Innovent Biologi Stock Price, News & Analysis

Innovent Biologics announced the results of a Phase 1 study of pemigatinib in Chinese patients with advanced solid tumors at the ASCO Annual Meeting 2021. The study included 12 patients from various cancer types who failed prior treatments. The most common adverse events were manageable, with no deaths linked to treatment. Among the 11 evaluable patients, there was a 16.7% objective response rate and a 41.7% disease control rate. Innovent is preparing a New Drug Application for pemigatinib in China, aiming to expand its use beyond FGFR2 mutations.

Innovent Biologics and HUTCHMED announced Phase 1b results for the combination of TYVYT® (sintilimab) and ELUNATE® (fruquintinib) in advanced colorectal cancer at the ASCO Annual Meeting. The study involved 44 patients with prior treatment failures, showing an objective response rate of 22.7%. Median progression-free survival was 5.6 months overall, with 6.9 months for the 5mg-intermittent dosage group. The safety profile was manageable, suggesting potential for future trials.

Innovent Biologics and AnHeart Therapeutics presented preliminary results from the TRUST phase II clinical trial of taletrectinib for treating ROS1 fusion positive non-small cell lung cancer at ASCO 2021. Data as of April 8, 2021, show a 93% overall response rate in treatment-naïve patients (n=15) and a 60% rate in pre-treated patients (n=5). Taletrectinib demonstrated a manageable safety profile. The companies aim to complete patient enrollment for the trial by Q3 2021 and are focused on global regulatory submissions.

Innovent Biologics announced results from the Phase Ia/Ib study of IBI110, an anti-LAG-3 monoclonal antibody, at the ASCO Annual Meeting 2021. The study involved 40 patients with advanced solid tumors, showing no dose-limited toxicity. Notably, one ovarian cancer patient achieved a partial response from IBI110 monotherapy, and 16.7% of patients in the combination group with sintilimab showed a partial response. Innovent is committed to advancing IBI110's potential, alongside a new bispecific antibody, IBI323, targeting LAG-3.

Innovent Biologics and Eli Lilly announce that the National Medical Products Administration of China has approved TYVYT® (sintilimab injection) in combination with gemcitabine and platinum chemotherapy for first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). This is the third indication for TYVYT®, following approvals for Hodgkin's lymphoma and nonsquamous NSCLC. The approval stems from the Phase 3 ORIENT-12 trial, which demonstrated significant improvements in progression-free survival, marking a crucial advance in the treatment landscape for lung cancer in China.

Innovent Biologics and IASO Biotherapeutics announced promising results from a clinical study of IBI326, a fully human BCMA-targeting CAR T-cell therapy for relapsed/refractory multiple myeloma, published in Blood. The study showed a 100% overall response rate (ORR) among 18 patients, with 72% achieving complete response. The one-year progression-free survival (PFS) and overall survival (OS) rates were 58.3% and 75%, respectively. Notably, IBI326 exhibited a favorable safety profile despite some cases of cytokine release syndrome. This innovative therapy was granted breakthrough therapy designation by China's NMPA in February 2021.

Innovent Biologics and AnHeart Therapeutics announced an exclusive license agreement for the co-development and commercialization of taletrectinib, a next-generation TKI targeting ROS1 and NTRK, in Greater China. AnHeart will handle development until regulatory approval, receiving upfront payments, R&D fees, and potential milestone payments totaling USD189 million. Currently, taletrectinib is under three phase 2 studies for treating ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors. Innovent aims to enhance its oncology portfolio with this collaboration.

Innovent Biologics has successfully initiated a global Phase 3 clinical trial for pemigatinib (IBI375), designed to treat unresectable or metastatic cholangiocarcinoma in China. The trial evaluates pemigatinib against the standard treatment of gemcitabine plus cisplatin, targeting patients with FGFR2 rearrangement. Dr. Hui Zhou noted the urgent need for improved therapies given the poor prognosis associated with existing treatments. Previous studies showed pemigatinib provided satisfactory safety with promising efficacy signals, suggesting a potential benefit for targeted therapy in this challenging patient population.

Innovent Biologics and Eli Lilly announced that the U.S. FDA has accepted for review a Biologics License Application (BLA) for sintilimab injection combined with pemetrexed and platinum chemotherapy for first-line treatment of nonsquamous non-small cell lung cancer (NSCLC). This landmark application marks the first submission of sintilimab outside of China, following its regulatory approval in China earlier in 2021.

The FDA plans to decide by March 2022, with no review issues identified at this stage.