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Results For "Center-for-Drug-Evaluation"

28 News Found

Zenas BioPharma and InnoCare hit key milestone in Lupus drug trial, secures China Phase 3 nod
Clinical Trials | December 16, 2025

Zenas BioPharma and InnoCare hit key milestone in Lupus drug trial, secures China Phase 3 nod

The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort


Kelun-Biotech’s Sac-TMT shows breakthrough results in first-line lung cancer trial
Clinical Trials | November 27, 2025

Kelun-Biotech’s Sac-TMT shows breakthrough results in first-line lung cancer trial

Sac-TMT is a novel human TROP2 ADC with proprietary intellectual property, targeting advanced solid tumors


Zhimeng Biopharma’s investigational drug approved to begin phase 2 epilepsy clinical trial in China
Drug Approval | September 15, 2025

Zhimeng Biopharma’s investigational drug approved to begin phase 2 epilepsy clinical trial in China

This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis


IOL Chemicals and Pharmaceuticals receives approval CDE of NMPA, China for Ibuprofen
Drug Approval | April 29, 2025

IOL Chemicals and Pharmaceuticals receives approval CDE of NMPA, China for Ibuprofen

This approval authorizes the company to export Ibuprofen to the Chinese markets


Morepen secures Loratadine approval for export to China
Drug Approval | April 01, 2025

Morepen secures Loratadine approval for export to China

This marks a significant milestone in Morepen’s strategic entry into one of the world’s largest pharmaceutical markets


Sanofi acquires rights to develop and commercialize Aficamten in Greater China
News | January 01, 2025

Sanofi acquires rights to develop and commercialize Aficamten in Greater China

In 2020, CORXEL acquired the rights to develop and commercialize aficamten in Greater China


Bayer starts Phase III trial in non-small cell lung cancer
Clinical Trials | August 30, 2024

Bayer starts Phase III trial in non-small cell lung cancer

First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations


IOL Chemicals and Pharmaceuticals posts Q1 FY25 PAT at Rs. 29.7 Cr
News | August 10, 2024

IOL Chemicals and Pharmaceuticals posts Q1 FY25 PAT at Rs. 29.7 Cr

The company reported total income at Rs. 509.8 crore in Q1 FY25 as compared to Rs. 570.3 crore in Q1 FY24


NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer
Drug Approval | March 30, 2024

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy