BeiGene announces China NMPA approval for Sylvant » 05:3712/0312/03/21
BeiGene announced that…
BeiGene announced that the China National Medical Products Administration, or NMPA, has approved Sylvant for the treatment of adult patients with multicentric Castleman disease, or MCD, who are human immunodeficiency virus, or HIV, negative and human herpes virus-8, or HHV-8, negative, also known as idiopathic MCD, or iMCD,. This disease is a rare, life-threatening, and debilitating condition of the lymph nodes and related tissues. Siltuximab is a monoclonal antibody approved in the United States, European Union, and other countries and regions around the world.
BeiGene announces three medicines included in NDRL by China NHSA » 05:3512/0312/03/21
BeiGene announced that…
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|Over a week ago|
BeiGene announces approval of Brukinsa in EU » 17:0011/2311/23/21
BeiGene announced that…
BeiGene announced that the European Commission approved BRUKINSA for the treatment of adult patients with Waldenstrom's macroglobulinemia who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy. The approval is applicable to all 27 European Union member states, plus Iceland and Norway. BeiGene is working to make this new treatment option available to WM patients in the EU as quickly as possible. "BTK inhibition is an established mode of treatment for patients with WM, and the approval of BRUKINSA provides an important new option for patients with WM that may offer improved outcomes," said Prof. Christian Buske, Medical Director at the University Hospital Ulm, Germany, and a trial investigator of the ASPEN study. "Patients and their physicians in the EU will soon have access to an innovative medicine that has potential to offer deep and durable responses and improved tolerability, as seen in the ASPEN trial."
BeiGene closes on property for new U.S. manufacturing and clinical R&D center » 07:0811/2311/23/21
BeiGene announced that it…
BeiGene announced that it has purchased a 42-acre site at the Princeton West Innovation Campus in Hopewell, N.J. to house a new state-of-the-art manufacturing campus and clinical R&D center. As a key part of BeiGene's continued growth, the company is investing in U.S. manufacturing to further expand and diversify its global supply chain and build new manufacturing capabilities for its deep pipeline of biologic and drug candidates. Subject to finalizing the development plans, BeiGene expects to invest several hundred million dollars in the initial phase of construction, in addition to the acquisition of the property, for the state-of-the-art facility that is expected to include up to approximately 400,000 square feet of dedicated commercial-stage biologic pharmaceutical manufacturing, including up to 16,000 liters of biologics capacity, along with clinical R&D and office space. Construction of the initial phase is expected to commence in 2022 and be completed in late-2023 or in 2024. In addition, the property has more than one million square feet of developable real estate for potential future expansion. "With this property acquisition, we plan to establish a flagship manufacturing and clinical R&D center in the U.S. to diversify our global supply chain. We are proud to take this next step in our journey to advance impactful treatments and make them more accessible to patients around the world," said John V. Oyler, Co-Founder, Chairman, and CEO of BeiGene. "We have already begun hiring additional colleagues from the deep talent pool in New Jersey and look forward to serving as a member of the thriving Princeton-Hopewell business community."
BeiGene begins 1st in-human Phase 1 trial of TYK2 inhibitor BGB-23339 » 07:0911/2211/22/21
BeiGene announced that…
BeiGene announced that the first patient has been dosed in a Phase 1 clinical trial of BGB-23339, a potent, allosteric investigational tyrosine kinase 2 TYK2 inhibitor internally developed by BeiGene scientists. TYK2 is a member of the JAK family and functions as a critical mediator in cytokine signaling pathways implicated in multiple immune-mediated disorders, such as psoriasis and inflammatory bowel disease. BGB-23339 is a potent, highly selective, investigational TYK2 inhibitor targeting the regulatory pseudokinase JH2 domain. "Discovered and developed by BeiGene, BGB-23339 is a highly selective, potent, allosteric TYK2 inhibitor that has shown promising activity in preclinical evaluation," commented Lai Wang, Ph.D., Global Head of R&D at BeiGene. "Building on our proven track record in oncology, BeiGene is expanding its clinical focus to discover new modalities and platforms in areas of high unmet need, including inflammation and immunology, to bring innovative, impactful medicines to patients." The first-in-human Phase 1 trial is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of BGB-23339. The trial is expected to enroll up to 115 healthy volunteers in Australia and/or China. In addition to its broad portfolio focused on hematological malignancies and solid tumors, BeiGene is applying its research excellence and clinical expertise to address inflammation and immunology, an area of high unmet medical need. BeiGene's internally developed, highly selective next-generation BTK inhibitor BRUKINSA is currently being evaluated in a Phase 2 trial in patients with active proliferative lupus nephritis. About BGB-23339 .
Zymeworks launches Phase 3 zanidatamab trial in first-line HER2-positive GEA » 08:4411/0911/09/21
Zymeworks (ZYME) announced, together with its partner BeiGene (BGNE), the launch of HERIZON-GEA-01. This is a randomized, global Phase 3 study evaluating Zymeworks' investigational HER2-targeted bispecific antibody, zanidatamab, plus chemotherapy, with or without BeiGene's anti-PD-1-targeted antibody tislelizumab, versus standard of care, trastuzumab plus chemotherapy, for the first-line treatment of metastatic HER2-postive GEA. "We are incredibly excited to launch our second pivotal, and first Phase 3 clinical trial for zanidatamab, HERIZON-GEA-01," said Ali Tehrani, Ph.D., Zymeworks' President & CEO. "Gastrointestinal cancers have significant unmet patient need and we have the opportunity to help a large and growing patient population. With two potential Biologics License Applications over the next 3 years, we believe zanidatamab has the potential to achieve blockbuster status and position Zymeworks as the leader in the treatment of HER2-positive GI cancers." The primary objective of the HERIZON-GEA-01 study is to evaluate the efficacy and safety of zanidatamab in combination with physician's choice chemotherapy [CAPOX or FP with or without tislelizumab compared to trastuzumab plus physician's choice chemotherapy in subjects with advanced or metastatic HER2-positive GEA. Primary endpoints are progression-free survival by RECIST 1.1, assessed by blinded independent central review, and overall survival. The HERIZON-GEA-01 study seeks to enroll approximately 700 patients at approximately 300 sites across 38 countries. BeiGene will oversee trial sites in Asia , Australia and New Zealand, and Zymeworks will oversee trial sites in the rest of the world, including North and South America, Japan, Europe, Middle East, and Africa.
BeiGene reports Q3 EPS ($4.46), consensus ($4.58) » 16:5911/0411/04/21
Reports Q3 revenue…
Reports Q3 revenue $206.4M, consensus $186.9M. "We remain focused on translating science into highly impactful medicines and making these medicines more affordable and accessible to many more people with cancer around the world," said John V. Oyler, Co-Founder, Chairman and Chief Executive Officer of BeiGene. "In the third quarter we had two new indications approved for BRUKINSA in the United States, and recent BRUKINSA approvals in Australia, Singapore, Brazil, Russia, and Chile as well as a positive CHMP opinion for our first BRUKINSA filing in Europe. Tislelizumab's BLA for esophageal squamous cell carcinoma has been accepted for review by the FDA, which is the first filing for our internally developed anti-PD-1 medicine outside of China and an important achievement in our collaboration with Novartis. This is one of many global tislelizumab studies that comprise a comprehensive PD-1 program that has enrolled over 5,600 patients in more than 30 countries and regions and includes over 1,700 patients from outside of China. We also continued to expand and strengthen our strategic competitive advantages that we feel are critical to transform the industry and bring innovative and accessible medicines to billions more people around the world. These include research, predominantly CRO-free global clinical development, global commercial infrastructure, and internal manufacturing capabilities."
BeiGene provides data on Brukinsa in CLL at ASH » 09:1211/0411/04/21
BeiGene announced clinical results and real world data from its hematology program to be presented at the 63rd American Society of Hematology Annual Meeting and Exposition, including two oral presentations on the Phase 3 SEQUOIA trial comparing BRUKINSA, zanubrutinib, to bendamustine and rituximab B+R in patients with treatment-naive chronic lymphocytic leukemia, CLL, or small lymphocytic lymphoma, SLL. The ASH meeting will take place on December 11-14, as a hybrid event in Atlanta, GA and in a virtual format.
|Over a month ago|
BeiGene, Nanolek receive Russia Ministry of Health approval for Brukinsa » 07:0510/2010/20/21
BeiGene and Nanolek…
BeiGene and Nanolek announced that Brukinsa has received approval from the Russia Ministry of Health for the treatment of adult patients with mantle cell lymphoma, or MCL, who have received at least one prior therapy. BeiGene and Nanolek entered into an exclusive distribution agreement for Nanolek to commercialize Brukinsa in the Russian Federation.
Fly Intel: Top five analyst initiations » 09:5410/1210/12/21
NKE, AMP, LEV, BGNE, PENN, DKNG, RSI
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Nike (NKE) initiated with a Buy at Goldman Sachs. 2. Ameriprise (AMP) initiated with an Outperform at Wolfe Research. 3. Lion Electric (LEV) initiated with a Sector Perform at Scotiabank. 4. BeiGene (BGNE) initiated with an Outperform at Bernstein. 5. DraftKings (DKNG) initiated with a Sell, Penn National (PENN) and Rush Street Interactive (RSI) initiated with a Buy at Roth Capital. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.