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

Innovent Reports the NMPA’s NDA Acceptance & Priority Review of Neoadjuvant Ipilimumab + Sintilimab for Colon Cancer

Shots:China’s NMPA has accepted NDA & granted priority review to ipilimumab (IBI310) + sintilimab as neoadj. treatment of operable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer Submission was based on P-III (NeoShot) trial assessing safety & efficacy of ipilimumab + sintilimab vs direct radical surgery in MSI-H/dMMR colon cancer pts …

ByRidhi RastogiFebruary 24, 2025

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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

News

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

Innovent Reports the NMPA’s Approval of Dovbleron (Taletrectinib Adipate Capsule) for Treating ROS1-Positive NSCLC

Shots:The NMPA has approved another NDA of Dovbleron (ROS1 tyrosine kinase inhibitor) for treating locally advanced or metastatic ROS1+ NSCLC. It was approved for those with ROS1+ NSCLC previously treated with ROS1 TKIs in Dec 2024 The approval was supported by pivotal P-II (TRUST-I) study assessing safety, tolerability and efficacy of Dovbleron to…

ByRidhi RastogiJanuary 3, 2025

INSIGHTS+

Insights+ Key Biosimilars Events of August 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patientsDuring the month of August, Sandoz’ Tyruko (biosimilar, natalizumab) received the US FDA’s…

BySenior EditorSeptember 6, 2023

INSIGHTS+

Insights+ Key Biosimilars Events of March 2023

Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of March, Biogen launched Byooviz (biosimilar, ranibizumab) for…

BySenior EditorApril 5, 2023

INSIGHTS+

Insights+ Key Biosimilars Events of June 2022

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of June, Organon entered into an agreement with Henlius…

BySenior EditorJuly 7, 2022

INSIGHTS+

Insights+ Key Biosimilars Events of May 2022

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of May, JSR Life Sciences launches Similis Bio business…

BySenior EditorJune 2, 2022

INSIGHTS+

Insights+ Key Biosimilars Events of December 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of December, Samsung Bioepis presented five-year follow-up results of…

BySenior EditorJanuary 6, 2022

Innovent Reports the NMPA Approval of Sycume for Thyroid Eye Disease

Innovent Reports the NMPA’s NDA Acceptance & Priority Review of Neoadjuvant Ipilimumab + Sintilimab for Colon Cancer

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

Innovent Reports the NMPA’s Approval of Dovbleron (Taletrectinib Adipate Capsule) for Treating ROS1-Positive NSCLC

Insights+ Key Biosimilars Events of August 2023

Insights+ Key Biosimilars Events of March 2023

Insights+ Key Biosimilars Events of June 2022

Insights+ Key Biosimilars Events of May 2022

Insights+ Key Biosimilars Events of December 2021

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