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BioWorld - Thursday, December 18, 2025
Home » Topics » Regulatory » NDA

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Jacobio seeks China approval of second-line KRAS lung cancer drug

May 7, 2024
By Marian (YoonJee) Chu
China and U.S. biotech Jacobio Pharmaceuticals Group Co. Ltd.’s shares (HKEX:1167) rose nearly 20% after it filed an NDA in China on May 6 for its independently developed KRAS G12C inhibitor, glecirasib (JAB-21822), to treat lung cancer.
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Injection pens and measuring tape

China advances semaglutide biosimilars, Jiuyuan seeks NMPA nod

April 16, 2024
By Marian (YoonJee) Chu
Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva; Amgen Inc.) and semaglutide are the latest examples.
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Injection pens and measuring tape

China advances semaglutide biosimilars, Jiuyuan seeks NMPA nod

April 11, 2024
By Marian (YoonJee) Chu
Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva; Amgen Inc.) and semaglutide are the latest examples.
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Chinese diabetes-focused biotech Pegbio plans Hong Kong IPO

March 19, 2024
By Marian (YoonJee) Chu
China’s Pegbio Co. Ltd. is planning a Hong Kong IPO to advance PB-119, its main glucagon-like peptide 1 receptor agonist for diabetes nearing domestic approval, as it hopes to transition to an operating profit.
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Chinese diabetes-focused biotech Pegbio plans Hong Kong IPO

March 13, 2024
By Marian (YoonJee) Chu
China’s Pegbio Co. Ltd. is planning a Hong Kong IPO to advance PB-119, its main glucagon-like peptide 1 receptor agonist for diabetes nearing domestic approval, as it hopes to transition to an operating profit.
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Chinese flag and pills

China NMPA approves 40 innovative new drugs in 2023

March 5, 2024
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
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Chinese flag and pills

China NMPA approves 40 innovative new drugs in 2023

Feb. 29, 2024
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
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China’s NMPA accepts Hutchmed’s sovleplenib NDA for primary immune thrombocytopenia

Jan. 16, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
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China’s NMPA accepts Hutchmed’s sovleplenib NDA for primary immune thrombocytopenia

Jan. 11, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
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Illustration of infected kidneys, ureter and bladder

FDA accepts Venatorx NDA for cUTI antibiotic; PDUFA early 2024

Aug. 16, 2023
By Marian (YoonJee) Chu
Venatorx Pharmaceuticals Inc. on Aug. 15 said the U.S. FDA accepted its NDA for an intravenous antibiotic combination, cefepime-taniborbactam, to treat complicated urinary tract infection (cUTI), including acute pyelonephritis.
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