BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene announced new data presentations at ASH 2024, featuring 21 abstracts including four oral presentations. The five-year follow-up results of the Phase 3 SEQUOIA study showed sustained progression-free survival benefits with BRUKINSA in CLL/SLL patients. Long-term extension studies demonstrated durable responses and favorable safety profiles across multiple B-cell malignancies.

The company also presented promising early data for their BTK degrader BGB-16673 and BCL2 inhibitor sonrotoclax. The first-in-human Phase 1/2 CaDAnCe-101 study showed manageable safety and promising efficacy for BGB-16673, while sonrotoclax in combination with BRUKINSA demonstrated promising efficacy in treatment-naïve CLL/SLL patients.

BeiGene (NASDAQ: BGNE) announced the passing of Donald Glazer, a Board member and chair of the nominating and corporate governance committee. Glazer, who helped establish the company in 2010, served as a passionate board member and was instrumental in building connections among cancer doctors worldwide. As a founding member, he supported BeiGene's mission to deliver innovative medicines faster and more affordably to patients globally. Despite his personal battle with lung cancer and multiple myeloma, Glazer's impact continues through a family charitable fund.

BeiGene announced positive CHMP opinions recommending extended authorization for TEVIMBRA® (tislelizumab) in two new indications:

1. First-line treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in combination with chemotherapy for HER2-negative locally advanced unresectable or metastatic cancer with PD-L1 TAP score ≥ 5%.

2. First-line treatment of esophageal squamous cell carcinoma (ESCC) in combination with chemotherapy for unresectable, locally advanced or metastatic cancer with PD-L1 TAP score ≥ 5%.

These recommendations are based on positive results from the RATIONALE-305 and RATIONALE-306 Phase 3 trials, which demonstrated significant overall survival benefits for TEVIMBRA in combination with chemotherapy compared to placebo plus chemotherapy in both indications.

BeiGene (NASDAQ: BGNE) announced its participation in the 12th International Workshop on Waldenström's Macroglobulinemia (IWWM) with seven presentations featuring research on BRUKINSA® (zanubrutinib), BTK CDAC degrader BGB-16673, and BCL2 inhibitor sonrotoclax. Key findings include:

1. Long-term safety and efficacy data from ASPEN LTE1 study showing maintained or improved efficacy in ibrutinib-treated patients who switched to BRUKINSA.

2. Preliminary data from CaDAnCe-101 study demonstrating BGB-16673's tolerable safety profile and promising antitumor activity in heavily pretreated patients.

3. Updated results from a Phase 2 study showing BRUKINSA's efficacy in patients intolerant to other BTK inhibitors.

4. Analysis of ASPEN study indicating faster peripheral neuropathy symptom resolution with BRUKINSA compared to ibrutinib.

5. Phase 1 study results showing sonrotoclax's tolerability and encouraging antitumor activity in heavily pretreated R/R WM patients.

BeiGene (NASDAQ: BGNE) announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) recognizes the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA® (tislelizumab-jsgr), for first-line treatment of advanced esophageal squamous cell carcinoma (ESCC) and gastric/gastroesophageal junction (G/GEJ) cancers with PD-L1 expression >1%. The committee voted to recommend a class-wide PD-L1 expression level cut-off across PD-1 inhibitors for these indications.

The ODAC voted 10-2 (1 abstaining) against using PD-1 inhibitors in G/GEJ with PD-L1 expression <1%, and 11-1 (1 abstaining) against use in ESCC patients with PD-L1 expression <1%. BeiGene's Phase 3 RATIONALE-305 (G/GEJ) and RATIONALE-306 (ESCC) studies met their overall survival endpoints. The Biologics License Applications (BLAs) for TEVIMBRA in these indications are under FDA review.

BeiGene, (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, has appointed Shalini Sharp to its Board of Directors and as a member of the Board's Audit Committee, effective September 27, 2024. Ms. Sharp, a leading financial executive with extensive experience in the pharmaceutical and investment banking industries, currently serves on the boards of Neurocrine Biosciences and Organon & Co. She previously held positions as CFO and Executive VP at Ultragenyx and CFO and VP at Agenus.

John V. Oyler, Co-Founder, Chairman and CEO of BeiGene, welcomed Ms. Sharp, highlighting her extensive experience in leading innovative global pharmaceutical companies as valuable for BeiGene's growth phase, market expansion, and pipeline advancement. Ms. Sharp expressed excitement about joining BeiGene's Board, emphasizing the company's commitment to innovation and mission to lower barriers to access worldwide.

BeiGene (NASDAQ: BGNE) has announced that the Israeli Ministry of Health has approved TEVIMBRA® (tislelizumab) for treating adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC) after prior systemic chemotherapy. This approval marks a significant step in BeiGene's mission to provide innovative cancer treatments globally.

BeiGene is expanding TEVIMBRA's availability in Israel, with recent submissions for first- and second-line treatments for non-small cell lung cancer (NSCLC) and planned filings for first-line OESCC and gastric cancer. The company has conducted over 17 potentially registration-enabling trials with TEVIMBRA, demonstrating its potential to improve survival benefits across various tumor types.

Globally, more than 900,000 patients have been prescribed TEVIMBRA. The drug received approval from the European Commission for advanced or metastatic ESCC in 2023 and a positive opinion from the EMA for NSCLC treatment in February 2024.

BeiGene (NASDAQ: BGNE) has appointed Matt Shaulis as General Manager of North America, effective September 25. Shaulis, with over 20 years of experience in biopharmaceutical companies, will lead the commercialization of BRUKINSA (zanubrutinib) and TEVIMBRA (tislelizumab) in North America. He will also spearhead future asset launches in hematology and solid tumors.

Shaulis replaces Josh Neiman, who is leaving to pursue a new opportunity. Neiman played a important role in establishing BeiGene's commercial presence in the U.S. and Europe, helping BRUKINSA achieve global blockbuster status. Shaulis's appointment comes at a transformative moment for BeiGene as it aims to replicate its hematology success in solid tumors with its pipeline of innovative therapies.

BeiGene (NASDAQ: BGNE) announced new data for TEVIMBRA® (tislelizumab) to be presented at ESMO 2024. Key highlights include:

1. RATIONALE-315: Significant event-free survival benefit in resectable NSCLC with neoadjuvant tislelizumab plus chemotherapy.

2. RATIONALE-305: Three-year overall survival data showing long-term efficacy in first-line advanced GC/GEJC.

3. RATIONALE-307: Continued OS benefit with promising four-year OS rates in first-line squamous NSCLC.

4. Comparative effectiveness data vs. other anti-PD-1 treatments in second-line ESCC.

TEVIMBRA has been launched in Germany, Austria, and Norway following EU approvals for ESCC and NSCLC indications.