INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

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.

Innovent Biologics and NeoCura Bio-Medical Technology have entered a strategic collaboration to study the combination therapy of sintilimab and the neoantigen vaccine NEO_PLIN2101 in cancer patients in China. The partnership aims to assess safety, pharmacokinetics, and preliminary efficacy, advancing the clinical development of combination immunotherapy for solid tumors. Innovent boasts a robust pipeline with five approved drugs and plans to launch over ten more in the next few years. This collaboration is expected to improve cancer treatment outcomes and enhance the therapeutic efficacy of sintilimab.

Innovent Biologics announced that the sintilimab ORIENT-31 study achieved its primary endpoint of progression-free survival (PFS) in patients with EGFR-mutated non-squamous non-small cell lung cancer (nsqNSCLC) after prior EGFR TKI treatment. This Phase 3 study is the first to show significant PFS improvement using sintilimab with BYVASDA® (bevacizumab biosimilar) plus chemotherapy compared to standard chemotherapy. The safety profile was consistent with previous studies, and detailed results will be presented at a medical meeting.

Innovent Biologics, a biopharmaceutical company, announced the successful dosing of the first patient in a Phase I/II clinical study of IBI351, a KRAS G12C inhibitor, for advanced solid tumors in China. This open-label study aims to evaluate the safety, pharmacokinetics, and efficacy of IBI351 in patients with the KRAS G12C mutation. The medication addresses a significant unmet medical need, as current treatments for this mutation are limited. Innovent collaborates with GenFleet Therapeutics for development and commercialization in China.

Innovent Biologics presented preliminary results from the Phase Ia study of IBI315, a first-in-class anti-Her2/PD-1 bispecific antibody, at the 2021 CSCO Annual Meeting. Conducted through May 25, 2021, 27 patients received varying doses, with no dose-limiting toxicities observed. The objective response rate was 20% among 15 patients who completed assessments. The study showed promise in safety and efficacy, paving the way for a planned Phase Ib trial to further investigate IBI315's applications in treating Her2 positive tumors.