BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene, Ltd. announced that the China National Medical Products Administration has approved BLINCYTO for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. This marks the first approval of BLINCYTO in China and BeiGene's first product licensed from Amgen to receive approval. BLINCYTO, a bispecific immunotherapy, has shown superiority in overall survival compared to chemotherapy, reportedly doubling patient survival rates. The approval is based on a Phase 3 trial that demonstrated a 47.8% efficacy rate in Chinese subjects.

BeiGene presented new clinical data for its BTK inhibitor BRUKINSA (zanubrutinib) at the 62nd ASH Annual Meeting. Results from a Phase 2 trial showed BRUKINSA was effective in patients with relapsed/refractory B-cell malignancies who were intolerant to previous treatments with ibrutinib and/or acalabrutinib, demonstrating a safety profile that encourages further development. A pivotal Phase 2 trial in China for Waldenström's Macroglobulinemia also yielded promising results, with a major response rate nearing 70%. Priority reviews are underway for the supplemental new drug application in China.

BeiGene, Ltd. (NASDAQ: BGNE) announced significant clinical findings for its BTK inhibitor BRUKINSA® (zanubrutinib) at the 62nd ASH Annual Meeting. Initial results from the Phase 2 MAGNOLIA trial showed a 74.2% overall response rate in patients with relapsed/refractory marginal zone lymphoma. Additionally, the Phase 3 SEQUOIA trial's follow-up results indicated a 94.5% overall response rate and a 90.6% progression-free survival rate at 18 months in treatment-naïve patients with CLL/SLL with del(17p). These results support ongoing global regulatory submissions for BRUKINSA.

BeiGene, a biotechnology company, announced the pricing of a public offering of 1,511,546 American Depositary Shares (ADSs) at $225 per ADS, totaling approximately $340 million. The deal involves Selling Shareholders with a 30-day option for an additional 151,154 ADSs. Notably, BeiGene will not receive proceeds from this offering but will incur certain expenses. The transaction is expected to close on December 4, 2020, pending customary conditions. Goldman Sachs is the underwriter for this offering.

BeiGene, Ltd. (NASDAQ: BGNE) has launched an underwritten public offering of 1,511,546 American Depositary Shares (ADSs) by Selling Shareholders, aiming to enhance its market presence. Each ADS represents 13 ordinary shares, and the underwriter, Goldman Sachs & Co. LLC, has a 30-day option to purchase an additional 151,154 ADSs. BeiGene won't receive proceeds from this sale but will incur certain expenses. This offering is subject to market conditions, and the final terms will be disclosed in a prospectus supplement.

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is set to participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference, where presentations will be available from November 23 to December 3, 2020. An archived replay will be accessible for 90 days on BeiGene’s investor webpages.

As a leading biotechnology firm, BeiGene is focused on innovative medicines, specifically in oncology, with products like BRUKINSA® and tislelizumab. The company's global team is dedicated to enhancing treatment options for patients worldwide.

BeiGene has received approval from the China National Medical Products Administration for XGEVA® (denosumab) to prevent skeletal-related events (SREs) in patients with bone metastases from solid tumors and multiple myeloma. The drug, developed by Amgen and licensed to BeiGene, is already approved in China for treating giant cell tumor of the bone. Clinical trials involving over 7,000 patients showed XGEVA significantly delayed SREs compared to the standard treatment zoledronic acid. This approval marks a crucial addition to BeiGene's oncology portfolio, enhancing treatment options for patients in China.

BeiGene announced that its RATIONALE 303 trial of tislelizumab met the primary endpoint of overall survival in patients with non-small cell lung cancer (NSCLC) who received prior platinum-based chemotherapy. Conducted globally, the trial included 805 patients, randomized to either tislelizumab or docetaxel. Tislelizumab exhibited a safety profile consistent with known risks, showing no new safety signals. This positive interim result marks a milestone in BeiGene's clinical development efforts, further supporting potential regulatory filings for tislelizumab.

BeiGene, a biotechnology company, will present clinical data on its BTK inhibitor BRUKINSA and anti-PD-1 antibody tislelizumab at the 62nd ASH Annual Meeting from December 5-8, 2020. Highlights include an oral presentation titled Efficacy and Safety of Zanubrutinib in Patients with Relapsed/Refractory Marginal Zone Lymphoma. Additionally, a symposium on BTK Inhibitors in CLL is co-sponsored by BeiGene. Publication numbers for presentations are provided, detailing various trials and studies.