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 therapy The 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

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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

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New Drug Designations – January 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 January 2025 report covers designations granted to 53 drugs and 9 medical devices, spanning 18 small molecules, 13 biologics, 13 cell and gene therapies & 9 medical devices among…

ByRidhi RastogiFebruary 28, 2025

NEWS

Ardelyx Reports China’s NMPA Approval of Tenapanor for Hyperphosphatemia in Patients

Shots: China’s NMPA has approved NDA of tenapanor for hyperphosphatemia in CKD pts on dialysis who inadequately responded or are intolerant to phosphorus binders Approval was based on data from 2 Fosun Pharma studies (PK study & pivotal trial in CKD pts on dialysis), plus clinical studies from Ardelyx Approval triggered $5M milestone…

ByRidhi RastogiFebruary 27, 2025

NEWS

GSK Reports the China’s NMPA Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD

Shots: China’s NMPA has accepted the NDA for Nucala as an add-on treatment for COPD with eosinophilic phenotype based on P-III (MATINEE) study; global regulatory filings is ongoing The MATINEE study assessing Nucala (100mg, Q4W, SC) vs PBO in addition to inhaled triple therapy in COPD pts (n=804) with type 2 inflammation achieved its 1EP, showing…

ByRidhi RastogiFebruary 20, 2025

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New Drug Designations – December 2024

Shots: PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, EMA, MHLW and NMPA The December 2024 report covers designations granted to 43 drugs and 3 devices, encompassing 13 small molecules, 10 biologics, 7 cell and gene therapies & 3 medical devices among others Significant…

ByPrince GiriJanuary 31, 2025

NEWS

Innovent and Ask Biopharma Receives China’s NMPA Approval for Limertinib to Treat Non-Small Cell Lung Cancer

Shots: NMPA approved limertinib (oral EGFRm TKI) to treat LA/M EGFR T790M-mutated NSCLC in adults, based P-IIb trial assessing limertinib in (n=301) NSCLC patients This study showed 68.8% ORR, 92.4% DCR, plus 11mos. mPFS with 11.1mos. mDoR. It also showed ORR & mPFS of 65.9% & 10.6mos., respectively in patients with assessable CNS lesions…

BySenior EditorJanuary 17, 2025

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Innovent’s IBI343 Secures the NMPA’s Breakthrough Therapy Designation for Advanced Pancreatic Cancer

Shots: The NMPA has granted BTD to IBI343 alone for treating CLDN18.2+ advanced pancreatic ductal adenocarcinoma (PDAC) progressed post 1L of systematic therapy Designation was based on the ongoing P-I trial of IBI343 (6mg/kg, Q3W) in CLDN18.2+ advanced PDAC patients (n=43) treated with at least 1L of therapy (5% received 2L+ of therapy) across…

ByRidhi RastogiJanuary 16, 2025

NEWS

HUTCHMED’ Orpathys (Savolitinib) Receives the NMPA’s Full Approval for Locally Advanced or Metastatic MET Exon 14 NSCLC

Shots: The NMPA has granted sNDA approval of Orpathys to treat locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, expanding its indication to include both treatment-naïve & experienced patients. Previous conditional approval is also converted to full approval Approval was based on P-IIIb study, with preliminary data from the first line…

ByRidhi RastogiJanuary 15, 2025

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

New Drug Designations – January 2025

Ardelyx Reports China’s NMPA Approval of Tenapanor for Hyperphosphatemia in Patients

GSK Reports the China’s NMPA Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD

New Drug Designations – December 2024

Innovent and Ask Biopharma Receives China’s NMPA Approval for Limertinib to Treat Non-Small Cell Lung Cancer

Innovent’s IBI343 Secures the NMPA’s Breakthrough Therapy Designation for Advanced Pancreatic Cancer

HUTCHMED’ Orpathys (Savolitinib) Receives the NMPA’s Full Approval for Locally Advanced or Metastatic MET Exon 14 NSCLC

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