Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Intravenous Eravacycline in Pediatric Patients From 8 Years to Less Than 18 Years of Age With Complicated Intra-abdominal Infections (cIAI)

A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to <18 years with cIAI.

开始日期2025-05-22

申办/合作机构

Tetraphase Pharmaceuticals, Inc.

[+1]

NCT06440304

/ Recruiting临床4期IIT

Therapeutic Strategies for Carbapenem-Resistant Acinetobacter Baumannii Infections: Study Protocol

CRAB infections in ICUs are on the rise, leading to higher morbidity, mortality, and healthcare costs due to resistance to most antibiotics, including carbapenems. The main resistance mechanisms include carbapenemases, efflux pumps, and changes in the bacterial cell wall.
Current treatments include polymyxins (Colistin, Polymyxin B), which are effective but can lead to resistance, aminoglycosides (Amikacin, Gentamicin), which are limited by resistance, and tetracyclines (Tigecycline, Eravacycline), which are effective against CRAB. Fosfomycin is effective in combination treatments, and combination therapy (e.g., colistin with sulbactam, fosfomycin, or eravacycline) can enhance outcomes.
Previous research shows promise for combination therapies, improving treatment efficacy and reducing mortality. New regimens are being studied to find optimal combinations. Individualized dosing is crucial, considering patient-specific factors like age, weight, and renal function. Adjustments depend on the infection site and comorbidities.
Strict infection control and antimicrobial stewardship programs (ASPs) are essential. ASPs focus on optimizing antibiotic use and reducing resistance through education and surveillance. Future directions include continued research for new drugs or combinations and strategies to overcome resistance and improve treatment efficacy.
Study goals include achieving negative samples after 10 days of therapy, 30-day survival, discharge rates, reduced SOFA scores, and improved clinical and radiological findings. A randomized study will compare colistin combined with fosfomycin, ampicillin/sulbactam, and eravacycline.
In summary, treating CRAB infections is complex, requiring combination therapy, individualized dosing, and strict infection control measures.

开始日期2025-01-30

申办/合作机构-

NCT06670872

/ Not yet recruitingN/AIIT

A Study on the Combination Therapy of Eravacycline for Treating Carbapenem-Resistant Acinetobacter Baumannii Pneumonia

This study intends to evaluate the efficacy and safety of eravacycline-based combination therapy in real words for Chinese patients with CRAB pneumonia, providing data reference for clinical treatment of CRAB pneumonia.

开始日期2024-10-01

申办/合作机构

北京大学第三医院（北京大学第三临床医学院）

100 项与盐酸依拉环素相关的临床结果

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100 项与盐酸依拉环素相关的转化医学

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100 项与盐酸依拉环素相关的专利（医药）

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378

项与盐酸依拉环素相关的文献（医药）

2026-05-01·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

In vitro activity of eravacycline compared to other antibiotics commonly used for treatment of infections involving anaerobic bacteria: a review of the literature and our own data

Review

作者: Boyanova, Liliya ; Boyanova, Lyudmila ; Marteva-Proevska, Yulia ; Dimitrov, Georgi ; Markovska, Rumyana ; Gergova, Raina ; Hadzhiyski, Petyo

Eravacycline is a third-generation tetracycline, a fluorocycline agent with two modifications that distinguish it from tigecycline. Eravacycline demonstrated effectiveness against various gram-positive and gram-negative facultatively anaerobic bacteria, including multidrug resistant Enterobacterales, Acinetobacter baumannii, staphylococci, enterococci, and pneumococci. However, whereas numerous studies focused on the impact of eravacycline on facultative anaerobic microbes, there is limited data regarding its efficacy against anaerobes. The aim of the present review was to compare eravacycline activity to that of other antibiotics used against anaerobic/microaerophilic bacteria and to assess potential benefits of the newer agent in anaerobic or mixed aerobic-anaerobic infections. We encompassed information from the literature published in English and included our own pilot study. Compared to most comparator antibiotics, eravacycline was more effective against anaerobes, including Bacteroides/Parabacteroides, Prevotella, Fusobacterium, Clostridioides difficile and other clostridial species, as well as gram-positive anaerobic cocci, and Cutibacterium acnes. Most frequently, eravacycline MICs were ≥4 to ≥8-fold lower than those of most comparator antibiotics. In addition, eravacycline did not trigger an infection with C. difficile and is considered a tolerable medication. So far, only the injectable eravacycline administration for complicated intraabdominal infections has been approved. However, more studies in more countries are needed to assess its usefulness for combination treatment and still not labeled indications.

2026-02-12·Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases

[New advances and future prospect in antifungal therapy for invasive pulmonary aspergillosis].

Review

作者: Sun, C ; Su, X

This article a comprehensive review of recent advances in the treatment of invasive pulmonary aspergillosis (IPA), with a focus on emerging antifungal drugs, innovations in drug-delivery approaches, and evolving therapeutic strategies. New antifungal agents, such as isavuconazole, new formulations of posaconazole, liposomal amphotericin B, rezafungin, and eravacycline, exhibit distinct pharmacokinetic, pharmacodynamic, and safety profiles. Nanoparticle delivery systems and inhaled formulations have increased drug concentrations at the airway site while reducing systemic adverse effects. Future research will focus on new drug development targeting fungal protein targets, multi-target approaches, and immunomodulatory therapies.

2026-02-02·JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Impact of eravacycline on fibrinogen

Article

作者: Daniels, Lindsay ; Jones, Travis ; Ponder, Madison ; Van Duin, David ; Stevenson, Emily ; Footer, Brent ; Bartelt, Luther

Abstract:

Objectives:

While tigecycline has been associated with hypofibrinogenaemia, limited data with eravacycline suggest this may also occur with this agent. However, the incidence and clinical significance of this finding are not well defined.

Methods:

This is a retrospective cohort study of hospitalized adults who received at least two doses of eravacycline between 1 August 2018 and 1 October 2024 and had two or more fibrinogen levels monitored while on therapy. The primary outcome was ≥50% reduction in fibrinogen while on eravacycline. Secondary outcomes included ≥25% reduction in fibrinogen, time to 50% fibrinogen reduction, development of hypofibrinogenemia (<200 mg/dL) and bleeding events.

Results:

Thirty-nine patients were included with 17 (44%) being solid organ transplant recipients and 11 (28%) patients not considered to be immunocompromised. Eravacycline was primarily used to treat nontuberculosis mycobacterial infections (82%). The median (IQR) duration of eravacycline therapy was 12 (8–22) days. Thirty-three per cent of patients met the primary outcome of ≥50% decrease in fibrinogen with a median (IQR) time to 50% decrease in fibrinogen of 10 (8–11) days. A substantially higher number, 79%, experienced ≥25% reduction in fibrinogen. Hypofibrinogenaemia developed in 18 (49%) patients. A total of four (10%) patients experienced minor bleeding events.

Discussion:

A majority of eravacycline-treated patients experienced at least a 25% decrease in fibrinogen levels. Although the decreased fibrinogen levels did not result in major clinically significant bleeding, fibrinogen levels should be monitored at baseline and at least weekly. Patients should also be monitored for any signs and symptoms of bleeding.

265

项与盐酸依拉环素相关的新闻（医药）

2026-02-26

·BioSpace

Innoviva Reports Fourth Quarter and Full Year 2025 Financial Results; Highlights Recent Company Progress

Durable royalties portfolio generated $58.4 million in revenue for the fourth quarter and $250.3 million for the full year IST achieved U.S. net product sales of $33.9 million for the fourth quarter and $119.2 million for the full year, representing 47% year-over-year growth IST product portfolio strengthened with U.S. FDA approval of NUZOLVENCE ® , a first-in-class treatment for uncomplicated urogenital gonorrhea $125 million share repurchase program initiated in the fourth quarter BURLINGAME, Calif.--(BUSINESS WIRE)--Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified biopharmaceutical company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the fourth quarter and full year ended December 31, 2025, and highlighted select corporate progress and achievements. “2025 marked an excellent year for Innoviva, demonstrating strength across all areas of our business, with 15% revenue growth to over $400 million and net income exceeding $270 million. Our royalty business continued to provide stable and resilient cash flow, while IST generated 47% year-over-year U.S. sales growth to $119 million,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “We expanded our commercial portfolio with the successful mid-2025 launch of ZEVTERA in the U.S., received nominations for two of our products for the prestigious 2025 Prix Galien USA Award, and ended the year on an exciting note with the FDA approval of our fifth product, NUZOLVENCE, a single-dose oral treatment for uncomplicated urogenital gonorrhea that addresses a critical public health challenge in light of the global rise of gonococcal drug resistance. We are excited about our growth prospects and anticipate $150 million or more in IST U.S. net product sales in 2026.” “Our portfolio of strategic assets remains a key platform for long-term growth and differentiation, demonstrated by significant advances and value creation at Armata Pharmaceuticals. Overall, we remain a well-capitalized company with multiple value-accretive capital deployment opportunities in our current business, novel assets, and capital strategies, including a recently announced $125 million share repurchase program. We look forward to multiple inflection points across Innoviva’s portfolio in the year ahead,” concluded Mr. Raifeld. Financial Highlights Total revenue: Total revenue for the fourth quarter 2025 was $114.6 million, representing 25% growth compared to total revenue of $91.8 million for the fourth quarter 2024. Total revenue for the full year 2025 was $411.3 million, reflecting 15% growth compared to total revenue of $358.7 million for the full year 2024. Royalty revenue: Fourth quarter 2025 gross royalty revenue from Glaxo Group Limited (“GSK”) was $58.4 million and full year was $250.3 million, compared to $66.0 million for the fourth quarter 2024 and $255.6 million for the full year 2024. Net product sales: Fourth quarter 2025 net product sales were $59.1 million, more than doubling from $28.9 million in the same quarter of 2024. Full year 2025 net product sales were $172.1 million, an increase of 77% compared to $97.5 million for the full year 2024. For the fourth quarter 2025, U.S. net product sales were $33.9 million and ex-U.S. net product sales were $25.1 million. Fourth quarter 2025 U.S. net product sales primarily consisted of $19.3 million from GIAPREZA ® , $10.7 million from XACDURO ® , and $3.8 million from XERAVA ® . For the full year 2025, U.S. net product sales were $119.2 million and ex-U.S. net product sales were $52.9 million. Full year 2025 U.S. net product sales primarily consisted of $71.8 million from GIAPREZA ® , $33.4 million from XACDURO ® , and $13.3 million from XERAVA ® . Income from operations: Fourth quarter 2025 income from operations was $39.0 million, compared to $43.1 million for the fourth quarter 2024. Full year 2025 income from operations was $163.7 million, compared to $166.9 million for the full year 2024, reflecting continued investments in research and development. Equity and long-term investments: Fourth quarter and full year 2025 net favorable changes in fair values of equity and long-term investments totaled $153.8 million and $161.6 million, respectively, and were primarily attributable to share price appreciation of Armata Pharmaceuticals. Innoviva’s portfolio of strategic assets held through the Company’s various subsidiaries was valued at $614.0 million as of December 31, 2025, and consisted of $397.9 million in Armata Pharmaceuticals investments, $136.4 million in other strategic equity and convertible debt investments, and $79.7 million in investments held by ISP Fund. Net income: Fourth quarter 2025 net income of $164.2 million ($2.19 basic earnings per share) and full year 2025 net income of $271.2 million ($4.02 basic earnings per share) were driven primarily by higher revenue and the positive impact of changes in the fair values of equity and long-term investments. Cash and cash equivalents: Totaled $550.9 million. Royalty and net product sales receivables totaled $93.3 million as of December 31, 2025. Key Business and R&D Highlights NUZOLVENCE ® (zoliflodacin): a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years and older weighing at least 35kg, developed in partnership with The Global Antibiotic Research & Development Partnership ("GARDP"). In December 2025, IST received U.S. Food and Drug Administration (FDA) approval of NUZOLVENCE ® for the treatment of uncomplicated urogenital gonorrhea. FDA approval was based on results from the largest Phase 3 clinical trial ever conducted for a new treatment against Neisseria gonorrhoeae infection in regions with a high prevalence of gonorrhea across five countries. Additionally, in December 2025, the positive NUZOLVENCE ® Phase 3 data for the treatment of uncomplicated urogenital gonorrhea were published in The Lancet . The Company plans to commercialize NUZOLVENCE ® in the second half of 2026, either in collaboration with a commercialization partner or independently. In October 2025, IST delivered data from six presentations at IDWeek 2025, including clinical data, pharmacokinetic/pharmacodynamic analyses, and microbiologic surveillance from its growing portfolio of antibiotics and critical care medicines. Both ZEVTERA ® (ceftobiprole medocaril sodium) and XACDURO ® (sulbactam for injection; durlobactam for injection) were nominated for the 2025 Prix Galien USA Award for Best Pharmaceutical Product by the Galien Foundation, one of the most prestigious honors in the biopharmaceutical and medical technology fields, celebrating groundbreaking achievements that drive meaningful progress. Capital Allocation Since the inception of the share repurchase program, the Company has repurchased 797,298 shares for $16.0 million. In October 2025, Innoviva invested $17.5 million in the Series B Preferred Stock of Beacon Biosignals, Inc., an AI-driven neurotechnology company developing treatments for neurological, psychiatric, and sleep disorders. About Innoviva Innoviva is a diversified biopharmaceutical company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . Innoviva’s critical care and infectious disease assets under the IST platform include GIAPREZA ® (angiotensin II) for increasing blood pressure in adults with septic or other distributive shock, XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus , XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults, ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic licensed from Basilea Pharmaceutica International Ltd, Allschwil, and NUZOLVENCE® (zoliflodacin), approved by the FDA for the oral treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years of age and older weighing at least 35 kg. For more information about Innoviva, go to . For information about Innoviva Specialty Therapeutics, go to . ANORO ® , RELVAR ® and BREO ® are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica Ltd, Allschwil. Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR ® /BREO ® ELLIPTA ® , ANORO ® ELLIPTA ® , GIAPREZA ® , XERAVA ® , XACDURO ® , ZEVTERA ® and NUZOLVENCE ® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at . Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. INNOVIVA, INC. Condensed Consolidated Statements of Income (in thousands, except per share data) (Unaudited) Three Months Ended Year Ended December 31, December 31, 2025 2024 2025 2024 Revenue: Royalty revenue, net (1) $ 54,896 $ 62,520 $ 236,479 $ 241,733 Net product sales 59,064 28,935 172,130 97,492 License and other revenue 653 351 2,719 19,486 Total revenue 114,613 91,806 411,328 358,711 Cost of products sold (inclusive of amortization of inventory fair value adjustments) 32,309 7,165 77,384 36,598 Amortization of acquired intangible assets 6,637 6,511 26,277 25,902 Gross profit 75,667 78,130 307,667 296,211 Operating expenses: Selling, general and administrative 32,124 31,326 113,318 115,690 Research and development 4,555 3,665 30,604 13,654 Total operating expenses 36,679 34,991 143,922 129,344 Income from operations 38,988 43,139 163,745 166,867 Changes in fair values of equity method investments, net 111,149 (21,256 ) 141,433 (64,253 ) Changes in fair values of equity and long-term investments, net 42,669 1,666 20,160 (59,161 ) Interest and dividend income 6,151 5,768 21,086 19,141 Interest expense (3,309 ) (4,749 ) (16,698 ) (22,209 ) Other expense, net (612 ) 126 (2,864 ) (2,997 ) Income before income taxes 195,036 24,694 326,862 37,388 Income tax expense (30,883 ) (4,362 ) (55,697 ) (13,996 ) Net income $ 164,153 $ 20,332 $ 271,165 $ 23,392 Net income per share: Basic $ 2.19 $ 0.32 $ 4.02 $ 0.37 Diluted $ 1.94 $ 0.26 $ 3.30 $ 0.36 Shares used to compute net income per share: Basic 74,796 62,626 67,395 62,726 Diluted 85,264 84,200 84,760 74,187 (1) Total net revenue is comprised of the following (in thousands): Three Months Ended Year Ended December 31, December 31, 2025 2024 2025 2024 (unaudited) (unaudited) Royalties $ 58,351 $ 65,975 $ 250,302 $ 255,556 Amortization of capitalized fees (3,455 ) (3,455 ) (13,823 ) (13,823 ) Royalty revenue, net $ 54,896 $ 62,520 $ 236,479 $ 241,733 INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands) (unaudited) December 31 2025 2024 Assets Cash and cash equivalents $ 550,941 $ 304,964 Royalty and product sale receivables 93,317 86,366 Inventory 39,172 33,725 Prepaid expense and other current assets 28,358 21,719 Current portion of ISP Fund investments 15,727 107,532 Property and equipment, net 1,555 514 Equity method and equity and long-term investments 598,223 393,957 Capitalized fees 56,138 69,961 Right-of-use assets 10,929 2,453 Goodwill 17,905 17,905 Intangible assets 182,156 208,433 Deferred tax assets, net — 12,054 Other assets 40,744 41,477 Total assets $ 1,635,165 $ 1,301,060 Liabilities and stockholders’ equity Other current liabilities $ 43,808 $ 39,507 Accrued interest payable 1,618 3,422 Deferred revenue 4,270 1,126 Convertible senior notes, due 2025, net — 192,028 Convertible senior notes, due 2028, net 257,731 256,316 Deferred tax liabilities, net 31,793 — Income tax payable, long term 57,013 53,227 Other long term liabilities 66,091 64,275 Stockholders’ equity 1,172,841 691,159 Total liabilities and stockholders’ equity $ 1,635,165 $ 1,301,060 INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited) Year Ended December 31, 2025 2024 Net cash provided by operating activities $ 196,930 $ 188,690 Net cash provided by (used in) investing activities 40,496 (63,786 ) Net cash provided by (used in) financing activities 8,551 (13,453 ) Net change $ 245,977 $ 111,451 Cash and cash equivalents at beginning of period 304,964 193,513 Cash and cash equivalents at end of period $ 550,941 $ 304,964 Contacts Investor Relations (Internal): Eleanor Barisser Director, Investor Relations and Corporate Communications Eleanor.barisser@inva.com Investors and Media: Argot Partners (212) 600-1902 innoviva@argotpartners.com

上市批准财报临床3期生物类似药引进/卖出

2026-02-23

·搜狐新闻

云顶新耀（01952.HK）南向资金动态分析：减持与增持背后的市场信号

在2026年2月23日，云顶新耀（01952.HK）遭遇了一波南向资金的减持，具体数字为9.95万股。这一动态引起了市场的广泛关注，尤其是在近5个交易日内，该公司南向资金增持了3天，累计净增持达14.6万股，展现出南向资金在该股的活跃性。更值得注意的是，在近20个交易日内，南向资金增持了17天，累计增持达到486.6万股，显示出市场对云顶新耀的强烈兴趣和潜在信心。云顶新耀是一家专注于创新药物和疫苗研发的生物制药公司，其产品管线涵盖了跨肾病、抗感染及自身免疫性疾病等多个领域。其中，耐赋康（TARPEYO）和依嘉（依拉环素）等药物在国内外市场均有显著的应用前景。南向资金的频繁交易是否意味着市场对其未来发展的看好？还是说反映了短期内资金流动性的变化？这无疑是值得我们深入探讨的。首先，我们来看云顶新耀的基本面。作为一家生物制药公司，其研发能力和产品管线的丰富程度直接影响了市场的信心。近年来，云顶新耀在肾病和感染性疾病领域取得了一系列突破，耐赋康作为治疗肾病的创新药物，已经获得了一定的市场认可。而依嘉作为针对多重耐药菌感染的抗生素，其市场需求也在逐年上升。然而，南向资金的减持与增持行为，却反映了市场对云顶新耀未来发展的不同预期。减持的发生，可能是因为部分投资者对短期市场波动的担忧，或是对公司当前估值的重新审视。而增持则显示出另一部分投资者对云顶新耀长期发展的信心。这样的资金流动，实际上为我们解读市场情绪提供了重要线索。在分析南向资金的动态时，我们也不能忽视外部环境的影响。2026年，全球经济复苏仍在持续，但各国政策的差异化也在加大市场的不确定性。尤其是在中美贸易关系、欧洲经济复苏等多重因素交织下，投资者在选择标的时更加谨慎。云顶新耀作为一家生物制药公司，能否在这样的环境中脱颖而出，关键在于其研发能力和市场策略。在此背景下，云顶新耀需要进一步加强与国际市场的对接，提升自身的竞争力。此外，公司也应关注研发投入的回报率，确保新产品的商业化能够顺利进行。投资者在关注南向资金动态的同时，也应综合考虑公司的基本面和外部环境，做出更为理性的投资决策。结尾时，我们可以说，云顶新耀（01952.HK）在南向资金的减持与增持中，展现出市场对于其未来发展的复杂情绪。这一现象不仅反映了投资者对公司基本面的关注，也揭示了市场在宏观经济背景下的敏感性。未来，如何把握云顶新耀的发展机会，将是每一位投资者需要思考的问题。希望在未来的日子里，云顶新耀能够在不断变化的市场中，保持其创新的步伐，为投资者带来丰厚的回报。返回搜狐，查看更多

2026-02-18

·Care与你同行

D7-1 抗生素的兴衰：亟待重建的防线（1940-2026）

声明：仅代表个人观点，与供职公司无关，与商业利益无关。不构成投资建议。摘要本报告对抗生素市场从1940年代的兴起到2026年的结构性崩塌进行了详尽的病理学分析。通过整合历史档案、财务数据、监管记录及最新的流行病学报告，我们揭示了这一公共卫生基石如何因经济激励机制的错位而逐渐被资本市场抛弃。分析表明，抗生素研发的黄金时代并非自由市场的产物，而是战时动员与政府主导的非排他性知识共享的结果。随后几十年，随着重磅炸弹药物商业模式的兴起、知识产权法律的变更以及监管风险的指数级上升，抗生素的风险调整后净现值（rNPV）暴跌至负值区间。尽管2020年代中期出现了人工智能辅助发现（如Halicin和Abaucin）和政策重构（如PASTEUR法案2026版）的迹象，但全球抗微生物药物耐药性（AMR）的蔓延速度仍远超市场修复的速度。本报告认为，当前的危机不仅是科学挑战，更是市场机制在处理具有正外部性的公共产品时的系统性失灵。第一章黄金时代的非市场起源与经济奇迹（1940-1960）1.1 战时动员模式：去风险化的极致案例抗生素历史上的“黄金时代”（Golden Age），通常界定为1943年至1962年，这一时期见证了包括链霉素、四环素、氯霉素在内的超过半数现有抗生素种类的发现 1。然而，这一创新爆发期并非源于现代意义上的风险投资或专利垄断驱动，而是源于二战期间独特的政府主导模式。在这一时期，美国科学研究与发展办公室（OSRD）扮演了核心角色。OSRD并非简单的资助机构，而是整个研发链条的架构师。它协调了57项独立的研究合同，涵盖了从青霉素菌株的初步筛选、化学结构的解析到临床试验的全过程 1。这种模式最显著的特征是“去风险化”（De-risking）：政府承担了早期基础研究中最高风险的成本，使得私营企业能够在技术路径相对明确后介入生产。更关键的是战时生产委员会（WPB）的角色。WPB协调了21家制药公司、5个学术团体以及农业部（USDA）下属的北部地区研究实验室（NRRL）3。在NRRL，科学家们不仅改良了霉菌菌种，还开发了深罐发酵技术，这一技术突破直接导致青霉素产量在数月内翻了四番3。为了促进这种技术扩散，WPB甚至从司法部获得了反垄断豁免，允许参与企业共享发酵工艺和菌株信息，这在今天的商业环境中是不可想象的。1.2 预先采购与“推力”机制的雏形在商业化层面，当时的政府行为构成了最早且最成功的“推力”激励机制（Push Incentive）。尽管当时的行业领袖已经意识到风险资本投入需要回报，但在1943年至1945年间，美国政府直接购买了价值200万美元的青霉素用于临床验证 3。这种“预先采购协议”消除了企业的市场不确定性，使得默克（Merck）、辉瑞（Pfizer）和施贵宝（Squibb）等公司敢于在药物获批前就通过改造工厂进行大规模生产。这种早期的成功掩盖了一个长期的经济学隐患：抗生素的研发在当时之所以有利可图，是因为其作为一种稀缺的救命药物，且在缺乏替代品的卖方市场中，即使没有严格的专利保护，企业也能通过技术壁垒获得利润。然而，这种模式并没有解决抗生素作为“一次性治愈”药物与制药业追求“长期慢性病管理”药物之间的根本矛盾，这一矛盾将在几十年后爆发。1.3 瓦克斯曼平台与土壤筛选的经济学黄金时代的另一个引擎是所谓的“瓦克斯曼平台”（Waksman platform）。自Selman Waksman发现链霉素以来，制药界确立了一套标准化的研发流程：系统性地筛选土壤中的放线菌以寻找天然抗生素4。从经济学角度看，这一时期的研发具有极高的投入产出比。由于土壤微生物是未被开发的化学宝库，筛选的边际成本极低，而发现新化合物的概率极高。这种“低垂果实”（Low-hanging fruit）效应使得抗生素研发在1950年代呈现出线性增长的特征 5。据统计，近三分之二的抗生素类别是在这一时期引入的1。然而，这种繁荣是建立在自然资源丰富基础上的粗放型增长，随着土壤样本的枯竭，研发的边际效益开始急剧下降，为后来的市场崩塌埋下了伏笔。第二章大分流：慢性病模型的崛起与抗生素的边缘化（1960-1990）2.1 商业模式的根本性转变：治愈与管理的博弈进入1960年代末和1970年代，全球制药行业的商业逻辑发生了根本性转变。随着人口老龄化和生活方式的改变，心血管疾病、代谢性疾病和精神疾病成为主要健康威胁。制药巨头发现，开发用于治疗高血压、高血脂或抑郁症的药物，能够带来稳定且长期的现金流。表 2.1：抗生素与慢性病药物的经济特征对比（1980-2000年代）经济指标抗生素 (Antibiotics)慢性病药物 (Chronic Disease Drugs)治疗时长短期 (7-14天)长期/终身 (数年至数十年)客户终身价值 (CLV)低 (一次性治愈)极高 (持续复购)市场替代性高 (存在大量廉价仿制药)低 (专利保护期内独占)耐药性风险高 (使用越多，失效越快)低 (疗效相对稳定)社会价值与经济价值关系负相关 (越有价值越被限制使用)正相关 (越有价值销量越高)研发难度 (1980s后)极高 (难以穿透革兰氏阴性菌膜)中等 (靶点相对明确) 这种差异导致了巨大的机会成本。据估算，抗生素的风险调整后净现值（rNPV）仅为1亿美元左右，而同期的肌肉骨骼类药物或肿瘤药物的rNPV可高达11.5亿美元甚至更高 7。对于追求股东回报最大化的上市药企而言，将研发资金投向抗生素在财务上几乎等同于渎职。 2.2 哈奇-韦克斯曼法案的双刃剑效应 1984年通过的《药品价格竞争与专利期恢复法案》（Drug Price Competition and Patent Term Restoration Act），通称Hatch-Waxman法案，旨在平衡创新激励与仿制药竞争，但其对抗生素市场造成了不对称的打击 10。该法案建立了简略新药申请（ANDA）程序，允许仿制药企业在无需重复昂贵临床试验的情况下进入市场，前提是证明生物等效性 11。这极大地降低了仿制药的准入门槛。在法案通过前，仿制药仅占处方量的19%；法案通过后，仿制药迅速占据市场主导地位12。对于抗生素而言，这种冲击尤为致命。抗生素多为化学结构相对简单的小分子药物，比复杂的生物制剂更容易被仿制。且由于抗生素的急诊属性，医院和支付方对价格极其敏感。一旦专利到期，品牌抗生素的销售额往往会在几个月内蒸发90%以上，也就是所谓的“专利悬崖”（Patent Cliff）。尽管法案试图通过专利期延长条款（Title II）来补偿原研药企，但在抗生素领域，短短几年的延长无法抵消短期疗程带来的收入劣势，反而导致品牌药企与仿制药企之间陷入了专利诉讼的僵局10。2.3 发现空窗期与技术路线的失败从1987年开始，抗生素研发进入了所谓的“发现空窗期”（Discovery Void）。尽管对于这一时期的确切定义存在争议——有观点认为2012年贝达喹啉（Diarylquinolines）的获批打破了这一空窗——但不可否认的是，在1987年之后的三十年里，几乎没有具有全新作用机制的广谱抗生素类别进入临床应用 2。这一时期的停滞不仅仅是由于经济原因，更是科学策略的失败。随着土壤筛选法的枯竭，制药界在1990年代转向了基因组学、组合化学和高通量筛选（HTS）14。科学家们认为，通过基因测序找到细菌的关键生存基因，再合成针对这些靶点的小分子，就能像流水线一样生产新抗生素。然而，这一策略在抗生素领域遭遇了惨败。合成化学库虽然庞大，但缺乏天然产物的结构复杂性，难以穿透细菌（特别是革兰氏阴性菌）复杂的双层细胞膜和外排泵系统14。此外，基因组学识别出的许多单一靶点非常容易通过单点突变产生耐药性。例如，针对亮氨酰-tRNA合成酶的药物虽然在体外有效，但在临床试验中仅用药一天就出现了耐药性14。这种技术路线的群体性失败，耗费了制药巨头数十亿美元的资金，进一步挫伤了它们留在该领域的信心。第三章监管寒冬与资本大撤退（1990-2010）3.1 Ketek丑闻：监管风险的分水岭 2000年代初发生的Ketek（泰利霉素）丑闻是抗生素监管历史的分水岭，它直接导致了临床试验成本的飙升和审批难度的增加，成为压垮许多企业研发意愿的最后一根稻草16。赛诺菲-安万特（Sanofi-Aventis）开发的Ketek原本被寄予厚望，用于治疗呼吸道感染。然而，后续调查揭示，其关键的安全性研究（Study 3014）存在严重的数据欺诈。一名招募了最多患者的医生甚至伪造了病例，导致数据完全不可信 17。此外，该药物上市后出现了严重的肝毒性报告，导致数名患者死亡。面对国会的严厉质询和公众的愤怒，FDA大幅收紧了抗生素审批标准。 1.适应症撤回：Ketek的两个主要适应症（急性细菌性鼻窦炎和慢性支气管炎急性加重）被强制撤回，仅保留了社区获得性肺炎18。 2.试验设计重构：FDA重新评估了“非劣效性”（Non-inferiority）试验的设计标准。为了排除安慰剂效应并确保安全性，新指南要求更窄的统计学边界（例如10%），这迫使临床试验所需的患者样本量成倍增加 18。对于研发企业而言，这一变化意味着III期临床试验的成本从数千万美元飙升至数亿美元。更糟糕的是，对于针对耐药菌的药物，招募足够数量的特定耐药患者变得几乎不可能。这种监管不确定性的急剧上升，使得抗生素研发从一项“高风险、低回报”的业务变成了“极高风险、极低回报”的赌博。3.2 巨头离场的连锁反应在利润率下降、监管风险上升和科学障碍的三重打击下，大型制药公司开始成群结队地退出抗生素领域。这一过程被称为“资本大撤退”（Capital Retreat）。表 3.1：主要制药公司退出抗生素研发时间表（1999-2010）公司名称退出/缩减时间当时背景与原因Eli Lilly (礼来)2002年战略重心全面转向中枢神经系统（如Prozac）和肿瘤药物；认为抗生素不再是“最佳成功机会” 3。Bristol-Myers Squibb (BMS)2000年代中期将重点转向病毒学（HIV/HCV）和肿瘤免疫疗法；剥离抗感染资产 3。Wyeth (惠氏)2003年缩减尽管拥有Tygacil（替加环素），但主要资源转向生物制剂。2009年被辉瑞收购后，相关管线进一步边缘化 3。Pfizer (辉瑞)2011年关闭关闭了位于康涅狄格州格罗顿的抗生素研发中心，标志着全球最大药企之一在这一领域的战略收缩 22。Roche (罗氏)1999年退出早期退出，专注于高利润的肿瘤药物。直到2010年代末才通过由于Inception Sciences的合作重新试探性回归 3。Aventis2003年在Ketek丑闻后，与其合并方Sanofi共同缩减了抗生素管线 3。Procter & Gamble2000年代初退出了药品研发业务，专注于消费者健康产品 3。资料来源：3 到2003年，抗菌药物在整个制药行业的研发管线中占比已不足1.6% 3。这一撤退造成了严重的后果：不仅仅是资金的流失，更是整个行业知识体系的崩塌。数以千计经验丰富的微生物学家和药物化学家被迫转行、退休或被裁员，导致行业在应对2020年代的耐药性危机时面临严重的“智力赤字” 19。第四章生物技术的幻象与商业模式的破产（2010-2020）随着大药企的离场，政策制定者和公共卫生专家一度寄希望于小型生物技术公司（SME）来填补空白。然而，2010年代的历史证明，这是一个致命的误判。SME虽然具有科学创新能力，但缺乏在大药企撤退后的市场真空中生存的财务韧性。4.1 Achaogen与Plazomicin：教科书式的市场失灵 Achaogen的破产是抗生素市场失灵最惨痛的案例，被业界称为“Achaogen时刻”，它彻底击碎了投资者对该领域的最后一点幻想。4.1.1 科学上的胜利 Achaogen开发了Plazomicin（商品名Zemdri），这是一种下一代氨基糖苷类抗生素，专门针对多重耐药的肠杆菌科细菌（CRE）。2018年6月，该药获得了FDA的批准，用于治疗复杂的尿路感染（cUTI）27。从科学和临床角度看，这是一款成功的药物，满足了迫切的未满足医疗需求。4.1.2 商业上的灾难然而，商业现实是毁灭性的。Achaogen在研发过程中消耗了约8亿至10亿美元的资金（包括公共资助和私募融资）。然而，Plazomicin上市第一年（2018年）的销售额仅为80万美元 19。造成这种巨大反差的原因在于美国医院的支付制度（DRG，疾病诊断相关分组）。在这一制度下，医院治疗一名尿路感染患者获得的是一笔固定费用。如果使用廉价的仿制药，医院可以留存更多利润；如果使用昂贵的新药（Plazomicin定价约为每疗程数千美元），医院不仅无利可图，甚至可能亏损。因此，医院药房极力限制新药的使用。此外，为了防止耐药性产生，公共卫生机构和医生将Plazomicin作为“最后一道防线”雪藏，仅在所有其他药物无效时使用。这意味着新药越有效、越重要，其销量反而越低。在现有的“按量付费”模式下，这种销量限制直接判了研发企业死刑。4.1.3 破产与贱卖 2019年4月，获批不到一年，Achaogen申请破产保护。其核心资产Plazomicin最终以1600万美元的“白菜价”拍卖给了印度仿制药公司Cipla和中国公司Sihuan Pharmaceutical 28。这一价格甚至不足以支付该药物研发成本的2%。Cipla随后撤回了在欧洲的上市申请，因为评估认为欧洲市场同样无利可图28。4.2 连锁反应：SME的集体倒塌 Achaogen并非孤例。在2019年至2020年间，多家拥有获批抗生素的SME陷入财务困境，形成了一股破产潮。 ●Melinta Therapeutics：尽管拥有Baxdela（德拉沙星）等四款获批抗生素，但在2019年底因无法偿还债务申请破产保护，后被私募股权公司Deerfield Management接手 30。 ●Tetraphase Pharmaceuticals：其药物Xerava（依拉环素）已获批，但公司市值在2020年暴跌，最终以约4000万美元的价格被La Jolla Pharmaceutical收购，这一价格仅略高于其账面现金，意味着市场给予其获批药物的估值几乎为零 19。 ●Paratek Pharmaceuticals：虽然其药物Nuzyra（奥马环素）获批，但公司股价长期低迷。它是极少数依靠美国政府BARDA的生物盾计划（Project BioShield）合同才勉强生存下来的公司之一，该合同将其药物作为针对炭疽生物恐怖主义的储备物资27。这一系列事件向资本市场传递了一个明确的信号：投资抗生素研发是死路一条。这导致风险资本（VC）几乎完全撤出了该领域。据统计，2018-2023年间，专注于抗生素和抗真菌药物的公司仅筹集了12亿美元，而同期肿瘤公司筹集了超过500亿美元 19。第五章经济病理学的全面爆发（2020-2024）5.1 风险调整后净现值（rNPV）的极端分化进入2020年代，经济学分析进一步量化了抗生素市场的崩塌。rNPV模型是制药行业评估项目价值的核心工具，它综合考虑了研发成本、成功概率、预期收入和资金时间价值。表 5.1：2020年代中期各治疗领域rNPV与经济指标对比指标抗生素 (Antibiotics)肿瘤药物 (Oncology)肌肉骨骼药物 (Musculoskeletal)平均研发成本~$12-13 亿美元~$6-10 亿美元 (差异大)~$10-15 亿美元上市第5年平均销售额~$1.2 亿美元>$5-10 亿美元~$8-10 亿美元rNPV (风险调整后净现值)~$1 亿美元>$10 亿美元~$11.5 亿美元年均收入预期~$4600 万美元>$10 亿美元>$10 亿美元市场规模 (耐药菌领域)针对CRE市场仅约$2.89亿/年单一PD-1药物可超$200亿/年巨大数据表明，抗生素的rNPV仅为其他主要治疗领域的十分之一甚至更低。对于一家理性的制药公司而言，如果不考虑社会责任，继续投资抗生素在财务逻辑上是不成立的。这种极端的rNPV分化解释了为什么即便有公共资金支持早期研发（如CARB-X），后期临床试验和商业化阶段依然无人问津，形成了所谓的“死亡之谷”（Valley of Death）。5.2 全球抗微生物药物耐药性（GRAM）报告的警示尽管市场在萎缩，但公共卫生危机却在加速恶化。2024年发布的《柳叶刀》全球抗微生物药物耐药性（GRAM）报告提供了迄今为止最详尽的统计数据，揭示了AMR对人类健康的毁灭性打击 33。 ●当前负担：2021年，全球有471万例死亡与细菌耐药性相关（Associated），其中114万例直接归因于（Attributable）耐药性。这意味着，AMR导致的死亡人数已经超过了艾滋病和疟疾的总和。 ●未来预测：报告预测，到2050年，直接归因于AMR的年死亡人数将增至191万，相关死亡人数将达到822万。 ●年龄分布的剪刀差：一个令人担忧的趋势是，尽管5岁以下儿童的AMR死亡率下降了50%（得益于疫苗和卫生改善），但70岁以上老年人的死亡率在1990-2021年间激增了80%以上。随着全球人口老龄化，这一趋势将对养老和医疗系统造成无法承受的负担。5.3 现代医学基石的动摇抗生素失效的连锁反应远远超出了感染科的范畴，它正在动摇现代医学的基石。ReAct 2026年发布的报告《在抗生素耐药时代保护癌症护理》详细阐述了这一风险 36。 ●癌症治疗：化疗、放疗和干细胞移植都会严重削弱患者的免疫系统，导致中性粒细胞减少症。如果没有有效的抗生素预防和治疗感染，这些疗法将变得过于危险。数据显示，近十分之一的癌症死亡实际上是由于严重败血症，而非癌症本身。对于血液癌患者，如果携带耐碳青霉烯类细菌，其治疗选择几乎为零。 ●外科手术：剖腹产、器官移植和关节置换等常规手术高度依赖预防性抗生素。2024年的研究显示，尽管使用了预防性抗生素，剖腹产后的手术部位感染（SSI）风险仍在上升，且与产妇体重增加和胎膜早破等因素相关 37。如果抗生素失效，剖腹产这一挽救了无数母婴生命的手术将变回高风险操作。 ●器官移植：移植受者需要终身服用免疫抑制剂，他们对抗生素的依赖是绝对的。AMR的上升直接导致移植成功率下降和术后死亡率上升38。第六章技术复兴：人工智能与非传统疗法的崛起（2023-2026）在传统小分子药物研发陷入死胡同的同时，技术创新开始寻找新的突破口。2023年至2026年间，人工智能（AI）和噬菌体疗法等非传统手段的成熟，为“发现空窗期”带来了一线曙光。6.1 AI驱动的抗生素发现：从Halicin到Abaucin 人工智能在抗生素研发中的应用，标志着从“运气驱动”的筛选向“数据驱动”的设计转变。6.1.1 Halicin：深度学习的跨界发现 Halicin是麻省理工学院（MIT）团队利用深度学习模型发现的全新抗生素，这一发现于2020年公布并在随后的几年中进行了深入研究。AI模型在从Drug Repurposing Hub筛选6000多种化合物时，识别出了这一原本用于治疗糖尿病的分子39。 ●机制创新：Halicin通过破坏细菌跨膜电化学梯度（pH梯度）来杀死细菌。由于这种机制涉及细菌的基本物理能量代谢，细菌极难通过基因突变产生耐药性。 ●广谱活性：研究表明，它对包括鲍曼不动杆菌、艰难梭菌和结核分枝杆菌在内的多种多重耐药菌有效，甚至对生物膜（Biofilms）中的细菌也有杀伤力 39。6.1.2 Abaucin：精准打击与效率革命 2023年，麦克马斯特大学和MIT的研究人员利用AI筛选了近7000种分子，发现了针对鲍曼不动杆菌的特异性抗生素Abaucin 41。 ●窄谱优势：与传统广谱抗生素“地毯式轰炸”不同，Abaucin只杀伤鲍曼不动杆菌，而不破坏肠道有益菌群。这种“精确制导”不仅减少了副作用，还降低了诱导其他细菌产生耐药性的风险。 ●效率革命：AI模型在几天内完成了传统实验室需要数年才能完成的筛选工作。到2026年，Abaucin及类似AI发现的分子已进入临床前优化或早期临床阶段，验证了AI缩短研发周期的潜力 19。6.2 噬菌体疗法的制度化除了小分子药物，噬菌体疗法（Bacteriophage Therapy）在2025-2026年重新获得了监管机构的重视。噬菌体是专门感染细菌的病毒，具有高度特异性。 ●美国进展：尽管FDA尚未批准任何噬菌体疗法正式上市，但在2025年，美国批准了首个基因编辑噬菌体的临床试验（NCT05488340），并在同情用药（Compassionate Use）和扩展使用计划（Expanded Access Program）框架下，允许更多危重患者使用噬菌体治疗 44。 ●欧洲模式：比利时和法国采取了更为灵活的策略，建立了噬菌体疗法的临时监管框架（Magistral preparation），允许药剂师根据医生处方为特定患者定制噬菌体鸡尾酒制剂 44。这绕过了传统药物审批对固定成分的要求，适应了噬菌体需要个性化匹配的特点。 ●临床管线：到2026年，像SNIPR Biome这样的公司正在推进CRISPR工程化噬菌体（如SNIPR001）的临床试验，试图解决天然噬菌体宿主范围窄和免疫原性问题19。第七章政策重构与市场的重新定义（2025-2026）面对市场彻底失灵的现实，以及AMR带来的迫在眉睫的威胁，各国政府在2025-2026年终于开始采取实质性行动，试图通过立法强行重构抗生素的经济模型。这一阶段的核心特征是“去挂钩化”（Delinking）——即将抗生素的收入与其销量彻底分离。7.1 PASTEUR法案的重启与机制创新（2026）在美国，历经多次失败后，更新版的《巴斯德法案》（PASTEUR Act 2026）于2026年初由众议院两党代表重新引入 45。该法案被视为拯救抗生素市场的最后希望。7.1.1 订阅模式（Subscription Model）法案的核心是建立一种“订阅模式”。美国政府将与药企签订合同，对于那些针对危急耐药菌的新药，政府将提供每年7500万至3亿美元的固定付款，合同期可能长达10年 45。这相当于将抗生素从“商品”转变为“服务”或“基础设施”。就好比政府购买消防车，无论是否发生火灾，政府都会支付购买和维护费用，以确保在危机发生时有车可用。药企不再需要为了盈利而推销抗生素，从而解决了“管理制度”与“盈利”之间的矛盾。7.1.2 评分系统与支付分级 2026版法案引入了更为透明和严格的评分系统，以决定合同的具体金额。评分基于三个核心维度： 1.创新性（Category II）：药物是否具有全新的作用机制，能否克服现有的耐药性。 2.患者护理贡献（Category I）：药物在临床结果（如降低死亡率、减少住院时间）上的实际表现。 3.公共卫生效益（Category III）：药物对于国家卫生安全和生物防御的战略价值 7。只有得分超过特定阈值的药物才能获得合同，且得分越高，年度付款额越高。这旨在防止企业开发仅仅是“me-too”类的微创新药物来骗取补贴。7.2 全球政策的同步与试水除美国外，其他国家也在探索类似的模式。 ●英国模式：英国NHS早已启动了订阅模式试点，向Pfizer和Shionogi等公司支付固定年费以换取抗生素供应。到2026年，这一模式已证明能有效保障供应并激励企业留在市场7。 ●加拿大与日本：加拿大、日本和澳大利亚也在2025-2026年间开始探索或实施类似的“拉力”激励措施（Pull Incentives），试图建立一个全球协调的激励网络 28。7.3 企业的战略回应与管线复苏在政策预期的推动下，部分制药巨头开始谨慎回归或调整其抗感染策略。 ●葛兰素史克（GSK）：在2025年财报中，GSK确认了其抗感染业务（尤其是HIV和疫苗）的强劲增长，并预计在2026年获得口服碳青霉烯类药物Tebipenem的批准。GSK的策略是通过疫苗和长效HIV药物的高利润来交叉补贴抗生素研发，同时押注政策落地带来的稳定性49。 ●罗氏（Roche）：罗氏在2026年初启动了Zosurabalpin的全球III期临床试验 51。这款药物针对碳青霉烯耐药鲍曼不动杆菌（CRAB），采用了一种全新的大环肽机制，能够阻断细菌外膜脂多糖的运输。罗氏此举被视为对PASTEUR法案和全球订阅模式的信任投票。 ●Cipla与仿制药巨头：在收购Achaogen的资产后，Cipla在2025年终于在印度推出了ZEMDRI（Plazomicin）53。尽管全球推广仍受阻，但这显示了仿制药企业在创新药生命周期后期接盘并维持供应的可能性。第八章结论：重建生物安全的基础设施8.1 经济学崩塌的本质反思回顾1940年至2026年的历史，抗生素市场的崩塌并非单纯的商业周期波动，而是“公共产品私有化供给”模式的必然失败。抗生素具有双重属性：它既是商品，又是类似于国防、消防的国家安全基础设施。在过去80年里，我们试图用通过销量获利的商品逻辑来维持这一基础设施。这种逻辑在抗生素“低垂果实”时期尚能维持，但随着研发难度的指数级上升和耐药性带来的负外部性增加，市场机制必然失灵。Achaogen的破产就是这一逻辑破产的墓志铭。8.2 2026年的十字路口站在2026年，人类正处于一个危险的十字路口。 ●乐观的一面：AI技术的突破解决了发现端（Discovery）的瓶颈，使得寻找新分子变得更快、更便宜；PASTEUR法案等政策工具试图解决支付端（Payment）的失效，通过“去挂钩化”重建商业可行性。 ●悲观的一面：耐药性的演化速度依然快于新药上市速度。全球供应链的脆弱性、地缘政治紧张局势以及人才断层的修复都需要时间。此外，像PASTEUR这样的法案从通过到真正落地拨款，仍面临政治博弈的不确定性。8.3 终极建议如果要避免“后抗生素时代”的全面降临，导致癌症治疗、器官移植和外科手术倒退回一个世纪前的高风险状态，必须彻底改变将抗生素视为普通商品的观念。未来的抗生素经济学必须建立在“价值”而非“体积”之上。这意味着： 1.国家层面的长期订阅：确保研发者获得与药物公共卫生价值相匹配的稳定回报，而非依赖不确定的销量。 2.全球协调的准入机制：防止像Plazomicin那样虽获批却因商业原因无法触达患者的悲剧，建立全球性的抗生素储备和分配网络。 3.技术生态的多元化：利用AI、合成生物学、噬菌体和免疫疗法拓宽武器库，不再单一依赖小分子化学药物。资本的撤退是一次惨痛的警钟。现在的任务不仅仅是把资本请回来，而是要为资本建立一个新的、可持续的栖息地，以保卫人类医学最宝贵的防线。参考文献 1.Nearly two-thirds of antibiotics were introduced during the “golden age of antibiotics”, 访问时间为二月 18, 2026， https://ourworldindata.org/data-insights/nearly-two-thirds-of-antibiotics-were-introduced-during-the-golden-age-of-antibiotics 2.Derivation of a Precise and Consistent Timeline for Antibiotic ..., 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC9495031/ 3.Rethinking Antibiotic Research and Development: World War II and ..., 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC3673487/ 4.Hunting for Antibiotics in Unusual and Unculturable Microbes, 访问时间为二月 18, 2026， https://asm.org/articles/2023/june/hunting-for-antibiotics-in-unusual-and-unculturabl 5.The Antibiotic Resistance Crisis: Part 1: Causes and Threats - PMC, 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC4378521/ 6.What was the Golden Age of Antibiotics, and how can we spark a new one?, 访问时间为二月 18, 2026， https://ourworldindata.org/golden-age-antibiotics 7.Current economic and regulatory challenges in developing ..., 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC12159177/ 8.The Economics of Antibiotic Resistance - Center for Global ..., 访问时间为二月 18, 2026， https://www.cgdev.org/sites/default/files/economics-antibiotic-resistance.pdf 9.Antibiotic development pipeline runs dry - PMC - NIH, 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC7135628/ 10. Patents, Innovation, and Competition in Pharmaceuticals: The Hatch-Waxman Act after 40 Years - American Economic Association, 访问时间为二月 18, 2026， https://www.aeaweb.org/articles?id=10.1257/jep.20241423 11. 40th Anniversary of the Generic Drug Approval Pathway - FDA, 访问时间为二月 18, 2026， https://www.fda.gov/drugs/cder-conversations/40th-anniversary-generic-drug-approval-pathway 12. Pharmaceutical Innovation - Incentives, Competition, and Cost-Benefit Analysis in International Perspective - DukeSpace, 访问时间为二月 18, 2026， https://dukespace.lib.duke.edu/bitstreams/8b9cc750-0755-490e-835a-b998a0015164/download 13. Few antibiotics under development - ReAct, 访问时间为二月 18, 2026， https://www.reactgroup.org/toolbox/understand/how-did-we-end-up-here/few-antibiotics-under-development/ 14. Read "Technological Challenges in Antibiotic Discovery and ..., 访问时间为二月 18, 2026， https://www.nationalacademies.org/read/18616/chapter/3 15. Synthetic biology of antimicrobial discovery - PMC - NIH, 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC3716841/ 16. KETEK CLINICAL STUDY FRAUD: WHAT DID AVENTIS KNOW? | Congress.gov, 访问时间为二月 18, 2026， https://www.congress.gov/event/110th-congress/house-event/LC9490/text 17. Ketek: FDA Managers Value Drug Maker Relations Over Patient Safety, 访问时间为二月 18, 2026， https://www.ucs.org/resources/attacks-on-science/ketek-fda-managers-value-drug-maker-relations-over-patient-safety 18. Understanding the regulatory hurdles for antibacterial drug ..., 访问时间为二月 18, 2026， https://pubmed.ncbi.nlm.nih.gov/22191531/ 19. Antibiotics re-booted—time to kick back against drug resistance - PMC, 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC12125309/ 20. Threats of antibiotic resistance: an obliged reappraisal - PMC, 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC8141826/ 21. Case No COMP/M.5476 - PFIZER/ WYETH REGULATION (EC) No 139/2004 MERGER PROCEDURE Article 6(1)(b) in conjunction with Art 6(2) Da - European Commission, 访问时间为二月 18, 2026， https://ec.europa.eu/competition/mergers/cases/decisions/m5476_20090717_20212_en.pdf 22. A history of the pharmaceutical industry | pharmaphorum, 访问时间为二月 18, 2026， https://pharmaphorum.com/r-d/a_history_of_the_pharmaceutical_industry 23. Pfizer | Robins School of Business, 访问时间为二月 18, 2026， https://robins.richmond.edu/files/Robins-Case-Network/2025/Pfizer.pdf 24. Rethinking Antibiotic Research and Development: World War II and the Penicillin Collaborative - American Journal of Public Health, 访问时间为二月 18, 2026， https://ajph.aphapublications.org/doi/pdf/10.2105/AJPH.2012.300693 25. The dwindling stock of antibiotics, and what to do about it - The Source - WashU, 访问时间为二月 18, 2026， https://source.washu.edu/2014/10/the-dwindling-stock-of-antibiotics-and-what-to-do-about-it/ 26. Historicising the “Empty Pipeline”: How Antibiotic Innovation Became a Market Failure (1980–2024) - ResearchGate, 访问时间为二月 18, 2026， https://www.researchgate.net/publication/397844950_Historicising_the_Empty_Pipeline_How_Antibiotic_Innovation_Became_a_Market_Failure_1980-2024 27. (PDF) Novel insights from financial analysis of the failure to ..., 访问时间为二月 18, 2026， https://www.researchgate.net/publication/382426841_Novel_insights_from_financial_analysis_of_the_failure_to_commercialise_plazomicin_Implications_for_the_antibiotic_investment_ecosystem 28. Plazomicin (Achaogen) financial post-mortem: #PassPASTEUR - AMR.Solutions, 访问时间为二月 18, 2026， https://amr.solutions/2024/10/14/plazomicin-achaogen-financial-post-mortem-passpasteur/ 29. A Broken Antibiotic Market: Review of Strategies to Incentivize Drug Development - PMC, 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC7336557/ 30. The antibiotic paradox: why companies can't afford to create life-saving drugs - Carb-X, 访问时间为二月 18, 2026， https://carb-x.org/carb-x-news/the-antibiotic-paradox-why-companies-cant-afford-to-create-life-saving-drugs/ 31. Manufacturers of new antibiotics go bankrupt - AMR Industry Alliance, 访问时间为二月 18, 2026， https://www.amrindustryalliance.org/mediaroom/manufacturers-of-new-antibiotics-go-bankrupt/ 32. A Definitive Guide to Valuing Pharmaceutical and Biotech ..., 访问时间为二月 18, 2026， https://www.drugpatentwatch.com/blog/valuation-of-pharma-companies-5-key-considerations-2/ 33. Global burden of bacterial antimicrobial resistance 1990-2021: a ..., 访问时间为二月 18, 2026， https://pubmed.ncbi.nlm.nih.gov/39299261/ 34. The Lancet: More than 39 million deaths from antibiotic-resistant infections estimated between now and 2050, suggests first global analysis | Institute for Health Metrics and Evaluation, 访问时间为二月 18, 2026， https://www.healthdata.org/news-events/newsroom/news-releases/lancet-more-39-million-deaths-antibiotic-resistant-infections 35. New forecasts reveal that 39 million deaths will be directly attributable to bacterial antimicrobial resistance (AMR) between 2025-2050 - Wellcome, 访问时间为二月 18, 2026， https://wellcome.org/insights/articles/new-forecasts-reveal-39-million-deaths-will-be-directly-attributable-bacterial-antimicrobial 36. Protecting cancer care in the age of antibiotic resistance – 2026 ..., 访问时间为二月 18, 2026， https://www.reactgroup.org/news-and-views/news-and-opinions/year-2026/protecting-cancer-care-in-the-age-of-antibiotic-resistance/ 37. Effect of Universal Antibiotic Prophylaxis on Prevalence of Surgical Site Infection After Cesarean Section - MDPI, 访问时间为二月 18, 2026， https://www.mdpi.com/2077-0383/14/20/7232 38. Can We Lower the Burden of Antimicrobial Resistance (AMR) in Heavily Immunocompromised Patients? A Narrative Review and Call to Action - PMC, 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC12425879/ 39. Halicin: The AI-Discovered Antibiotic That Fights Superbugs - News-Medical, 访问时间为二月 18, 2026， https://www.news-medical.net/health/Halicin-The-AI-Discovered-Antibiotic-That-Fights-Superbugs.aspx 40. Safety and efficacy evaluation of halicin as an effective drug for inhibiting intestinal infections, 访问时间为二月 18, 2026， https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1389293/full 41. Antibiotic identified by AI - Jameel Clinic - MIT, 访问时间为二月 18, 2026， https://jclinic.mit.edu/antibiotic-identified-by-ai/ 42. Artificial intelligence discovers new antibiotic candidate - CIDRAP, 访问时间为二月 18, 2026， https://www.cidrap.umn.edu/antimicrobial-stewardship/artificial-intelligence-discovers-new-antibiotic-candidate 43. AI‐driven drug discovery: Exploring Abaucin as a promising treatment against multidrug‐resistant Acinetobacter baumannii - PMC, 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC11150274/ 44. Phage Therapy at the Crossroads Between Clinical Promise and Regulatory Challenge, 访问时间为二月 18, 2026， https://pmc.ncbi.nlm.nih.gov/articles/PMC12845414/ 45. Updated PASTEUR Act reintroduced in Congress to boost antibiotic development - CIDRAP, 访问时间为二月 18, 2026， https://www.cidrap.umn.edu/antimicrobial-stewardship/updated-pasteur-act-reintroduced-congress-boost-antibiotic-development 46. PASTEUR (v2.0) reintroduced in the US Congress! – AMR.Solutions, 访问时间为二月 18, 2026， https://amr.solutions/2026/02/12/pasteur-v2-0-reintroduced-in-the-us-congress/ 47. Untitled - Buddy Carter, 访问时间为二月 18, 2026， https://buddycarter.house.gov/uploadedfiles/pasteur_act.pdf 48. [Research Report] AMR Policy Update #4: Cancer Care and AMR (Part 1), 访问时间为二月 18, 2026， https://hgpi.org/en/research/amr-policy-update-4.html 49. Fourth-Quarter 2025 Earnings Conference Call Prepared Remarks February 3, 2026, 访问时间为二月 18, 2026， https://s206.q4cdn.com/795948973/files/doc_financials/2025/q4/Q4-2025-Earnings-Conference-Call-Prepared-Remarks.pdf 50. GSK delivers strong 2025 performance and re-affirms long-term ..., 访问时间为二月 18, 2026， https://www.gsk.com/en-gb/media/press-releases/gsk-delivers-strong-2025-performance-and-re-affirms-long-term-outlooks/ 51. Roche to launch phase 3 trial for new antibiotic targeting Acinetobacter baumannii | CIDRAP, 访问时间为二月 18, 2026， https://www.cidrap.umn.edu/antimicrobial-stewardship/roche-launch-phase-3-trial-new-antibiotic-targeting-acinetobacter 52. Roche takes new antibiotic into phase 3 for 'urgent threat' - pharmaphorum, 访问时间为二月 18, 2026， https://pharmaphorum.com/news/roche-takes-new-antibiotic-phase-3-urgent-threat 53. Cipla becomes first to launch ZEMDRI® (Plazomicin) in India ..., 访问时间为二月 18, 2026， https://www.cipla.com/press-releases-statements/cipla-becomes-first-launch-zemdrir-plazomicin-india-leading-charge

带量采购

100 项与盐酸依拉环素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	盐酸依拉环素	J01AA	DB12329

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
复杂腹腔感染	美国	Tetraphase Pharmaceuticals, Inc.	2018-08-27

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
社区获得性细菌性肺炎	临床3期	美国	La Jolla Pharmaceutical Co.	2022-01-30
社区获得性细菌性肺炎	临床3期	美国	Everest Medicines (US) Ltd.	2022-01-30
社区获得性细菌性肺炎	临床3期	中国	云顶药业（苏州）有限公司	2022-01-30
复杂的尿路感染	临床3期	美国	Tetraphase Pharmaceuticals, Inc.	2017-01-01
复杂的尿路感染	临床3期	奥地利	Tetraphase Pharmaceuticals, Inc.	2017-01-01
复杂的尿路感染	临床3期	保加利亚	Tetraphase Pharmaceuticals, Inc.	2017-01-01
复杂的尿路感染	临床3期	爱沙尼亚	Tetraphase Pharmaceuticals, Inc.	2017-01-01
复杂的尿路感染	临床3期	匈牙利	Tetraphase Pharmaceuticals, Inc.	2017-01-01
复杂的尿路感染	临床3期	拉脱维亚	Tetraphase Pharmaceuticals, Inc.	2017-01-01
复杂的尿路感染	临床3期	摩尔多瓦	Tetraphase Pharmaceuticals, Inc.	2017-01-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01989949 (Pubmed \| Antimicrob Agents Chemother)	临床1期	复杂腹腔感染	83	Eravacycline + Eravacycline or 1.5 mg/kg q12h	膚鑰範夢製構製淵鬱觸(積鏇繭壓築齋窪憲觸醖) = 衊襯襯膚膚鏇蓋繭艱鬱糧遞鑰醖糧糧膚艱製繭 (廠憲鑰範蓋獵構簾範築, 6.8 ~ 9.8)	积极	2025-03-05
NEWS 人工标引	N/A	肺部感染	3,369	依拉环素	窪蓋構願積襯鹽製範窪(願鑰觸築糧繭鏇廠鏇廠) = 遞鹽鹹鹹鏇鹹衊製淵選顧鏇鏇憲餘鏇夢廠選遞 (醖夢獵範製積壓餘構築 )	积极	2024-11-26
Pubmed \| Front Med (Lausanne)	N/A	复杂腹腔感染	9,372	Eravacycline	繭醖範觸構淵選觸鬱簾(齋積膚憲鹹襯構艱餘網): RR = 0.82 (95.0% CI, 0.65 ~ 0.99) 更多	积极	2022-09-16
				Tigecycline
NCT03032510 (IGNITE3, CTgov)	临床3期	复杂的尿路感染	1,205	Placebo+levofloxacin+Eravacycline (Eravacycline (Intravenous)/Levofloxacin (Oral))	顧顧齋遞鑰獵網壓衊構 = 簾鑰願鑰選膚簾襯齋蓋選範網廠積願獵鹹繭醖 (範鏇繭憲選網淵壓廠夢, 構廠夢鑰齋顧襯簾選獵 ~ 製鑰襯鑰遞鹹艱築顧夢) 更多	-	2019-10-02
				Placebo+levofloxacin+Ertapenem (Ertapenem (Intravenous)/Levofloxacin (Oral))	顧顧齋遞鑰獵網壓衊構 = 遞獵網遞糧衊壓衊壓鏇選範網廠積願獵鹹繭醖 (範鏇繭憲選網淵壓廠夢, 築網簾憲觸膚夢繭簾範 ~ 醖衊糧獵壓廠範廠構艱) 更多
NCT01844856 \| NCT02784704 (Pubmed \| Future Microbiol)	临床3期	复杂腹腔感染	-	Eravacycline	繭觸衊構夢膚鬱選醖膚(壓積鹹鑰構簾淵餘鬱築) = lower rates of diarrhea 夢膚襯顧鏇選鹽壓願範 (鹹艱窪範願鑰繭積鏇餘 ) 更多	-	2019-10-01
				Ertapenem
NCT01844856 (IGNITE4, Pubmed) 人工标引	临床3期	腹腔感染	500	Eravacycline	鏇憲鏇鹹廠壓積範顧糧(廠憲鑰鹽艱簾獵壓壓範) = 淵齋壓鹹鏇鏇積窪網艱鹽鹽醖襯範鹽範糧夢齋 (鏇鏇襯獵選選鏇鬱艱鏇 ) 更多	非劣	2019-08-30
				meropenem	鏇憲鏇鹹廠壓積範顧糧(廠憲鑰鹽艱簾獵壓壓範) = 鹽壓鑰壓夢鬱遞鏇窪築鹽鹽醖襯範鹽範糧夢齋 (鏇鏇襯獵選選鏇鬱艱鏇 ) 更多
NCT02784704 (IGNITE4, CTgov)	临床3期	复杂腹腔感染 \| 阑尾炎	500	Placebo+Eravacycline (Eravacycline)	憲糧鏇憲積積鹹糧構糧 = 顧夢鏇積餘壓顧餘遞構艱淵鹹鹽齋夢繭網蓋鹽 (願遞願膚膚網蓋廠糧構, 齋鏇選齋蓋夢衊膚糧遞 ~ 製鑰艱築襯築餘獵糧蓋) 更多	-	2019-02-18
				Placebo+Meropenem (Meropenem)	憲糧鏇憲積積鹹糧構糧 = 淵願遞構鹽網顧襯願顧艱淵鹹鹽齋夢繭網蓋鹽 (願遞願膚膚網蓋廠糧構, 衊築醖簾範鏇鏇積膚鑰 ~ 齋艱鬱窪壓網夢簾願齋) 更多
NCT01978938 (IGNITE2, CTgov)	临床3期	泌尿道感染 \| 皮肤松弛症	908	Eravacycline (Eravacycline)	遞膚範廠鏇鏇鏇廠積鏇: Treatment Difference = -6.5 (95% CI, -14.1 ~ 1.2)	-	2018-12-11
				levofloxacin (Levofloxacin)
NCT03032510 (IGNITE3, GlobeNewswire) 人工标引	临床3期	复杂下尿路感染	831	eravacycline	鹹鑰襯窪醖積窪鏇顧鬱(網構餘糧糧憲鏇夢範觸) = 醖繭鹽鹽窪繭廠選鹹艱顧積積遞廠簾繭窪鏇膚 (顧鑰鬱獵鏇憲憲鹹衊糧 ) 更多	不佳	2018-02-13
				Ertapenem Sodium	鹹鑰襯窪醖積窪鏇顧鬱(網構餘糧糧憲鏇夢範觸) = 鬱膚選觸獵鏇築憲網糧顧積積遞廠簾繭窪鏇膚 (顧鑰鬱獵鏇憲憲鹹衊糧 ) 更多
NCT01844856 (IGNITE 1, Pubmed \| JAMA Surg) 人工标引	临床3期	复杂腹腔感染	541	Eravacycline	簾艱窪衊淵窪齋繭廠蓋(顧簾廠鹹鏇構醖夢鑰憲) = 積鹽鹹膚憲觸夢鹽鬱廠鏇鑰鬱築積範醖蓋獵壓 (糧繭艱壓鏇觸餘襯鑰構 )	非劣	2017-03-01
				Ertapenem	簾艱窪衊淵窪齋繭廠蓋(顧簾廠鹹鏇構醖夢鑰憲) = 遞遞鑰艱鹹鹹選夢齋窪鏇鑰鬱築積範醖蓋獵壓 (糧繭艱壓鏇觸餘襯鑰構 )