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Lead Product(s) : Pidnarulex,Cemiplimab
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Sanofi
Deal Size : Undisclosed
Deal Type : Collaboration
Senhwa Biosciences’ Pidnarulex Joins Forces with Global PD-1 Leaders
Details : The company’s novel investigational drug, CX-5461 (pidnarulex), will be evaluated in combination with the approved PD-1 inhibitor Libtayo (cemiplimab), provided by Sanofi and Regeneron.
Product Name : CX-5461
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 16, 2025
Lead Product(s) : Pidnarulex,Cemiplimab
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Sanofi
Deal Size : Undisclosed
Deal Type : Collaboration

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Lead Product(s) : Silmitasertib
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Senhwa Reports Positive Phase 1 Data for Silmitasertib in Carcinoma
Details : CX-4945 (silmitasertib) is a first-in-class small molecule drug that acts as a CK2 inhibitor. It is being evaluated for the treatment of basal cell carcinoma.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 02, 2025
Lead Product(s) : Silmitasertib
Therapeutic Area : Oncology
Highest Development Status : Phase I
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Pidnarulex
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Issues Approval for Pidnarulex Study in Advanced Solid Tumors
Details : Pidnarulex (CX-5461) is a first-in-class small-molecule designed to stabilize G4 structures, it induces DNA damage and promotes cancer cell death, holding a great potential for various cancers.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 14, 2024
Lead Product(s) : Pidnarulex
Therapeutic Area : Oncology
Highest Development Status : Phase I
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Pidnarulex
Therapeutic Area : Oncology
Study Phase : Preclinical
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Senhwa Submits IND for Pidnarulex Study in Advanced Solid Tumors Sponsored by NCI
Details : (CX-5461 (pidnarulex), is a first-in-class small-molecule designed to stabilize G-quadruplex structures, which is being evaluated for the treatment of Solid Tumors.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 17, 2024
Lead Product(s) : Pidnarulex
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Silmitasertib,Irinotecan Hydrochloride,Temozolomide
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Grants RPD Designation to Senhwa Bio’ Silmitasertib for Pediatric Neuroblastoma
Details : CX-4945 (silmitasertib) is a first-in-class small molecule drug that acts as a CK2 inhibitor. It is being evaluated for the treatment of pediatric neuroblastoma.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 12, 2024
Lead Product(s) : Silmitasertib,Irinotecan Hydrochloride,Temozolomide
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Silmitasertib
Therapeutic Area : Oncology
Study Phase : IND Enabling
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Senhwa Biosciences Gets FDA Study May Proceed Letter for Silmitasertib in Young Patients
Details : CX-4945 (silmitasertib) is a first-in-class small molecule drug that acts as a CK2 inhibitor. It is being evaluated for the treatment of relapsed refractory solid tumors in children & young adults.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 06, 2024
Lead Product(s) : Silmitasertib
Therapeutic Area : Oncology
Highest Development Status : IND Enabling
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Pidnarulex,Talazoparib
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : CX-5461 (pidnarulex) stabilizes the DNA G-quadruplexes of cancer cells which leads to disruption of the cell's replication fork. Pidnarulex demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers, such as BRCA1...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 31, 2022
Lead Product(s) : Pidnarulex,Talazoparib
Therapeutic Area : Oncology
Highest Development Status : Phase I
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Pidnarulex,Talazoparib
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : CX-5461 (Pidnarulex) demonstrated clinically significant and persist benefits in patients with specific tumor biomarkers, such as BRCA1/2, and PALB2 mutations, and who had been exposed to platinum and other chemotherapeutics.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 06, 2022
Lead Product(s) : Pidnarulex,Talazoparib
Therapeutic Area : Oncology
Highest Development Status : Phase I
Sponsor : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Silmitasertib
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Given the interplay between CK2 and GLI-1 and the importance of Hh signaling activation, Senhwa’s Silmitasertib (CX-4945), a potent CK2 inhibitor, may provide benefits for BCC patients with SMOi resistant cancers.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 28, 2022
Lead Product(s) : Silmitasertib
Therapeutic Area : Oncology
Highest Development Status : Phase I
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Silmitasertib,Cisplatin,Gemcitabine
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : USFDA has granted Orphan drug designation for CX-4945 (silmitasertib), a highly selective inhibitor of casein kinase 2, on the basis of significant results from pre-clinical studies which demonstrate DNA repair and induce apoptosis in patients with Bilia...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 20, 2022
Lead Product(s) : Silmitasertib,Cisplatin,Gemcitabine
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
