INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics announced the final analysis results of its Phase 3 study, ORIENT-16, at the AACR Annual Meeting 2023. The study evaluated sintilimab, an anti-PD-1 antibody, in combination with chemotherapy for advanced gastric or gastroesophageal junction (G/GEJ) cancer. Results showed a 41.3% reduction in the risk of death for patients with CPS ≥5 and a 6.3-month improvement in median overall survival (19.2 months vs. 12.9 months) compared to chemotherapy alone. The safety profile remained consistent with interim analyses, confirming sintilimab's role as a first-line standard of care. Sintilimab is now included in the National Reimbursement Drug List, enhancing access to this treatment option for patients in China, where gastric cancer has a high incidence and poor prognosis.

Innovent Biologics announced updated results for IBI351 (GFH925), a KRAS^G12C inhibitor, from a Phase 1 clinical trial at the 2023 AACR Annual Meeting. The trial, which enrolled 74 subjects, primarily focused on patients with advanced non-small cell lung cancer (NSCLC). Key highlights include:

• 41 of 67 evaluable NSCLC patients achieved partial response, yielding an overall response rate (ORR) of 61.2%.
• In the 600mg BID cohort, the ORR was 66.7%, with a disease control rate (DCR) of 96.7%.
• The treatment was well tolerated, with most adverse events being low-grade.

Innovent plans to advance IBI351 into late-stage clinical development, emphasizing its promising safety profile and efficacy in targeting KRAS mutations.

Innovent Biologics announced the final analysis results of the Phase 3 ORIENT-15 study, which evaluated sintilimab combined with chemotherapy for treating esophageal squamous cell carcinoma (ESCC). The study involved 690 patients with a median follow-up of 32.2 months. Sintilimab showed a significant improvement in median overall survival (mOS), reducing the risk of death by 33.9% in all patients (HR 0.661; P<0.0001) and 36.5% in PD-L1 positive patients (HR 0.635; P=0.0001). The estimated OS rates at 12 and 24 months were 64.0% vs 53.5% and 41.4% vs 22.9%, respectively. Sintilimab has been approved by NMPA as a first-line treatment for advanced ESCC and included in China's National Reimbursement Drug List, broadening patient access. Notably, the safety profile aligns with prior studies, indicating no new safety concerns with the extended follow-up.

Innovent Biologics, a leading biopharmaceutical firm, reported its 2022 annual results on March 28, 2023. The company achieved a revenue of RMB4,556.4 million, up 6.7% year-on-year, despite facing challenges such as COVID-19 impacts. Innovent now has eight approved products and has expanded its commercial portfolio. The company's losses for the year were RMB2,179.3 million, largely due to ongoing investments in R&D, which reached RMB2,871.2 million. Notably, operational efficiency improved, with a decrease in the ratio of selling and marketing expenses to revenue from 65.5% in 2021 to 62.6% in 2022. Innovent aims for sustainable growth and global innovation.

Innovent Biologics announced that clinical data from various trials will be presented at the AACR Annual Meeting 2023 in Orlando from April 14-19, 2023. Key presentations include updated results from a Phase I trial of IBI351 for advanced solid tumors and overall survival outcomes from Phase III studies of sintilimab in esophageal and gastric cancers. Sintilimab, approved in China for multiple indications, shows promise in ongoing trials, with over 20 studies evaluating its efficacy. The company is increasingly focusing on expanding its oncology pipeline, which includes collaborations for Pemazyre and IBI351.

Innovent Biologics has initiated a phase 1 clinical trial for IBI333, a bispecific fusion protein targeting neovascular age-related macular degeneration (nAMD). The trial aims to assess the safety and tolerability of IBI333, which simultaneously binds VEGF-A and VEGF-C, potentially improving treatment outcomes for patients resistant to current therapies. The trial, designated as CTR20222674, represents a step towards providing innovative therapeutic options for nAMD, a major cause of blindness. With the incidence of AMD rising, successful development of IBI333 could significantly impact the treatment landscape for this condition.

Innovent Biologics has successfully dosed its first patient in a Phase 3 clinical trial (CLEAR) for its anti-IL23p19 monoclonal antibody, picankibart (IBI112), targeting moderate-to-severe plaque psoriasis. This multicenter, double-blind study aims to enroll around 500 subjects over 68 weeks, assessing the drug's efficacy and safety against placebo. Previous Phase 2 results indicated significant clinical benefits, with up to 86% of participants achieving substantial improvements in skin condition. This trial marks a pivotal step in developing innovative psoriasis treatments in China, addressing unmet medical needs.

Innovent Biologics has successfully dosed its first patient in a Phase 2 clinical trial for IBI311, an anti-IGF-1R monoclonal antibody targeting thyroid-associated ophthalmopathy (TAO). This randomized, double-blinded, placebo-controlled study aims to evaluate IBI311's efficacy in improving proptosis in TAO patients. Currently, there are no approved treatments for TAO in China, creating a significant unmet medical need. IBI311's preclinical studies have shown promising safety and biological activity, with plans for further clinical development depending on Phase 2 results.

Innovent Biologics announced five products' inclusion in China's updated National Reimbursement Drug List (NRDL), effective March 1, 2023. Key additions include two new indications for its PD-1 inhibitor TYVYT (sintilimab), now covering gastric and esophageal cancer. Olverembatinib has made its first listing for T315I-mutant chronic myeloid leukemia (CML). Additionally, new indications for BYVASDA, HALPRYZA, and SULINNO expand reimbursement coverage for various cancers and autoimmune diseases. This progress aligns with China's healthcare reforms, aimed at enhancing drug access and affordability for patients.