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BeOne Medicines’ Tevimbra Receives the EC Approval for Nasopharyngeal Carcinoma

Shots:The EC has approved Tevimbra (tislelizumab) + gemcitabine & cisplatin for 1L treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapyApproval was based on P-III (RATIONALE-309) trial assessing Tevimbra + gemcitabine & cisplatin vs PBO + gemcitabine & cisplatin in 263 treatment-naïve NPC ptsTrial…

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Biocytogen Pharmaceuticals Enters a Licensing Agreement with BeOne Medicines for Multiple Antibody Candidates

Shots:Biocytogen & BeOne have entered into a global licensing agreement for multiple fully human antibodies discovered using Biocytogen’s RenMicefully human antibody platformAs per the deal, Biocytogen will receive an upfront payment, development, regulatory, & commercial milestones, with net sales-based tiered royalties on licensed products. Although, financial terms remain undisclosedCollaboration builds on BeOne Medicines…

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BeOne Receives CHMP Positive Opinion for New Brukinsa Tablet Formulation Across All Approved Indications

Shots:Following the US FDA approval, EMA's CHMP issued a positive opinion of Brukinsa (zanubrutinib) film‑coated tablets for all approved indications. EC will now review the opinion for MAA in the EU, Norway, and IcelandBRUKINSA tablets (160mg) are bioequivalent to the capsule form, supported by a P-I study. With a recommended daily dose of 320mg,…

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Zymeworks

Zymeworks’ Zanidatamab Receives the NMPA’s Conditional Approval for the Treatment of Biliary Tract Cancer

Shots:The NMPA has granted conditional approval to zanidatamab for the treatment of pts with previously treated, inoperable or metastatic HER2+ biliary tract cancer (BTC) following the CHMP’s positive opinion in Apr 2025Approval was based on P-IIb (HERIZON-BTC-01) trial, which assessed anti-tumor activity of zanidatamab monotx. in HER2+ inoperable & advanced or metastatic BTCApproval…

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