New Drug Designations – March 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 March 2025 report covers designations granted to 37 drugs and 3 medical devices, spanning 11 small molecules, 10 biologics, 10 cell and gene therapies & 3 medical devices among…

ByRidhi RastogiApril 29, 2025

NEWS

Rona Therapeutics Reports NMPA’s IND Acceptance of RN1871 for Hypertension

Shots: China’s NMPA has accepted IND application for RN1871 for hypertension, with Rona planning to advance it in P-I trial to assess its safety, PK, & preliminary efficacy in humans Preclinical studies have demonstrated AGT suppression & sustained blood pressure control, with reduced dosing frequency of RN1871 RN1871 is engineered to suppress AGT mRNA expression in the…

ByRidhi RastogiApril 22, 2025

NEWS

HUTCHMED Reports Enrollment Completion in P-II Trial of Savolitinib for Gastric Cancer in China

Shots: HUTCHMED has completed pts enrollment in P-II trial assessing savolitinib for G/GEJ adenocarcinoma pts (n=64) with MET amplification to evaluate ORR per IRC (1EP) & 2EPs incl. PFS & AE incidence; HUTCHMED plans to file for potential NMPA’s Approval in late 2025 Interim analysis of the trial showed 45% cORR by IRC & 50% ORR in…

ByRidhi RastogiApril 22, 2025

NEWS

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 therapies Preclinical 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 adult Clinical 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 fusions In a registrational trial, zurletrectinib demonstrated favorable safety & strong efficacy, with the ability to overcome acquired resistance to the 1st generation TRK inhibitors in mentioned pts Zurletrectinib is a next-generation pan-TRK inhibitor…

ByRidhi RastogiApril 17, 2025

NEWS

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 Q2’25 Trial 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

New Drug Designations – March 2025

Rona Therapeutics Reports NMPA’s IND Acceptance of RN1871 for Hypertension

HUTCHMED Reports Enrollment Completion in P-II Trial of Savolitinib for Gastric Cancer in China

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)

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