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BioWorld - Monday, December 15, 2025
Home » Topics » Regulatory » IND

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3D rendering of CAR T therapy in cell
Newco news

US-China company Triarm on a mission to democratize CAR Ts

March 21, 2024
By Tamra Sami
Triarm Therapeutics Ltd. is on a mission to democratize CAR T therapies to make them more accessible and affordable, Triarm CEO Jay Zhang told BioWorld. “Nearly half of the patients eligible for CAR T therapies still cannot get treated, and the main reason is the expense, and the second is they cannot afford to wait.
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Brain and DNA
Neurology/Psychiatric

Depymed’s DPM-1003 receives IND clearance for Rett syndrome evaluation

March 20, 2024
Depymed Inc. has received FDA clearance to initiate a phase I trial for DPM-1003 for the treatment of Rett syndrome.
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Immune

Imunon files IND application for COVID-19 booster

March 14, 2024
Imunon Inc. has filed an IND application with the FDA seeking clearance to begin a phase I study of IMNN-101 as a seasonal COVID-19 booster vaccine.
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Multiple myeloma cells in the bone marrow.
Immuno-oncology

Trispecific antibody SIM-0500 approved for trials in the US and China for multiple myeloma

March 12, 2024
Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group Ltd., has received approval from the FDA and China’s National Medical Products Administration (NMPA) to conduct clinical trials with SIM-0500 in patients with relapsed or refractory multiple myeloma.
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Cancer cells
Cancer

Aprea’s WEE1 inhibitor set to enter phase I for cyclin E-overexpressing cancers

March 12, 2024
Aprea Therapeutics Inc. has received FDA clearance of its IND application for APR-1051, a next-generation inhibitor of WEE1 kinase.
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Test tubes, dropper and capsules
Cancer

Eilean Therapeutics’ menin inhibitor cleared for first-in-human study in Australia

March 12, 2024
Eilean Therapeutics LLC has announced clearance by the Human Research Ethics Committee in Australia for a first-in-human phase I trial of balamenib (ZE63-0302), an oral small-molecule inhibitor of the menin-KMT2A interaction.
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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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Cancer

Jacobio’s P53 Y220C activator gains FDA clearance to enter clinic for advanced solid tumors

March 1, 2024
Jacobio Pharmaceuticals Group Co. Ltd. has received FDA approval of its IND application for JAB-30300, allowing it begin a phase I/IIa trial in the U.S. in advanced solid tumors.
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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.
Read More
3D cross-section illustration of muscle anatomy
Neurology/Psychiatric

Arthex’s ATX-01 receives FDA clearance for first-in-human study in myotonic dystrophy type 1

Feb. 28, 2024
Arthex Biotech SL has received FDA clearance to initiate the phase I/IIa Arthemir study of ATX-01 for the treatment of myotonic dystrophy type 1 (DM1).
Read More
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