Key Takeaways
Shares of Boan Biotech (6955.HK) fell 4.3% even as the company announced it received approval for a new indication in China for its denosumab injection, Boluojia. The stock closed down 4.29% despite the positive regulatory news.
China’s National Medical Products Administration approved the supplemental application for Boluojia for the treatment of bone metastases from solid tumors or multiple myeloma, the company said in a statement. The approval aims to delay or reduce the risk of skeletal-related events in patients.
The new indication significantly expands the drug's addressable market from its initial approval in May 2024 for the treatment of giant cell tumor of bone. Boluojia is a biosimilar of Amgen Inc.'s Xgeva, a widely used treatment for preventing skeletal-related events in cancer patients.
The approval is a key step in Boan's global strategy for Boluojia, which it developed independently. The negative stock reaction suggests investors may be focused on the competitive landscape for denosumab biosimilars and the timeline for international revenue.
Boan Biotech is accelerating its efforts to launch Boluojia in major international markets. The company has successfully completed international multi-center Phase III clinical trials for the drug in Europe, the United States, and Japan, demonstrating high similarity to the reference drug Xgeva.
A marketing application for Boluojia is currently under review in the United Kingdom. Boan also plans to initiate marketing filings in the United States, the European Union, Japan, and other high-potential international markets, which could open up significant new revenue streams.
This latest approval in China could bolster confidence in the drug's profile as it seeks clearance from regulators in more lucrative Western markets. Investors will be closely watching for updates on the UK review and the planned filings in the US and EU as the next major catalysts.
This article is for informational purposes only and does not constitute investment advice.
