China's NMPA Approves Innovent's Byvasda Biosimilar

Suzhou, China-based Innovent Biologics said China’s National Medical Products Administration (NMPA) has approved its biosimilar bevacizumab, Byvasda, for marketing for the treatment of advanced non—small cell lung cancer (NSCLC) and metastatic colorectal cancer.

"The launch of Byvasda will provide Chinese patients with high-quality and relatively more-affordable bevacizumab," Innovent said in a statement. The company noted that cancer incidence for the drug's indications is high and the cost of the reference product is beyond the reach of many patients.

The competition to bring bevacizumab biosimilars to market in China is heating up. Also this week, Shanghai Henlius Biotech said its bevacizumab biosimilar candidate HLX04 met the 9-month primary end point of progression-free survival in patients with metastatic colorectal cancer (mCRC).

Henlius said the drug is being developed specifically for use in treating mCRC and nonsquamous NSCLC.

“Currently, there still remains huge unmet clinical demand for bevacizumab treatment in China, as many ordinary Chinese patients cannot afford it,” Innovent said.

Among malignant tumors, lung cancer has the highest incidence and mortality rate in China, with more than 770,000 newly diagnosed patients and 690,000 deaths in 2018, according to a report from the World Health Organization (WHO)'s International Agency for Cancer Research.

Also in China in 2018, there were 517 million patients with newly diagnosed colorectal cancer and 245 million deaths from this disease, according to the WHO.

Bevacizumab is a recombinant humanized anti—vascular endothelial growth factor monoclonal antibody (mAb) drug and is used to treat patients with multiple malignant tumors globally, including NSCLC, mCRC, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The bevacizumab biosimilar references Genentech’s Avastin and is Innovent’s second mAb drug approved by the NMPA in China following a sintilimab (Tyvyt) injectable approved in 2018 for patients with Hodgkin lymphoma.

In January 2020, Innovent sold the US and Canadian commercialization rights for Byvasda to Coherus BioSciences, of Redwood City, California.

Innovent has rituximab (IBI301) and adalimumab (IBI303) biosimilars in development. A phase 3 trial of IB301 concluded in 2019 and results showed that safety and pharmacokinetic data demonstrated equivalency to the reference drug, Rituxan. IBI303 is currently under review by the NMPA after an application for this was accepted in 2018.