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Home » Topics » Regulatory » IND

IND
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3D rendering of skin cells and elastin with collagen layer
Dermatologic

Sagimet’s FASN inhibitor cleared to enter clinic for acne

March 12, 2025
Sagimet Biosciences Inc. has obtained IND clearance from the FDA for TVB-3567 (ASC-60), a selective small-molecule fatty acid synthase (FASN) inhibitor set to enter clinical development for the treatment of acne. A first-in-human phase I trial of TVB-3567 in individuals with or without acne is expected to begin this year.
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Cancer

Mindrank’s dual WEE1 and YES1 kinase inhibitor cleared to enter clinic in US

March 10, 2025
Mindrank Ltd. has announced that the FDA has cleared the company’s IND application for MRANK-106, a potentially first-in-class, orally available dual inhibitor of WEE1 and YES1 kinases, for the treatment of pancreatic cancer, small-cell lung cancer, ovarian cancer, breast cancer and colorectal cancer.
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3D illustration demonstrating CAR T therapy
Immuno-oncology

Bioheng Therapeutics’ CD7-targeted universal CAR T-cell therapy gains IND clearance

March 5, 2025
Bioheng Therapeutics US LLC has obtained IND approval from the FDA for CTD-402, a CD7-targeted universal CAR T-cell therapy, for the treatment of pediatric and adult patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma.
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Illustration of tumor
Immuno-oncology

Fapon’s immunocytokine FP-008 gains IND clearance for solid tumors

March 4, 2025
Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.
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Illustration of tumor
Immuno-oncology

Fapon’s immunocytokine FP-008 gains IND clearance for solid tumors

Feb. 28, 2025
Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.
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Globe showing Asia-Pacific region

Asia recap: Innocare, Akeso in phase III; Deepseek in Antengene

Feb. 25, 2025
By Marian (YoonJee) Chu
Several Asia biotechs this week – including Innocare Pharma Ltd., Akeso Pharmaceuticals Inc., Sanbio Co. Ltd. and Ascletis Pharma Inc. – unveiled the start of new late-stage clinical trials or interim findings from early stage studies.
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3D illustration demonstrating antibody-drug conjugate.

Radiance wins ROR1 ADC rights from CSPC in potential $1B+ deal

Feb. 25, 2025
By Marian (YoonJee) Chu
Radiance Biopharma Inc. bought its way into the ROR1 antibody-drug conjugate (ADC) space through a potential $1 billion-plus licensing deal, including a $15 million up-front payment, with CSPC Megalith Biopharmaceutical Co. Ltd. for rights to RB-164 (SYS-6005) in the U.S. and select countries.
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Globe showing Asia-Pacific region

Asia recap: Innocare, Akeso in phase III; Deepseek in Antengene

Feb. 21, 2025
By Marian (YoonJee) Chu
Several Asia biotechs this week – including Innocare Pharma Ltd., Akeso Pharmaceuticals Inc., Sanbio Co. Ltd. and Ascletis Pharma Inc. – unveiled the start of new late-stage clinical trials or interim findings from early stage studies.
Read More
3D illustration demonstrating antibody-drug conjugate.

Radiance wins ROR1 ADC rights from CSPC in potential $1B+ deal

Feb. 20, 2025
By Marian (YoonJee) Chu
Radiance Biopharma Inc. bought its way into the ROR1 antibody-drug conjugate (ADC) space through a potential $1 billion-plus licensing deal, including a $15 million up-front payment, with CSPC Megalith Biopharmaceutical Co. Ltd. for rights to RB-164 (SYS-6005) in the U.S. and select countries.
Read More
Illustration of pancreas, close up of islet
Endocrine/metabolic

Cour’s CNP-103 gains IND clearance for type 1 diabetes

Feb. 5, 2025
Cour Pharmaceuticals Development Co. Inc. has obtained IND clearance from the FDA for CNP-103, a nanoparticle in development to address the underlying autoimmunity of type 1 diabetes. A first-in-human phase Ib/IIa trial will begin later this year and will enroll adults (aged 18-35 years) and pediatric patients (aged 12-17) who have stage III or newly diagnosed (within the last 6 months) type 1 diabetes as well as C-peptide >0.2 ng/mL.
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