INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

The FDA's Oncology Drug Advisory Committee voted for additional clinical trials for sintilimab, an investigational PD-1 inhibitor, before considering its first-line treatment application for non-squamous non-small cell lung cancer (nsqNSCLC) based on the ORIENT-11 trial conducted in China. The committee highlighted a need for data validating the drug's applicability to the U.S. population. Innovent and Lilly, who are collaborating on sintilimab, acknowledged the disappointment but remain optimistic about its potential and will continue working with the FDA.

Innovent Biologics has received approval from the Hong Kong Department of Health for Pemazyre® (pemigatinib) to treat adults with locally advanced or metastatic cholangiocarcinoma exhibiting FGFR2 fusion or rearrangement after prior therapy. This marks the first approval of a tyrosine kinase inhibitor for this cancer type in Hong Kong. The approval follows previous approvals in Taiwan and NDA acceptance in Mainland China. The FIGHT-202 study demonstrated an overall response rate of 37.0% with a median duration of response of 8.08 months. The treatment was generally well tolerated.

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.