BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene has announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for tislelizumab, an anti-PD1 antibody, for treating locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after first-line chemotherapy failure. Tislelizumab has shown improved efficacy over chemotherapy in a Phase 3 trial involving 512 patients across multiple regions. This sBLA represents the eighth marketing application for tislelizumab, which has already received five approvals in China.

BeiGene announced that the China National Medical Products Administration (NMPA) has granted approval for its anti-PD-1 antibody tislelizumab for first-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC) and conditional approval for hepatocellular carcinoma (HCC). This brings tislelizumab's total indications in China to five, enhancing its role in treating major cancer types. Based on positive results from recent clinical trials, BeiGene aims to increase access to these therapies in China and globally.

BeiGene has announced that its drug BRUKINSA (zanubrutinib) has received conditional approval from the China National Medical Products Administration for treating adult patients with Waldenström’s macroglobulinemia (WM) who have undergone at least one prior therapy. This marks the third approval in China for BRUKINSA, which was designed to provide cardiovascular safety advantages and effective responses in treating B-cell malignancies. The approval follows a pivotal Phase 2 trial showing a major response rate of 72.1% in WM patients.

BeiGene has initiated the global Phase 3 AdvanTIG-302 trial for its investigational anti-TIGIT antibody, ociperlimab (BGB-A1217), in combination with tislelizumab, targeting first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The trial aims to enroll approximately 605 patients whose tumors exhibit high PD-L1 expression. Key endpoints include progression-free survival and overall survival. This marks a significant milestone as ociperlimab enters pivotal clinical development, possibly offering a chemotherapy-free treatment alternative for NSCLC patients.

BeiGene announced long-term follow-up results for pivotal trials of its therapies at the 26th EHA Virtual Congress. Tislelizumab exhibited a 87.1% overall response rate and 67.1% complete response rate in R/R classical Hodgkin's lymphoma after 34 months, with a median progression-free survival of 31.5 months. BRUKINSA demonstrated an 83.7% overall response rate in R/R mantle cell lymphoma, with a median progression-free survival of 33 months over 35 months of follow-up, and continued efficacy in R/R chronic lymphocytic leukemia. All therapies maintained tolerable safety profiles.

BeiGene presented positive interim results from the Phase 3 ALPINE trial for its BTK inhibitor, BRUKINSA, at EHA2021. The trial showed superiority in the overall response rate (ORR) of 78.3% compared to 62.5% for ibrutinib (p=0.0006). Additionally, BRUKINSA had a significantly lower rate of atrial fibrillation (2.5% vs. 10.1%, p=0.0014) and better progression-free survival (PFS) rates (94.9% vs. 84.0%). The positive data reinforces BRUKINSA's safety and efficacy, offering significant benefits for patients with chronic lymphocytic leukemia.

BeiGene (BGNE) announced a strategic collaboration with Shoreline Biosciences to develop and commercialize NK-based cell therapeutics using Shoreline's iPSC technology. The partnership includes an upfront cash payment of $45 million and potential milestone payments and royalties. Four therapeutic targets will be jointly developed, with BeiGene leading clinical development globally and Shoreline handling clinical manufacturing. The collaboration aims to accelerate the delivery of advanced cell therapies for patients globally, enhancing BeiGene's pipeline.

BeiGene, Ltd (NASDAQ: BGNE) announced the acceptance of a supplemental Biologics License Application (sBLA) by China's CDE for tislelizumab, an anti-PD-1 antibody aimed at treating patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors. This filing, based on positive Phase 2 trial results with 80 participants, marks the seventh indication for tislelizumab. The company aims to expand access to this potentially differentiated checkpoint inhibitor, reinforcing its commitment to addressing unmet medical needs.

BeiGene announced positive clinical results for its anti-PD-1 antibody, tislelizumab, at ASCO 2021. The Phase 3 RATIONALE 302 trial demonstrated a median overall survival (OS) of 8.6 months for tislelizumab versus 6.3 months for chemotherapy in advanced or metastatic esophageal squamous carcinoma (ESCC). Additionally, a Phase 2 trial reported an objective response rate (ORR) of 45.9% across various solid tumors. Both trials highlighted tislelizumab’s favorable safety profile. The company aims for broader international use of tislelizumab, advancing discussions with health authorities.