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BioWorld - Monday, February 9, 2026
Home » Topics » Regulatory » NMPA

NMPA
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NMPA clears I-Mab's IND for China trial of CD73 antibody

Oct. 9, 2019
By David Ho
HONG KONG – I-Mab Biopharma (Shanghai) Co. Ltd. has received IND approval from China's National Medical Products Administration (NMPA) for its CD73 antibody, getting the go-ahead for a phase I/II trial of TJD-5 in patients with advanced solid tumors.
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IP enforcement in China improving slowly but surely

Sep. 25, 2019
By Mark McCarty

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
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