- The Food and Drug Administration on Thursday approved BeiGene's cancer drug zanubrutinib, to be marketed as Brukinsa in the rare cancer mantle cell lymphoma at a wholesale acquisition cost of $12,935 for a 30-day supply. It is the first U.S. approval for the Beijing-headquartered company and came three months ahead of the decision deadline.
- Brukinsa will face Johnson & Johnson and AbbVie's Imbruvica and AstraZeneca's Calquence in patients who have already progressed after treatment with chemotherapy. BeiGene hopes to expand into other forms of lymphoma in which Imbruvica is already approved.
- The approval is a breakthrough for innovative Chinese biopharma developers, which are setting their sights on Western markets even as big pharma seeks to expand into China.
BeiGene has ambitions beyond Brukinsa. Not too far behind it in the pipeline are its immuno-oncology entry tislelizumab, which is in Phase 3 trials in lung, liver and other cancers that, if successful, could be used for regulatory submissions in the U.S. and Europe.
The pipeline also includes a potential competitor to AstraZeneca's Lynparza (olaparib) and an innovative type of immuno-oncology agent called a TIM-3 for which no company so far has achieved approval.
In mantle cell lymphoma, Brukinsa will have tough competition. Imbruvica (ibrutinib) was the first agent in this class of drugs, called Bruton's tyrosine kinase inhibitor, and so far this year has recorded more than $5 billion in sales across its indications, which also includes the more common chronic lymphocytic leukemia. AstraZeneca's Calquence (acalabrutinib) has recorded $108 million in mantle cell lymphoma.
Brukinsa should have a fighting chance on efficacy. The drug scored an 84% response rate in its clinical trial, similar to the 80% of Calquence and numerically higher than the 66% of Imbruvica.
Piper Jaffray analyst Tyler Van Buren wrote in a Nov. 14 note to clients that mantle cell lymphoma represents 10% of Bruton's tyrosine kinase inhibitor use. Based on a forecast that the class will reach $10 billion in sales in the U.S., Van Buren estimates that mantle cell lymphoma represents a $1 billion opportunity.
The early approval, coming more than 100 days ahead of a Feb. 27 FDA decision deadline, is a signal that the "FDA considers BeiGene's global clinical program to be of high quality," the analyst added.
Besides being a drug development company, BeiGene has served as the Chinese marketing arm of Celgene, selling Revlimid (lenalidomide), Abraxane (paclitaxel) and Vidaza (azacitidine). Product sales and collaboration income has accounted for $371 million in revenue this year, but because of its expansive R&D work it has recorded a $561 million loss through the first nine months.
The opportunity to become an in-country partner for big biopharma has grown. Amgen recently signed a deal for BeiGene to market up to 23 drugs in China, a collaboration that brought with it a $2.7 billion share purchase by the U.S.-based company.