Innovent Reports the US FDA’s IND Clearance of IBI3032 for Cardiometabolic Disorders

Shots: The US FDA has approved IND application of IBI3032 to initiate P-I trial for cardiometabolic disorders The P-I trials will be initiated simultaneously in China & the US, with dosing in healthy & overweight or obese participants anticipated to start in H2’25 IBI3032, an oral GLP-1 receptor agonist biased toward the cAMP pathway, showed…

ByRidhi RastogiAugust 5, 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

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

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

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 potency Biosimilars 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 patients During 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 potency Biosimilars 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 patients During 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 potency Biosimilars 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 patients During 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 potency Biosimilars 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 patients During the month of May, JSR Life Sciences launches Similis Bio business…

BySenior EditorJune 2, 2022

Innovent Reports the US FDA’s IND Clearance of IBI3032 for Cardiometabolic Disorders

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

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