Eravacycline Dihydrochloride

5月7日，云顶新耀的布地奈德肠溶胶囊（耐赋康®）正式获得中国国家药品监督管理局（NMPA）的完全批准，这标志着该药物从附条件批准转为全面获批，也意味着其在IgA肾病治疗领域的地位进一步巩固，它成为国内首个且唯一获得完全批准的IgA肾病对因治疗药物，同时取消了对蛋白尿水平的限制，扩大了适用患者群体。布地奈德肠溶胶囊的完全批准基于全球III期临床试验NefIgArd研究的完整数据。这项研究覆盖了接受RAS抑制剂优化治疗的原发性IgA肾病患者，采用随机、双盲、多中心设计，结果显示，与安慰剂相比，布地奈德肠溶胶囊在9个月治疗期和15个月停药随访期内显著降低了蛋白尿水平，并减少了镜下血尿风险。更重要的是，它在估算肾小球滤过率（eGFR）这一关键指标上展现出统计学差异（p<0.0001），全球数据显示其减少肾功能衰退达50%，而中国亚组数据更为亮眼，延缓肾功能衰退达66%，预计将疾病进展至透析或肾移植的时间推迟12.8年。此前，布地奈德肠溶胶囊于2023年11月通过优先审评程序获得附条件批准，但当时适应症限于蛋白尿水平较高的患者，如尿蛋白肌酐比≥1.5g/g。此次取消限制后，所有具有疾病进展风险的IgA肾病患者均可使用，覆盖人群大幅扩大。例如，原本尿蛋白未达标的患者也能尽早接受对因治疗，从而延缓肾功能恶化。这一变化直接回应了临床需求，中国约有500万IgA肾病患者，每年新增超10万例，且东亚人群疾病进展更快、预后更差，传统治疗手段如激素和免疫抑制剂副作用大，疗效有限。IgA肾病的核心病理机制是半乳糖缺陷的IgA1抗体（Gd-IgA1）在肾脏沉积引发炎症反应，而这一抗体的产生与回肠末端的派尔集合淋巴结中的B细胞活化密切相关。布地奈德肠溶胶囊通过特殊的肠溶缓释工艺，将布地奈德靶向释放至回肠末端，抑制局部B细胞的活化和Gd-IgA1的生成，从而减少循环中的致病性免疫复合物，从上游阻断疾病进展。这种局部作用的设计大幅降低了全身副作用，布地奈德的首过代谢率高达90%，全身暴露量仅为10%，避免了传统激素的骨质疏松、高血糖等问题。价格曾是布地奈德肠溶胶囊推广的一大障碍。未纳入医保前，其疗程费用高达15万-18万元，9个月需服用约4盒，每盒1.5万-2万元，对普通患者而言负担沉重。但2024年11月，该药成功进入国家医保目录（乙类），并于2025年1月1日正式执行医保价格。截至今年3月底，全国26个省市已实现医保落地，覆盖医院和药店的渠道逐步完善。这一举措显著提升了药物可及性，尤其考虑到IgA肾病需长期管理，医保支持对患者坚持治疗至关重要。在实际应用中，布地奈德肠溶胶囊的用药方案为每日一次16mg（4粒），需整粒吞服且早餐前1小时空腹服用，以确保药物在肠道靶向释放。疗程固定为9个月，随后进入停药观察期，其疗效呈现延迟效应，蛋白尿最大降幅出现在停药后3个月（即第12个月），而肾功能保护作用在24个月的随访中持续显现。这提示医生和患者需耐心等待疗效显现，避免过早中断治疗。此外，药物代谢依赖CYP3A4酶，因此需避免与强效抑制剂，如酮康唑、西柚汁联用，以防血药浓度异常升高。对云顶新耀而言，布地奈德肠溶胶囊的完全批准是其商业化进程的关键一步。公司早在2019年通过授权引进获得该药在大中华区及新加坡的开发权益，2022年进一步扩展至韩国。目前，药物已在中国大陆、香港、澳门和新加坡上市，韩国及台湾地区预计年内跟进。为加速市场渗透，云顶新耀组建了200人的销售团队，目标覆盖全国600家医院，并与博鳌乐城先行区合作探索早期准入模式。财务方面，公司预计2025年实现现金流打平，天风证券预测其2025年营收或超18亿元。这一布局不仅依赖布地奈德肠溶胶囊，还需另一获批产品依拉环素（抗感染药）的协同效应，但IgA肾病领域的巨大需求仍是核心驱动力。布地奈德肠溶胶囊的临床价值已获国际权威指南认可。2024版KDIGO（改善全球肾脏病预后组织）指南将其列为推荐疗法，强调其作为“唯一可降低致病性IgA水平”的对因治疗地位。与传统治疗方案相比，其优势在于疗效持久且安全性更优，III期研究显示，即使停药后，eGFR下降速度仍较安慰剂组减少2.47mL/min/年，提示黏膜免疫调节的延续效应。尽管布地奈德肠溶胶囊疗效显著，但仍存在局限性。例如，其对严重肾功能不全（eGFR<30mL/min）患者无效，且价格即便纳入医保仍高于传统药物。未来，联合治疗可能是突破方向，与补体抑制剂联用，或与抗纤维化药物协同，有望进一步提升疗效。信息来源：[1]云顶新耀官媒[2]National Medical Products Administration (NMPA). (2024). Approval of Nefecon (Budesonide Delayed-Release Capsules) for IgA Nephropathy.[3]Everest Medicines. (2024). NefIgArd III Study Results Presented at ISN World Congress of Nephrology 2024.药事纵横投稿须知：稿费已上调，欢迎投稿

BURLINGAME, Calif.--(BUSINESS WIRE)--Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding 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 first quarter ended March 31, 2025, and highlighted select corporate progress and achievements. “We are pleased with our strong first quarter financial results, highlighted by robust cash flows from our GSK royalties portfolio and continued excellent growth from the IST-marketed products,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “Our therapeutics business remains a key driver, with an NDA filing for zoliflodacin on track and the U.S. commercial launch of ZEVTERA® (ceftobiprole) anticipated by mid-2025, underscoring our commitment to delivering innovative treatments to patients and our ability to leverage the operating platform.” “Additionally, we remain dedicated to creating value for our shareholders by strategically enhancing our healthcare assets. We are cognizant of the increased market volatility and believe that the strength of our balance sheet, combined with a disciplined approach to capital allocation, positions us well to advance our diversified portfolio and capitalize on new opportunities, thereby supporting sustained growth across market environments,” concluded Mr. Raifeld. Financial Highlights Royalty revenue: First quarter 2025 gross royalty revenue from Glaxo Group Limited (“GSK”) was $61.3 million, compared to $61.9 million for the first quarter of 2024. Net product sales: First quarter 2025 net product sales totaled $30.3 million, consisting of $26.4 million in U.S. net product sales and $3.9 million in ex-U.S. net product sales, compared to $19.1 million in net product sales for the first quarter of 2024. U.S. net product sales included $17.4 million from GIAPREZA ® , $5.8 million from XACDURO ® , and $3.2 million from XERAVA ® , representing a 52% increase compared to total U.S. net product sales of $17.4 million in the first quarter of 2024. Income from operations: First quarter 2025 income from operations was $41.4 million, an increase of 61% from $25.8 million in the first quarter of 2024. Equity and long-term investments: First quarter 2025 unfavorable changes in fair values of equity and long-term investments totaled $78.8 million, compared to favorable changes of $22.0 million in the first quarter of 2024, primarily due to the share price depreciation of Armata Pharmaceuticals and certain equity investments managed by ISP Fund LP. Net income: First quarter 2025 net loss was $46.6 million, or ($0.74) basic per share, compared to net income of $36.5 million, or $0.58 basic per share, for the first quarter of 2024. Cash and cash equivalents: Totaled $319.1 million. Royalty and net product sales receivables totaled $77.9 million as of March 31, 2025. Key Business and R&D Highlights Zoliflodacin: a potential first-in-class, single dose, oral antibiotic is currently being developed together with The Global Antibiotic Research & Development Partnership ("GARDP") for the treatment of patients with uncomplicated gonorrhea. Zoliflodacin NDA on track for filing with the U.S. FDA in the first half of 2025. Zoliflodacin NDA on track for filing with the U.S. FDA in the first half of 2025. ZEVTERA ® (ceftobiprole): an advanced-generation cephalosporin antibiotic that is approved in the U.S. for three specific treatment indications. ZEVTERA ® is the only FDA-approved methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin antibiotic for treating adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB) and endocarditis. ZEVTERA ® is indicated for the treatment of adult patients with SAB, including right-sided infective endocarditis, adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). Following the exclusive distribution and license agreement with Basilea Pharmaceutica Ltd. in December 2024, Innoviva anticipates launching ZEVTERA ® in the U.S. in mid-2025. Following the exclusive distribution and license agreement with Basilea Pharmaceutica Ltd. in December 2024, Innoviva anticipates launching ZEVTERA ® in the U.S. in mid-2025. XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use: a targeted antibacterial treatment for patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. In April, the Company presented in vivo and in vitro data on the activity of durlobactam against Enterobacterales at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global). In April, the Company presented in vivo and in vitro data on the activity of durlobactam against Enterobacterales at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global). Innoviva’s portfolio of strategic assets held through the Company’s various subsidiaries was valued at $457.6 million as of March 31, 2025. In the first quarter of 2025, we invested a total of $34.7 million in various strategic healthcare assets, including $15.0 million in a convertible note of Gate Neurosciences and $10.0 million in a term loan to Armata Pharmaceuticals. About Innoviva Innoviva is a diversified holding 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 other commercial and marketed products include infectious disease and critical care assets: GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock; XERAVA® (eravacycline), approved for the treatment of complicated intra-abdominal infections in adults; and XACDURO® (sulbactam for injection; durlobactam for injection), approved for the treatment of hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter in adults. In addition, ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, will be exclusively commercialized by us in the U.S. under a distribution and license agreement with Basilea Pharmaceutica Ltd., (“Basilea”), entered into in December 2024. We continue to advance our pipeline with zoliflodacin, a potentially first in class, single-dose oral treatment for uncomplicated gonorrhea. 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® and ZEVTERA® 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, 2024 and subsequently Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at www.sec.gov. 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. 2025 2024 $ 57,807 $ 58,415 30,279 19,084 546 — 88,632 77,499 8,842 10,971 6,475 6,440 73,315 60,088 27,491 30,405 4,396 3,878 31,887 34,283 41,428 25,805 (13,549 ) 35,342 (65,299 ) (13,335 ) 4,538 4,399 (4,711 ) (5,851 ) (996 ) (1,236 ) (38,589 ) 45,124 (7,995 ) (8,592 ) $ (46,584 ) $ 36,532 $ (0.74 ) $ 0.58 $ (0.74 ) $ 0.46 62,709 63,185 62,709 84,531 2025 2024 $ 61,263 $ 61,871 (3,456 ) (3,456 ) $ 57,807 $ 58,415 2025 2024 $ 319,090 $ 304,964 77,936 86,366 41,479 33,725 15,727 21,719 127,790 107,532 483 514 329,844 393,957 66,505 69,961 2,110 2,453 17,905 17,905 201,958 208,433 12,294 12,054 41,269 41,477 $ 1,254,390 $ 1,301,060 $ 40,695 $ 39,507 833 3,422 1,002 1,126 192,215 192,028 256,670 256,316 62,009 64,275 54,061 53,227 646,905 691,159 $ 1,254,390 $ 1,301,060 2025 2024 $ 48,617 $ 37,047 (34,674 ) (43,038 ) 183 (9,165 ) $ 14,126 $ (15,156 ) 304,964 193,513 $ 319,090 $ 178,357