SAN CARLOS, Calif. - BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), soon to be known as BeOne Medicines Ltd., has successfully challenged a competitor’s patent, leading to a U.S. Patent and Trademark Office (USPTO) decision to invalidate all claims of Pharmacyclics LLC’s U.S. Patent No. 11,672,803. The patent in question was related to Pharmacyclics’ allegations of infringement by BeiGene’s cancer drug BRUKINSA® (zanubrutinib).
The USPTO’s Final Written Decision came as a result of a post-grant review (PGR) initiated by BeiGene. The company had petitioned the USPTO on November 1, 2023, after facing a patent infringement lawsuit from Pharmacyclics. The review was granted on May 1, 2024, and the recent decision to invalidate the patent claims is subject to appeal by Pharmacyclics.
BeiGene’s General Counsel, Chan Lee, expressed satisfaction with the USPTO’s ruling, emphasizing the company’s belief in the "overly broad and invalid" nature of the ’803 patent. Lee also highlighted the company’s confidence in BRUKINSA’s intellectual property and its status as a differentiated medicine approved in over 70 countries for treating multiple B-cell malignancies.
BRUKINSA is an oral BTK inhibitor designed to offer sustained inhibition of the BTK protein, with potential advantages in bioavailability, half-life, and selectivity compared to other approved BTK inhibitors. It is the only BTK inhibitor with a global label that allows for both once or twice daily dosing. The drug’s success has contributed to BeiGene’s remarkable revenue growth of 55% over the last twelve months. InvestingPro subscribers can access 8 additional key insights about BeiGene’s growth potential. The drug is part of a clinical development program that includes approximately 7,100 patients across more than 35 trials worldwide.
BeiGene, a global oncology company, is focused on developing affordable and accessible cancer treatments. The company boasts a diverse pipeline of novel therapeutics and a commitment to improving access to medicines for patients. BeiGene employs over 11,000 people across six continents.
This news is based on a press release statement, and the USPTO’s decision marks a significant development for BeiGene as it continues to navigate the competitive landscape of cancer treatment innovations. The decision is a key aspect of the company’s ongoing effort to protect its intellectual property rights and secure its position in the global market for oncology treatments. Analysts maintain a strong buy consensus on the stock, with InvestingPro data showing expectations for profitability in the current fiscal year. The company’s next earnings report is scheduled for May 7, 2025.
In other recent news, BeiGene Ltd. has reported its financial results for 2024 under the PRC GAAP, highlighting key financial metrics such as gross profit margin and research and development expenses. The report, filed with the Shanghai Stock Exchange’s STAR Market, provides additional insights into BeiGene’s financial health, although it is only available in Chinese. Meanwhile, RBC Capital Markets initiated coverage of BeiGene with an Outperform rating, setting a price target of $312. RBC Capital emphasized the revenue growth potential of Brukinsa, BeiGene’s leading treatment, and projected operational profitability by 2025.
In another development, JMP analysts maintained a Market Outperform rating with a $348 price target, despite the discontinuation of BeiGene’s TIGIT mAb development due to a Phase 3 study halt. JMP views the reallocation of resources as a strategic move. Bernstein SocGen Group also raised BeiGene’s price target to $259, citing the competitive edge of sonrotoclax and promising early-stage data for BGB-16673. Bernstein adjusted its peak sales estimate for sonrotoclax to $1.9 billion and expects BeiGene to achieve profitability by 2025.
Additionally, JPMorgan maintained an Overweight rating with a $311 target, following a discussion with BeiGene’s management that focused on revenue projections and pipeline developments. JPMorgan anticipates significant operating leverage as BeiGene aims for GAAP operating profitability this year. These recent developments reflect the varied perspectives of analysts regarding BeiGene’s strategic direction and market potential.
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