BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • 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 - Saturday, January 17, 2026
Home » Topics » Regulatory » NMPA

NMPA
NMPA RSS Feed RSS

Kelun Biotech rendering of sacituzumab tirumotecan

China approves Kelun-Biotech’s TROP2 ADC for breast cancer

Dec. 3, 2024
By Marian (YoonJee) Chu
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. won local approval of the first China-made trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC), sacituzumab tirumotecan, as a third-line therapy for advanced breast cancer.
Read More
Jiuyuang Gene Engineering IPO ceremony

Jiuyuan Gene raises HKD$485M in Hong Kong IPO

Dec. 3, 2024
By Tamra Sami
Hangzhou Jiuyuan Gene Engineering Co. Ltd. raised HKD$485.4 million (US$62.38 million) in a November 28 IPO on the main board of the Hong Kong Stock Exchange (HKEX:2566).
Read More
Jiuyuang Gene Engineering IPO ceremony

Jiuyuan Gene raises HKD$485M in Hong Kong IPO

Dec. 2, 2024
By Tamra Sami
Hangzhou Jiuyuan Gene Engineering Co. Ltd. raised HKD$485.4 million (US$62.38 million) in a November 28 IPO on the main board of the Hong Kong Stock Exchange (HKEX:2566).
Read More
Kelun Biotech rendering of sacituzumab tirumotecan

China approves Kelun-Biotech’s TROP2 ADC for breast cancer

Dec. 2, 2024
By Marian (YoonJee) Chu
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. won local approval of the first China-made trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC), sacituzumab tirumotecan, as a third-line therapy for advanced breast cancer.
Read More
Mast cell releasing histamine during allergic response
Immune

Longbio’s LP-003 receives NMPA clearance to enter clinic for food allergy

Nov. 26, 2024
Longbio Pharma (Suzhou) Co. Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) for LP-003, the company’s next-generation anti-IgE antibody, to enter a clinical trial for the treatment of food allergy.
Read More

NMPA clears Alpha’s oral EGFR-TKI for NSCLC with brain metastases

Nov. 26, 2024
By Marian (YoonJee) Chu
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
Read More

NMPA clears Alpha’s oral EGFR-TKI for NSCLC with brain metastases

Nov. 21, 2024
By Marian (YoonJee) Chu
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
Read More

China’s NMPA accepts Ascentage NDA for Bcl-2 inhibitor lisaftoclax

Nov. 19, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted Ascentage Pharma Group Corp. Ltd.’s NDA for its in-house-developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which could be the first domestically approved Bcl-2 inhibitor in China and the second global approval.
Read More
Chinese flag and microscopes
Drug design, drug delivery & technologies

‘A decade of innovation, a decade to come’ for China pharma

Nov. 19, 2024
By Marian (YoonJee) Chu
As China rises to second place, next only to the U.S., for innovative new drugs, a new report by Clarivate – A Decade of Innovation, A Decade to Come – outlines key policy reforms and regulatory, R&D and investment trends driving past and future growth of Chinese biopharmaceuticals.
Read More
Chinese flag and microscopes

‘A decade of innovation, a decade to come’ for China pharma

Nov. 18, 2024
By Marian (YoonJee) Chu
As China rises to second place, next only to the U.S., for innovative new drugs, a new report by Clarivate – A Decade of Innovation, A Decade to Come – outlines key policy reforms and regulatory, R&D and investment trends driving past and future growth of Chinese biopharmaceuticals.
Read More
Previous 1 2 … 12 13 14 15 16 17 18 19 20 … 61 62 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Jan 16, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Jan. 16, 2026.
  • SERPINB1 as potential biomarker for spinocerebellar ataxia type 2

    BioWorld Science
    Researchers from Goethe-Universität and collaborators investigated novel molecular biomarker candidates for spinocerebellar ataxia type 2, a progressive...
  • Abbvie snags PD-1/VEGF bispecific in potential $5B Remegen deal

    BioWorld
    With rumors regarding a couple of potential mega-mergers making the rounds, the week of the annual J.P. Morgan Healthcare Conference kicked off with the official...
  • Businesswoman pressing dollar sign on touchscreen

    JPM 2026: Year kicks off with biopharma Q4 revenue and guidance

    BioWorld
    It was a battle of the companies with drugs for transthyretin-mediated amyloidosis on the first day of the J.P. Morgan 2026 Healthcare Conference with Alnylam...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • NME Digest
    • Patents
  • 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