INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics and Ascentage Pharma announced that the China National Medical Products Administration has accepted and granted Priority Review designation for a New Drug Application supporting the full approval of olverembatinib, targeting chronic myeloid leukemia (CML) patients resistant to first- and second-generation therapies. This follows a conditional approval in November 2021. The recent decision highlights the urgency of addressing unmet medical needs in drug-resistant CML. Olverembatinib's efficacy was demonstrated in a Phase II study, significantly improving event-free survival compared to standard treatments.

Innovent Biologics announced that its phase 2 study of mazdutide (IBI362), a dual agonist targeting GLP-1R and GCGR, met its primary endpoint in Chinese patients with type 2 diabetes. The study demonstrated significant reductions in HbA1c levels across all dosage groups compared to placebo (p < 0.0001) and highlighted a dose-dependent weight loss effect. Mazdutide improved various metabolic metrics and showed a favorable safety profile with no severe hypoglycemic events. The company plans to proceed to phase 3 trials, aiming to address the urgent clinical need in diabetes treatment.

Innovent Biologics has successfully dosed the first patient in a Phase 2 study of IBI112, an anti-IL-23p19 monoclonal antibody, for treating moderate-to-severe active ulcerative colitis in China. This multi-center, double-blind trial aims to evaluate the drug's efficacy, safety, and pharmacokinetics. IBI112, developed independently by Innovent, shows promising safety profiles from previous studies and addresses a significant unmet need in ulcerative colitis treatment, particularly as there are no current self-developed IL-23p19 inhibitors in China.

Innovent Biologics has published results from a phase 1b study of mazdutide (IBI362), a GLP-1 and glucagon receptor dual agonist, in Chinese patients with type 2 diabetes, in Nature Communications. The study demonstrated that IBI362 was well-tolerated, with notable improvements in blood glucose control and weight loss. Key findings included a reduction in HbA1c levels (up to −2.23%) and significant weight loss (up to −5.4%). The company plans to advance to phase II studies and pursue registration for IBI362 in China.

Innovent Biologics and Eli Lilly announced that China's NMPA approved TYVYT® (sintilimab injection) combined with chemotherapy for advanced gastric cancer. This marks TYVYT®'s sixth NMPA indication and is significant as it is the first domestic PD-1 inhibitor approved for this type of cancer. The approval is based on the Phase III ORIENT-16 trial, which showed a 34% reduction in risk of death and a median overall survival improvement of 5.5 months. This development enhances Innovent's portfolio, addressing a critical need for effective gastric cancer treatments in China.

Innovent Biologics and Eli Lilly announced the approval of TYVYT® (sintilimab injection) by China's NMPA for first-line treatment of unresectable esophageal squamous cell carcinoma (ESCC) in combination with chemotherapy. This marks the fifth approved indication for TYVYT® in China. The approval was based on the ORIENT-15 Phase 3 trial, which showed a significant overall survival improvement (16.7 months vs. 12.5 months) compared to placebo. The safety profile remained consistent with previous data, further solidifying TYVYT®'s position in cancer treatment.

Innovent Biologics and PT Etana Biotechnologies Indonesia announced the approval of Bevagen®, a bevacizumab biosimilar, by the Indonesian Food and Drugs Authority (BPOM) on June 13, 2022. This approval allows for five cancer treatment indications, including colorectal and breast cancer. Bevagen® will be the first Chinese antibody drug produced in Southeast Asia. The collaboration aims to leverage Etana's local market expertise to enhance patient access to affordable cancer treatments. Innovent's portfolio includes 32 assets, with several approved in China, showcasing its commitment to global market expansion.

Innovent Biologics announced that China's NMPA has accepted the New Drug Application (NDA) for tafolecimab injection, aimed at treating primary hypercholesterolemia and mixed dyslipidemia. This marks a significant advancement in the availability of PCSK-9 monoclonal antibodies in China. The NDA is based on three successful phase 3 trials (CREDIT-1, CREDIT-2, CREDIT-4), demonstrating up to a 65% reduction in LDL-C levels. Tafolecimab is expected to be the first recombinant fully human anti-PCSK-9 monoclonal antibody launched in China, potentially enhancing treatment options for patients with dyslipidemia.

IASO Biotherapeutics and Innovent Biologics presented updated data from the Phase 1/2 study of Equecabtagene Autoleucel, a CAR T-cell therapy for relapsed/refractory multiple myeloma, at the 27th EHA Annual Meeting on June 9-12, 2022. The study involved 79 patients, showing an overall response rate (ORR) of 94.9% and a complete response rate of 68.4%. The therapy exhibited manageable safety profiles, with 94.9% experiencing cytokine release syndrome (CRS), mostly mild. Key findings reveal potential for Equecabtagene Autoleucel as a breakthrough treatment for hard-to-treat patients.