BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene announced FDA's accelerated approval for BRUKINSA (zanubrutinib) to treat adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20 regimen. This marks the third FDA approval for BRUKINSA, showing a 56% overall response rate and 20% complete remission in a pivotal trial. The drug demonstrated a good safety profile. Continued approval is contingent upon further clinical trials.

BeiGene has announced that the FDA has accepted its Biologics License Application (BLA) for tislelizumab, an anti-PD-1 antibody aimed at treating unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior therapy. This marks a significant step in their strategy to expand treatment options globally, having previously secured approval for tislelizumab in five indications in China. The PDUFA target action date is July 12, 2022, and the submission is backed by positive results from the global Phase 3 RATIONALE 302 trial.

BeiGene, Ltd. (NASDAQ: BGNE) announced the presentation of clinical results from its lung cancer program at the ESMO Congress 2021. The company is focused on enhancing its immuno-oncology portfolio, particularly through the combination of tislelizumab with investigational agents like ociperlimab and sitravatinib. Various Phase 3 trials are currently in progress, addressing non-small cell lung cancer (NSCLC). Subgroup analyses reveal consistent survival benefits with tislelizumab, regardless of patient characteristics. BeiGene aims to improve outcomes for NSCLC patients worldwide.

BeiGene announced FDA approval for BRUKINSA (zanubrutinib) as a treatment for adult patients with Waldenström's macroglobulinemia. This marks the second indication for BRUKINSA in the U.S. and its third globally. The approval follows the Phase 3 ASPEN trial, which demonstrated improved efficacy and tolerability compared to ibrutinib. Key results showed a VGPR rate of 28% for BRUKINSA versus 19% for ibrutinib. The company continues to expand its global clinical program, solidifying its commitment to innovate in B-cell malignancies.

BeiGene announces that the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for tislelizumab in combination with chemotherapy as a first-line treatment for recurrent or metastatic nasopharyngeal cancer (NPC). This milestone, supported by positive results from the RATIONALE 309 trial, highlights the need for effective treatment options in a cancer type that predominantly affects patients in China. Tislelizumab has received multiple approvals in China across various indications, showcasing its expanding therapeutic potential.

BeiGene has received conditional approval from the China National Medical Products Administration (NMPA) for QARZIBA® (dinutuximab beta) to treat high-risk neuroblastoma in children aged 12 months and older. This therapy is indicated for those who've undergone chemotherapy and myeloablative treatment. Clinical trials showed significant efficacy, with a five-year event-free survival rate of 57% compared to 42% of historical controls. Despite the approval, common adverse reactions include fever and pain, raising considerations regarding patient management.

BeiGene, Ltd. (NASDAQ: BGNE) announced an investor conference call on August 25, 2021, at 9:30 a.m. ET to discuss its early development pipeline and research initiatives. The event will be accessible via a live webcast on BeiGene’s investor website, with an archived replay available for 90 days post-event. BeiGene is committed to innovative and affordable medicines aimed at enhancing patient access, with a portfolio of over 40 clinical candidates and a goal of improving access for two billion people by 2030. The company has a global team of around 7,000 employees.

BeiGene reported strong advancements in its oncology drug portfolio, showcasing significant growth in product sales, particularly for BRUKINSA, which generated $42.4 million, up from $7.0 million YoY. Their second quarter revenue reached $150 million, a substantial increase from $65.6 million in 2020. The company highlighted positive interim results from key trials, including SEQUOIA and ALPINE, and secured conditional approvals for treatments in multiple markets. However, a net loss of $480.3 million was noted, a wider loss per share of $0.40 compared to $0.33 in Q2 2020.

BeiGene has announced plans to establish a new R&D and manufacturing campus at the Princeton West Innovation Campus in Hopewell, NJ. The company has entered a purchase agreement for a 42-acre site, aiming to develop over one million square feet for biologic pharmaceutical manufacturing and clinical R&D. This facility is expected to enhance BeiGene's supply chain capabilities and create hundreds of jobs in the region. Construction completion is anticipated in mid-2023, with interim leasing of nearby space to commence hiring immediately.