Chinese biotech BeiGene (BGNE) has announced that it has begun commercializing XGEVA (denosumab) in China for the treatment of giant cell tumor of bone (GCTB).
This marks the first Amgen (AMGN) product that has been transitioned to BeiGene for commercialization in China since the parties signed a global strategic oncology deal at the beginning of the year.
In May 2019, the China National Medical Products Administration (NMPA) approved XGEVA for the treatment of adults and skeletally mature adolescents with GCTB that is unresectable or where surgical resection is likely to result in severe morbidity.
GCTB is a mostly benign, but often aggressive bone tumor, that is more common in China than in the US or Europe. Indeed, it is estimated that GCTB represents 20% of primary bone tumors in China. The tumors can result in the complete destruction of the affected bone and can also spread to the lungs in rare cases. Before the approval of XGEVA, surgery was the main treatment option.
In addition, a supplemental new drug application (sNDA) for XGEVA as a prevention for skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors has been accepted by the Center for Drug Evaluation (CDE) of the NMPA in April 2020 and is currently under review.
“The commencement of our commercialization of XGEVA in China signifies an important milestone in our strategic collaboration with Amgen. XGEVA is the first and currently only medical therapy approved for the treatment of GCTB in China, which offers patients a more innovative treatment option,” commented Xiaobin Wu, President of BeiGene.
The approval of XGEVA was based on clinical results from two open-label trials. It achieved durable response in patients with unresectable GCTB, with 88% five-year progression-free survival (PFS) probability. In addition, 80% of the patients with resectable GCTB who received XGEVA as neoadjuvant therapy experienced improvement, including 37% who avoided surgeries.
XGEVA is a fully human IgG2 monoclonal antibody specifically binding to RANK Ligand (RANKL), a protein essential for the formation, function and survival of osteoclasts – the cells responsible for bone resorption.
Shares in BeiGene are currently trading up 14% year-to-date, and analysts have a bullish Strong Buy outlook on the stock’s prospects. That’s alongside an average analyst price target of $197 for upside potential of 4%. (See BGNE stock analysis on TipRanks)
BeiGene expects to launch three Amgen oncology medicines in China in the near term: Xgeva, Kyprolis, and Blincyto, writes Maxim analyst Jason McCarthy. Under the EUSA collaboration, BeiGene has another two assets nearing launch: Sylvant and Qarziab, he notes.
The analyst has a buy rating on the stock and $190 price target, writing that the decreased sales from the legacy Celgene collaboration products (Abraxane, Revlimid and Vidaza) have been partially offset by initial sales of tislelizumab (PD-1) in China and Brukinsa (BTK) in the US.
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