Atorvastatin Calcium/Ezetimibe

Full year 2025 revenue of $6.2 billion, down 3% on both an as-reported basis and at constant currency Full year 2025 diluted earnings per share of $0.72 and non-GAAP Adjusted diluted earnings per share of $3.66 Full year 2025 Adjusted EBITDA of $1.91 billion inclusive of $6 million of IPR&D, representing a 30.7% Adjusted EBITDA margin The company expects to deliver approximately $6.2 billion of revenue and approximately $1.9 billion of Adjusted EBITDA for the full year 2026, both measures in-line with full year 2025 performance. JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the fourth quarter and full year ended December 31, 2025. “In 2025 we took action that demonstrated our commitment to improving the balance sheet and to building more financial flexibility,” said Joe Morrissey, Organon’s interim Chief Executive Officer. “In 2026 our primary objective is to maintain operational performance that aligns with last year. At the same time, we remain committed to disciplined expense management and capital deployment to achieve progress on our deleveraging efforts.” Fourth Quarter 2025 Revenue in $ millions Q4 2025 Q4 2024 VPY VPY ex-FX Women’s Health $ 398 $ 466 (15)% (16)% General Medicines Biosimilars 181 163 11% 11% Established Brands 913 935 (2)% (5)% Other (1) 15 28 (48)% (49)% Revenue $ 1,507 $ 1,592 (5)% (8)% Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to third parties. For the fourth quarter of 2025, total revenue was $1.507 billion, down 5% on an as-reported basis and down 8% excluding the impact of foreign currency (ex-FX), compared with the fourth quarter of 2024. Women’s Health revenue declined 15% as-reported and declined 16% ex-FX in the fourth quarter of 2025, compared with the fourth quarter of 2024. Sales of Nexplanon® (etonogestrel implant) decreased 20% ex-FX in the fourth quarter compared with the prior year period primarily due to: an approximate $17 million decrease in sales due to the cessation of certain identified U.S. wholesaler sales practices described in the company’s Form 8-K filed with the U.S. Securities and Exchange Commission on October 27, 2025; lower U.S. demand mainly associated with policy-related access restrictions and a reduction in physician demand in certain commercial segments; and an increase in the rebate rate in the U.S. attributable to patient mix. The company’s fertility business declined 6% ex-FX in the fourth quarter of 2025 which is primarily related to sales performance in China, where socio-economic trends continue to weigh on the broader fertility market. Biosimilars revenue increased 11% on both an as-reported basis and ex-FX in the fourth quarter of 2025, compared with the fourth quarter of 2024, primarily due to strong performance of Hadlima® (adalimumab-bwwd). To a lesser extent, during the fourth quarter the Biosimilars portfolio also benefitted from contribution from new assets; Bildyos® (denosumab-nxxp) and Bilprevda® (denosumab-nxxp), which were approved by the U.S. Food and Drug Administration (“FDA”) in third quarter 2025, and Tofidence® (tocilizumab-bavi), which the company acquired in the second quarter of 2025. Established Brands revenue declined 2% as-reported and declined 5% ex-FX in the fourth quarter of 2025. Revenue contributions from Emgality® (1) (galcanezumab-gnlm), Vtama® (2) (tapinarof) and Arcoxia TM (etoricoxib) partially offset a decline in the respiratory portfolio which was driven by pricing pressure, particularly in the U.S. and China, as well as volume declines related to the adoption of revised medical guidelines that deprioritize the use of montelukast, including Singulair® (montelukast sodium) , in various international markets. (1) Organon acquired certain European licensing and distribution rights to Emgality and Rayvow from Eli Lilly and Company (“Eli Lilly”) beginning in early 2024. Emgality and Rayvow are registered trademarks of Eli Lilly in the European Union and other countries (used under license). (2) Vtama was acquired as part of Organon's acquisition of Dermavant Sciences Ltd. (“Dermavant”), which closed on October 28, 2024. Fourth Quarter 2025 Profitability in $ millions, except per share amounts Q4 2025 Q4 2024 VPY Revenues $ 1,507 $ 1,592 (5)% Cost of sales 766 696 10% Gross profit 741 896 (17)% Non-GAAP Adjusted gross profit (1) 854 965 (12)% Net (loss) income (205 ) 109 NM Non-GAAP Adjusted net income (1) 165 235 (30)% Diluted (Loss) Earnings per Share (EPS) (0.79 ) 0.42 NM Non-GAAP Adjusted diluted EPS (1) 0.63 0.90 (30)% Acquired in-process research & development (IPR&D) and milestones — — —% Adjusted EBITDA (Non-GAAP) (1) 383 448 (15)% Q4 2025 Q4 2024 Gross margin 49.2 % 56.3 % Non-GAAP Adjusted gross margin (1) 56.7 % 60.6 % Adjusted EBITDA margin (Non-GAAP) (1, 2) 25.4 % 28.1 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures. Reported gross margin in the fourth quarter of 2025 was 49.2% compared with 56.3% in the prior year period. One-time costs associated with optimizing the company’s manufacturing and supply network were the most significant driver of the year-over-year decline in reported gross margin. Non-GAAP Adjusted gross margin was 56.7% in the fourth quarter of 2025, compared to 60.6% in the fourth quarter of 2024. Unfavorable pricing, foreign exchange rates and product mix were notable drivers in the decline of both reported gross margin and non-GAAP Adjusted gross margin. Net loss for the fourth quarter of 2025 was $205 million, or $0.79 per diluted share, compared with net income of $109 million, or $0.42 per diluted share, in the fourth quarter of 2024. Net loss for the fourth quarter of 2025 includes a non-cash goodwill impairment of $301 million, or $1.16 per share, related to underperformance of several products in the U.S. For the fourth quarter of 2025, non-GAAP Adjusted net income was $165 million, or $0.63 per diluted share, compared with $235 million, or $0.90 per diluted share, in 2024. Non-GAAP Adjusted EBITDA margin was 25.4% in the fourth quarter of 2025 compared with 28.1% in the fourth quarter of 2024. The year-over-year decline in the fourth quarter 2025 Adjusted EBITDA margin was primarily driven by the lower Adjusted Gross Margin, which was only partially offset by a 5% reduction in non-GAAP operating expenses. Full Year 2025 Revenue in $ millions FY 2025 FY 2024 VPY VPY ex-FX Women’s Health $ 1,752 $ 1,777 (1)% (2)% General Medicines Biosimilars 691 662 4% 5% Established Brands 3,691 3,849 (4)% (5)% Other (1) 82 115 (28)% (28)% Revenue $ 6,216 $ 6,403 (3)% (3)% Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to third parties. Full year 2025 revenue was $6.2 billion, a decrease of 3% on both an as-reported basis and at constant currency as compared with full year 2024. Women’s Health revenue declined 1% as-reported and 2% ex-FX for full year 2025, compared with 2024. Growth in the company’s fertility business and in the JADA ® system substantially offset a 23% ex-FX decline in NuvaRing ® (etonogestrel / ethinyl estradiol vaginal ring) and a 4% ex-FX decline in Nexplanon . Strong growth in Nexplanon outside the U.S. helped to offset a 9% decline in the U.S. where access has been restricted by U.S. policy since early 2025. The company’s fertility business grew 8% ex-FX for full year 2025 driven by performance in the U.S., particularly in the first half of 2025, as well as geographic footprint expansion, which together offset declines in China driven by socio-economic trends. For full year 2025, the JADA ® system delivered $74 million of revenue. On January 28, 2026 the company completed the divestiture of the JADA ® system. Biosimilars revenue increased 4% on an as-reported basis and 5% on an ex-FX basis for full year 2025, compared with the prior year, primarily driven by continued growth in Hadlima . Renflexis and Ontruzant declined 8% ex-FX and 30% ex-FX, respectively, as both products are in the mature phase of their product life cycles and face significant competitive pricing pressure in the U.S. and Europe. Revenue for Established Brands declined 4% on an as-reported basis and 5% ex-FX for full year 2025. Contributions from Emgality and Vtama partially offset the aforementioned declines in the respiratory portfolio and the impact from the loss of exclusivity of Atozet in Europe and Japan. Full Year 2025 Profitability in $ millions, except per share amounts 2025 2024 VPY Revenues $ 6,216 $ 6,403 (3)% Cost of sales 2,903 2,688 8% Gross profit 3,313 3,715 (11)% Non-GAAP Adjusted gross profit (1) 3,737 3,944 (5)% Net income 187 864 (78)% Non-GAAP Adjusted net income (1) 954 1,065 (10)% Diluted Earnings per Share (EPS) 0.72 3.33 (78)% Non-GAAP Adjusted diluted EPS (1) 3.66 4.11 (11)% Acquired in-process research & development (IPR&D) and milestones 6 81 (93)% Adjusted EBITDA (1, 2) 1,907 1,958 (3)% 2025 2024 Gross margin 53.3 % 58.0 % Non-GAAP Adjusted gross margin (1) 60.1 % 61.6 % Adjusted EBITDA margin (1, 2) 30.7 % 30.6 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures. (2) Adjusted EBITDA and Adjusted EBITDA margin include $6 million in 2025 and $81 million in 2024 related to acquired IPR&D and milestones. Reported gross margin was 53.3% for full year 2025 compared with 58.0% for full year 2024. One-time costs associated with optimizing the company’s manufacturing and supply network were the most significant driver in the year-over-year decline in reported gross margin, followed by amortization expense and acquisition-related costs associated with the company’s purchase of Dermavant in October 2024. Adjusted gross margin was 60.1% for full year 2025, compared with 61.6% for full year 2024. Pricing pressure adversely impacted both reported and Adjusted gross margin. Adjusted EBITDA margin was 30.7% for full year 2025 consistent with full year 2024 as the decline in Adjusted gross margin was substantially offset by lower R&D expense. Net income for full year 2025 was $187 million, or $0.72 per diluted share, compared with $864 million, or $3.33 per diluted share in 2024. Full year 2025 reported net-income includes the aforementioned fourth quarter goodwill impairment. Non-GAAP Adjusted net income was $954 million for full year 2025, or $3.66 per share, compared with $1,065 million, or $4.11 per share, in full year 2024. Other Matters On February 11, 2026, information was brought to the Audit Committee’s attention relating to the timing of the company’s purchases of biosimilars from a supplier in prior years. A review by the Audit Committee will ensue. At this time, the company has not determined that anything inappropriate occurred in connection with these purchases. The company is not aware of the need for any changes to prior financial statements, and currently anticipates that it will be able to timely Form 10-K for the year ended December 31, 2025 and update its disclosure in relation to this matter. Capital Allocation Today, Organon’s Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of the company's common stock. The dividend is payable on March 12, 2026, to stockholders of record at the close of business on February 23, 2026. As of December 31, 2025, cash and cash equivalents were $574 million, and debt was $8.64 billion. Full Year Guidance Organon does not provide GAAP financial measures on a forward-looking basis because the company cannot predict with reasonable certainty and without unreasonable effort, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts, and acquisition-related expenses. These items are uncertain, depend on various factors, and could be material to Organon’s results computed in accordance with GAAP. For full year 2026, the company expects to achieve revenue of approximately $6.2 billion and Adjusted EBITDA of approximately $1.9 billion; both measures in-line with 2025 performance. The company expects that the annual revenue foregone with the sale of the JADA ® system will be approximately offset by favorable currency translation, resulting in constant currency revenue growth about flat with prior year, pro forma for the JADA ® system divestiture. Full year 2026 financial guidance is presented below on a non-GAAP basis, except revenue. Full Year 2025 Actuals Full Year 2026 Guidance Revenue $6.216B ~$6.2B Nominal revenue growth (3)% ~flat FX translation impact ~$35M ~75M Ex-FX revenue growth (3%) ~(1.5%) Adjusted gross margin 60.1% ~75-100 bps lower than 2025 SG&A 26.1% Mid 20% range R&D 5.5% Mid-single digit range IPR&D* $6M N/A Adjusted EBITDA (non-GAAP) $1.91B ~$1.9B Interest $504M ~$500M Depreciation $141M ~$140M Effective non-GAAP tax rate 24.4% 27.5%-29.5% Fully diluted weighted average shares outstanding 261M ~265M *The company does not provide guidance for forward-looking IPR&D and milestone expense. Webcast Information Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its fourth quarter and full year financial results. To listen to the event and view the presentation slides via webcast, join from the Organon Investor Relations website at . A replay of the webcast will be available approximately two hours after the conclusion of the live event on the company’s website. Institutional investors and analysts interested in participating in the call may join by dialing (888) 596-4144 (U.S. and Canada Toll-Free) or (646) 968-2525 and using the access code Conference ID: 1036555#. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at and follow us on LinkedIn , Instagram , X , YouTube , TikTok and Facebook . Cautionary Note Regarding Non-GAAP Financial Measures This press release contains “non-GAAP financial measures,” which are financial measures that either exclude or include amounts that are correspondingly not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles (“GAAP”). Specifically, the company makes use of the non-GAAP financial measures Adjusted EBITDA, Adjusted EBITDA margin, Adjusted gross margin, Adjusted gross profit, Adjusted net income, and Adjusted diluted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This press release also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. The company believes that these non-GAAP financial measures help to enhance an understanding of the company’s financial performance. However, the presentation of these measures has limitations as an analytical tool and should not be considered in isolation, or as a substitute for the company’s results as reported under GAAP. Because not all companies use identical calculations, the presentations of these non-GAAP measures may not be comparable to other similarly titled measures of other companies. Please refer to Table 4 and Table 5 of this press release for additional information, including relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures. In addition, the company’s full-year 2026 guidance measures (other than revenue) are provided on a non-GAAP basis because the company is unable to reasonably predict certain items contained in the GAAP measures. Such items include, but are not limited to, acquisition-related expenses, restructuring and related expenses, stock-based compensation, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts and other items not reflective of the company's ongoing operations. The company’s management uses the non-GAAP financial measures described above to evaluate the company’s performance and to guide operational and financial decision making. Further, the company’s management believes that these non-GAAP financial measures, which exclude certain items, help to enhance its ability to meaningfully communicate its underlying business performance, financial condition and results of operations. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about the Audit Committee’s review described above, Organon’s full-year 2026 guidance estimates and predictions regarding other financial information and metrics, as well as expectations regarding Organon’s franchise and product performance and strategy expectations for future periods. Forward-looking statements may be identified by words such as “guidance,” “potential,” “should,” “will,” “continue,” “expects,” “believes,” “future,” “estimates,” “opportunity,” “likely,” “pursue,” “drive,” “intend,” “anticipate,” “be able to,” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, the timing and completion of the Audit Committee’s review and result thereof; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and healthcare reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including most-favored-nation drug pricing, and other pricing related initiatives and policy efforts; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting the company’s business; the impact of tariffs and other trade restrictions or domestic sourcing requirements; changes in tax laws including changes related to the taxation of foreign earnings; economic factors over which we have no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; the company’s inability to remediate the material weaknesses in its internal control over financial reporting; the company’s use of artificial intelligence technologies; the company’s ability to execute on its capital allocation priorities and to deleverage its business; the impact of our substantial levels of indebtedness; expanded brand and class competition in the markets in which the company operates; difficulties with performance of third parties the company relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to the company; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as the company’s products lose patent protection; any failure by the company to retain market exclusivity for Nexplanon® (etonogestrel implant) or to obtain an additional period of exclusivity in the United States for Nexplanon® subsequent to the expiration of the rod patents in 2027; the continued impact of the September 2024 loss of exclusivity for Atozet™ (ezetimibe and atorvastatin) ; the success of the company’s efforts to adopt its business and sales strategies to address the changing market and regulatory landscape in order to achieve its business objectives and remain competitive; restructuring or other disruptions at the FDA, the U.S. Securities and Exchange Commission (the “SEC”) and other U.S. and comparable foreign government agencies; cyberattacks on, or other failures, accidents, or security breaches of, the company’s or third-party providers’ information technology systems, which could disrupt the company’s operations and those of third parties upon which it relies; increased focus on privacy issues in countries around the world, including the United States, the European Union, and China, and a more difficult legislative and regulatory landscape for privacy and data protection that continues to evolve with the potential to directly affect the company’s business; difficulties and uncertainties inherent in the implementation of the company’s business development strategy or failure to recognize the benefits of strategic transactions; the impact of higher selling and promotional costs; efficacy, safety or other quality concerns with respect to the company’s marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes or declining sales; delays or failures to demonstrate adequate efficacy and safety of the company’s product candidates in pre-clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of the company’s product candidates; future actions of third-parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing healthcare insurance coverage; legal factors, including product liability claims, antitrust litigation and governmental investigations, including tax disputes, environmental claims and patent disputes with branded and generic competitors, any of which could preclude commercialization of products or negatively affect the profitability of existing products; lost market opportunity resulting from delays and uncertainties in clinical trials and the approval or clearance process of the FDA and other regulatory authorities; the failure by the company or its third party collaborators and/or their suppliers to fulfill their or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of the company’s products; the impact of any future pandemic, epidemic, or similar public health threat on the company’s business, operations and financial performance; the company’s ability to hire and retain a permanent CEO, other members of the company’s senior management, or other key employees; changes in accounting pronouncements promulgated by standard-setting or regulatory bodies, including the Financial Accounting Standards Board and the SEC, that are adverse to the company; volatility of commodity prices, fuel, and shipping rates that impact the costs and/or ability to supply the company’s products; and uncertainties surrounding matters relating to the Audit Committee investigation and any related investigations, inquiries, claims, proceedings or actions. Contacts Media Contacts: Felicia Bisaro (646) 703-1807 Kate Vossen (732) 675-8448 Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129 Read full story here

每周药品注册获批数据，分门别类呈现，一目了然。(2.2-2.8） 新药上市申请 药品名称 企业 注册分类 受理号 甲磺酸伏美替尼片 上海艾力斯医药科技股份有限公司 2.4 CXHS2500084 盐酸安罗替尼胶囊 正大天晴药业集团股份有限公司 2.4 CXHS2500035 注射用芦康沙妥珠单抗 四川科伦博泰生物医药股份有限公司 2.2 CXSS2500052 新药临床申请 药品名称 企业 注册分类 受理号 ICP-538片 北京诺诚健华医药科技有限公司 1 CXHL2600035 ICP-538片 北京诺诚健华医药科技有限公司 1 CXHL2600034 ICP-538片 北京诺诚健华医药科技有限公司 1 CXHL2600033 ABP-745片 杭州新元素药业股份有限公司 1 CXHL2501525 LDR2515注射液 成都先衍生物技术有限公司 1 CXHL2501532 APG-3288片 苏州亚盛药业有限公司 1 CXHL2501514 APG-3288片 苏州亚盛药业有限公司 1 CXHL2501513 SY-9453胶囊 首药控股(北京)股份有限公司 1 CXHL2501324 SY-9453胶囊 首药控股(北京)股份有限公司 1 CXHL2501323 XW014片 杭州先为达生物科技股份有限公司 1 CXHL2501322 XW014片 杭州先为达生物科技股份有限公司 1 CXHL2501321 ANS014004片 北京鞍石生物科技股份有限公司 1 CXHL2501320 ANS014004片 北京鞍石生物科技股份有限公司 1 CXHL2501319 XTYW007片 西安新通药物研究股份有限公司 1 CXHL2501327 XTYW007片 西安新通药物研究股份有限公司 1 CXHL2501326 XTYW007片 西安新通药物研究股份有限公司 1 CXHL2501328 注射用SJ001 上海施江生物科技有限公司 1 CXHL2501309 BEBT-701注射液 广州必贝特医药股份有限公司 1 CXHL2501308 UBT251注射液 联邦生物科技(珠海横琴)有限公司 1 CXHL2501306 CMS-D017胶囊 深圳市康哲生物科技有限公司 1 CXHL2501314 CMS-D017胶囊 深圳市康哲生物科技有限公司 1 CXHL2501313 RG002C0106注射液 北京炫景瑞医药科技有限公司 1 CXHL2501310 HS-10390片 常州恒邦药业有限公司 1 CXHL2501305 塞拉维诺片 中国科学院上海药物研究所 1 CXHL2501300 塞拉维诺片 中国科学院上海药物研究所 1 CXHL2501299 TJ0113胶囊 杭州天玑济世生物科技有限公司 1 CXHL2501298 ABSK-011胶囊 上海和誉生物医药科技有限公司 1 CXHL2501290 ABSK-011胶囊 上海和誉生物医药科技有限公司 1 CXHL2501291 ABSK-011胶囊 上海和誉生物医药科技有限公司 1 CXHL2501292 DP22001口服乳 中国科学院上海药物研究所 2.2 CXHL2501307 SBK014干混悬剂 成都施贝康生物医药科技有限公司 2.2 CXHL2501296 带状疱疹mRNA疫苗 安徽智飞龙科马生物制药有限公司 1.2 CXSL2500961 重组带状疱疹ZFA01佐剂疫苗(CHO细胞) 安徽智飞龙科马生物制药有限公司 1.3 CXSL2500978 B群脑膜炎球菌OMV疫苗 上海羽冠生物技术有限公司 2.2 CXSL2500969 B群脑膜炎球菌OMV疫苗 上海羽冠生物技术有限公司 2.2 CXSL2500968 B群脑膜炎球菌OMV疫苗 上海羽冠生物技术有限公司 2.2 CXSL2500967 冻干水痘灭活疫苗 安徽智飞龙科马生物制药有限公司 2.2 CXSL2500962 冻干人用狂犬病疫苗(人二倍体细胞) 浙江普康生物技术股份有限公司 2.5 CXSL2500972 注射用GenSci136 长春金赛药业有限责任公司 1 CXSL2600033 注射用HMPL-A580 和记黄埔医药(上海)有限公司 1 CXSL2600011 注射用经应激诱导的间充质干细胞衍生物 达尔文起点(湖北)生物制药有限责任公司 1 CXSL2501153 注射用SSS50 沈阳三生制药有限责任公司 1 CXSL2501038 HB0056注射液 上海华奥泰生物药业股份有限公司 1 CXSL2501039 VERT-002注射液 皮尔法伯(上海)医疗科技有限公司 1 CXSL2501031 注射用GQ1001冻干粉针剂 启德医药科技(苏州)有限公司 1 CXSL2501029 注射用SSS57 沈阳三生制药有限责任公司 1 CXSL2501027 AK139注射液 中山康方生物医药有限公司 1 CXSL2501026 AK139注射液 中山康方生物医药有限公司 1 CXSL2501024 AK139注射液 中山康方生物医药有限公司 1 CXSL2501023 注射用SSS57 沈阳三生制药有限责任公司 1 CXSL2501019 HL08 华兰生物工程股份有限公司 1 CXSL2501017 DR10624注射液 浙江道尔生物科技有限公司 1 CXSL2501013 ESG206注射液 上海诗健生物科技有限公司 1 CXSL2501011 注射用HBT-708 沈阳三生制药有限责任公司 1 CXSL2501007 注射用HBT-708 沈阳三生制药有限责任公司 1 CXSL2501006 IBI3013 信达生物制药(苏州)有限公司 1 CXSL2501010 IBI3013 信达生物制药(苏州)有限公司 1 CXSL2501009 注射用ASKG915 江苏奥赛康生物医药有限公司 1 CXSL2501005 SENL103自体T细胞注射液 河北森朗生物科技有限公司 1 CXSL2500958 人脐带间充质干细胞注射液 杭州易文赛生物技术有限公司 1 CXSL2500951 卡度尼利单抗注射液(皮下注射) 康方药业有限公司 2.1 CXSL2501034 泰它西普注射液 荣昌生物制药(烟台)股份有限公司 2.1;2.2 CXSL2501028 注射用MK-2870 默沙东研发(中国)有限公司 2.2 CXSL2501037 注射用MK-2870 默沙东研发(中国)有限公司 2.2 CXSL2501036 注射用MK-2870 默沙东研发(中国)有限公司 2.2 CXSL2501016 阿得贝利单抗注射液 上海盛迪医药有限公司 2.2 CXSL2500979 注射用重组A型肉毒毒素 河北封章生物科技有限公司 2.4 CXSL2501012 仿制药申请 药品名称 企业 注册分类 受理号 比拉斯汀口服溶液 南京黄龙生物科技有限公司 3 CYHS2502060 盐酸异丙肾上腺素注射液 江苏迪赛诺制药有限公司 3 CYHS2502023 盐酸异丙肾上腺素注射液 江苏迪赛诺制药有限公司 3 CYHS2502022 比拉斯汀口服溶液 嘉亨(珠海横琴)医药科技有限公司 3 CYHS2502018 对乙酰氨基酚布洛芬片 南京海纳医药科技股份有限公司 3 CYHS2500835 甲氨蝶呤片 海南卓科制药有限公司 3 CYHS2500619 门冬氨酸钾镁注射液 海南慧通生物医药科技有限公司 3 CYHS2500049 钠钾镁钙注射用浓溶液 成都瑞尔医药科技有限公司 3 CYHS2402996 盐酸布比卡因注射液 石家庄凯达生物工程有限公司 3 CYHS2403026 舒林酸片 沐源(安徽)药业有限公司 3 CYHS2402934 吡拉西坦注射液 西藏海金药业有限公司 3 CYHS2402512 吡拉西坦注射液 西藏海金药业有限公司 3 CYHS2402511 盐酸艾司氯胺酮注射液 成都倍特药业股份有限公司 3 CYHS2402446 法莫替丁注射液 成都康泰源医药科技有限责任公司 3 CYHS2402403 法莫替丁注射液 成都康泰源医药科技有限责任公司 3 CYHS2402402 注射用盐酸罗沙替丁醋酸酯 沈阳新马药业有限公司 3 CYHS2402066 复方聚乙二醇(3350)电解质口服溶液 广西维威制药有限公司 3 CYHS2402002 维生素B6注射液 海南皇隆制药股份有限公司 3 CYHS2401955 酒石酸美托洛尔注射液 北京远方通达医药技术有限公司 3 CYHS2401933 盐酸溴己新口服溶液 福元药业有限公司 3 CYHS2401932 法莫替丁注射液 海南未见药业有限公司 3 CYHS2401455 盐酸多西环素片 浙江赛默制药有限公司 3 CYHS2401422 盐酸多西环素片 浙江赛默制药有限公司 3 CYHS2401421 盐酸氨溴索滴剂 南京海纳制药有限公司 3 CYHS2401318 米诺地尔搽剂 浙江浙北药业有限公司 3 CYHS2401225 米诺地尔搽剂 浙江浙北药业有限公司 3 CYHS2401224 米诺地尔搽剂 山东华铂凯盛生物科技有限公司 3 CYHS2400977 米诺地尔搽剂 山东华铂凯盛生物科技有限公司 3 CYHS2400976 恩格列净二甲双胍缓释片 乐普药业股份有限公司 3 CYHS2400624 恩格列净二甲双胍缓释片 乐普药业股份有限公司 3 CYHS2400623 恩格列净二甲双胍缓释片 乐普药业股份有限公司 3 CYHS2400622 小儿复方氨基酸注射液(19AA-I) 天津金耀药业有限公司 3 CYHS2302761 普瑞巴林口服溶液 上海美优制药有限公司 3 CYHS2300005国;CYHS2300005 硫酸氨基葡萄糖胶囊 江西铜鼓仁和制药有限公司 4 CYHS2504334 艾拉莫德片 宜昌东阳光长江药业股份有限公司 4 CYHS2503152 聚乙烯醇滴眼液 四川好医生攀西药业有限责任公司 4 CYHS2502634 碳酸镧咀嚼片 康臣药业(内蒙古)有限责任公司 4 CYHS2501023 碳酸镧咀嚼片 康臣药业(内蒙古)有限责任公司 4 CYHS2501022 硫酸氨基葡萄糖胶囊 四川新斯顿制药股份有限公司 4 CYHS2404083 硫酸氨基葡萄糖胶囊 苏州第四制药厂有限公司 4 CYHS2403877 聚乙烯醇滴眼液 苏州乐珠制药有限公司 4 CYHS2403847 美阿沙坦钾片 江西施美药业股份有限公司 4 CYHS2403818 美阿沙坦钾片 江西施美药业股份有限公司 4 CYHS2403817 卡格列净片 浙江诺得药业有限公司 4 CYHS2403626 沙库巴曲缬沙坦钠片 湖南威特制药股份有限公司 4 CYHS2403620 沙库巴曲缬沙坦钠片 湖南威特制药股份有限公司 4 CYHS2403619 阿法骨化醇软胶囊 大连美创药业有限公司 4 CYHS2403490 阿法骨化醇软胶囊 大连美创药业有限公司 4 CYHS2403489 头孢丙烯片 华北制药河北华民药业有限责任公司 4 CYHS2403463 枸橼酸西地那非口腔崩解片 四川省通园制药集团有限公司 4 CYHS2403279 硫酸艾沙康唑胶囊 江西艾施特制药有限公司 4 CYHS2403240 达格列净片 任曦医药科技河北有限公司 4 CYHS2403161 培哚普利氨氯地平片(III) 桂林华信制药有限公司 4 CYHS2403160 地夸磷索钠滴眼液 江苏万高药业股份有限公司 4 CYHS2403146 盐酸氨溴索口服溶液 北京四环科宝制药股份有限公司 4 CYHS2403121 盐酸氨溴索口服溶液 北京四环科宝制药股份有限公司 4 CYHS2403120 盐酸氨溴索口服溶液 北京四环科宝制药股份有限公司 4 CYHS2403119 盐酸氨溴索口服溶液 北京四环科宝制药股份有限公司 4 CYHS2403118 坎地沙坦酯片 珠海润都制药股份有限公司 4 CYHS2403102 奥美沙坦酯片 修正药业集团长春高新制药有限公司 4 CYHS2402945 玻璃酸钠滴眼液 石家庄凯达生物工程有限公司 4 CYHS2402932 玻璃酸钠滴眼液 石家庄凯达生物工程有限公司 4 CYHS2402931 小儿法罗培南钠颗粒 湖南普道医药技术有限公司 4 CYHS2402888 甲钴胺片 湖北广济药业股份有限公司 4 CYHS2402791 复方氨基酸注射液(18AA-VII) 武汉久安药物研究院有限公司 4 CYHS2402708 硫酸氨基葡萄糖胶囊 山东新华制药股份有限公司 4 CYHS2402615 莫匹罗星软膏 山东如至生物医药科技有限公司 4 CYHS2402324 注射用醋酸西曲瑞克 南京海融制药有限公司 4 CYHS2402278 非布司他片 温岭市创新生物医药科技股份有限公司 4 CYHS2402180 非布司他片 温岭市创新生物医药科技股份有限公司 4 CYHS2402179 乳果糖口服溶液 江苏广承药业有限公司 4 CYHS2401706 乳果糖口服溶液 重庆和平制药有限公司 4 CYHS2401612 拉坦前列素滴眼液 广州仁恒医药科技股份有限公司 4 CYHS2401577 富马酸伏诺拉生片 天方药业有限公司 4 CYHS2401374 富马酸伏诺拉生片 天方药业有限公司 4 CYHS2401373 盐酸氟西汀分散片 山东达因海洋生物制药股份有限公司 4 CYHS2401339 依折麦布阿托伐他汀钙片 南京海纳制药有限公司 4 CYHS2401279 依折麦布阿托伐他汀钙片 南京海纳制药有限公司 4 CYHS2401278 硫辛酸注射液 北京双鹭药业股份有限公司 4 CYHS2401186 盐酸尼卡地平注射液 海南爱科制药有限公司 4 CYHS2401045 帕妥珠单抗注射液 杭州博之锐生物制药有限公司 3.3 CXSS2400116 注射用甲磺酸萘莫司他 天津红日药业股份有限公司 3 CYHL2500211 盐酸西替利嗪滴眼液 南京海纳制药有限公司 3 CYHL2500210 非那雄胺喷雾剂 福元药业有限公司 4 CYHL2500207 进口申请 药品名称 企业 注册分类 受理号 达罗他胺片 Bayer HealthCare Pharmaceuticals Inc. 2.4 JXHS2500001 伊曲莫德片 EVEREST MEDICINES (SINGAPORE) PTE. LTD. 5.1 JXHS2400112 THR1442片 TheracosBio, LLC 5.1 JXHS2400002 达雷妥尤单抗注射液(皮下注射) Janssen-Cilag International NV 3.1 JXSS2500061 司库奇尤单抗注射液 Novartis Pharma Schweiz AG 3.1 JXSS2500054 帕博利珠单抗注射液 Merck Sharp & Dohme LLC 3.1 JXSS2500051 注射用重组人促卵泡黄体激素α Merck Europe B.V. 3.1 JXSS2300059 注射用塞替派 Esteve Pharmaceuticals GmbH 5.2 JYHS2400035 他克莫司胶囊 Alkem Laboratories Limited 5.2 JYHS2101030国;JYHS2101030 他克莫司胶囊 Alkem Laboratories Limited 5.2 JYHS2101029国;JYHS2101029 他克莫司胶囊 Alkem Laboratories Limited 5.2 JYHS2101031国;JYHS2101031 AMG 436 Amgen Inc. 1 JXHL2500397 AMG 436 Amgen Inc. 1 JXHL2500396 RO7435846片 F. Hoffmann-La Roche Ltd. 1 JXHL2500373 RO7435846片 F. Hoffmann-La Roche Ltd. 1 JXHL2500372 RO7435846片 F. Hoffmann-La Roche Ltd. 1 JXHL2500371 AMG 410 Amgen Inc. 1 JXHL2500370 AMG 410 Amgen Inc. 1 JXHL2500368 AMG 410 Amgen Inc. 1 JXHL2500369 MK-1084片 Merck Sharp & Dohme LLC 1 JXHL2500365 MK-1084片 Merck Sharp & Dohme LLC 1 JXHL2500364 E6742 Eisai Co., Ltd. 1 JXHL2500363 Omecamtiv Mecarbil缓释片 Cytokinetics, Incorporated 1 JXHL2500362 Omecamtiv Mecarbil缓释片 Cytokinetics, Incorporated 1 JXHL2500361 Omecamtiv Mecarbil缓释片 Cytokinetics, Incorporated 1 JXHL2500360 AZD2936 AstraZeneca AB 1 JXSL2500234 AZD8205 AstraZeneca AB 1 JXSL2500233 RO7790121注射液 F. Hoffmann-La Roche Ltd. 1 JXSL2500235 注射用MK-1022 Merck Sharp & Dohme LLC 1 JXSL2500230 注射用AZD1163 AstraZeneca AB 1 JXSL2500231 HMBD-001 Hummingbird Bioscience Pte Ltd. 1 JXSL2500228 Lesigercept注射液 Yuhan Corporation 1 JXSL2500229 注射用IPN10200 Ipsen Innovation 1 JXSL2500225 中药相关申请 药品名称 企业 注册分类 受理号 清瘟止咳颗粒 江西保中制药有限公司 1.1 CXZL2500119 女珍颗粒 山东凤凰制药股份有限公司 2.3 CXZL2500118 湿润烧伤膏 汕头市美宝制药有限公司 2.3 CXZL2500117 注：橙色字体部分结论为不批准或收到通知件；