Acetylcysteine

口服补铁剂应用接受度高，其中，蛋白琥珀酸铁市场规模稳健增长。 米内网数据显示，中国三大终端六大市场，化药口服铁剂市场规模为注射剂的5倍多，占据84%的市场份额。 蛋白琥珀酸铁口服溶液，位列口服铁剂年销售额第二名。 2021-2024年产品销售额保持在8亿元以上，2025年Q1-Q3增长率为13.76%，是抗贫血制剂（化+生）市场TOP5产品。 从销售渠道来看，蛋白琥珀酸铁口服溶液2022-2024年在中国公立医疗机构终端的销售额有所下滑，2025年Q1-Q3止跌回升0.59%。 该产品在零售药店终端的销售额一路飙涨，2023-2025年Q1-Q3分别大涨了35.23%、49.74%、50.03%，年销售额超过两亿，潜力不容小觑。 图：蛋白琥珀酸铁口服溶液零售药店终端销售金额及增长率 1、蛋白琥珀酸铁口服溶液 【优势】 •市场年均销售额超8亿元，市场规模持续稳定增长，是目前口服补铁剂黄金品种。 •医院、药店连锁、基层医疗各个终端动销，一二三线城市全面深度覆盖。 •一线用药，权威认可。国内外权威指南一致推荐，全科室用药，临床接受度高。 •高安全性、高依从性、高品质。独特蛋白包裹技术，胃肠道刺激小，口感佳，尤其适用于孕妇、儿童及敏感人群，患者依从性显著优于传统补铁剂。 【临床价值】 •高效吸收，生物利用度高 其铁元素与蛋白质结合形成稳定复合物，可在十二指肠和空肠上段被选择性吸收，相比传统无机铁（如硫酸亚铁），吸收更充分，生物利用度更高。 每瓶含铁量高达40mg，能有效满足每日补铁需求，快速提升血红蛋白水平。 •安全性高，不良反应少 由于铁离子释放缓慢，对胃肠道黏膜刺激小，显著降低了恶心、呕吐、便秘等传统铁剂常见的不良反应。 被《铁缺乏症和缺铁性贫血诊治和预防的多学科专家共识（2022年版）》等权威指南推荐为一线有机补铁剂，且为OTC药品，安全性得到广泛验证。 •适用人群广泛，依从性好 适用于各年龄段人群，包括孕妇、哺乳期妇女、儿童及术后恢复期患者。 溶液剂型，味甜气香，无铁腥味，口感佳，极大提升了儿童和成人患者的服药依从性。 •临床证据充分，指南一致推荐 多项临床研究证实其在治疗妊娠期缺铁性贫血、小儿营养性缺铁性贫血及早产儿贫血（AOP）方面疗效确切。 被《双胎妊娠期缺铁性贫血诊治及保健指南（2023年版）》、《儿童铁缺乏和缺铁性贫血防治专家共识》及WHO《产后妇女补铁指南》等权威文献推荐。 2、乙酰半胱氨酸 乙酰半胱氨酸一直是市场上的明星产品，备受关注，据米内网数据显示，该通用名在我国公立医疗机构终端2021-2024年，年销售规模均超过37亿元。 四川大通信宏医药集团重点打造乙酰半胱氨酸注射液全套产品，在这个系列上，国内最全，别无他家。 均为近期上市产品，市场价格干净，有成本优势，适合医院和三终端。 乙酰半胱氨酸注射液（3ml:0.3g） 【优势】 祛痰药注射液剂市场总额近百亿，乙酰半胱氨酸、溴己新、氨溴索等品种占据主导，目前氨溴索，溴己新已纳入国家集采。乙酰半胱氨酸注射液3ml未纳入国家集采，成熟临床大品种。 乙酰半胱氨酸注射液3ml原研2025年5月21日获批上市。海梦为国内首仿，目前全国独家招商。 适用于治疗浓稠粘液分泌物过多的呼吸道疾病，全科用药，等级医院、社区医院、诊所等各级终端均有巨大临床需求，一二三线城市全面深度覆盖。 《慢性气道炎症性疾病气道黏液高分泌管理中国专家共识》《慢性阻塞性肺疾病诊治指南》祛痰类药物推荐用药。 使用便捷，不需要其它雾化装置;通过注射给药，能够实现100%的生物利用度，全气道快速达到有效血药浓度且持续作用，更能满足气流受限或无法吞咽的患者(例如重症、手术、老年患者)的治疗需求。 【临床价值】 •国内首仿静脉“碎痰药” —— 独家剂型，直击重症呼吸道管理痛点唯一国产静脉用乙酰半胱氨酸制剂，专治浓稠黏液阻塞气道疾病（如慢支急性加重、支气管扩张、肺脓肿等），解决口服/雾化无法覆盖的重症患者需求。 •双重机制驱动 —— 祛痰 + 抗氧化，改善预后而非仅缓解症状 断裂二硫键（-S-S-）→ 降低痰液黏度 → 促进排痰 提升GSH、清除ROS、抑制炎症因子（TNF-α, IL-6）→ 减轻肺损伤、保护肝肾功能 •多器官保护证据确凿 —— “肺 - 肾 - 肝”三位一体防护网 肺：显著降低痰液黏稠度与咳痰难度（P<0.01），缩短ICU住院时间4.7天 肾：降低万古霉素肾毒性风险，减少心脏术后AKI发生率16% 肝：预防重症患者转氨酶升高及肝损伤，死亡率降低30% •权威指南背书 + 安全性优异 —— 临床放心使用获意大利新冠指南、中国外科围术期共识等多项推荐；安全性与安慰剂相当，无显著不良反应差异，耐受性良好。 •重症感染防治基石策略 —— 从“被动治疗”转向“主动干预”肺部感染是ICU死亡主因（占比60.1%），早期使用NAC可有效廓清气道、阻断炎症，防止病情恶化，符合“防重于治”的现代重症理念。 乙酰半胱氨酸注射液（20ml:4g） 【优势】 •20ml规格乙酰半胱氨酸注射液适应症:肝衰竭早期治疗，以降低胆红素，提高凝血酶原活动度。目前获批这个适应症能供应临床的厂家仅2家，属于稀缺产品。 •上市多年成熟临床产品，乙酰半胱氨酸注射液的销售规模近10亿元，市场基础良好，潜力巨大。急抢救药品直接挂网采购示范药品》，直接挂网，价格稳定。 •大品类，全科室用药:唯一被美国FDA批准用于肝衰竭和药物性肝损伤的药品，临床运用广泛。 •《2017年欧洲肝病学会临床实践指南:急性(爆发性)肝衰竭的管理》等顶级指南明确推荐，药物性肝损伤和肝衰竭的一线治疗性用药。 【临床价值】 •唯一Ⅰ级循证护肝药 —— 指南首选，证据确凿国内外权威指南一致推荐，是唯一被证实能改善药物性肝损伤（DILI）及肝衰竭患者预后的药物，疗效优于还原型谷胱甘肽。 •多重机制全面护肝 —— 解毒+抗氧化+抗炎+促再生 补充谷胱甘肽前体 → 中和毒性代谢物（如NAPQI）  清除自由基 → 减轻氧化应激与细胞坏死 改善微循环 → 促进肝细胞修复与功能恢复 • 静脉给药急救无忧 —— 起效快、适用广适用于呕吐、昏迷或无法口服患者，确保重症/急症患者及时获得有效治疗剂量，生物利用度稳定可靠。 • 早期干预效果显著 —— “黄金8小时”决定预后中毒或肝损后8–10小时内使用可近乎完全预防肝衰竭。 •一药多护，适用于：抗结核/抗肿瘤药致DILI、酒精性肝炎、病毒性肝炎、化疗相关肝损、肝癌辅助治疗等。 乙酰半胱氨酸注射液（25ml：5g） 3、维生素K1滴剂（即将上市品种） 1、2025年全球维生素K市场规模11亿美元，中国滴剂市场将成为主要增长点，国内维生素K1滴剂2025年产值约5亿元，市场规模超30亿元； 2、国内维生素K1滴剂为创新剂型，目前市场包括原研仅两家企业，我司冲刺国产第二家； 3、随着国家相关政策放开，预计未来三年我国新生儿仍然维持在900万左右； 4、过往维生素K1其它剂型均，不适宜于预防婴幼儿维生素K出血的风险。维生素K1滴剂可使健康足月产婴儿在出生后第一周内免受维生素K缺乏引起出血的风险； 5、属于国家政策鼓励的临床急需儿童用药，相较于其他维生素K1剂型产生的安全问题，口服剂型行业前景广阔。 大通全产品 想寻求合作的朋友，一定不要错过！

Enters into Strategic Transaction, unlocking $100 million in value Sharpens focus on Orphan Drug candidates to address unmet medical needs NASHVILLE, Tenn., May 5, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, announced today that its product portfolio of FDA-approved brands delivered combined net revenues of $9.1 million during the first quarter of 2026. Cumberland ended the quarter with $71.0 million in total assets, $49.7 million in liabilities and $21.6 million of shareholders' equity. "We entered 2026 with strong momentum following an outstanding 2025, which featured double-digit revenue growth, the addition of a new product to our portfolio, new international approvals and breakthrough clinical study results," said A.J. Kazimi, Cumberland Pharmaceuticals CEO. "We have built on that momentum through our recently announced Strategic Transaction, which represents an important next step in our Company's evolution, enabling us to sharpen our focus on developing high-value product candidates, while unlocking significant value for our shareholders." RECENT COMPANY DEVELOPMENTS INCLUDE: Strategic Transaction Cumberland recently announced a Strategic Transaction with Apotex Inc., the largest Canadian-based pharmaceutical company, to integrate the branded U.S. commercial businesses. Under the terms of the agreement, Apotex will acquire Cumberland's portfolio of FDA-approved brands for $100 million in cash consideration, subject to Cumberland shareholders' approval and certain other customary closing conditions. This transaction is designed to unlock value and sharpen Cumberland's focus on advancing its pipeline of differentiated product candidates designed to address unmet medical needs. The integration of Cumberland's products will create more critical mass to support patient care and expand product distribution. Following the closing of the transaction, Cumberland will retain its development programs, as well as its majority ownership in Cumberland Emerging Technologies. This positions Cumberland to operate with the profile of an innovative, development-stage biopharmaceutical organization devoted to new medicines for the future. Development Pipeline In addition to its portfolio of FDA-approved brands involved in the transaction with Apotex, Cumberland is developing ifetroban, a potent thromboxane antagonist, through a series of clinical programs designed to address unmet medical needs with significant market potential. Cumberland has announced breakthrough results in a Phase II clinical study of ifetroban in patients with cardiomyopathy associated with Duchenne muscular dystrophy ("DMD"). This rare, fatal genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles. Discussions with the FDA are underway regarding the study results and remaining requirements for approval. During the first quarter of 2026, the FDA granted Fast Track Designation for Cumberland's ifetroban candidate product for DMD patients. This designation is intended to accelerate the development and review of therapies that address serious conditions with unmet medical needs. Importantly, it allows for more frequent FDA interaction, rolling data submissions and earlier guidance throughout the approval process. The program previously received both Orphan Drug and Rare Pediatric Disease designations from the FDA. In addition, Cumberland has a Phase II clinical program evaluating its ifetroban product candidate in patients with Systemic Sclerosis ("SSc") or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs. Enrollment in the study is completed and the next milestone will be announcing its top-line study results. Cumberland's third development program involves the use of ifetroban in patients with Idiopathic Pulmonary Fibrosis ("IPF"), the most common form of progressive fibrosing interstitial lung disease. Enrollment in the study is well underway at medical centers across the U.S., with interim safety and interim efficacy results pending. FINANCIAL RESULTS: Net Revenue: For first quarter of 2026, the Company's net revenues of $9.1 million, which represented a 5% increase compared to the first quarter of 2025 after removing the $3 million milestone payment last year associated with the approval of Vibativ® in China. Cumberland's branded portfolio revenue included $1.0 million for Kristalose®, $2.9 million for Sancuso®, $2.1 million for Vibativ®, $1.0 million for Caldolor® and $1.9 million for Talicia.® Operating Expenses: Total operating expenses for the quarter were $12.3 million. Net Income (Loss): The net loss for the first quarter of 2026 was approximately $3.3 million. Adjusted Earnings (Loss): Adjusted loss for the quarter was $1.9 million, or $0.13 per share. Balance Sheet: At March 31, 2026, Cumberland had approximately $71.0 million in total assets, including $11.0 million in cash and cash equivalents. Liabilities totaled $49.7 million, including $5.2 million on the company's credit facility. Total shareholders' equity was $21.6 million on March 31, 2026. EARNINGS REPORT CALL: A conference call will be held today, May 5, 2026, at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results. The link to register is . Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference. A replay of the call will be available for one year and can be accessed via Cumberland's website or by visiting: . ABOUT CUMBERLAND PHARMACEUTICALS: Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote ® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor ® (ibuprofen) injection, for the treatment of pain and fever; Kristalose ® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso ® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol ® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; Vibativ ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections; and Talicia ® (omeprazole, amoxicillin and rifabutin) oral capsule, for the treatment of H. pylori infection. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with Duchenne Muscular Dystrophy, Systemic Sclerosis and Pulmonary Fibrosis. For more information on Cumberland's approved products, including full prescribing information, please visit the links to the individual product websites, which can be found on the company's website at . About Acetadote ® (acetylcysteine) Injection Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. For full prescribing and safety information, visit . About Caldolor ® (ibuprofen) Injection Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) as well as patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit . About Kristalose ® (lactulose) Oral Solution Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit . About Sancuso ® ( granisetron) Transdermal System Sancuso is the only skin patch approved by the FDA for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the Sancuso patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient's bloodstream. It can prevent CINV for chemotherapy regimens of up to five consecutive days. For full prescribing and safety information, visit . About Vaprisol ® (conivaptan hydrochloride) Injection Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit . About Vibativ ® (telavancin) for Injection Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information, please visit . About Talicia ® Talicia® is an FDA approved oral capsule for the treatment of Helicobacter pylori (H. pylori) infection in adults, a bacterial infection of the stomach and leading risk factor for gastric cancer. Talicia is listed as a first line option in the 2024 ACG Guideline for the treatment of H. pylori and features three key advantages: 1) high eradication rates - >90% in confirmed adherent patients, 2) the simplicity of an all-in-one capsule, and 3) low resistance to the two antibiotics - amoxicillin and rifabutin. For more information, please visit . FORWARD LOOKING STATEMENTS: This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the Company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "goal", "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include risks and uncertainties related to the strategic transaction, risks related to our ability to develop our pipeline of new product candidates, macroeconomic conditions, including changes in interest rates, inflation, tariffs, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the Company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the Company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. The Company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. These financial measures should be considered supplemental to, and not as a substitute for, financial information prepared in accordance with Generally Accepted Accounting Principles ("GAAP"). The definition of these supplemental measures may differ from similarly titled measures used by others. Because these supplemental financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the supplemental financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Cumberland's management believes these supplemental financial performance measures are important as they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance. In addition, Cumberland believes that they will be used by certain investors to measure the Company's operating results. Management believes that presenting these supplemental measures provides useful information about the Company's underlying performance across reporting periods on a consistent basis by excluding items that Cumberland does not believe are indicative of its core business performance or reflect long-term strategic activities. Certain of these items are not settled through cash payments and include: depreciation, amortization of intangible and right-of-use assets, share-based compensation expense and income taxes. Cumberland utilizes its net operating loss carryforwards to pay minimal income taxes. In addition, the use of these financial measures provides greater transparency to investors of supplemental information used by management in its financial and operational decision-making, including the evaluation of the Company's operating performance. The Company defines these supplemental financial measures as follows: Adjusted Earnings (loss): Net income (loss) adjusted for the impact of income taxes, depreciation and amortization expense, share-based compensation, interest income and interest expense. (a) Represents the share-based compensation of Cumberland. (b) Represents the straight line reduction in carrying value of right-of-use assets. Adjusted Diluted Earnings (loss) Per Share: Adjusted Earnings (loss) divided by diluted weighted-average common shares outstanding. SOURCE Cumberland Pharmaceuticals Inc. 21% more press release views with Request a Demo