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Home » Topics » Regulatory » NDA

NDA
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China accepts NDA of influenza tablet, clears Tepezza biosimilar

March 18, 2025
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
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Polycythemia vera illustration

Protagonist’s rusfertide hits phase III goals in rare leukemia

March 5, 2025
By Marian (YoonJee) Chu
Rusfertide could become a blockbuster therapy for polycythemia vera, H.C. Wainwright analyst Douglas Tsao wrote March 4 after the injectable hepcidin mimetic peptide hit its primary endpoint and all four key secondary endpoints in the ongoing phase III Verify study.
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Chimerix moves up US NDA for rare pediatric glioma drug; stock soars

Dec. 10, 2024
By Karen Carey
In a surprise move that drove its stock up by 292% in early trading, Chimerix Inc. revealed plans for a U.S. NDA filing by year-end, seeking accelerated approval of dordaviprone (ONC-201) to treat recurrent H3 K27M-mutant diffuse glioma, a highly aggressive tumor with limited treatment options.
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FDA hands complete response letter to Astellas’ Izervay sNDA

Nov. 19, 2024
By Marian (YoonJee) Chu
The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
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3d illustration of ovarian cancer

Verastem preps an NDA as the stock struggles

Oct. 18, 2024
By Lee Landenberger
With fresh phase II ovarian cancer data in hand, Verastem Oncology Inc. plans to file an NDA by the end of the month for its avutometinib and defactinib combination treatment. The NDA will be for adults who have recurrent KRAS mutant recurrent low-grade serous ovarian cancer, a direction that may have caused the stock to wilt.
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No sweat: FDA approves Botanix’s axillary hyperhidrosis NDA

June 25, 2024
By Lee Landenberger
The U.S. FDA has approved the NDA for Sofdra (sofpironium) for treating excessive underarm sweating from Botanix Pharmaceuticals Ltd. The approval was based on two pivotal phase III studies and is approved for those ages 9 and older.
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Joshua Smiley, president and chief operating officer, Zai Lab

Zai Lab exec buys stock as Augtyro, Vyvgart SC advances in China

May 21, 2024
By Marian (YoonJee) Chu
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
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Joshua Smiley, president and chief operating officer, Zai Lab

Zai Lab exec buys stock as Augtyro, Vyvgart SC advances in China

May 16, 2024
By Marian (YoonJee) Chu
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
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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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