HighField Biopharmaceuticals Seeks NMPA’s IND Clearance for HF158K1 & HFK2 to Treat Solid Tumors

Shots:China’s NMPA has received 2 IND applications for HF158K1 (K1) & HFK2 (K2) to initiate P-I dose escalation trial in China to evaluate safety & PK of K1 alone & its preliminary efficacy with K2 to treat pts with solid tumors refractory to prior therapiesPreclinical studies of K1, K2, & their combination showed…

ByRidhi RastogiApril 21, 2025

News

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

Shots:Akeso’s ebdarokimab has received NMPA approval for the treatment of moderate-to-severe plaque psoriasis in adultClinical study showed strong efficacy and safety of ebdarokimab (135mg) two doses at weeks 0 and 4, with a PASI 75 response rate of 79.4% at 16wks. and ebdarokimab Q12W 77.9% at 52wks. along with significant improvements in patients'…

ByRidhi RastogiApril 18, 2025

News

InnoCare Pharma Reports NMPA’s NDA Acceptance of Zurletrectinib to Treat NTRK Fusion-Positive Solid Tumors

Shots:China’s NMPA has accepted NDA of zurletrectinib (ICP-723) for the treatment of pts (≥12yrs.) with advanced solid tumors having NTRK gene fusionsIn a registrational trial, zurletrectinib demonstrated favorable safety & strong efficacy, with the ability to overcome acquired resistance to the 1st generation TRK inhibitors in mentioned ptsZurletrectinib is a next-generation pan-TRK inhibitor…

ByRidhi RastogiApril 17, 2025

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Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

Shots:Remegen has reported P-III trial data assessing Telitacicept (RC18; 240mg; n=57) vs PBO (n=57) in 114 chinese gMG pts, with baseline MG-ADL score ≥6 & QMG score ≥8; trial incl. 24wk. double-blind phase followed by an open-label phase. BLA is under the NMPA’s review, with decision expected in Q2’25Trial showed 98.1% vs 12% pts achieved…

ByRidhi RastogiApril 9, 2025

INSIGHTS+

New Drug Designations – February 2025

Shots: PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA The February 2025 report covers designations granted to 53 drugs and 4 medical devices, spanning 16 small molecules, 14 biologics, 18 cell and gene therapies & 4 medical devices among…

ByRidhi RastogiMarch 25, 2025

News

Innovent Reports the NMPA Approval of Sycume for Thyroid Eye Disease

Shots:China’s NMPA has approved Sycume for the treatment of thyroid eye disease (TED) Approval was based on P-III (RESTORE-1) trial in TED pts, which met its 1EP in 2024, with 85.8% pts achieving ≥2mm proptosis reduction at 24wks., along with improved inflammation & QoL; data was presented at WOC, CSE, and CCOS Sycume (teprotumumab…

ByRidhi RastogiMarch 18, 2025

News

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

Shots:The US FDA has accepted sNDA & granted priority review to finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF), with approval expected in Q3’25. Awaits authorization in China, EU & Japan, with global applications planned Application was backed by P-III…

ByRidhi RastogiMarch 18, 2025

News

China’s NMPA Accepts BLA of Zai Lab’s Tivdak for Recurrent or Metastatic Cervical Cancer

Shots:China’s NMPA has accepted BLA of Tivdak for the treatment of recurrent or metastatic cervical cancer in pts who had disease progression on or after systemic therapyThe BLA was supported by P-III (innovaTV 301) trial data, incl. clinical evidence from Chinese cohort, evaluating Tivdak vs CT in adults. Chinese pts had prior standard…

ByRidhi RastogiMarch 13, 2025

News

China’s NMPA Approves Kelun-Biotech’s Sacituzumab Tirumotecan (sac-TMT) for EGFR-mutant NSCLC

Shots:China’s NMPA has approved label expansion of sacituzumab tirumotecan (SKB264/MK-2870) to locally advanced or metastatic (LA/M) EGFRm NSCLC following disease progression on EGFR-TKI therapy or Pt-based Ct Approval was based on OptiTROP-Lung03 trial assessing sac-TMT alone (5mg/kg, IV, Q2W) vs docetaxel in mentioned pts, where it demonstrated improved ORR, PFS & OS sac-TMT is…

ByRidhi RastogiMarch 11, 2025

News

HUTCHMED Reports Enrollment Completion in P-II Trial of Fanregratinib for Intrahepatic Cholangiocarcinoma in China

Shots:HUTCHMED has reported enrollment completion in P-II trial of fanregratinib to treat intrahepatic cholangiocarcinoma (IHCC) in pts with FGFR2 fusion or rearrangement; favorable trial results will support NMPA’s NDA submission The P-II trial of fanregratinib will assess ORR as 1EP whereas PFS, DCR, DoR, & OS as 2EPs in pts (n=87). Topline data…

ByRidhi RastogiMarch 7, 2025

HighField Biopharmaceuticals Seeks NMPA’s IND Clearance for HF158K1 & HFK2 to Treat Solid Tumors

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

InnoCare Pharma Reports NMPA’s NDA Acceptance of Zurletrectinib to Treat NTRK Fusion-Positive Solid Tumors

Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

New Drug Designations – February 2025

Innovent Reports the NMPA Approval of Sycume for Thyroid Eye Disease

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

China’s NMPA Accepts BLA of Zai Lab’s Tivdak for Recurrent or Metastatic Cervical Cancer

China’s NMPA Approves Kelun-Biotech’s Sacituzumab Tirumotecan (sac-TMT) for EGFR-mutant NSCLC

HUTCHMED Reports Enrollment Completion in P-II Trial of Fanregratinib for Intrahepatic Cholangiocarcinoma in China

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