Beigene Ltd Stock Price, News & Analysis

BeOne Medicines (NASDAQ: ONC) received a positive CHMP opinion recommending approval for a new film-coated tablet formulation of BRUKINSA® (zanubrutinib) for all approved indications in Europe. The new 160 mg tablet formulation is bioequivalent to existing capsules and reduces daily pill intake from four to two tablets while maintaining the 320 mg daily dosage.

The tablet version offers several advantages including easier swallowing, flexible dosing options, and environmental benefits through 70% smaller bottle size and reduced temperature control requirements during shipping. This follows recent FDA approval of the tablet formulation, where BRUKINSA leads in new patient starts for chronic lymphocytic leukemia and overall BTK inhibitor market share.

BeOne Medicines (NASDAQ: ONC) presented breakthrough clinical data at EHA 2025 for their hematology assets. Their BCL2 inhibitor sonrotoclax combined with BRUKINSA showed impressive results with 96% ORR in R/R CLL and 79% ORR in R/R MCL patients. The BTK degrader BGB-16673 demonstrated strong efficacy with 84.8% ORR in R/R CLL/SLL and 84.4% ORR in Waldenström macroglobulinemia. Long-term BRUKINSA data from the SEQUOIA trial showed sustained benefits with 72.2% progression-free survival at 60 months in CLL patients with del(17p). The combination of BRUKINSA plus venetoclax achieved 97% ORR and 92% 24-month PFS rate. These results support advancement into Phase 3 studies and potential regulatory submissions.

BeOne Medicines announced FDA approval of a new tablet formulation of BRUKINSA (zanubrutinib) for all five approved indications. The new 160mg tablets reduce pill burden from four 80mg capsules to two tablets daily while maintaining the 320mg recommended daily dose. BRUKINSA has become the overall BTK inhibitor market share leader and leads in new chronic lymphocytic leukemia patient starts across all therapy lines in the U.S. The tablet formulation, which offers the same efficacy and safety as capsules based on Phase 1 studies, features a film coating for easier swallowing. BRUKINSA remains the only BTK inhibitor offering flexible once or twice daily dosing and recommended dosing for severe hepatic impairment. The tablets will replace capsules starting October 2025, with EMA approval expected later this year.

BeOne Medicines (NASDAQ: ONC) has announced an upcoming Investor R&D Day event scheduled for June 26, 2025, at 8:30 am ET, to be held in New York City with a simultaneous webcast option. The event will feature presentations from CEO John V. Oyler and the company's leadership team, along with key opinion leaders. They will provide updates on BeOne's global innovation pipeline, platforms, new assets, targets, and clinical data. The company will also share insights on its vision, capabilities, and value creation strategies. Investors can access the webcast through BeOne's investor relations websites, with registration recommended 15 minutes before the event. An archived version will be available afterward.

BeOne Medicines (NASDAQ: ONC) presented promising clinical data for two breast cancer therapies at ASCO 2025. The first drug, BG-C9074, a B7-H4-targeting antibody-drug conjugate (ADC), showed a 16.1% confirmed overall response rate and 73.2% disease control rate in 56 evaluable patients with advanced solid tumors. The second drug, BG-68501, a CDK2 inhibitor, demonstrated a 5.4% overall response rate in 37 evaluable patients, with two breast cancer patients achieving partial responses. Both drugs exhibited manageable safety profiles. BG-C9074's most common adverse events included nausea, fatigue, and neutropenia, while BG-68501's included vomiting, nausea, and fatigue. These preliminary results suggest potential new treatment options for breast cancer patients, particularly addressing resistance mechanisms in HR+/HER2- breast cancer patients previously treated with CDK4/6 inhibitors.

BeOne Medicines presented new data from the Phase 3 SEQUOIA trial of BRUKINSA (zanubrutinib) at ASCO 2025, demonstrating strong efficacy in CLL treatment. The trial's Arm D showed BRUKINSA plus venetoclax achieved a 92% 24-month progression-free survival rate and 97% overall response rate. In high-risk del(17p)/TP53 mutation patients, 87.6% remained progression-free at 36 months. The Arm C 5-year follow-up showed sustained benefits with BRUKINSA monotherapy, with 72.2% of del(17p) patients remaining progression-free at 60 months. The best undetectable minimal residual disease rate in peripheral blood was 59%, with 11 patients able to discontinue treatment early while maintaining remission. The safety profile remained consistent with previous studies, with no new safety signals identified.

BeOne Medicines (NASDAQ: ONC), formerly BeiGene, announced its official redomiciliation to Switzerland and rebranding. The company, a global oncology leader, highlighted its significant achievements including BRUKINSA's market leadership and a robust pipeline of over 50 investigational assets. In 2024, BeOne's research team of 1,100+ colleagues launched 13 new molecular entities into clinical trials. The company's clinical development team of 3,700 members manages trials across 45+ countries, having enrolled 25,000+ patients in 170+ trials. BeOne is expanding its global presence with an $800 million manufacturing facility in Hopewell, NJ. The company focuses on hematology with BRUKINSA, TEVIMBRA (PD-1 inhibitor), and is developing treatments for breast, lung, and gastrointestinal cancers.

BeiGene received a positive CHMP opinion recommending approval of TEVIMBRA® in combination with chemotherapy for first-line treatment of nasopharyngeal cancer (NPC). The recommendation is based on the RATIONALE-309 Phase 3 study results, which showed significant improvements in patient outcomes. The study demonstrated: - Median progression-free survival of 9.2 months for TEVIMBRA with chemotherapy vs 7.4 months for placebo - Median overall survival of 45.3 months vs 31.8 months for placebo - Hazard ratio of 0.52 [95% CI:0.38, 0.73] p<0.0001 This marks TEVIMBRA's second positive CHMP opinion in 2025, with the drug already approved in major markets including the US, EU, China, and Japan for various cancer indications. The treatment showed a manageable safety profile with no new safety signals identified.

BeiGene (NASDAQ: ONC) will present 23 abstracts at the 2025 ASCO Annual Meeting (May 30-June 3) showcasing their oncology portfolio. Key highlights include:

Two rapid oral presentations featuring BRUKINSA® (zanubrutinib) data from the SEQUOIA trial in chronic lymphocytic leukemia (CLL), including: - Long-term follow-up results from Arm C in treatment-naïve CLL patients with del(17p) mutations - First results from Arm D evaluating BRUKINSA plus venetoclax combination therapy

The company will present early-phase data for novel breast cancer treatments: - BG-C9074: A B7-H4-targeting antibody-drug conjugate for advanced solid tumors - BG-68501: A CDK2 inhibitor for HR+/HER2- breast cancer - TEVIMBRA®: Final analysis showing promising efficacy in esophageal squamous cell carcinoma

The presentations demonstrate BeiGene's commitment to advancing cancer treatment across multiple fronts, from hematologic malignancies to solid tumors.