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NEWS

BeOne Medicines Reports the US FDA Approval of Tevimbra + Ziihera to Treat HER2+ GEA

Shots: The US FDA has approved the sBLA for Tevimbra (tislelizumab) + Ziihera (zanidatamab) & CT for the 1L treatment of adults with unresectable locally advanced or metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA)  Approval was based on the P-III (HERIZON-GEA-01) assessing the efficacy & safety of Ziihera+ CT, with and without Tevimbra, to the…
August 26, 2026

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BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted accelerated approval to BeOne's Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52%…
May 14, 2026

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BeOne Receives the US FDA Priority Review to  Tevimbra Combination for 1L Treatment of HER2+ GEA Cancers

Shots: FDA has granted priority review to BeOne's Tevimbra + Ziihera & CT for the 1L treatment of unresectable locally advanced/metastatic HER2+ gastric, GEJ, or esophageal adenocarcinoma; BeOne plans to participate in the FDA’s Project Orbis sBLA was based on the P-III (HERIZON-GEA-01) trial, which assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as…
April 30, 2026

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Huahui Health and BeOne Medicines Partner for HH160 in a ~$2.02B Deal

Shots: Huahui Health has entered into a global exclusive option, license & collaboration agreement, granting BeOne an exclusive option for the development, manufacturing, & commercialization of HH160, a novel trispecific antibody in oncology immunotherapy As per the deal, Huahui will receive $20M upfront, $100M upon exercising the option, & ~$1.9B in development, regulatory & sales milestones, as well as tiered…
April 30, 2026

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BeOne Medicines’ Sonrotoclax Receives FDA’s Breakthrough Therapy Designation for R/R Mantle Cell Lymphoma (MCL)

Shots: The US FDA has granted BTD to sonrotoclax for adults with r/r MCL & accepted BeOne’s request for participation in Project Orbis for concurrent global review of the therapy Decision was based on P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on…
October 13, 2025

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Royalty Pharma Signs Agreement to Acquire Interest in Amgen’s Imdelltra Royalties from BeOne Medicines for ~$950M

Shots: Royalty Pharma has acquired a royalty interest in Amgen’s Imdelltra from BeOne Medicines for ~$950M As per the deal, Royalty Pharma will acquire BeOne’s ~7% royalty on global Imdelltra sales for ~$950M, including $885M upfront and an option for BeOne to sell more for $65M within 12mos. The royalty, including shared sales above $1.5B…
August 26, 2025

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