On May 20, the National Medical Products Administration (NMPA) approved the marketing of Entasis Therapeutics, Inc.'s innovative Category 1 sulbactam sodium injection/dulobactam sodium injection combination package (trade name: XACDURO) through priority review and approval. This drug is indicated for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible isolates of the Acinetobacter baumannii-calcoaceticus complex in patients aged 18 years and older.

Entasis Therapeutics, Inc. is a downstream formulation customer of Fushine Pharmaceuticals' sulbactam product. On May 24, 2023, the company's new intravenous combination antibiotic, XACDURO® (sulbactam sodium-dulobactam sodium for injection), which had been submitted for priority review, received approval from the U.S. Food and Drug Administration (FDA).

About Sulbactam Sodium-Dulobactam Sodium

Sulbactam sodium-dulobactam sodium is a combination product containing sulbactam sodium for injection and dulobactam sodium for injection. Sulbactam is a β-lactam antibacterial drug and an Ambler A class serine β-lactamase inhibitor. Dulobactam is a diazabicyclooctane, non-β-lactam β-lactamase inhibitor that protects sulbactam from degradation by β-lactamases. This drug, launched today, provides a new treatment option for patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of the Acinetobacter baumannii-calcoaceticus complex.

"Acinetobacter poses a significant danger to hospitalized patients, who are often seriously ill and particularly susceptible to infections. Effectively treating infections caused by drug-resistant Acinetobacter is a challenge, making new, effective treatment options for this patient population highly needed," said Andrew F. Shorr, Clinical Professor of Medicine at Georgetown University School of Medicine in Washington, D.C. "I am encouraged by the approval of the combination package of sulbactam sodium and dulobactam sodium, as it means physicians will soon have a new treatment option that may help address this urgent public health threat."

Fushine Pharmaceuticals, a major global supplier of sulbactam

Fushine Pharmaceuticals is the only domestic supplier of sulbactam certified for the international market and a major global sulbactam production base, leading the industry in product quality assurance and cost control. Over the years, the company has established a long-term strategic partnership with Dobfar, the manufacturer of sulbactam sodium in XACDURO® (sulbactam sodium-dulobactam sodium for injection), and has maintained a consistent supply relationship.

In the future, Fushine Pharmaceuticals will continue to maintain its leading position in the global sulbactam market, continuously promote the innovation and optimization of sulbactam production processes, supply customers with higher-quality sulbactam products, promote the marketing of new drugs in regulated markets at home and abroad, provide new options for the effective treatment of infections caused by drug-resistant Acinetobacter, and contribute Fushine's strength to the health of all mankind.