Innovent Updates on Mazdutide GLORY-1 Study and Biomedicine Pipeline

Innovent Biologics, Inc. (Innovent), a renowned biopharmaceutical company specializing in the development, manufacture, and commercialization of high-quality medicines for various diseases, shared insights and updates on clinical data from its GLORY-1 study of mazdutide. This update was presented during an investor conference call on June 25. The focus of the discussion was on mazdutide, a GLP-1R/GCGR dual agonist, and its potential in treating overweight or obese adults, specifically in China.

At the 2024 American Diabetes Association (ADA) Scientific Meeting, Innovent revealed the promising results from its first Phase 3 clinical study (GLORY-1) of mazdutide (IBI362). The study evaluated its efficacy in weight loss and its impact on liver fat content. The conference call included detailed interpretations of these clinical findings, with contributions from Innovent's Chief Financial Officer, Rachel You, and Lei Qian, Vice President of Clinical Development for General Biomedicine. Commentary was also provided by Professor Linong Ji, MD, the principal investigator of the GLORY-1 study and a leading figure in diabetes research at Peking University.

GLORY-1 is the pioneering Phase 3 clinical study globally to evaluate a GLP-1R/GCGR dual agonist for weight management. The study highlighted significant weight reduction, enhanced safety, notable liver fat reduction, and overall improvements in metabolic indicators, thereby showcasing the effectiveness of mazdutide as a dual agonist targeting GLP-1R and GCGR. Innovent is also exploring new avenues for development, focusing on innovative molecules for beyond Type 2 Diabetes (T2D) and weight management to deliver transformative treatments in metabolic health.

Mazdutide, an analogue of oxyntomodulin (OXM), is a natural peptide hormone that activates both the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR). This dual activation results in significant weight reduction, increased energy expenditure, fat burning, and improved liver fat metabolism, leading to comprehensive metabolic benefits. The GLORY-1 findings emphasize mazdutide's impressive weight loss capabilities, safety, and tolerability, along with its potential to significantly reduce liver fat content and improve various cardiovascular metabolic risk factors.

The GLORY-1 study demonstrated mazdutide's exceptional weight loss efficacy, with an average weight reduction of 14.3% after 48 weeks in the 6mg treatment group. The study also showed significant reductions in waist, hip, and neck circumferences, indicating its potential to reduce body fat.

Moreover, mazdutide exhibited unprecedented liver health benefits, with an 80.2% reduction in liver fat content, suggesting its potential to treat metabolic-associated fatty liver disease (MAFLD) and metabolic-associated steatohepatitis (MASH). The data also indicated significant reductions in multiple cardiovascular metabolic risk indicators such as waist circumference, systolic blood pressure, triglycerides, total cholesterol, LDL-C, blood uric acid, and ALT levels.

Mazdutide was well tolerated with a favorable safety profile. Most gastrointestinal symptoms observed, such as nausea, vomiting, and diarrhea, were mild or moderate, and there were no indications of increased cardiovascular risk. The marketing application for mazdutide's weight loss indication is currently under review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). If approved, mazdutide could become a comprehensive solution for chronic weight management in obese and overweight individuals in China.

Innovent also discussed its innovative cardiovascular and metabolic products under development. These include SINTBILO® (PCSK9), the first Chinese-developed PCSK9 monoclonal antibody for hyperlipidemia, IBI128, a next-generation candidate for managing gout and hyperuricemia, and IBI3016, an innovative siRNA therapy for hypertension. Additionally, several early-stage projects are poised to enter the IND stage, strengthening Innovent's strategic positioning in cardiovascular and metabolic diseases.

In the autoimmune field, Innovent has successfully launched SULINNO® (adalimumab injection) for multiple indications and is advancing Picankibart (IBI112), which showed significant efficacy in treating moderate to severe plaque psoriasis. Innovent is also developing other innovative molecules targeting various autoimmune diseases.

In ophthalmology, Innovent's new drug application for IBI311 Injection to treat thyroid eye disease (TED) has been accepted, addressing a significant gap in TED treatment. Phase 3 trials for IBI302 for neovascular age-related maculopathy are also underway, along with early-stage trials for other innovative ophthalmic treatments.

Founded in 2011, Innovent Biologics is committed to providing affordable, high-quality biopharmaceuticals to patients worldwide, with a focus on cancer, cardiovascular and metabolic diseases, autoimmune conditions, and ophthalmology.