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Rezubio Reports First Cohort Dosing in P-I Trial of RZ-520 Following FDA and NMPA IND Clearances

Shots: Rezubio has completed dosing of the first cohort in its P-I trial of RZ-520, following US FDA & Chinese NMPA clearances to assess its safety, tolerability, PK & PD in healthy volunteers RZ-520 is a clinical-stage asset developed using Rezubio’s MADD platform, with preclinical studies showing robust efficacy, superior safety & negligible systemic exposure…
September 7, 2026

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Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease
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Biogen and Eisai Report NMPA Approval of Leqembi (SC) as an Initiation Dose for Early Alzheimer’s Disease

Shots: The NMPA has approved Leqembi (SC autoinjector/SC-AI) as an initiation dose administered as 500mg given QW as two consecutive 250mg injections, each delivered in ~15secs, for the treatment of early Alzheimer's disease  Approval was supported by 18mos. P-III Clarity AD data & multiple SC administration sub-studies (incl. Chinese cohort), with SC-AI 500mg (QW) showing…
September 3, 2026

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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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Innocare Pharma
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InnoCare Pharma Reports NMPA Approval for P-III Trial of Mesutoclax + Azacitidine in Treatment-Naive AML

Shots: Chinese NMPA has approved the P-III trial of mesutoclax (ICP-248) in combination with azacitidine vs venetoclax with azacitidine in elderly or unfit pts with treatment-naïve acute myeloid leukemia (TN AML) At ASCO’26, the combination achieved an 81.8% composite CR rate in evaluable TN AML pts (as of Apr 13, 2026), with 86.5% of responders…
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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Hansoh Pharma Reports P-III (ARTEMIS-011) Trial Data on Ris-Rez for Osteosarcoma

Shots: Hansoh has reported P-III (ARTEMIS-011) trial data assessing risvutatug rezetecan (HS-20093), a B7-H3–directed ADC, vs CT in pts with osteosarcoma who had progressed or relapsed after receiving ≥2 prior lines of systemic therapy Trial met its 1EP of improved PFS as assessed by the IRC, with consistent benefits observed across 2EPs, incl. OS & investigator-assessed…
July 28, 2026

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