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Leads Biolabs Reports NMPA NDA Acceptance for Opamtistomig in Previously Treated Advanced EP-NEC

Shots: Chinese NMPA CDE has accepted the NDA for opamtistomig (LBL-024) as monotx. for previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) The NDA is supported by a registrational study led by Professor Shen Lin of Peking University Cancer Hospital, conducted across 34 sites; the study enrolled 96 pts with EP-NEC and completed enrollment in Aug 2025,…
August 21, 2026

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Harbour BioMed Reports NMPA IND Approval for HBM7004 to Treat Solid Tumors

Shots: The NMPA has approved the IND application for HBM7004 for the treatment of advanced solid tumors HBM7004 is a B7H4xCD3 bispecific antibody developed using HBM’s HBICE platform, designed to offer a differentiated cancer immunotherapy approach with potential efficacy & safety benefits  In preclinical studies, HBM7004 induced B7H4-dependent intratumoral T-cell activation & demonstrated strong anti-tumor…
August 18, 2026

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Leads Biolabs Reports NMPA IND Clearnce to Initiate P-Ib/II Trial for Opamtistomig Combination Therapy in mCRC

Shots: The NMPA has approved IND application to initiate P-Ib/II trial of opamtistomig (LBL-024) in combination therapy for metastatic colorectal cancer (mCRC) Trial will evaluate the safety & efficacy of opamtistomig combination regimens in pts with mCRC & explore potential predictive biomarkers. Opamtistomig mechanism was already validated across EP-NEC, NSCLC, SCLC, & biliary tract cancer…
August 3, 2026

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NEWS

Synlogic and Caldera Report Merger Agreement and Concurrent $278M Private Placement to Advance CLD-423

Shots: Synlogic & Caldera have agreed to merge in an all-stock transaction, forming a new holding company that will operate as Caldera Therapeutics & plans to list on Nasdaq under the ticker “CALD” Upon closing, Synlogic, Caldera, and private placement investors are expected to own ~2.3%, ~62.8%, and ~34.9% of the combined company, respectively, with…
July 30, 2026

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NEWS

Nanjing Leads Biolabs Receives NMPA Priority Review for Opamtistomig to Treat EP-NEC

Shots: The Chinese NMPA has accepted the BLA & granted priority review to Opamtistomig (LBL-024) as a monotx. for the treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) BLA was supported by the registrational trial data, designed to assess the efficacy & safety of Opamtistomig in pts with advanced EP-NEC whose disease had progressed following ≥2…
July 10, 2026

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NEWS

NMPA Accepts IND Application for Harbour BioMed’s HBM7004 to Treat Advanced Solid Tumors

Shots: The NMPA has accepted IND application for HBM7004 for the treatment of advanced solid tumors HBM7004, developed using Harbour’s HBICE platform, is a novel B7H4×CD3 bispecific antibody that is designed to enhance cancer immunotherapy, aiming to improve both efficacy & safety through targeted immune activation In preclinical studies, HBM7004 induced B7H4-dependent T-cell activation within…
June 10, 2026

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The US FDA Grants IND Clearance to Harbour BioMed’s HBM7004 to Initiate P-I Trial in Advanced Solid Tumors

Shots: The US FDA has granted IND clearance to initiate the P-I trial assessing the safety, tolerability, PK, & anti-tumor activity of Harbour Biomed's HBM7004 in advanced solid tumors  Preclinical studies showed that HBM7004 induced B7H4-dependent intratumoral T-cell activation, strong anti-tumor activity, in vivo stability, & reduced systemic toxicity, while combination with a B7H4x4-1BB BsAb…
May 8, 2026

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EpiBiologics Reports First Patient Dosed in P-I Study of EPI-326 for EGFR-Driven Solid Tumors

Shots: EpiBiologics has dosed the first patient in a global P-I study evaluating EPI-326, a tissue-selective bispecific antibody targeting EGFR, in advanced solid tumors The first-in-human study will assess safety, tolerability, PK, and preliminary anti-tumor activity in pts with NSCLC and HNSCC, with potential expansion into colorectal cancer Preclinical data showed robust anti-tumor activity across…
April 20, 2026

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Amgen
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The CHMP Recommends Amgen’s Imdylltra to Treat 1L ES-SCLC   

Shots:  The CHMP has recommended Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with Pt-based CT  Opinion was based on the P-III study in 509 ES-SCLC pts post Pt therapy, where Imdylltra showed improved mOS (13.6 vs 8.3 mos.; ~40% lower death risk) and higher mPFS (4.2 vs 3.2 mos.) vs SoC  Imdylltra is…
March 26, 2026

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