BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that the U.S. FDA has accepted its New Drug Application (NDA) for Sotoclax, a next‑generation BCL2 inhibitor, and granted Priority Review designation for the treatment of relapsed or refractory (R/R) Mantle Cell Lymphoma (MCL) in patients previously treated with BTK inhibitors.
Regulatory Milestone
Item
Detail
Product
Sotoclax (next‑generation BCL2 inhibitor)
Company
BeOne Medicines Ltd. (ONC; 6160; 688235)
Agency
U.S. Food and Drug Administration (FDA)
Application Type
New Drug Application (NDA) with Priority Review
Indication
R/R MCL post BTK inhibitor therapy
Study Basis
BGB‑11417‑201 (NCT05471843), global Phase 1/2
Primary Endpoint
Overall Response Rate (ORR) – met
Key Secondary Endpoints
CR rate, DOR, PFS – positive results
Safety Profile
Well‑tolerated, manageable
Next Steps
FDA review; Project Orbis participation; EMA submission planned
Clinical Evidence – BGB‑11417‑201 Study
Endpoint
Result
Overall Response Rate (ORR)
Clinically meaningful responses in heavily pre‑treated population
Complete Response (CR) Rate
Positive results reported
Duration of Response (DOR)
Positive results reported
Progression‑Free Survival (PFS)
Positive results reported
Safety
No DLTs; manageable adverse events
Strategic Initiatives
Project Orbis: BeOne will participate in FDA’s Project Orbis framework for cooperative oncology review with international regulators
Global Expansion: Plans to submit Phase 1/2 data to EMA and other regulatory bodies to expedite approvals in more countries
Market Access: Priority Review designation shortens FDA review timeline from 10 to 6 months
$2.5 billion globally (2024); expanding in hematology
Pricing
Expected $150,000‑200,000/year (aligns with oral oncolytics)
Peak Sales Forecast
$300‑450 million (U.S. peak) by 2031
Competitive Landscape:AbbVie/Roche’s Venclexta approved in CLL/SLL but not MCL; Sotoclax could be first BCL2 inhibitor in MCL
Forward‑Looking Statements This brief contains forward‑looking statements regarding Sotoclax’s regulatory review, commercial potential, and global expansion plans. Actual results may differ materially due to risks including FDA approval outcomes, competitive responses, and market adoption rates.-Fineline Info & Tech
By Fineline Cube 