INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics and AnHeart Therapeutics presented interim clinical data for taletrectinib (AB-106), a next-generation ROS1/NTRK inhibitor, at the CSCO 2021 Annual Meeting. The Phase 2 trial (TRUST) evaluated its efficacy in ROS1-positive non-small cell lung cancer (NSCLC). In treatment-naïve patients, the objective response rate (ORR) was 90.5%, while in pre-treated patients, the ORR was 43.8%. Taletrectinib showed good safety profiles, primarily causing mild gastrointestinal adverse effects. This promising data could provide hope for patients with limited treatment options in China.

Innovent Biologics has successfully dosed the first patient in a Phase 2 clinical trial for IBI112, an anti-interleukin 23 monoclonal antibody, aimed at treating moderate-to-severe plaque psoriasis. This trial, the first of its kind for domestic IL-23p19 inhibitors in China, seeks to evaluate the efficacy and safety of IBI112. With approximately 6 million psoriasis patients in China, the trial represents a significant advancement for patients seeking effective treatment options. The promising Phase 1 results highlight IBI112's safety profile and its potential for improved treatment adherence.

Innovent Biologics announced that the NMPA of China has accepted the supplemental New Drug Application for Sintilimab in combination with chemotherapy for treating esophageal squamous cell carcinoma (ESCC). This application is based on positive interim results from the Phase 3 ORIENT-15 clinical trial, which showed significant overall survival improvement. Esophageal cancer remains a major health concern in China, with Sintilimab representing a potential new treatment option. Innovent aims to expedite the review process for this regimen to address the urgent clinical need in ESCC patients.

Innovent Biologics reported interim analysis results from the Phase 3 ORIENT-16 study of sintilimab combined with chemotherapy for advanced gastric cancer. As of June 20, 2021, 650 patients were enrolled. Results showed a 34% reduction in death risk with median overall survival improving by 5.5 months in patients meeting specific criteria. Sintilimab's safety profile remained consistent with previous studies. The company plans to file for a supplemental drug application in China, aiming to provide a new treatment option for gastric cancer, which has a poor prognosis globally.

Innovent Biologics announced positive interim results from the Phase 3 ORIENT-15 study, presented at ESMO 2021, validating sintilimab's efficacy when combined with chemotherapy for esophageal squamous cell carcinoma (ESCC). The study achieved all endpoints: a median overall survival (mOS) of 16.7 months versus 12.5 months for the placebo group, and a median progression-free survival (mPFS) of 7.2 months versus 5.7 months. Sintilimab's safety profile was consistent with earlier studies. The company has submitted an application to the NMPA in China to secure first-line treatment approval for ESCC.

Innovent Biologics announced results from a Phase 2 study of pemigatinib in advanced cholangiocarcinoma patients at the ESMO Congress 2021. The study enrolled 34 subjects, revealing a 50% objective response rate (ORR) among 30 efficacy-evaluable participants. With a median follow-up of 5.13 months, the disease control rate was 100%. Safety analysis indicated that all subjects experienced treatment-related adverse events, with hyperphosphatemia (73.5%) as the most common. The New Drug Application for pemigatinib is under review in China, following approval in Taiwan.

Innovent Biologics has initiated a phase 2 clinical trial for IBI362, a dual agonist targeting GLP-1R and GCGR, for treating type 2 diabetes in China. The trial (NCT04965506) aims to assess IBI362's efficacy and safety compared to placebo and dulaglutide, focusing on HbA1c level changes over 20 weeks. Preliminary phase Ib results show a favorable safety profile and promising preliminary efficacy. IBI362 is licensed from Eli Lilly and may offer enhanced weight loss and metabolic benefits, appealing in a market where diabetes prevalence is 11.6% among adults in China.

Innovent Biologics and GenFleet Therapeutics have entered into an exclusive license agreement for the development and commercialization of GenFleet's KRAS G12C candidate, GFH925, in China and beyond. GFH925 has received Investigational New Drug approval in China and shows potential as a best-in-class treatment. Innovent will oversee clinical development in China and can pursue global commercialization. GenFleet will receive a $22 million upfront payment, with additional potential milestone payments totaling $290 million tied to development and sales success.

Innovent Biologics reported impressive interim results for the first half of 2021, achieving total revenue of RMB1,941.8 million, up 97.3% year-over-year driven by a doubling of product revenue to RMB1,854.6 million. The firm expanded its commercial portfolio from four to five products, thanks to the approval of PEMAZYRE® in Taiwan. Continuously growing revenue from TYVYT® and new products contributed significantly to their success. Innovent's pipeline now boasts 25 high-value assets, with six in pivotal trials, marking a strong trajectory for future growth.