Innovent Biologi Stock Price, News & Analysis

Innovent Biologics announces the successful dosing of the first patient in a Phase 2 clinical trial for IBI302, a bispecific fusion protein targeting both VEGF and complement pathways for neovascular age-related macular degeneration (nAMD). The trial aims to evaluate the efficacy and safety of IBI302 in improving visual acuity and addressing retinal fibrosis. Preliminary Phase 1 results showed good safety and improvements in visual acuity and retinal thickness. By targeting both pathways, IBI302 aims to overcome limitations of current therapies for nAMD.

Innovent Biologics announced positive results from the Phase 3 ORIENT-3 study, comparing TYVYT® (sintilimab injection) to docetaxel for advanced squamous non-small cell lung cancer (sqNSCLC). The trial with 290 patients showed significant improvements in overall survival (11.79 months vs. 8.25 months, P=0.02489) and progression-free survival (4.30 months vs. 2.79 months, P<0.00001). The data were presented at the AACR Annual Meeting. This trial highlights the potential of TYVYT® as a critical therapy for sqNSCLC, where treatment options are limited, showcasing Innovent's commitment to patient care.

Innovent Biologics announced that the NMPA in China has granted Breakthrough Therapy Designation for Parsaclisib (IBI376) to treat relapsed/refractory follicular lymphoma. This designation is based on ongoing Phase 2 studies showcasing promising efficacy, with a 75% objective response rate and a 15.8-month median progression-free survival. Innovent, which has rights for Parsaclisib in Greater China, emphasizes its commitment to developing effective cancer therapies. The BTD status will facilitate faster review processes, advancing treatment accessibility for patients.

Innovent Biologics reported significant financial growth for 2020, achieving a total revenue of RMB 3,843.8 million, up 266.9% from RMB 1,047.5 million in 2019. The company's product revenue reached RMB 2,367.5 million, a 133.0% increase year-over-year. Innovent launched three new antibody drugs, augmenting its portfolio to four commercial products. The firm expanded its production capacity from 5,000L to 24,000L and raised approximately US$1.3 billion through share placements, with US$1.8 billion in cash on hand by February 2021.

Innovent Biologics, a biopharmaceutical company, reports the successful dosing of the first patient outside China in a Phase 1 clinical trial of IBI322, a first-in-class recombinant anti-CD47/PD-L1 bispecific antibody.

This trial, conducted in the U.S., aims to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI322 in patients with advanced malignancies. Pre-clinical studies suggest that IBI322 could offer enhanced anti-tumor activity and a better safety profile compared to existing treatments. The company aims to develop this innovative drug globally following IND approvals from NMPA and the U.S. FDA.

Innovent Biologics and IASO Biotherapeutics announced that their CAR-T cell therapy, IBI326, received Breakthrough Therapy Designation from China's NMPA. This designation, granted on Feb. 22, 2021, is based on results from an ongoing Phase 1/2 study for treating relapsed/refractory multiple myeloma. IBI326 is a fully-human CAR-T therapy targeting BCMA, showing rapid anti-myeloma activity and positive safety profiles. This designation may expedite its development and review in China, allowing earlier patient access.

Innovent Biologics has successfully dosed the first patient in a Phase III clinical trial (NCT04720716) for IBI310, an anti-CTLA-4 monoclonal antibody, in combination with TYVYT® (sintilimab injection) for advanced hepatocellular carcinoma (HCC). This multicenter trial aims to evaluate the efficacy and safety of this combination treatment, focusing on overall survival and response rate. With over 50 clinical centers involved, the study led by prominent professors is expected to provide valuable insights into new therapeutic options for HCC patients.

Innovent Biologics and Eli Lilly announced that China's National Medical Products Administration has approved TYVYT® (sintilimab injection) for treating nonsquamous non-small cell lung cancer (nsqNSCLC) in combination with pemetrexed and platinum chemotherapy. This approval follows a successful Phase 3 clinical trial (ORIENT-11) demonstrating significant improvements in progression-free survival (PFS) and overall survival (OS) for TYVYT® over placebo. This marks the second indication for TYVYT® since its initial approval for Hodgkin's lymphoma in December 2018.

Innovent Biologics has appointed Dr. Yong Jun Liu as the new president, enhancing its leadership in R&D and global operations. With over 30 years of experience, Dr. Liu has significant achievements in biotechnology, notably at AstraZeneca and Sanofi, where he led drug research initiatives. Innovent, established in 2011, has a robust pipeline of 23 assets and has approved four products in China, including TYVYT®, a PD-1 inhibitor. Dr. Liu's leadership is expected to strengthen Innovent's commitment to innovative drug development.