Chi-Med, BeiGene enter clinical collaboration » 05:1905/2605/26/20
Hutchison China MediTech,…
Hutchison China MediTech, or Chi-Med (HCM), and BeiGene (BGNE) announced that they have entered into a clinical collaboration agreement to evaluate the safety, tolerability and efficacy of combining two of Chi-Med's drug candidates, surufatinib and fruquintinib, with BeiGene's anti-PD-1 antibody tislelizumab, for the treatment of various solid tumor cancers, in the U.S., Europe, China and Australia. Under the terms of the agreement, Chi-Med and BeiGene each plan to explore development of the combination of surufatinib with tislelizumab or fruquintinib with tislelizumab in different indications and regions. The companies have agreed to provide mutual drug supply and other support.
|Over a week ago|
BeiGene, Medison Pharma announce distribution agreement for BRUKINSA » 07:2005/2105/21/20
BeiGene and Medison…
BeiGene and Medison Pharma announced an exclusive distribution agreement for Medison to commercialize BeiGene's BTK inhibitor BRUKINSA in Israel and the acceptance of a new drug application in Israel for BRUKINSA for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
BeiGene files to sell 300.2M shares of common stock for holders 17:3605/1105/11/20
Fly Insider: Five Point, Acadia among week's notable insider trades » 12:4605/0405/04/20
CINF, IMMU, ROIC, FPH, ORIC, ACAD, ABT, BGNE, CROX, GH
Welcome to "Fly Insider,"…
BeiGene, Atreca to collaborate on antibody development targeting COVID-19 » 20:1404/2904/29/20
IGMS, BGNE, BCEL
Atreca ( BCEL), BeiGene…
Atreca ( BCEL), BeiGene (BGNE), and IGM Biosciences (IGMS) announced their plans to collaborate to help address the COVID-19 pandemic. The companies will leverage their combined technology and expertise in an effort to discover, develop, and manufacture novel IgM and IgA antibodies targeting SARS-CoV-2 for the potential treatment of COVID-19. Given the urgency of the global COVID-19 pandemic, the parties have agreed to begin work immediately and plan to finalize financial details and other terms in the future. Immunoglobulin M and immunoglobulin A are classes of antibodies naturally produced by the human immune system and are differentiated from immunoglobulin G antibodies in part by their greater number of binding domains. IGM Biosciences engineers IgM and IgA antibodies with greater binding power per antibody, relative to comparable IgG antibodies. This greater binding power could potentially result in better activity against a broader range of variants of the virus which causes COVID-19, as compared to traditional IgG antibodies. IgA and IgM antibodies also have the inherent property of active transport from the blood stream to mucosal surfaces, such as in the lung, which may provide a therapeutic advantage for respiratory diseases such as COVID-19. The alliance will utilize Atreca's proprietary discovery platform to generate the sequences of antibodies made by particular B cells found in blood obtained from acutely infected COVID-19 patients. IGM's technology platform will then be leveraged in an effort to develop and manufacture engineered IgM and IgA therapeutic antibodies from the identified sequences. BeiGene has agreed to provide global clinical development support by leveraging its more than 1,100-person global development team across China, the United States, Europe, and Australia, including leading global regulatory interactions for any potential drug candidate that is developed. BeiGene is a leader in global clinical development with 26 potentially registration-enabling trials ongoing and over 60 studies enrolling patients in more than 35 countries. Its large, global clinical development team is focused on high-quality, efficient drug development optimized for global regulatory submissions.
|Over a month ago|
BeiGene announces acceptance of sNDA for Tislelizumab in China » 16:0804/2004/20/20
BeiGene announced that…
BeiGene announced that the Center for Drug Evaluation, or CDE, of the China National Medical Products Administration, or NMPA, has accepted a supplemental new drug application, or sNDA, of BeiGene's anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens for first-line treatment of patients with advanced squamous non-small cell lung cancer. This sNDA is supported by clinical results from a Phase 3 trial of tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel and carboplatin compared to paclitaxel and carboplatin alone in patients with untreated stage IIIB or IV squamous NSCLC from mainland China.
BeiGene says trial of tislelizumab paired with chemo met primary endpoint » 16:1204/1304/13/20
BeiGene announced that…
BeiGene announced that the Phase 3 trial evaluating its anti-PD-1 antibody tislelizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer, NSCLC, met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival, PFS, compared to pemetrexed and platinum chemotherapy alone at the planned interim analysis, as assessed by independent review committee, IRC. The safety profile of tislelizumab in combination with pemetrexed and platinum chemotherapy was consistent with the known risks of each study treatment, and no new safety signals were identified. "We are excited to announce the positive outcome in the interim analysis of this Phase 3 study of tislelizumab in first-line non-squamous NSCLC, following the positive interim analysis in first-line squamous NSCLC earlier this year," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "These results add to our growing body of evidence demonstrating the efficacy and safety of tislelizumab for the treatment of advanced cancers. We look forward to continuing to evaluate tislelizumab in more than 25 studies, including 15 potentially registration-enabling trials."
BeiGene's tislelizumab receives second approval in China, first in solid tumor » 15:4404/1204/12/20
BeiGene announced that…
BeiGene announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration as a treatment for patients with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Following tislelizumab's initial approval in classical Hodgkin's lymphoma by the NMPA in December 2019, this is the second indication approved for tislelizumab, and the first in a solid tumor indication. The supplemental new drug application was previously granted priority review by the Center for Drug Evaluation of the NMPA. The NMPA approval is based on the clinical results from a single-arm, multi-center pivotal Phase 2 trial of tislelizumab in patients in China and South Korea with PD-L1+ locally advanced or metastatic UC who were previously treated with platinum-containing chemotherapy. Among patients who were evaluable for response, with a minimum follow-up of 12 months and a median follow-up of 14 months, the objective response rate as assessed by the independent review committee per RECIST v1.1 criteria was 24.8%, and the complete response rate was 9.9%. The safety data for tislelizumab included in the label is based on 934 patients treated with tislelizumab monotherapy from four clinical trials, including the aforementioned pivotal Phase 2 trial in patients with UC. Most common adverse reactions included rash, fatigue, and increased alanine aminotransferase. Grade 3 or higher adverse reactions occurring in greater than or equal to 1% of patients included: increased gamma-glutamyl transferase, anemia, increased aspartate aminotransferase, increased alanine aminotransferase, pneumonitis, severe skin reactions, and hypokalemia. Like other immune checkpoint inhibitors, tislelizumab could cause immune-related adverse reactions that mainly include pneumonitis, diarrhea and colitis, hepatitis, endocrinopathies, and skin adverse reactions. Occasionally, nephritis, pancreatitis, myocarditis, myositis, and other immune-related adverse reactions were also reported. The recommended dose of tislelizumab is 200 mg administered as an intravenous infusion every three weeks until disease progression or intolerable toxicity.
BeiGene Abraxane issue could take months to resolve, says Piper Sandler » 12:4903/2503/25/20
Piper Sandler analyst…
Piper Sandler analyst Tyler Van Buren made no change to his Neutral rating and $165 price target for BeiGene (BGNE) after the company announced a failed inspection by the Chinese NMPA at a Celgene (BMY) contract manufacturing site, saying that all use and sales of Abraxane have been immediately suspended. Of the $222M in Celgene product sales recorded last year by BeiGene, the analyst notes that Abraxane accounted for roughly 50% and given that this is a process issue and not a batch issue, he expects it to take months to resolve.
BeiGene trading resumes 09:5003/2503/25/20