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Results For "National-Medical-Products-Administration"

54 News Found

China approves BeiGene’s tislelizumab
Drug Approval | March 12, 2022

China approves BeiGene’s tislelizumab

Tislelizumab is now approved for seven indications in China


China’s NMPA accepts supplemental NDA for Carteyva
Drug Approval | February 28, 2022

China’s NMPA accepts supplemental NDA for Carteyva

The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China


USFDA approves IND application for Allied’s cancer treatment
Biotech | January 24, 2022

USFDA approves IND application for Allied’s cancer treatment

APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types


China approves MIOK Keratoprosthesis’ artificial cornea
Biotech | January 19, 2022

China approves MIOK Keratoprosthesis’ artificial cornea

The artificial cornea is 100% made of non-biological materials and require no co-implantation of donor corneas and it is an ideal option for treating patients with corneal blindness


Green Valley receives US FDA approval for Phase II clinical trial for Parkinson’s disease
Biotech | January 17, 2022

Green Valley receives US FDA approval for Phase II clinical trial for Parkinson’s disease

The global multi-center phase-II clinical trial will be a 36-week, multi-center, randomized, double-blind, placebo-controlled trial, followed by a 36-week open-label extension period


Ascletis expands ritonavir oral tablet production
Biotech | January 03, 2022

Ascletis expands ritonavir oral tablet production

ASC10 is an oral direct-acting antiviral drug candidate targeting RNA dependent RNA polymerase (RdRp) to treat SARS-CoV-2 infection


NMPA approves CStone's NDA for Cejemly
Drug Approval | December 21, 2021

NMPA approves CStone's NDA for Cejemly

The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients


China approves Brii Bio’s antibody combination to neutralise Covid-19
Drug Approval | December 10, 2021

China approves Brii Bio’s antibody combination to neutralise Covid-19

Brii Bio announces amubarvimab/romlusevimab combination received approval from NMPA


Merck’s KEYTRUDA receives China approval for Esophageal cancer
Drug Approval | September 09, 2021

Merck’s KEYTRUDA receives China approval for Esophageal cancer

The medicine is now approved for eight indications across five different types of cancer in China.


Accutest enables NMPA approval for Qilu’s Abiraterone
Drug Approval | September 06, 2021

Accutest enables NMPA approval for Qilu’s Abiraterone

The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India