China-based biotech BeiGene (Nasdaq: BGNE, HKG: 6160) provided an update on its company strategy and R&D plans at this week’s J.P. Morgan Healthcare Summit in San Francisco. BeiGene CEO John Oyler presented the firm’s globally disruptive R&D model, which includes in-house discovery capabilities and new treatment modalities set to drive future growth.
Key Takeaways from the Presentation
- Discovery Pipeline: BeiGene expects its discovery pipeline to generate 10 Investigational New Drug (IND) applications each year going forward.
Revenue Milestone: Revenues for 2022 are set to break through the USD 1 billion mark for the first time. - Brukinsa Growth: Brukinsa growth is expected to be boosted by approval decisions this year in sizeable chronic lymphocytic leukemia (CLL) indications in the US, China, Canada, and Australia.
- Tislelizumab Approvals: Tislelizumab is expected to gain approvals in the US potentially later this year once onsite inspections are completed in China, for second-line esophageal squamous cell carcinoma (ESCC) in partnership with Novartis. This will be followed by submissions for first-line ESCC and gastric cancer.
BeiGene Reaching World-Class Scale
Oyler emphasized BeiGene’s increasingly globally competitive scale, with 2022 revenues set to exceed USD 1 billion for the first time. As previously reported, Q1-Q3 revenues already reached USD 962 million after a 109% year-on-year expansion. Sales are being generated by 16 commercial-stage products marketed by a global team of over 3,500, including the two cornerstone in-house discoveries: the programmed death-1 (PD-1) inhibitor tislelizumab and the Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib).
The company employs over 9,000 people, including 950 discovery scientists, making it one of the largest oncology-focused teams globally. With 2,700 clinical development and medical affairs staff, BeiGene operates “largely CRO-free,” generating significant cost and time savings. This allows the firm to conduct development at a 30% discount to the industry standard.
Strength of the Pipeline
Oyler highlighted the strength of BeiGene’s pipeline, which includes over 60 preclinical programs, with the majority viewed as potential best- or first-in-class candidates. The expectation is for 10 IND filings each year for new molecules emerging from the pipeline.
Key Pipeline Candidates
Oyler identified three key pipeline candidates with significant potential:
- BGB-11417: A BCL-2-targeted therapy, positioned as a best-in-class competitor to first-generation drug venetoclax (AbbVie’s Venclexta) for the treatment of relapsed or refractory CLL and mantle cell lymphoma (MCL).
- BGB-15025: A first-in-class inhibitor of the novel immune checkpoint HPK1, complementing BeiGene’s other immunotherapy pipeline candidates targeting TIGIT, OX40, TIM-3, and LAG3.
- BGB-16673: A chimeric degradation activating compound (CDAC), BeiGene’s term for proteolysis targeting chimera (PROTAC) technology or targeted protein degradation. As noted by Oyler, “Protein degradation is a field in which BeiGene will be a major player.”
Future Outlook
BeiGene’s presentation at the J.P. Morgan Healthcare Summit underscores its commitment to innovation and global competitiveness. With a robust pipeline, significant revenue growth, and a focus on disruptive R&D, BeiGene is poised to make a meaningful impact in the global oncology market.-Fineline Info & Tech
