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Akesobio
NEWS

Akeso Receives NMPA Approval to Initiate P-II Trials of AK139 Across Seven Indications

Shots: The Chinese NMPA has approved the initiation of P-II trials of AK139 across seven indications, incl. COPD, severe bronchial asthma, chronic spontaneous urticaria, allergic rhinitis, CRSwNP, mod. to sev. atopic dermatitis, & prurigo nodularis AK139 is an IL-4Rα/ST2 bispecific antibody that blocks both the IL-4/IL-13 pathway via binding to IL-4Rα subunit & the IL-33/ST2…
February 11, 2026

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Akesobio
NEWS

Akeso’s Ivonescimab + CT Receives the NMPA Breakthrough Therapy Designation for Biliary Tract Cancer

Shots: The Chinese NMPA has granted BTD to ivonescimab + CT for the 1L treatment of advanced biliary tract cancer (BTC) Ivonescimab is being assessed in the fully-enrolled P-III (AK112-309/HARMONi-GI1) in combination with CT for the 1L treatment of advanced BTC The P-Ib/II trial data presented at ASCO 2024 showed ivonescimab plus CT showed an…
February 6, 2026

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NEWS

Summit Therapeutics Reports the US FDA’s BLA Acceptance for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Shots: The US FDA has accepted BLA of ivonescimab + CT for the treatment of EGFR-mutated locally advanced or metastatic non-squamous NSCLC post-TKI therapy (PDUFA: Nov 14, 2026) BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC who…
January 30, 2026

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NEWS

Boehringer Ingelheim and Simcere Pharmaceutical ~$1.26B Deal to Develop SIM0709

Shots: Boehringer Ingelheim and Simcere have entered a license and collaboration agreement to develop SIM0709, a preclinical TL1A/IL-23p19 bispecific antibody, for the treatment of inflammatory bowel disease (IBD) As per the deal, Boehringer Ingelheim gains global rights to the asset excluding Greater China, while Simcere is eligible for an upfront payment, milestones up to €1.058B…
January 28, 2026

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Abbvie
NEWS

AbbVie Reports Topline P-III (EPCORE DLBCL-1) Trial Data on Epcoritamab for R/R Diffuse Large B-cell Lymphoma (DLBCL)

Shots: AbbVie has reported topline P-III (EPCORE DLBCL-1) trial results assessing epcoritamab vs chemoimmunotherapy (R-GemOx or BR) in 483 adults with r/r DLBCL, who had received ≥1L of therapy (73% had received ≥2L) & were ineligible for HDT-ASCT Trial showed improved PFS, with improvements across CRR, DoR, & time to next treatment, plus the study did not…
January 19, 2026

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NEWS

J&J Reports P-III Trial Outcomes Showing Tecvayli Monotherapy Extends PFS and OS in R/R Multiple Myeloma

Shots: J&J has reported positive topline Phase III (MajesTEC-9) results demonstrating that Tecvayli (teclistamab) monotx. significantly outperformed SoC in r/r multiple myeloma The study included patients with 1–3 prior therapies, all previously treated with anti-CD38 antibodies and lenalidomide. Most patients were refractory to anti-CD38 mAbs (85%), lenalidomide (79%), and their last therapy (>90%). Tecvayli achieved…
January 15, 2026

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NEWS

Summit Therapeutics Reports the US FDA’s BLA Submission for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Shots: The US FDA has received BLA of ivonescimab + CT for ≥2L treatment of pts with EGFR-mutated locally advanced or metastatic non-squamous NSCLC; decision is expected by Q4’26 BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC…
January 13, 2026

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NEWS

AbbVie Enters PD-1×VEGF Bispecific Race with ~$5.6B Deal for Remegen’s RC148 

Shots: RemeGen has granted AbbVie exclusive rights to develop, manufacture, & commercialize RC148 outside of the Greater China In return, RemeGen will receive $650M upfront, ~$4.95B in development, regulatory, & commercial milestones, with tiered, double-digit royalties on sales in AbbVie’s licensed areas RC148 is a PD-1/VEGF-targeted bispecific antibody that is being developed as a monotx.…
January 13, 2026

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NEWS

InduPro Therapeutics Collaborates with Eli Lilly in ~$950M Oncology Therapeutic Discovery Deal

Shots: InduPro has entered into a global strategic collaboration & licensing agreement with Eli Lilly to discover novel oncology treatments using InduPro’s proximity-guided platform Lilly will gain access to InduPro’s AI/ML-enabled MInt platform, with InduPro leading early discovery to identify co-target pairs & advance bispecific & multispecific antibody programs from the collaboration As per the…
January 8, 2026

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NEWS

Windward Bio Secures Exclusive Rights to WIN027 from Qyuns Therapeutics in a ~$700M Deal

Shots: Windward Bio via its affiliate, LE2025 Therapeutics, has entered into a licensing agreement with Qyuns to develop & commercialize WIN027 (QX027N; anti-TSLPxIL-13 bsAb) As per the deal, Windward will obtain exclusive rights to develop, manufacture, & commercialize WIN027 outside of China, with Qyuns receiving an upfront payment, equity, & development, regulatory, & commercial milestones,…
December 24, 2025

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