INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

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.

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.