Qilu Pharmaceutical Secures Approval for Two Blockbuster Drugs: Ceftazidime-Avibactam and Sunitinib Malate

Today (October 11), the NMPA official website indicates that Qilu Pharmaceutical's Ceftazidime and Avibactam Sodium for Injection and Sunitinib Malate Capsules have been approved for marketing. Among them, Ceftazidime and Avibactam Sodium for Injection is the first generic version in China, while Sunitinib Malate Capsules is the fifth domestically produced version.

Ceftazidime-avibactam sodium is a novel β-lactamase inhibitor combination formulation composed of the third-generation cephalosporin antibiotic ceftazidime and the sodium salt of the novel β-lactamase inhibitor avibactam. It is indicated for the treatment of infections caused by drug-resistant Gram-negative bacteria, including carbapenem-resistant Enterobacteriaceae (CRE), multidrug-resistant Pseudomonas aeruginosa, and extended-spectrum β-lactamase (ESBL)-producing bacteria.

Terminal Sales of Ceftazidime-Avibactam in Public Medical Institutions in China (Unit: RMB 10,000)

Source: Menet Competitive Landscape of China's Public Medical Institution Terminals

Pfizer's Zavicefta (ceftazidime and avibactam sodium for injection) was approved for import in China on May 21, 2019. According to data from Menet, terminal sales of ceftazidime/avibactam across urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (collectively referred to as China's public medical institutions) exceeded RMB 200 million in 2020, representing a year-on-year increase of 1,343.39%, an astonishing growth rate.

Notably, Qilu Pharmaceutical is the only company in China to have developed a generic version of ceftazidime and avibactam sodium for injection, successfully securing the first generic approval in the country.

Sunitinib is a multi-targeted receptor tyrosine kinase inhibitor developed by Pfizer, clinically indicated primarily for the treatment of adult patients with gastrointestinal stromal tumors, renal cell carcinoma, and pancreatic neuroendocrine tumors. According to data from Menet, Pfizer's sunitinib malate capsules reached peak global sales of USD 1.236 billion in 2012, with global sales amounting to USD 819 million in 2020.

In recent years, the domestic market size of sunitinib has continued to expand. Data from MENET shows that in 2020, terminal sales of sunitinib at public medical institutions in China exceeded RMB 500 million, representing a year-on-year increase of 44.22%.

Sales of Sunitinib at the Terminal of Public Medical Institutions in China (Unit: 10,000 RMB)

Source: MENET, Competitive Landscape of China's Public Medical Institution Terminals

With the marketing approval of Qilu Pharmaceutical's Sunitinib Malate Capsules, the number of manufacturers in China for this product has reached six, including Pfizer, CSPC Pharmaceutical Group, Hansoh Pharmaceutical, Kelun Pharmaceutical, and Chia Tai Tianqing Pharmaceutical, among others.

Data Source: Menet Database, NMPA