CUMBERLAND PHARMACEUTICALS ANNOUNCES LAUNCH OF VIBATIV® IN CHINA
Commercialization in China through partnership with SciClone Pharmaceuticals
Expands access to potentially life-saving antibiotic in the world's second-largest pharmaceutical market
NASHVILLE, Tenn., May 28, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX), an innovation focused biopharmaceutical company, today announced the launch of its Vibativ® (telavancin) injection in China, following regulatory approval and a strategic partnership with SciClone Pharmaceuticals (Holdings) Limited.
The launch follows a previously announced agreement granting SciClone exclusive rights to register, promote and distribute telavancin, injection across China. The product's approval by China's National Medical Products Administration (NMPA) enables SciClone to commercialize the product in one of the world's largest and fastest-growing pharmaceutical markets.
Telavancin is a patented, FDA-approved injectable anti-infective that serves as a potentially life-saving treatment for patients with serious bacterial infections, including hospital-acquired and ventilator-associated pneumonia. The therapy is designed to treat infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-sensitive Staphylococcus aureus (MSSA). Vibativ addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.
"Launching telavancin in China marks a significant milestone in advancing our mission of providing unique products that improve the quality of patient care," said A.J. Kazimi, Cumberland Pharmaceuticals CEO. "Through our partnership with SciClone, we are expanding access to this important therapy and providing physicians in China with a valuable new option to treat serious, difficult-to-manage infections."
Antimicrobial resistance continues to be a critical global health challenge, reducing the effectiveness of many existing antibiotics and increasing the need for innovative treatments. Telavancin was specifically designed to address resistant pathogens, offering potent activity against difficult-to-treat infections.
Mr. Zhao Hong, President and Chief Executive Officer of SciClone Pharmaceuticals, stated, "The successful launch of telavancin for injection in China represents another important milestone for SciClone Pharmaceuticals in the anti-infective field. Currently, MRSA remains a serious challenge and poses a significant clinical threat, particularly in respiratory tract infections, especially those that are hospital-acquired. With its unique dual bactericidal mechanism, broad antibacterial spectrum, and once-daily dosing regimen, telavancin offers an important new anti-infective option for Chinese patients with severe infections, delivering both improved efficacy and clinical convenience. Looking ahead, SciClone Pharmaceuticals will continue to focus on severe infection and oncology, address unmet medical needs, and accelerate the launch of more innovative products in China to contribute to the 'Healthy China 2030' initiative."
About Vibativ®
Vibativ® (telavancin) injection was discovered in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including MRSA and MSSA. It is a once-daily, injectable lipoglycopeptide antibiotic with in vitro potency, bactericidal activity within six hours and penetration into target infection sites. The drug is approved in the U.S. and Saudi Arabia for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable.
In addition, telavancin is approved in the U.S. and Saudi Arabia for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains. The product labeling also describes the use of telavancin in treating patients whose pneumonia or skin infection is complicated by concurrent bacteremia. The product's proven efficacy against difficult-to-treat Gram-positive infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with S. aureus infections studied to date. Importantly, these studies demonstrated significantly higher cure rates for telavancin as compared to vancomycin in HABP/VABP due to any single Gram-positive pathogen or S. aureus with vancomycin MIC ≥1 µg/mL. Additionally, there is extensive and well-documented evidence of the drug's in vitro potency and in vivo activity against a broad collection of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.
For full prescribing information, including important safety information, visit www.vibativ.com.
About SciClone Pharmaceuticals
SciClone Pharmaceuticals (Holdings) Limited ("SciClone Pharmaceuticals") is a global biopharmaceutical company with an integrated platform for the development and commercialization of innovative therapies for cancer and severe infection.
With an innovation-driven strategic transformation, SciClone Pharmaceuticals has established a product portfolio with differentiated advantages, including a number of first-in-class and best-in-class potential products / pipelines. Staying true to its original aspiration of "SciClone gives life hope," SciClone Pharmaceuticals is dedicated to improving patients' health by providing top-tier health care products and services with global standards of care.
For more information regarding SciClone Pharmaceuticals, please visit: www.sciclone.com.
For SciClone press contacts please reach out to pr@sciclone.com.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on developing innovative products that improve the quality of patient care. The company is advancing a clinical pipeline of late stage product candidates across multiple therapeutic areas with significant unmet medical needs.
For more information, please visit www.cumberlandpharma.com.
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.
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