Innovent Biologi Stock Price, News & Analysis

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.

Innovent Biologics announced the Phase Ib clinical trial results for IBI302, a novel ophthalmic anti-VEGF and anti-complement bi-specific fusion protein targeting neovascular age-related macular degeneration (nAMD). Conducted with 18 subjects, the trial revealed that IBI302 had a favorable safety profile and showed significant improvements in visual acuity, with a mean enhancement of 6.4 letters after treatment. The study aims to address unmet clinical needs in AMD therapy. Innovent plans to further investigate IBI302's efficacy in future studies.

Innovent Biologics has published preclinical results of its bispecific antibody IBI319 in Nature Communications. The findings demonstrate that IBI319 enhances antitumor efficacy by simultaneously blocking PD-1 and activating CD137, without causing hepatotoxicity. A non-human primate study indicates a favorable safety profile, although clinical evaluation is awaited. Currently in Phase I development in China, IBI319 represents a promising advancement in immune onco-therapy, targeting both PD-1 and CD137 to overcome limitations of existing treatments.

Innovent Biologics announced that the NMPA of China has accepted its supplemental New Drug Application for sintilimab combined with chemotherapy for the first-line treatment of advanced gastric cancer. This decision is based on interim results from the Phase 3 ORIENT-16 trial, demonstrating a significant improvement in overall survival compared to chemotherapy alone. The trial involved 650 patients and met its primary endpoints. Sintilimab is already approved for various cancer treatments in China and aims to address critical treatment gaps in advanced gastric cancer.