2500593氯化钾注射液山西普恒制药有限公司3CYHS2500588二硫化硒洗剂广东恒健制药有限公司3CYHS2500586甲氨蝶呤片海南卓科制药有限公司3CYHS2500619维生素B6注射液海韬新药研发(江苏)有限公司3CYHS2500618微量元素注射液4-I合肥市未来药物开发有限公司3CYHS2500635注射用吲哚菁绿海南倍特药业有限公司3CYHS2500640注射用硫酸多黏菌素B福建省福抗药业股份有限公司3CYHS2500632复方聚乙二醇(3350)电解质口服溶液海南广升誉制药有限公司3CYHS2500631尿素[13C]呼气试验药盒深圳市中核海得威生物科技有限公司3CYHS2500629盐酸舍曲林口服浓缩液江苏润恒制药有限公司3CYHS2500685盐酸舍曲林口服浓缩液万特制药(海南)有限公司3CYHS2500677盐酸纳美芬注射液新乡市常乐制药有限责任公司3CYHS2500675盐酸纳美芬注射液新乡市常乐制药有限责任公司3CYHS2500673山梨醇甘露醇冲洗剂青岛奥瑞森医疗科技有限公司3CYHS2500672美沙拉秦肠溶缓释胶囊成都倍特药业股份有限公司3CYHS2500660磷酸芦可替尼片哈尔滨三联药业股份有限公司4CYHS2500362磷酸芦可替尼片哈尔滨三联药业股份有限公司4CYHS2500361磷酸芦可替尼片哈尔滨三联药业股份有限公司4CYHS2500360奈妥匹坦帕洛诺司琼胶囊浙江康莱特药业有限公司4CYHS2500384注射用帕瑞昔布钠广州一品红制药有限公司4CYHS2500383布瑞哌唑片山东京卫制药有限公司4CYHS2500382布瑞哌唑片山东京卫制药有限公司4CYHS2500381布瑞哌唑片山东京卫制药有限公司4CYHS2500380瑞舒伐他汀依折麦布片(I)江苏利泰尔药业有限公司4CYHS2500379地屈孕酮片广州朗圣药业有限公司4CYHS2500377沙库巴曲缬沙坦钠片四川百利药业有限责任公司4CYHS2500374硫酸镁钠钾口服用浓溶液浙江国镜药业有限公司4CYHS2500373ω-3脂肪酸乙酯90软胶囊山西鑫煜制药股份有限公司4CYHS2500369利格列汀片迪沙药业集团有限公司4CYHS2500366苯磺酸左氨氯地平片成都欣捷高新技术开发股份有限公司4CYHS2500393苯磺酸左氨氯地平片成都欣捷高新技术开发股份有限公司4CYHS2500392帕拉米韦氯化钠注射液广东大翔制药有限公司4CYHS2500391帕拉米韦氯化钠注射液广东大翔制药有限公司4CYHS2500390乳果糖口服溶液湖北迪喜药业有限公司4CYHS2500389磷酸芦可替尼片常州制药厂有限公司4CYHS2500388磷酸芦可替尼片常州制药厂有限公司4CYHS2500387磷酸芦可替尼片常州制药厂有限公司4CYHS2500386富马酸伏诺拉生片陕西白鹿制药股份有限公司4CYHS2500418富马酸伏诺拉生片陕西白鹿制药股份有限公司4CYHS2500417西甲硅油乳剂湖南华纳大药厂股份有限公司4CYHS2500411磷酸芦可替尼片成都倍特药业股份有限公司4CYHS2500409乳酸钠林格注射液重庆安诺生生命科技有限公司4CYHS2500408脂肪乳氨基酸(17)葡萄糖(19)注射液费森尤斯卡比华瑞制药有限公司4CYHS2500400达芦那韦片江苏艾迪药业股份有限公司4CYHS2500397乌帕替尼缓释片浙江花园药业有限公司4CYHS2500441乳果糖口服溶液湖南千金湘江药业股份有限公司4CYHS2500437阿奇霉素胶囊悦康药业集团股份有限公司4CYHS2500436阿奇霉素干混悬剂湖南九典制药股份有限公司4CYHS2500434米库氯铵注射液成都市海通药业有限公司4CYHS2500432米库氯铵注射液成都市海通药业有限公司4CYHS2500431环硅酸锆钠散海南先声药业有限公司4CYHS2500428环硅酸锆钠散海南先声药业有限公司4CYHS2500427盐酸达泊西汀片浙江莎普爱思药业股份有限公司4CYHS2500426盐酸达泊西汀片浙江莎普爱思药业股份有限公司4CYHS2500425盐酸曲唑酮缓释片浙江赛默制药有限公司4CYHS2500424盐酸曲唑酮缓释片浙江赛默制药有限公司4CYHS2500423盐酸尼卡地平注射液南京瑞捷医药科技有限公司4CYHS2500422罗沙司他胶囊上海医药集团青岛国风药业股份有限公司4CYHS2500420罗沙司他胶囊上海医药集团青岛国风药业股份有限公司4CYHS2500419阿司匹林肠溶片石家庄市华新药业有限责任公司4CYHS2500445达格列净片浙江宏元药业股份有限公司4CYHS2500471达格列净片浙江宏元药业股份有限公司4CYHS2500470阿达帕林凝胶杭州和泽坤元药业有限公司4CYHS2500469艾拉莫德片安徽省先锋制药有限公司4CYHS2500466富马酸喹硫平缓释片国药集团工业有限公司4CYHS2500465氟伐他汀钠缓释片浙江高跖医药科技股份有限公司4CYHS2500464阿帕他胺片江西科睿药业有限公司4CYHS2500463糠酸氟替卡松鼻用喷雾剂齐鲁制药有限公司4CYHS2500462钆特酸葡胺注射液通用电气药业(上海)有限公司4CYHS2500456钆特酸葡胺注射液通用电气药业(上海)有限公司4CYHS2500455钆特酸葡胺注射液通用电气药业(上海)有限公司4CYHS2500454盐酸氮斯汀滴眼液成都普什制药有限公司4CYHS2500453卡前列素氨丁三醇注射液甘肃成纪生物药业有限公司4CYHS2500452甲苯磺酸艾多沙班片华北制药股份有限公司4CYHS2500450甲苯磺酸艾多沙班片华北制药股份有限公司4CYHS2500449屈螺酮炔雌醇片四川科伦药业股份有限公司4CYHS2500446米库氯铵注射液江苏润恒制药有限公司4CYHS2500478米库氯铵注射液江苏润恒制药有限公司4CYHS2500477培哚普利氨氯地平片(III)四川国为制药有限公司4CYHS2500476克立硼罗软膏山东百诺医药股份有限公司4CYHS2500474美阿沙坦钾片山西德元堂药业有限公司4CYHS2500473美阿沙坦钾片山西德元堂药业有限公司4CYHS2500472利奥西呱片南京黄龙生物科技有限公司4CYHS2500489利奥西呱片南京黄龙生物科技有限公司4CYHS2500488利奥西呱片南京黄龙生物科技有限公司4CYHS2500487硫酸氨基葡萄糖胶囊河南福森药业有限公司4CYHS2500482环孢素滴眼液(III)广州大光制药有限公司4CYHS2500480比索洛尔氨氯地平片宁夏康亚药业股份有限公司4CYHS2500479骨化三醇注射液河南泰丰生物科技有限公司4CYHS2500496盐酸莫西沙星片北大医药股份有限公司4CYHS2500495达格列净二甲双胍缓释片(III)山东鲁抗医药股份有限公司4CYHS2500523达格列净二甲双胍缓释片(I)山东鲁抗医药股份有限公司4CYHS2500522羧基麦芽糖铁注射液博瑞制药(苏州)有限公司4CYHS2500520苯磺酸阿曲库铵注射液扬州中宝药业股份有限公司4CYHS2500519磷酸芦可替尼片杭州中美华东制药有限公司4CYHS2500518美阿沙坦钾片北京民康百草医药科技有限公司4CYHS2500517美阿沙坦钾片北京民康百草医药科技有限公司4CYHS2500516美阿沙坦钾片浙江高跖医药科技股份有限公司4CYHS2500510美阿沙坦钾片浙江华润三九众益制药有限公司4CYHS2500509药用炭颗粒河北长天药业有限公司4CYHS2500507盐酸罗哌卡因注射液湖北津药药业股份有限公司4CYHS2500505盐酸罗哌卡因注射液湖北津药药业股份有限公司4CYHS2500504吸入用七氟烷河北仁合益康药业有限公司4CYHS2500503洛索洛芬钠贴剂石家庄探索医药科技有限公司4CYHS2500501洛索洛芬钠贴剂石家庄探索医药科技有限公司4CYHS2500500盐酸倍他洛尔滴眼液苏州欧康维视生物科技有限公司4CYHS2500543恩扎卢胺软胶囊正大天晴药业集团股份有限公司4CYHS2500542荧光素钠注射液苏州朗科生物技术股份有限公司4CYHS2500541甲苯磺酸艾多沙班片江苏华阳制药有限公司4CYHS2500540甲苯磺酸艾多沙班片江苏华阳制药有限公司4CYHS2500539非奈利酮片重庆华邦制药有限公司4CYHS2500538非奈利酮片重庆华邦制药有限公司4CYHS2500537布洛芬混悬液山西同达药业有限公司4CYHS2500536盐酸决奈达隆片安徽艾立德制药有限公司4CYHS2500534盐酸乙哌立松片大桐制药(中国)有限责任公司4CYHS2500532帕利哌酮缓释片辰欣药业股份有限公司4CYHS2500531聚多卡醇注射液福安药业集团庆余堂制药有限公司4CYHS2500530聚多卡醇注射液福安药业集团庆余堂制药有限公司4CYHS2500529聚多卡醇注射液福安药业集团庆余堂制药有限公司4CYHS2500528富马酸伏诺拉生片江苏华阳制药有限公司4CYHS2500527富马酸伏诺拉生片江苏华阳制药有限公司4CYHS2500526富马酸伏诺拉生片四川梓橦宫药业股份有限公司4CYHS2500525富马酸伏诺拉生片四川梓橦宫药业股份有限公司4CYHS2500524非奈利酮片江苏德源药业股份有限公司4CYHS2500544丁溴东莨菪碱注射液四川沃翔生物医药有限公司4CYHS2500546盐酸胺碘酮注射液海南卓科制药有限公司4CYHS2500556注射用阿莫西林钠克拉维酸钾山东安信制药有限公司4CYHS2500555注射用阿莫西林钠克拉维酸钾山东安信制药有限公司4CYHS2500554磷酸奥司他韦胶囊江西泰吉立生物医药科技有限公司4CYHS2500552泊沙康唑注射液河南泰丰生物科技有限公司4CYHS2500551磷/碳酸氢钠血滤置换液成都青山利康药业股份有限公司4CYHS2500548甲磺酸伊马替尼片山东鲁抗医药股份有限公司4CYHS2500566甲磺酸伊马替尼片山东鲁抗医药股份有限公司4CYHS2500565氧(液态)洛阳天泽气体有限公司4CYHS2500564维生素B12滴眼液河北龙海药业有限公司4CYHS2500561地诺孕素片株洲千金药业股份有限公司4CYHS2500559富马酸伏诺拉生片陕西天宇制药有限公司4CYHS2500558富马酸伏诺拉生片陕西天宇制药有限公司4CYHS2500557伏格列波糖片上海现代制药股份有限公司4CYHS2500581伏格列波糖片上海现代制药股份有限公司4CYHS2500580瑞舒伐他汀依折麦布片(I)山东百诺医药股份有限公司4CYHS2500577奥氮平片山东普瑞曼药业有限公司4CYHS2500575丙戊酸钠口服溶液郑州维先医药科技有限公司4CYHS2500574尼莫地平片石家庄四药有限公司4CYHS2500573硝苯地平控释片天津力生制药股份有限公司4CYHS2500572硫酸氨基葡萄糖胶囊辽宁康博士制药有限公司4CYHS2500571托伐普坦片石家庄市华新药业有限责任公司4CYHS2500570熊去氧胆酸胶囊四川迪菲特药业有限公司4CYHS2500613富马酸伏诺拉生片济南高华制药有限公司4CYHS2500611富马酸伏诺拉生片济南高华制药有限公司4CYHS2500610左氧氟沙星滴眼液盈科瑞(珠海金湾)制药有限公司4CYHS2500609注射用醋酸西曲瑞克山西威奇达光明制药有限公司4CYHS2500608醋酸加尼瑞克注射液苏州东瑞制药有限公司4CYHS2500604达格列净片苏州第壹制药有限公司4CYHS2500603阿戈美拉汀片河南福森药业有限公司4CYHS2500602布瑞哌唑片石药集团欧意药业有限公司4CYHS2500601布瑞哌唑片石药集团欧意药业有限公司4CYHS2500600布瑞哌唑片石药集团欧意药业有限公司4CYHS2500599富马酸贝达喹啉片沈阳红旗制药有限公司4CYHS2500596吸入用布地奈德混悬液山东泰合医药科技有限公司4CYHS2500592布地奈德福莫特罗吸入粉雾剂(II)上海新黄河制药有限公司4CYHS2500591玻璃酸钠滴眼液国药集团三益药业(芜湖)有限公司4CYHS2500590玻璃酸钠滴眼液国药集团三益药业(芜湖)有限公司4CYHS2500589沙美特罗替卡松吸入气雾剂长风药业股份有限公司4CYHS2500587富马酸伏诺拉生片江苏诺泰澳赛诺生物制药股份有限公司4CYHS2500585富马酸伏诺拉生片江苏诺泰澳赛诺生物制药股份有限公司4CYHS2500584乌帕替尼缓释片华益泰康药业股份有限公司4CYHS2500617富马酸伏诺拉生片江苏诚康药业有限公司4CYHS2500616盐酸屈他维林注射液广东星昊药业有限公司4CYHS2500615注射用醋酸西曲瑞克浙江众延医药科技有限公司4CYHS2500614苯磺酸左氨氯地平片安徽肽渡生物医药科技有限公司4CYHS2500645依折麦布阿托伐他汀钙片(I)江苏康缘药业股份有限公司4CYHS2500644盐酸达泊西汀片济南高华制药有限公司4CYHS2500643盐酸达泊西汀片济南高华制药有限公司4CYHS2500642地屈孕酮片湖南醇健制药科技有限公司4CYHS2500641富马酸伏诺拉生片浙江华义制药有限公司4CYHS2500639富马酸伏诺拉生片寿光富康制药有限公司4CYHS2500638黄体酮阴道缓释凝胶浙江仙琚制药股份有限公司4CYHS2500634注射用尼可地尔锦州九泰药业有限责任公司4CYHS2500633注射用氟氧头孢钠海韬新药研发(江苏)有限公司4CYHS2500630他达拉非片山西辅仁恒峰药业有限公司4CYHS2500628他达拉非片山西辅仁恒峰药业有限公司4CYHS2500627碘佛醇注射液山东如至生物医药科技有限公司4CYHS2500626枸橼酸托法替布缓释片安徽艾立德制药有限公司4CYHS2500625聚多卡醇注射液河南泰丰生物科技有限公司4CYHS2500624聚多卡醇注射液河南泰丰生物科技有限公司4CYHS2500623聚多卡醇注射液河南泰丰生物科技有限公司4CYHS2500622吡仑帕奈片成都康弘药业集团股份有限公司4CYHS2500621吡仑帕奈片成都康弘药业集团股份有限公司4CYHS2500620瑞舒伐他汀依折麦布片(I)四川科伦药业股份有限公司4CYHS2500684美阿沙坦钾片陕西白鹿制药股份有限公司4CYHS2500683美阿沙坦钾片陕西白鹿制药股份有限公司4CYHS2500682克立硼罗软膏四川科伦药业股份有限公司4CYHS2500681低钙腹膜透析液(乳酸盐-G2.5%)辰欣药业股份有限公司4CYHS2500680低钙腹膜透析液(乳酸盐-G1.5%)辰欣药业股份有限公司4CYHS2500679乌美溴铵维兰特罗吸入粉雾剂正大天晴药业集团股份有限公司4CYHS2500678酒石酸西尼必利片安徽佳和药业有限公司4CYHS2500676小儿法罗培南钠颗粒浙江普洛康裕制药有限公司4CYHS2500674左乙拉西坦注射用浓溶液江苏润恒制药有限公司4CYHS2500671阿帕他胺片浙江诺得药业有限公司4CYHS2500670沙库巴曲缬沙坦钠片山东普瑞曼药业有限公司4CYHS2500669他克莫司胶囊北京以岭生物工程技术有限公司4CYHS2500668他克莫司胶囊北京以岭生物工程技术有限公司4CYHS2500667普拉洛芬滴眼液重庆药谷制药有限公司4CYHS2500666硫酸艾沙康唑胶囊江苏奥赛康药业有限公司4CYHS2500665沙库巴曲缬沙坦钠片苏州中化药品工业有限公司4CYHS2500664罗沙司他胶囊浙江贝得药业有限公司4CYHS2500663罗沙司他胶囊浙江贝得药业有限公司4CYHS2500662硫酸氨基葡萄糖胶囊山东康林医药有限公司4CYHS2500661注射用头孢他啶阿维巴坦钠福安药业集团庆余堂制药有限公司4CYHS2500659盐酸多奈哌齐口腔崩解片山东淄博新达制药有限公司4CYHS2500658伊布替尼胶囊浙江诺得药业有限公司4CYHS2500657他克莫司胶囊江西远超医药科技有限公司4CYHS2500656他克莫司胶囊江西远超医药科技有限公司4CYHS2500655依折麦布阿托伐他汀钙片 (I)湖北午时药业股份有限公司4CYHS2500654依折麦布阿托伐他汀钙片 (II)湖北午时药业股份有限公司4CYHS2500653瑞舒伐他汀依折麦布片(I)齐鲁制药(海南)有限公司4CYHS2500652布瑞哌唑片江苏康缘药业股份有限公司4CYHS2500651布瑞哌唑片江苏康缘药业股份有限公司4CYHS2500650布瑞哌唑片江苏康缘药业股份有限公司4CYHS2500649枸橼酸托法替布缓释片宁波美诺华天康药业有限公司4CYHS2500648帕利哌酮缓释片北大医药股份有限公司4CYHS2500647帕利哌酮缓释片北大医药股份有限公司4CYHS2500646富马酸伏诺拉生片浙江恒研医药科技有限公司4CYHS2500637富马酸伏诺拉生片浙江恒研医药科技有限公司4CYHS2500636四价流感病毒裂解疫苗成大生物(本溪)有限公司3.3CXSS2500012吸附破伤风疫苗康希诺生物股份公司3.3CXSS2500022长效重组人促卵泡激素注射液北京双鹭药业股份有限公司3.2CXSS2500014长效重组人促卵泡激素注射液北京双鹭药业股份有限公司3.2CXSS2500013注射用曲妥珠单抗上海生物制品研究所有限责任公司3.3CXSS2500007司美格鲁肽注射液珠海联邦生物医药有限公司3.3CXSS2500008司美格鲁肽注射液珠海联邦生物医药有限公司3.3CXSS2500009重组人促卵泡激素注射液珠海市丽珠单抗生物技术有限公司3.3CXSS2500016地舒单抗注射液泰州迈博太科药业有限公司3.3CXSS2500019地舒单抗注射液泰州迈博太科药业有限公司3.3CXSS2500018司库奇尤单抗注射液百奥泰生物制药股份有限公司3.3CXSS2500023司库奇尤单抗注射液百奥泰生物制药股份有限公司3.3CXSS2500024德谷胰岛素注射液宜昌东阳光长江药业股份有限公司3.3CXSS2500026德谷胰岛素注射液宜昌东阳光长江药业股份有限公司3.3CXSS2500025注射用重组人脑利钠肽苏州兰鼎生物制药有限公司3.4CXSS2500006阿瑞匹坦注射液山东百诺医药股份有限公司3CYHL2500021阿仑膦酸钠氯化钠注射液湖南先施制药有限公司3CYHL2500022酮洛芬贴剂河北一品制药股份有限公司3CYHL2500023无水甜菜碱散剂伊春五加参药业有限责任公司3CYHL2500026贝派度酸片合肥立方制药股份有限公司3CYHL2500025伏环孢素软胶囊博瑞制药(苏州)有限公司3CYHL2500031氟比洛芬贴剂江西康恩贝中药有限公司3CYHL2500030帕立骨化醇软胶囊青岛国信制药有限公司3CYHL2500029帕立骨化醇软胶囊青岛国信制药有限公司3CYHL2500028双氯芬酸钠贴剂深圳珐玛易药品科技有限公司3CYHL2500027艾氟洛芬贴剂齐鲁制药有限公司3CYHL2500032贝派度酸依折麦布片江西施美药业股份有限公司3CYHL2500034甘露醇山梨醇注射液四川美大康佳乐药业有限公司3CYHL2500033琥珀酰明胶电解质醋酸钠注射液内蒙古白医制药股份有限公司4CYHL2500020洛索洛芬钠凝胶贴膏云南白药集团无锡药业有限公司4CYHL2500024罗莫佐单抗注射液珠海联邦生物医药有限公司3.3CXSL2500056地舒单抗注射液华兰基因工程(河南)有限公司3.3CXSL2500127 进口申请药品名称企业注册分类受理号普乐司兰钠注射液Arrowhead Pharmaceuticals, Inc.1JXHS2500018非奈利酮片Bayer AG2.4JXHS2500017非奈利酮片Bayer AG2.4JXHS2500016非奈利酮片Bayer AG2.4JXHS2500015盐酸拉多替尼胶囊IL-YANG PHARM. CO., LTD.5.1JXHS2500014曲安奈德脉络膜上腔注射混悬液ARCTIC VISION SINGAPORE PTE. LTD.5.1JXHS2500019盐酸非索非那定口服混悬液Sanofi-Aventis Healthcare Pty Ltd.5.1JXHS2500021盐酸非索非那定口服混悬液Sanofi-Aventis Healthcare Pty Ltd.5.1JXHS2500020地塞米松泪小管植入剂Ocular Therapeutix Inc.5.1JXHS2500022瑞玛奈珠单抗注射液TEVA GmbH3.1JXSS2500003西罗莫司片Zydus Lifesciences Limited5.2JYHS2500006西罗莫司片Zydus Lifesciences Limited5.2JYHS2500005Bexicaserin口服溶液Longboard Pharmaceuticals, Inc.1JXHL2500013MT-7117 片Mitsubishi Tanabe Pharma Corporation1JXHL2500014[225Ac]Ac-PSMA-617注射液Novartis Pharma AG1JXHL2500015ALXN2030注射液Alexion Pharmaceuticals, Inc.1JXHL2500017TAK-279胶囊Takeda Development Center Americas, Inc.1JXHL2500018Bleximenib片Janssen Research & Development, LLC1JXHL2500023Bleximenib片Janssen Research & Development, LLC1JXHL2500022Bleximenib片Janssen Research & Development, LLC1JXHL2500021放射性药物镓[68Ga]oxodotreotide注射液配制用药盒Novartis Pharma AG2.4JXHL2500020镥[177Lu]oxodotreotide注射液Novartis Pharma AG2.4JXHL2500019用于制备放射性药物镓(68Ga)gozetotide注射液的药盒Novartis Europharm Limited5.1JXHL2500016AZD2936AstraZeneca AB1JXSL2500014AZD5492AstraZeneca AB1JXSL2500016AZD5492AstraZeneca AB1JXSL2500015Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2500013Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2500012度伐利尤单抗注射液MedImmune LLC2.2JXSL2500018度伐利尤单抗注射液MedImmune LLC2.2JXSL2500017本瑞利珠单抗注射液AstraZeneca AB2.2JXSL2500019注射用德曲妥珠单抗Daiichi Sankyo, Inc.2.2JXSL2500020Tezepelumab注射液AstraZeneca AB2.2JXSL2500021阿托伐醌口服混悬液Hetero Labs Limited5.2JYHL2500001 中药相关申请药品名称企业注册分类受理号吾斯提库都斯颗粒和田维吾尔药业股份有限公司1.1CXZL2500004反流清颗粒1.1CXZL2500005黄苓凝胶山东汉方制药有限公司1.1CXZL2500006安神滴丸天士力医药集团股份有限公司1.1CXZS2500002苓桂术甘颗粒湖南易能生物医药有限公司3.1CXZS2500003芍药甘草颗粒山东润中药业有限公司3.1CXZS2500004七福饮颗粒河南福地生物科技有限公司1.1CXZL2500007 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

疫苗申请上市

100 项与奈妥匹坦帕洛诺司琼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	奈妥匹坦帕洛诺司琼	A04AA	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
恶心	加拿大	Knight Therapeutics, Inc.	2017-11-20
呕吐	加拿大	Knight Therapeutics, Inc.	2017-11-20
化疗引起的恶心和呕吐	美国	Helsinn Healthcare SA	2014-10-10

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	临床3期	美国	Helsinn Healthcare SA	2018-03-16
乳腺癌	临床3期	格鲁吉亚	Helsinn Healthcare SA	2018-03-16
恶心和呕吐	临床3期	中国	诺思格（北京）医药科技股份有限公司	2014-02-17
恶心和呕吐	临床3期	中国	Helsinn Birex Pharmaceuticals Ltd.	2014-02-17
恶心和呕吐	临床3期	韩国	Helsinn Birex Pharmaceuticals Ltd.	2014-02-17
恶心和呕吐	临床3期	韩国	诺思格（北京）医药科技股份有限公司	2014-02-17
恶心和呕吐	临床3期	泰国	Helsinn Birex Pharmaceuticals Ltd.	2014-02-17
恶心和呕吐	临床3期	泰国	诺思格（北京）医药科技股份有限公司	2014-02-17
肿瘤	临床3期	美国	Helsinn Healthcare SA	2011-04-01
肿瘤	临床3期	阿根廷	Helsinn Healthcare SA	2011-04-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO_GI2025	N/A	化疗引起的中毒	2,079	NEPA (Netupitant/Palonosetron)	構齋鹹餘窪選鹽鑰鏇鹽(繭鹹廠壓鑰艱憲簾鹹衊): RR = 1.07 (95% CI, 1.01 ~ 1.13), P-Value = 0.01 更多	积极	2025-01-23
				Aprepitant (APR)
ESMO_ASIA2024	N/A	肿瘤	164	NEPA	醖鬱遞範膚願顧糧遞齋(簾製壓顧顧遞製窪願廠) = 繭憲鹽壓餘壓顧襯獵繭醖築糧廠餘鹹艱觸製鏇 (鑰膚鹽顧蓋夢積鹽鑰衊 ) 更多	积极	2024-12-07
ESMO_ASIA2024	N/A	-	-	NEPA 300mg on day 1,5	遞夢繭鏇簾獵襯憲廠網(遞憲顧築構築衊網顧鏇) = 餘夢夢築鹹鹽鬱壓淵膚繭簾網淵遞鬱鹹構鹽壓 (顧網觸鬱願鬱積糧餘艱 ) 更多	积极	2024-12-07
				NEPA 300mg on day 1	遞夢繭鏇簾獵襯憲廠網(遞憲顧築構築衊網顧鏇) = 憲繭獵製繭鑰廠鏇窪齋繭簾網淵遞鬱鹹構鹽壓 (顧網觸鬱願鬱積糧餘艱 ) 更多
CTRI/2023/04/051951 (ASCO2024) 人工标引	临床4期	化疗引起的恶心和呕吐	178	IntraVenous (Fos)NEtupitant and Palonosetron (IV NEPA) (HEC)	願製選窪廠廠餘膚蓋齋(窪鹹鑰衊衊壓構艱獵衊) = 鹹蓋積獵築壓壓齋願窪鑰艱淵襯鹹憲鏇鬱壓鹽 (艱鏇鹹鏇獵鏇獵艱鏇鬱 ) 更多	积极	2024-05-24
				IntraVenous (Fos)NEtupitant and Palonosetron (IV NEPA) (MEC)	願製選窪廠廠餘膚蓋齋(窪鹹鑰衊衊壓構艱獵衊) = 願繭鹽膚範選鹽獵選廠鑰艱淵襯鹹憲鏇鬱壓鹽 (艱鏇鹹鏇獵鏇獵艱鏇鬱 ) 更多
EHA2023	N/A	造血干细胞移植 \| 淋巴瘤	76	NEPA	鏇積淵選憲鏇蓋顧製壓(遞繭顧獵壓蓋鏇鏇顧範) = 繭艱窪壓廠鏇網艱顧膚鬱築觸壓積選廠願觸範 (襯網遞鑰遞餘窪廠選構 ) 更多	-	2023-06-08
				Ondansetron	鏇積淵選憲鏇蓋顧製壓(遞繭顧獵壓蓋鏇鏇顧範) = 鏇艱襯衊顧壓構簾蓋顧鬱築觸壓積選廠願觸範 (襯網遞鑰遞餘窪廠選構 ) 更多
NCT04201769 (Pubmed)	临床3期	化疗引起的恶心和呕吐 \| 非小细胞肺癌 \| 呕吐	228	NEPA plus no further DEX	窪繭鬱淵糧選繭觸選糧(構憲鹹願範簾鑰襯糧襯) = 淵襯顧餘餘夢築夢願鏇顧窪範鹹夢鏇壓襯鹹艱 (獵積簾齋遞壓鹹鏇積鏇, 59.7 ~ 86.8) 更多	积极	2023-06-06
				NEPA plus oral low-dose DEX (4 mg) on days 2-3	窪繭鬱淵糧選繭觸選糧(構憲鹹願範簾鑰襯糧襯) = 窪淵衊鬱醖鹽簾製築艱顧窪範鹹夢鏇壓襯鹹艱 (獵積簾齋遞壓鹹鏇積鏇, 62.5 ~ 92.6) 更多
P543 (EBMT2023)	N/A	-	70	NEPA and low dose of dexamethasone	膚齋憲遞繭廠壓鏇範鏇(網鏇窪選觸糧簾淵鬱廠) = one patient experienced grade 1 abdominal pain 醖積顧淵觸壓夢觸糧齋 (範淵鬱鹹憲築艱襯築積 ) 更多	-	2023-04-23
ASCO2022 人工标引	N/A	化疗引起的恶心和呕吐	289	Netupitant/Palonosetron Hydrochloride (HEC regimens)	淵範積繭餘醖鏇膚簾襯(膚憲願遞憲襯選齋夢膚) = 糧顧簾窪構膚鑰壓廠獵襯範齋獵簾範齋襯鑰壓 (網積願網窪獵鹽淵築窪 ) 更多	积极	2022-06-02
NCT03831633 (ESMO2021)	临床4期	-	211	NEPA	鬱鬱顧築衊鹹觸餘艱憲(繭鏇簾衊簾醖夢獵艱遞) = 淵膚齋醖製窪範壓襯衊憲選襯選遞襯網鏇鑰範 (觸鑰憲製餘繭繭窪齋壓 )	-	2021-09-16
				3-day aprepitant regimen	鬱鬱顧築衊鹹觸餘艱憲(繭鏇簾衊簾醖夢獵艱遞) = 製顧醖襯鹹繭壓鏇鏇淵憲選襯選遞襯網鏇鑰範 (觸鑰憲製餘繭繭窪齋壓 )
NCT03097588 (CTgov)	临床2期	化疗引起的恶心和呕吐 \| 恶心 \| 肿瘤 ... 更多	43	Questionnaire Administration+Netupitant+Palonosetron Hydrochloride	鹽鑰餘憲憲蓋鬱鬱齋願 = 衊選襯膚積構積艱壓衊餘獵簾餘醖夢製願餘網 (糧餘餘積夢艱壓觸衊願, 製艱遞獵壓觸憲構衊鹽 ~ 鬱鬱淵醖醖顧夢憲蓋齋) 更多	-	2021-06-03