http://new.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Tue, 25 Aug 2026 10:40:19 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://new.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html <p>BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).</p> <p>The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which were published in <em>The New England Journal of Medicine</em>. The trial randomized 914 patients across approximately 300 sites in more than 30 countries.</p> <p>Key trial results include a median overall survival (OS) of 26.4 http://www.streetinsider.com/FDA/FDA+approves+BeOne%27s+Tevimbra+combo+for+HER2%2B+stomach+cancer/26972655.html Tue, 25 Aug 2026 10:40:19 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html <p class="bwalignc"> <i>TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status</i> </p><p class="bwalignc"> <i>Regimen poised to become standard of care in this difficult-to-treat disease. </i> </p> <p> SAN CARLOS, Calif.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fbeonemedicines.com%2F&amp;esheet=54594386&amp;newsitemid=20260825943679&amp;lan=en-US&amp;anchor=BeOne+Medicines+Ltd.&amp;index=1&amp;md5=11f5f59e7a2f0342c87a0d056436f88a" shape="rect">BeOne Medicines Ltd.</a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adult patients http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html Tue, 25 Aug 2026 10:40:00 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html <p class="bwalignc"> <i>TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status</i> </p><p class="bwalignc"> <i>Regimen poised to become standard of care in this difficult-to-treat disease. </i> </p> <p> SAN CARLOS, Calif.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fbeonemedicines.com%2F&amp;esheet=54594386&amp;newsitemid=20260825943679&amp;lan=en-US&amp;anchor=BeOne+Medicines+Ltd.&amp;index=1&amp;md5=11f5f59e7a2f0342c87a0d056436f88a" shape="rect">BeOne Medicines Ltd.</a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adult patients http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html Tue, 25 Aug 2026 10:40:00 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html <p class="bwalignc"> <i>TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status</i> </p><p class="bwalignc"> <i>Regimen poised to become standard of care in this difficult-to-treat disease. </i> </p> <p> SAN CARLOS, Calif.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fbeonemedicines.com%2F&amp;esheet=54594386&amp;newsitemid=20260825943679&amp;lan=en-US&amp;anchor=BeOne+Medicines+Ltd.&amp;index=1&amp;md5=11f5f59e7a2f0342c87a0d056436f88a" shape="rect">BeOne Medicines Ltd.</a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adult patients http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html Tue, 25 Aug 2026 10:40:00 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html <p class="bwalignc"> <i>TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status</i> </p><p class="bwalignc"> <i>Regimen poised to become standard of care in this difficult-to-treat disease. </i> </p> <p> SAN CARLOS, Calif.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fbeonemedicines.com%2F&amp;esheet=54594386&amp;newsitemid=20260825943679&amp;lan=en-US&amp;anchor=BeOne+Medicines+Ltd.&amp;index=1&amp;md5=11f5f59e7a2f0342c87a0d056436f88a" shape="rect">BeOne Medicines Ltd.</a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adult patients http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html Tue, 25 Aug 2026 10:40:00 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html <p class="bwalignc"> <i>TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status</i> </p><p class="bwalignc"> <i>Regimen poised to become standard of care in this difficult-to-treat disease. </i> </p> <p> SAN CARLOS, Calif.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fbeonemedicines.com%2F&amp;esheet=54594386&amp;newsitemid=20260825943679&amp;lan=en-US&amp;anchor=BeOne+Medicines+Ltd.&amp;index=1&amp;md5=11f5f59e7a2f0342c87a0d056436f88a" shape="rect">BeOne Medicines Ltd.</a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adult patients http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html Tue, 25 Aug 2026 10:40:00 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html <p class="bwalignc"> <i>TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status</i> </p><p class="bwalignc"> <i>Regimen poised to become standard of care in this difficult-to-treat disease. </i> </p> <p> SAN CARLOS, Calif.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fbeonemedicines.com%2F&amp;esheet=54594386&amp;newsitemid=20260825943679&amp;lan=en-US&amp;anchor=BeOne+Medicines+Ltd.&amp;index=1&amp;md5=11f5f59e7a2f0342c87a0d056436f88a" shape="rect">BeOne Medicines Ltd.</a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adult patients http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html Tue, 25 Aug 2026 10:40:00 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html <p class="bwalignc"> <i>TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status</i> </p><p class="bwalignc"> <i>Regimen poised to become standard of care in this difficult-to-treat disease. </i> </p> <p> SAN CARLOS, Calif.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fbeonemedicines.com%2F&amp;esheet=54594386&amp;newsitemid=20260825943679&amp;lan=en-US&amp;anchor=BeOne+Medicines+Ltd.&amp;index=1&amp;md5=11f5f59e7a2f0342c87a0d056436f88a" shape="rect">BeOne Medicines Ltd.</a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adult patients http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html Tue, 25 Aug 2026 10:40:00 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html <p class="bwalignc"> <i>TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status</i> </p><p class="bwalignc"> <i>Regimen poised to become standard of care in this difficult-to-treat disease. </i> </p> <p> SAN CARLOS, Calif.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fbeonemedicines.com%2F&amp;esheet=54594386&amp;newsitemid=20260825943679&amp;lan=en-US&amp;anchor=BeOne+Medicines+Ltd.&amp;index=1&amp;md5=11f5f59e7a2f0342c87a0d056436f88a" shape="rect">BeOne Medicines Ltd.</a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adult patients http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html Tue, 25 Aug 2026 10:40:00 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html <p class="bwalignc"> <i>TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status</i> </p><p class="bwalignc"> <i>Regimen poised to become standard of care in this difficult-to-treat disease. </i> </p> <p> SAN CARLOS, Calif.--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fbeonemedicines.com%2F&amp;esheet=54594386&amp;newsitemid=20260825943679&amp;lan=en-US&amp;anchor=BeOne+Medicines+Ltd.&amp;index=1&amp;md5=11f5f59e7a2f0342c87a0d056436f88a" shape="rect">BeOne Medicines Ltd.</a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adult patients http://www.streetinsider.com/Press+Releases/BeOne+Medicines+Announces+U.S.+FDA+Approval+for+TEVIMBRA-Based+Regimen+for+First-Line+HER2%2B+GEA/26972653.html Tue, 25 Aug 2026 10:40:00 -0400 06160 688235 A.06822034 A.09649487 A.22403962 A.22847412 A.33615634 A.50209015 O.00048429 O.00225875 O.00861113 O.03960636 O.07116439 O.20026344 O.76306903 ONC