VIBATIV® RECEIVES MARKETING APPROVAL IN CHINA
Cumberland Pharmaceuticals (CPIX) and SciClone Pharmaceuticals announced that Vibativ® (telavancin) injection has received NMPA marketing approval in China. Vibativ is an FDA-approved injectable antibiotic used to treat hospital-acquired pneumonia and complicated skin infections, including those caused by drug-resistant bacteria.
The approval enables SciClone to exclusively register, promote, and distribute Vibativ in China, the world's second-largest market. The companies plan to launch the product later this year. Two published studies involving over 39,000 clinical isolates demonstrate that Vibativ maintains its potency against difficult-to-treat and multidrug-resistant bacteria, even after a decade since its introduction.
Vibativ has shown significantly higher cure rates compared to vancomycin in certain pneumonia cases and doesn't require therapeutic drug monitoring. A recent study also suggested the drug's safety in children aged 2-17 years.
Cumberland Pharmaceuticals (CPIX) e SciClone Pharmaceuticals hanno annunciato che l'iniezione di Vibativ® (telavancin) ha ricevuto l'approvazione per la commercializzazione da parte della NMPA in Cina. Vibativ è un antibiotico iniettabile approvato dalla FDA, utilizzato per trattare la polmonite acquisita in ospedale e infezioni cutanee complicate, comprese quelle causate da batteri resistenti ai farmaci.
L'approvazione consente a SciClone di registrare, promuovere e distribuire esclusivamente Vibativ in Cina, il secondo mercato più grande al mondo. Le aziende prevedono di lanciare il prodotto entro la fine di quest'anno. Due studi pubblicati che coinvolgono oltre 39.000 isolati clinici dimostrano che Vibativ mantiene la sua potenza contro batteri difficili da trattare e multiresistenti, anche dopo un decennio dalla sua introduzione.
Vibativ ha mostrato tassi di guarigione significativamente più elevati rispetto alla vancomicina in alcuni casi di polmonite e non richiede monitoraggio terapeutico dei farmaci. Uno studio recente ha anche suggerito la sicurezza del farmaco nei bambini di età compresa tra 2 e 17 anni.
Cumberland Pharmaceuticals (CPIX) y SciClone Pharmaceuticals anunciaron que la inyección de Vibativ® (telavancin) ha recibido la aprobación de comercialización de la NMPA en China. Vibativ es un antibiótico inyectable aprobado por la FDA, utilizado para tratar la neumonía adquirida en el hospital y las infecciones cutáneas complicadas, incluidas las causadas por bacterias resistentes a los medicamentos.
La aprobación permite a SciClone registrar, promover y distribuir exclusivamente Vibativ en China, el segundo mercado más grande del mundo. Las empresas planean lanzar el producto a finales de este año. Dos estudios publicados que involucran más de 39,000 aislados clínicos demuestran que Vibativ mantiene su potencia contra bacterias difíciles de tratar y multirresistentes, incluso después de una década desde su introducción.
Vibativ ha mostrado tasas de curación significativamente más altas en comparación con la vancomicina en ciertos casos de neumonía y no requiere monitoreo terapéutico de medicamentos. Un estudio reciente también sugirió la seguridad del fármaco en niños de 2 a 17 años.
컴벌랜드 제약(CPIX)과 사이클론 제약은 비바티브®(텔라반신) 주사가 중국에서 NMPA의 마케팅 승인을 받았다고 발표했습니다. 비바티브는 FDA에서 승인한 주사 항생제로, 병원에서 발생한 폐렴 및 복잡한 피부 감염, 특히 약물 내성 박테리아에 의해 발생한 감염 치료에 사용됩니다.
이번 승인은 사이클론이 중국에서 비바티브를 독점적으로 등록, 홍보 및 유통할 수 있게 합니다. 중국은 세계에서 두 번째로 큰 시장입니다. 두 회사는 올해 말 제품을 출시할 계획입니다. 39,000개 이상의 임상 분리가 포함된 두 개의 발표된 연구는 비바티브가 치료하기 어려운 다제내성 박테리아에 대해 강력한 효능을 유지하고 있음을 보여줍니다. 이는 비바티브가 도입된 지 10년이 지난 후에도 마찬가지입니다.
비바티브는 특정 폐렴 사례에서 반코마이신에 비해 유의미하게 높은 치료율을 보였으며, 치료 약물 모니터링이 필요하지 않습니다. 최근 연구에서는 2세에서 17세 아동에 대한 약물의 안전성도 제안했습니다.
Cumberland Pharmaceuticals (CPIX) et SciClone Pharmaceuticals ont annoncé que l'injection de Vibativ® (telavancin) a reçu l'approbation de mise sur le marché de la NMPA en Chine. Vibativ est un antibiotique injectable approuvé par la FDA, utilisé pour traiter la pneumonie acquise à l'hôpital et les infections cutanées compliquées, y compris celles causées par des bactéries résistantes aux médicaments.
Cette approbation permet à SciClone d'enregistrer, de promouvoir et de distribuer exclusivement Vibativ en Chine, le deuxième plus grand marché au monde. Les entreprises prévoient de lancer le produit plus tard cette année. Deux études publiées impliquant plus de 39 000 isolats cliniques montrent que Vibativ maintient sa puissance contre des bactéries difficiles à traiter et multirésistantes, même après une décennie depuis son introduction.
Vibativ a montré des taux de guérison significativement plus élevés par rapport à la vancomycine dans certains cas de pneumonie et ne nécessite pas de surveillance thérapeutique des médicaments. Une étude récente a également suggéré la sécurité du médicament chez les enfants âgés de 2 à 17 ans.
Cumberland Pharmaceuticals (CPIX) und SciClone Pharmaceuticals haben bekannt gegeben, dass die Injektion von Vibativ® (Telavancin) die Genehmigung für den Vertrieb durch die NMPA in China erhalten hat. Vibativ ist ein von der FDA zugelassenes injizierbares Antibiotikum, das zur Behandlung von im Krankenhaus erworbener Pneumonie und komplizierten Hautinfektionen eingesetzt wird, einschließlich solcher, die durch antibiotikaresistente Bakterien verursacht werden.
Die Genehmigung ermöglicht es SciClone, Vibativ exklusiv in China zu registrieren, zu bewerben und zu vertreiben, dem zweitgrößten Markt der Welt. Die Unternehmen planen, das Produkt noch in diesem Jahr auf den Markt zu bringen. Zwei veröffentlichte Studien mit über 39.000 klinischen Isolaten zeigen, dass Vibativ seine Wirksamkeit gegen schwer zu behandelnde und multiresistente Bakterien auch nach einem Jahrzehnt seit seiner Einführung beibehält.
Vibativ hat in bestimmten Fällen von Pneumonie signifikant höhere Heilungsraten im Vergleich zu Vancomycin gezeigt und erfordert keine therapeutische Medikamentenüberwachung. Eine aktuelle Studie hat auch die Sicherheit des Medikaments bei Kindern im Alter von 2 bis 17 Jahren nahegelegt.
- Secured marketing approval in China, the world's second-largest market
- Maintained efficacy against drug-resistant bacteria over 10 years, proven by large-scale studies
- Demonstrates higher cure rates compared to vancomycin in specific pneumonia cases
- Requires no therapeutic drug monitoring, reducing healthcare professional exposure
- None.
Insights
The NMPA approval of Vibativ in China marks a pivotal expansion opportunity for Cumberland Pharmaceuticals, opening access to a $25+ billion antibiotics market. This regulatory milestone is particularly significant given China's growing challenge with antimicrobial resistance and hospital-acquired infections.
Several factors enhance the commercial potential of this approval:
- Vibativ maintains its potency against resistant bacteria even after a decade of use, as demonstrated by extensive clinical isolate studies
- The once-daily dosing without therapeutic drug monitoring requirement reduces healthcare staff exposure and operational costs
- SciClone Pharmaceuticals brings established relationships with over 2,000 hospitals across China
The partnership structure, while not detailed in financial terms, typically involves milestone payments and royalties in similar deals within the Chinese pharmaceutical market. The planned launch later this year suggests potential revenue contribution starting in early 2026, following typical 6-9 month commercialization preparation periods in the Chinese market.
The approval's timing is opportune, as China's healthcare reforms have accelerated hospital adoption of new anti-infective treatments, particularly those addressing resistant pathogens. Vibativ's proven efficacy against MRSA and other difficult-to-treat infections positions it favorably in a market where approximately 25-30% of Staphylococcus aureus infections are methicillin-resistant.
For Cumberland, with its
Vibativ® is a life-saving antibiotic for pneumonia and serious skin infections
Approval in
Vibativ is a potent, FDA-approved injectable anti-infective that serves as a potentially life-saving treatment in patients with hospital-acquired and ventilator-associated pneumonia resulting from a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and are multidrug-resistant. Vibativ is also used for the treatment of complicated skin and skin structure infections, such as MRSA. As a once-daily dosed antibiotic, it does not require therapeutic drug monitoring, decreasing health care professionals' exposure to the patient.
While many recently introduced antibiotics are quickly losing the battle to fight the bacteria they were designed to kill because those bacteria have become drug-resistant, Vibativ was specifically designed to kill drug-resistant bacteria. Two published studies – one that tested over 24,000 clinical isolates and one that tested over 15,000 – show that Vibativ is just as potent today against difficult-to-treat and multidrug-resistant bacteria as it was when it was introduced over 10 years ago.
"Vibativ's life-saving potential for patients with certain difficult-to-treat infections makes it an important addition to our portfolio and supports our mission to provide quality medical products that improve patient care," said Zhao Hong, Executive Director, President and CEO of SciClone Pharmaceuticals. "We strongly believe in this product and look forward to providing it to patients in
"SciClone has a strong distribution network throughout
SciClone and Cumberland plan to launch Vibativ in
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 patients' target infection sites.
The drug is approved in the
In addition, Vibativ is approved 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 and both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.
The product labeling also describes the use of Vibativ 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 Vibativ 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.
In October 2023, Cumberland announced a new publication in Antimicrobial Agents and Chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of Vibativ in children 2 to 17 years of age. The results of the study suggest that a single dose of Vibativ is safe in children and they experience reduced exposure to Vibativ, compared with the same body weight-based dosing in adults.
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.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in
Cumberland's portfolio comprises six FDA-approved brands. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne muscular dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis.
For more information on Cumberland's approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the company's website at 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. 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 results of operations. These factors include market conditions, 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, maintaining an effective sales and marketing infrastructure, natural disasters, public health epidemics, and other events beyond its control as more fully discussed in the company's most recent Form 10-K and any additional updates filed with the SEC. 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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SOURCE Cumberland Pharmaceuticals Inc.
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