Welcome to our dedicated page for Innovent Biologi news (Ticker: IVBIY), a resource for investors and traders seeking the latest updates and insights on Innovent Biologi stock.
Innovent Biologics (IVBIY) is a global biopharmaceutical leader developing precision therapies for oncology, autoimmune disorders, and chronic diseases. This page provides investors and healthcare professionals with timely updates on clinical advancements, regulatory milestones, and strategic partnerships shaping the company's trajectory.
Access official press releases and curated analysis covering key developments including clinical trial results, drug approval updates, and collaboration announcements. Our repository simplifies tracking Innovent's progress in bringing innovative treatments to market through its robust pipeline of immune checkpoint inhibitors and targeted biologics.
Content spans financial disclosures, manufacturing expansions, and research breakthroughs across therapeutic areas. Bookmark this page for streamlined monitoring of Innovent's contributions to advancing treatments for lung cancer, metabolic conditions, and ophthalmologic diseases through its global network of 30+ healthcare partners.
Innovent Biologics and Eli Lilly announced the final outcomes of Phase Ib study NCT04072679, which evaluated sintilimab with bevacizumab biosimilar for treating advanced hepatocellular carcinoma (HCC). Conducted in China, the study included 50 patients, showing an overall response rate of 34%, with disease control at 78%. Notably, median progression-free survival was 10.5 months and overall survival was 20.2 months. Safety profiles were consistent with previous studies, but side effects included hypertension (32%) and proteinuria (26%). The findings may advance individualized treatment options for HCC.
Sana Biotechnology, Inc. has entered into a license agreement with IASO Biotherapeutics and Innovent Biologics for a clinically validated fully-human BCMA CAR construct. This agreement enables Sana to utilize the BCMA CAR construct for in vivo gene therapy and ex vivo hypoimmune cell therapy applications. IASO Bio and Innovent are set to receive an upfront payment along with potential milestone payments of up to $204 million. The licensed construct is part of a promising CAR T therapy for relapsed/refractory multiple myeloma, which has shown a high overall response rate of 94.9% in clinical trials.
Innovent Biologics announced that the National Medical Products Administration of China accepted its supplemental New Drug Application for sintilimab plus bevacizumab biosimilar injection and chemotherapy for EGFR-mutated non-squamous non-small cell lung cancer (nsqNSCLC) patients who have progressed after EGFR-TKI therapy. This decision follows a Phase 3 clinical trial (ORIENT-31) showing significant improvement in progression-free survival for patients treated with sintilimab in combination with bevacizumab and chemotherapy. The safety profile remains consistent with prior studies.
Innovent Biologics has presented promising data from its ongoing Phase 2 study (CIBI376A201) of parsaclisib, an oral PI3Kδ inhibitor, for treating relapsed or refractory follicular lymphoma. The study enrolled 36 patients, with 24 evaluable, showing an objective response rate (ORR) of 91.7%. The study's results, discussed at the ASH 2021 meeting, indicate parsaclisib's potential as a new treatment option. The drug demonstrated a generally manageable safety profile, providing hope for patients in China facing this challenging condition.
Innovent Biologics and IASO Biotherapeutics presented updated data from their phase 1/2 clinical study of IBI326, a BCMA CAR-T therapy for relapsed/refractory multiple myeloma (RRMM), at the 63rd ASH Annual Meeting. Involving 79 patients, the therapy achieved an impressive objective response rate (ORR) of 94.9% and a complete response rate of 58.2%. It demonstrated a favorable safety profile, with most adverse events classified as mild. The study highlights IBI326's potential as a breakthrough therapy, addressing the significant unmet need in treating RRMM.
Innovent Biologics announced the results of a Phase 1b clinical trial for IBI362 (LY3305677), a dual GLP-1 and glucagon receptor agonist, in Chinese patients with type 2 diabetes at the International Diabetes Federation Congress 2021. The study showed IBI362 was well tolerated with a safety profile similar to dulaglutide. At week 12, mean HbA1c reductions were noted at −1.46%, −2.28%, and −1.87% for IBI362 cohorts versus −1.46% for dulaglutide. IBI362 also resulted in significant weight loss, improving metabolic parameters. Next steps include a larger Phase II trial.
On December 2, 2021, Innovent Biologics and Eli Lilly announced the inclusion of sintilimab in China's updated National Reimbursement Drug List (NRDL), effective January 1, 2022. Sintilimab now covers four indications: first-line treatments for advanced lung cancers and hepatocellular carcinoma, along with a renewal for Hodgkin's lymphoma. This inclusion aims to enhance drug accessibility and reduce healthcare costs for patients in China, aligning with the 'Healthy China 2030' initiative. Innovent is committed to improving drug affordability and expanding its clinical studies globally.
Innovent Biologics and Ascentage Pharma have received approval from the China National Medical Products Administration for olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor, targeting T315I-mutant chronic myeloid leukemia (CML). This marks the first approval of its kind in China, addressing a significant treatment gap for patients resistant to first- and second-generation therapies. The approval is based on positive Phase II study results demonstrating its efficacy and safety. Innovent plans to co-commercialize olverembatinib in China, enhancing its oncology portfolio and addressing unmet medical needs.
Innovent Biologics, a biopharmaceutical company, announced its inclusion in the Hang Seng China Enterprises Index (HSCEI), effective December 6, 2021. This index comprises 50 leading Chinese enterprises listed in Hong Kong, highlighting Innovent's market cap and trading volume. It is the first biopharmaceutical company listed under Chapter 18A to be included. CFO Ronald Ede emphasized the significance of this recognition as a milestone in Innovent's growth, aiming to evolve into a global biopharma leader.
Innovent Biologics announced the first interim analysis results from the Phase 3 ORIENT-31 study, which evaluated the combination of sintilimab and BYVASDA® (bevacizumab biosimilar) with chemotherapy in EGFR-mutated non-squamous non-small cell lung cancer (nsqNSCLC) patients post-EGFR-TKI therapy. Results showed a statistically significant improvement in progression-free survival (PFS) for the combination therapy compared to chemotherapy alone (HR 0.464, p<0.0001), with median PFS of 6.9 vs. 4.3 months. Innovent plans to submit a supplemental New Drug Application (sNDA) to the NMPA in China.
