BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Med-tech outlook 2026
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Wednesday, April 22, 2026
Home » Topics » Regulatory » NMPA

NMPA
NMPA RSS Feed RSS

Lung cancer illustration
AACR 2026

Xuanzhu shares dip despite phase III ALK inhibitor data

April 21, 2026
By Marian (YoonJee) Chu
No Comments
Xuanzhu Biopharmaceutical Co. Ltd. reported positive data from a local phase III study of dirozalkib (Xuan Fei Ning), an ALK inhibitor approved in China to treat patients with advanced non-small-cell lung cancer.
Read More
Global handshake silhouette

Biogen amasses full felzartamab rights with $850M TJ deal

April 21, 2026
By Marian (YoonJee) Chu
No Comments
Biogen Inc. has consolidated full global rights to felzartamab through an $850 million deal with TJ Biopharma Co. Ltd. April 20, closing the chapter on a complex 10-year license saga.
Read More
Lung cancer illustration
AACR 2026

Xuanzhu shares dip despite phase III ALK inhibitor data

April 20, 2026
By Marian (YoonJee) Chu
No Comments
Xuanzhu Biopharmaceutical Co. Ltd. reported positive data from a local phase III study of dirozalkib (Xuan Fei Ning), an ALK inhibitor approved in China to treat patients with advanced non-small-cell lung cancer.
Read More
3D rendering of an antibody drug conjugate
Immuno-oncology

CSPC’s SYS-6051 cleared for clinic in China for solid tumors

April 16, 2026
No Comments
CSPC Pharmaceutical Group Ltd.’s SYS-6051 has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for advanced solid tumors. SYS-6051 is a human tissue factor-targeted antibody-drug conjugate that binds to tissue factor expressed on the surface of tumor cells.
Read More
Microscopic image of acute myeloid leukemia (AML) cells.
Immuno-oncology

China’s NMPA accepts Mabwell’s IND application for 6MW5311

April 16, 2026
No Comments
Mabwell (Shanghai) Bioscience Co. Ltd.’s has announced IND acceptance by China’s National Medical Products Administration (NMPA) for the company’s LILRB4/CD3 T-cell engager bispecific antibody 6MW5311. The drug candidate is being developed for hematologic malignancies, specifically acute myeloid leukemia (AML), chronic myelomonocytic leukemia and multiple myeloma.
Read More
Radiopharmaceutical illustration
Neurology/psychiatric

Mabwell announces Chinese clinical trial clearance for SST-001

April 15, 2026
No Comments
Mabwell (Shanghai) Bioscience Co. Ltd. has announced that SST-001 (18F-FD4), an α-synuclein-targeted PET tracer developed by Mabwell’s incubated company Synusight Biotech, has received clinical trial clearance from China’s National Medical Products Administration (NMPA). The planned phase I trial will enroll healthy volunteers, patients with multiple system atrophy (MSA), and patients with Parkinson’s disease.
Read More
3D illustration of tumor
Immuno-oncology

Fosun gains clinical trial approval in China for FXB-0871

April 2, 2026
No Comments
Fosun Pharmaceutical (Group) Co. Ltd. has received the approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of FXB-0871 (TEV-56278) for the treatment of locally advanced or metastatic solid tumors.
Read More
Woman taking Amsler grid eye exam

Innovent’s IBI-302 meets phase III endpoints in neovascular AMD

March 31, 2026
By Tamra Sami
No Comments
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.
Read More
Monoclonal antibody illustration

Simcere’s rademikibart meets phase III endpoints in atopic dermatitis

March 31, 2026
By Tamra Sami
No Comments
Simcere Pharmaceutical Group Ltd.’s monoclonal antibody, rademikibart (CBP-201), met the primary endpoint in a Chinese phase III study in adults and adolescents with moderate to severe atopic dermatitis.
Read More
Woman taking Amsler grid eye exam

Innovent’s IBI-302 meets phase III endpoints in neovascular AMD

March 25, 2026
By Tamra Sami
No Comments
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.
Read More
Previous 1 2 3 4 5 6 7 8 9 … 65 66 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for April 22, 2026.
  • Man holding raised arm with illustrated overlay of nerves

    Biohaven reports details on discovery of BHV-2100

    BioWorld Science
    Transient receptor potential melastatin 3 (TRPM3) is a calcium-permeable TRP channel that is highly expressed in somatosensory neurons, including nociceptors of...
  • Elderly woman holding illustration of brain with missing puzzle piece

    Meta-analysis: Anti-amyloid Alzheimer’s drugs not ‘clinically meaningful’

    BioWorld
    The ongoing controversy over the effectiveness of anti-amyloid drugs is about to get more heated, after a review of clinical trials showed statistically...
  • New GABA(B) receptor PAMs revealed in Addex Pharma patents

    BioWorld Science
    Addex Pharma SA has disclosed new GABA(B) receptor positive allosteric modulators (PAMs) potentially useful for the treatment of chronic cough, urinary...
  • MMP inhibitors divulged in Accure Therapeutics patent

    BioWorld Science
    Accure Therapeutics has reported new oligopeptide derivatives acting as matrix metalloproteinase-2 (MMP-2) and MMP-9 inhibitors. As such, they are described as...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing