BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene (NASDAQ: BGNE) has announced promising results from the interim analysis of its Phase 3 RATIONALE 303 trial, comparing the efficacy of its anti-PD-1 antibody, tislelizumab, to docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC). The trial showed an overall survival (OS) median of 17.2 months for tislelizumab versus 11.9 months for docetaxel, with significant improvements across various metrics. These findings support a supplemental biologics application currently under regulatory review in China.

BeiGene (NASDAQ: BGNE) presented clinical data on its anti-PD-1 antibody, tislelizumab, combined with the investigational sitravatinib at the AACR Annual Meeting 2021. The Phase 1b trial focused on patients with unresectable/metastatic melanoma resistant to PD-1/L1 inhibitors and advanced platinum-resistant ovarian cancer.

The combination showed promising results, with a 24% objective response rate and an 88% disease control rate in melanoma patients. Adverse events were reported, with 100% of patients experiencing treatment-emergent adverse events.

BeiGene officially launched BRUKINSA (zanubrutinib) in Canada for treating adult patients with Waldenström’s macroglobulinemia (WM). Authorized on March 1, 2021, BRUKINSA aims to enhance patient access through the myBeiGene support program, offering financial assistance and education. The product's approval is based on the Phase 3 ASPEN trial, which, despite showing a favorable safety profile, did not meet the primary endpoint of statistical superiority over ibrutinib. The recommended daily dose is 320mg, as BeiGene expands its distribution efforts across Canada.

BeiGene, Ltd. (NASDAQ: BGNE) announced that its Phase 2 trial of BRUKINSA^® (zanubrutinib) for hospitalized COVID-19 patients did not achieve co-primary endpoints, specifically for respiratory failure-free survival and reduction in oxygen days compared to placebo. No new safety signals for zanubrutinib were identified. The trial included 67 patients who required supplemental oxygen or mechanical ventilation. Results will be submitted for future scientific presentation. Despite this setback, the firm aims to continue exploring zanubrutinib's efficacy against COVID-19-related respiratory distress.

BeiGene, Ltd. (NASDAQ: BGNE) has received approval from the NMPA to manufacture tislelizumab at its new biologics facility in Guangzhou, China. This facility, spanning over 1 million square feet, will start producing tislelizumab for the local market and expand its capacity to 64,000 liters by the end of 2022. Tislelizumab is approved for various cancer treatments in China and is under review for additional uses. The plant adheres to cGMP standards and incorporates advanced technologies for enhanced manufacturing efficiency.

BeiGene, Ltd. (NASDAQ: BGNE) has appointed Julia Wang as its new Chief Financial Officer, effective June 30, 2021. She succeeds Howard Liang, who is retiring after a significant tenure. Julia previously served as Senior Vice President and Deputy CFO at BeiGene, bringing extensive finance experience from the biotech and pharmaceutical sectors. The transition aims to strengthen BeiGene's financial leadership as it expands globally. CEO John Oyler praised Wang's contributions, noting her strategic role in enhancing resource allocation and value creation within the company.

BeiGene (NASDAQ: BGNE) is set to present multiple studies at the AACR Annual Meeting 2021, including three oral presentations on the anti-PD-1 antibody tislelizumab and its combination with the investigational sitravatinib for treating various cancers. Key presentations include:

• RATIONALE 303: Phase 3 study results of tislelizumab in NSCLC, presented on April 12.
• Sitravatinib plus tislelizumab: Safety and preliminary activity in ovarian cancer, on April 11.
• Melanoma study: Safety and tolerability results, also on April 11.

These findings may impact the company's future drug development and market strategies.

BeiGene, Ltd. (NASDAQ: BGNE) has announced the initiation of a Phase 1 clinical trial for BGB-15025, an investigational HPK1 inhibitor aimed at enhancing T cell activation in cancer treatment. The trial will evaluate the safety, pharmacokinetics, and early antitumor activity of BGB-15025, both as a monotherapy and in combination with tislelizumab, BeiGene's anti-PD-1 antibody. This study marks a significant step in BeiGene's research into immuno-oncology therapies, potentially offering new treatment avenues for patients with advanced solid tumors.

BeiGene announced that its supplemental Biologics License Application (sBLA) for tislelizumab has been accepted by the China National Medical Products Administration. This application targets treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in the second or third-line after platinum-based chemotherapy. The sBLA is based on interim results from the Phase 3 RATIONALE 303 trial, highlighting improved overall survival compared to docetaxel. Tislelizumab has already received three approvals in China, focusing on expanding its usage in treating NSCLC.