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BioWorld - Saturday, February 7, 2026
Home » Topics » Regulatory » NMPA

NMPA
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China confirms drug reforms to spur innovation, ensure drug quality, ease restrictions

Sep. 10, 2019
By Elise Mak
BEIJING – China has finally written all its drug-related reforms into law, as it passed the amendment of its drug administration law in late August, the amendment to take effect on Dec. 1. Those moves carry one goal: to bring more and better drugs into the Chinese market as quickly as possible.
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China's NMPA approves Focus V for third-line treatment of SCLC

Sep. 6, 2019

China's NMPA approves roxadustat for anemia in patients with CKD not receiving dialysis

Aug. 22, 2019

Ascletis receives IND approval for ASC-18 in China

Aug. 6, 2019

CD47 race heats up in China as I-Mab's antibody cleared for trials in advanced tumors

July 19, 2019
By Elise Mak
HONG KONG – China has approved the fourth homegrown CD47 antibody to start clinical trials, intensifying the local CD47 race. Chinese biologics developer I-Mab Biopharma (Shanghai) Co. Ltd. said it received the go-ahead for the clinical study of TJC-4, its differentiated fully human CD47 monoclonal antibody for treating advanced malignant tumors.
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First soft tissue sarcoma drug cleared in China as NMPA approves Focus V

July 11, 2019
By Elise Mak
HONG KONG – China biopharma pioneer Chia Tai Tianqing Pharmaceutical Holdings Co. Ltd. said its self-developed chemical oncology, Focus V (anlotinib hydrochloride capsules), is now approved for a second indication to treat soft tissue sarcoma, becoming the only approved therapy for this rare cancer in China.
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Focus V approved in China for soft tissue sarcoma

July 8, 2019

Clinical testing approved for the third-generation EGFR inhibitor XZP-5809

May 31, 2019

China's NMPA clears HDAC6 inhibitor CS-3003 for phase I trials

March 14, 2019

China's NMPA accepts IND filing for combination of CS-1001 and IMP-4297 for solid tumors

Feb. 11, 2019
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