Beigene Ltd Stock Price, News & Analysis

BeOne Medicines (NASDAQ: ONC) will report its third quarter 2025 financial results on Thursday, November 6, 2025 before U.S. markets open. Management will host a live webcast at 8:00 a.m. ET following the release.

Investors can access the live webcast via the company's investor websites (U.S., HK, SSE) and are recommended to register at least 15 minutes before the scheduled start. An archived webcast will be posted on the investor site after the event.

BeOne Medicines (NASDAQ: ONC) presented new Phase 3 and Phase 1 data at ESMO 2025 on October 17-21 showing TEVIMBRA (tislelizumab) continued clinical benefit in lung cancer and early activity for investigational HPK1 inhibitor BGB-26808. RATIONALE-307 long-term data showed TEVIMBRA plus chemotherapy significantly improved overall survival in squamous NSCLC across subgroups, despite high in-study crossover. RATIONALE-312 three-year results confirmed durable OS and safety for first-line TEVIMBRA plus chemotherapy in ES-SCLC. Phase 1a BGB-26808 plus TEVIMBRA achieved an unconfirmed ORR of 15.4% with manageable safety; Grade 3/4 TRAEs for BGB-26808 were ~21%.

BeOne Medicines (NASDAQ: ONC) announced on October 13, 2025 that the U.S. FDA granted Breakthrough Therapy Designation for sonrotoclax for adult patients with relapsed or refractory mantle cell lymphoma (MCL).

The FDA also accepted BeOne for Project Orbis review. Decisions were based on early positive topline data from a Phase 1/2 study (BGB-11417-201) after prior BTKi and anti-CD20 therapy. BeOne reported sonrotoclax also holds Fast Track and Orphan Drug designations; a Phase 3 confirmatory CELESTIAL-RRMCL study is underway.

BeOne Medicines (Nasdaq: ONC) announced positive topline results from its Phase 1/2 study of sonrotoclax, a next-generation BCL2 inhibitor, for treating relapsed/refractory mantle cell lymphoma (MCL). The study, involving 125 adult patients, met its primary endpoint of overall response rate (ORR).

The trial consisted of two parts: Part 1 with 22 patients receiving 160mg or 320mg daily doses, and Part 2 with 103 patients receiving the recommended 320mg daily dose. The treatment showed promising results across secondary endpoints, including complete response rate, duration of response, and progression-free survival, with a manageable safety profile.

BeOne plans to submit the data to the FDA and other global regulatory authorities for potential approval. The drug has already received Orphan Drug Designation from the FDA for MCL treatment.

BeOne Medicines (NASDAQ: ONC) has received European Commission approval for TEVIMBRA (tislelizumab) as a neoadjuvant/adjuvant treatment for resectable non-small cell lung cancer (NSCLC). The approval is based on the Phase 3 RATIONALE-315 trial, which demonstrated significant overall survival benefits.

Key findings from the final analysis include a statistically significant improvement in overall survival (HR=0.65) with a median follow-up of 38.5 months, and sustained event-free survival benefits (HR=0.58). The drug showed consistent benefits across major sub-groups, regardless of PD-L1 expression, disease stage, and histology.

TEVIMBRA now has nine approved indications in solid tumors in the EU, including five in lung cancer, positioning it as a comprehensive treatment option throughout the care continuum.

BeOne Medicines (NASDAQ: ONC), a global oncology company, has announced its participation in the upcoming Morgan Stanley 23rd Annual Global Healthcare Conference. The company will engage in a fireside chat on September 8, 2025, at 1:50 p.m. EDT.

Investors can access the live webcast through BeOne's investor relations websites, and an archived version will be available after the event.

BeOne Medicines (Nasdaq: ONC) has entered into a significant royalty purchase agreement with Royalty Pharma for up to $950 million for IMDELLTRA® worldwide sales rights (excluding China). The deal includes an $885 million upfront payment and a potential additional $65 million within 12 months.

IMDELLTRA® is a groundbreaking DLL-3 targeting bispecific T-cell engager approved for treating extensive-stage small cell lung cancer (ES-SCLC) patients who have progressed after platinum-based chemotherapy. BeOne will retain a portion of royalties on annual sales above $1.5 billion and maintain rights to other assets under its Amgen collaboration, including xaluritamig.

BeOne Medicines (Nasdaq: ONC) has received European Commission approval for a new film-coated tablet formulation of BRUKINSA® (zanubrutinib) across all approved indications. The new tablet version offers significant improvements in treatment administration, reducing the daily pill burden from four to two pills while maintaining the recommended 320mg daily dose.

The 160mg tablets feature a smaller size and film coating for easier swallowing, enhancing patient convenience. This development comes as BRUKINSA maintains its position as the BTK inhibitor with the broadest label in Europe, having treated more than 200,000 patients globally.

BeOne Medicines (NASDAQ: ONC) reported strong Q2 2025 financial results with total revenues increasing 42% to $1.3 billion compared to Q2 2024. The company's flagship product BRUKINSA achieved 49% growth to $950 million in global revenues. BeOne reported GAAP diluted EPS of $0.84 and non-GAAP diluted EPS of $2.25 per ADS.

The company updated its FY2025 revenue guidance to $5.0-$5.3 billion and maintained operating expense guidance. BeOne's strong performance was driven by BRUKINSA's U.S. market leadership and global expansion, with U.S. sales reaching $684 million (43% growth) and European sales hitting $150 million (85% growth). The company anticipates over 20 R&D milestones in the next 18 months across its hematology and solid tumor pipeline.

Gross margin improved to 87.4% from 85.0% year-over-year, while free cash flow reached $220 million, a significant improvement from -$206 million in Q2 2024.