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…

ByRidhi Rastogi2 days ago

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Zymeworks Raises $250M from Royalty Pharma Backed by Ziihera Royalties

Shots: Zymeworks secured $250M from Royalty Pharma via a non-recourse royalty-backed note, repayable from 30% of worldwide tiered royalties on Ziihera owed by Jazz Pharmaceuticals and BeOne Medicines Royalty will receive payments until it achieves 1.65x of the note by Dec 31, 2033, or 1.925x thereafter; Zymeworks retains 70% of royalties during repayment, with full…

ByRidhi RastogiMarch 2, 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…

ByRidhi RastogiOctober 13, 2025

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BeOne Medicines Reports Topline P-III (BGB-11417-201) Trial Data on Sonrotoclax in R/R Mantle Cell Lymphoma (MCL)

Shots: The P-I/II (BGB-11417-201) trial of sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on sonrotoclax (160 or 320mg, QD), while Part 2 enrolled 103 pts on 320mg QD after ramp-up Trial met its 1EP of improved ORR per IRC & showed significant improvements across 2EPs,…

ByRidhi RastogiAugust 29, 2025

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BeOne Medicine’s Perioperative Tevimbra (Tislelizumab) Receives the EC’s Approval for Resectable NSCLC

Shots: The EC has approved neoadj. Tevimbra + Pt-based CT followed by adj. Tevimbra monotx. for adults with resectable NSCLC at high risk of recurrence Approval was based on P-III (RATIONALE-315) trial assessing perioperative Tevimbra with CT before surgery vs PBO + CT in NSCLC pts (n=453), which met its dual 1EPs of EFS &…

ByRidhi RastogiAugust 27, 2025

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Anbogen Therapeutics Reports the US FDA’s IND Clearance of ABT-301 for Metastatic Colorectal Cancer

Shots: The US FDA has approved IND application of ABT-301 to initiate P-I/II trial for pts with metastatic colorectal cancer (mCRC) Trial will assess ABT-301 + Tevimbra (provided by Beone) + Avastin in ~66 pts across Taiwan & Australia, with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC Additionally, Anbogen is pursuing global licensing,…

ByRidhi RastogiAugust 4, 2025

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

Zymeworks Raises $250M from Royalty Pharma Backed by Ziihera Royalties

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

BeOne Medicines Reports Topline P-III (BGB-11417-201) Trial Data on Sonrotoclax in R/R Mantle Cell Lymphoma (MCL)

BeOne Medicine’s Perioperative Tevimbra (Tislelizumab) Receives the EC’s Approval for Resectable NSCLC

Anbogen Therapeutics Reports the US FDA’s IND Clearance of ABT-301 for Metastatic Colorectal Cancer

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