
High-end Biologics Developer
A Chinese New Drug Rewriting Global Obesity Treatment Guidelines, A High-Value Rights Issue: Innovent Bio’s Global Blueprint Becomes Increasingly Clear.
On June 26, Innovent Bio announced that the Company had entered into a placing agreement with Morgan Stanley and Goldman Sachs to place 55 million new shares to no fewer than six independent professional, institutional, or other investors under a general mandate. The placing price was HK$78.36 per share, representing a discount of approximately 4.9% to the closing price on the last trading day (June 25) prior to the signing of the placing agreement, with total proceeds exceeding HK$4.3 billion (approximately US$550 million). According to the announcement, the net proceeds from this share placement will be primarily used to advance the global research and development of the Company’s core pipeline and to expand its global facilities and infrastructure, with a small portion allocated for daily operational purposes.
The following day, Innovent Bio announced another major development. The National Medical Products Administration (NMPA) approved the marketing application for mazdutide injection, a glucagon (GCG)/glucagon-like peptide-1 (GLP-1) dual receptor agonist submitted by Innovent Bio, for long-term weight management in adults with obesity or overweight. Mazdutide has become the first and only approved GCG/GLP-1 dual-target weight-loss drug globally. In addition to this approved indication for weight loss, the NMPA has accepted for review the New Drug Application (NDA) for mazdutide for glycemic control in adult patients with type 2 diabetes.
World’s First! Dual-Target GLP-1 New Drug Approved
Mazdutide is a GLP-1R/GCGR dual agonist for which Innovent Bio obtained the license from Eli Lilly in China. In 2019, Innovent Bio and Eli Lilly entered into a licensing agreement, granting Innovent the rights to develop and potentially commercialize mazdutide in China.
Unlike traditional single-target GLP-1 receptor agonists, mazdutide can simultaneously and highly selectively activate both GLP-1 and GCG receptors. It achieves multidimensional regulation of energy metabolism through a unique dual approach that combines “reducing expenditure” with “increasing output.”
The approval is primarily based on the results of GLORY-1 (NCT05607680), a Phase 3 clinical trial conducted in subjects with overweight or obesity. The GLORY-1 study enrolled a total of 610 subjects with obesity (BMI ≥28 kg/m²) or overweight (24 kg/m² ≤ BMI <28 kg/m²) who had at least one obesity-related complication. The mean baseline body weight was 87.2 kg, and the mean baseline BMI was 31.1 kg/m².
These subjects were randomly assigned to receive mazdutide 4 mg, 6 mg, or placebo, administered via subcutaneous injection once weekly for 48 weeks. The primary endpoints of the study were the percentage change in body weight from baseline at Week 32 and the proportion of subjects achieving a ≥5% reduction in body weight from baseline.
Study results demonstrated that mazdutide at all doses significantly reduced body weight compared with placebo. Based on the estimand for efficacy, the mean percentage changes from baseline in body weight at Week 32 were −10.97%, −13.38%, and −0.24% for the mazdutide 4 mg, 6 mg, and placebo groups, respectively; at Week 48, the corresponding values were −12.05%, −14.84%, and −0.47%.
At Week 32, the proportions of subjects achieving a weight reduction of ≥5% from baseline in the mazdutide 4 mg, 6 mg, and placebo groups were 76.3%, 84.0%, and 10.9%, respectively. At Week 48, the proportions of subjects achieving a weight reduction of ≥15% from baseline in the mazdutide 4 mg, 6 mg, and placebo groups were 37.0%, 50.6%, and 2.1%, respectively.
Mazdutide significantly reduced cardiovascular and metabolic indicators, including blood pressure, blood lipids (triglycerides, total cholesterol, and low-density lipoprotein cholesterol), serum uric acid, and transaminase levels. Furthermore, the product also significantly reduced liver fat content in overweight or obese subjects.
In April 2025, the National Health Commission incorporated the “Healthy Weight Management Initiative” into the “Healthy China 2030” special program, aiming to curb the rising trend of overweight and obesity by 2030. With 500 million people in China classified as overweight or obese—nearly 90% of whom suffer from at least one comorbidity, such as fatty liver disease—mazdutide holds substantial future market potential. Currently approved GLP-1-based weight-loss medications in the Chinese market include Novo Nordisk’s semaglutide (Wegovy), Eli Lilly’s tirzepatide (Mounjaro), and Huadong Medicine’s liraglutide biosimilar, among others.
$550 Million International Multicenter Clinical Trial for Core Blood Transfusion Pipeline
On the day before the announcement of mazdutide’s approval, Innovent Bio announced the completion of a $550 million private placement of new shares. The placement attracted support from international long-term funds and specialized healthcare funds; oversubscription led to a 10% increase in the amount raised compared with the original plan, and the shares were priced at a 14% premium to the average trading price over the preceding 30 trading days, underscoring capital market confidence in Innovent’s prospects.
Specifically, the financing will be prioritized for international multi-center clinical trials (MRCTs) of five pipeline assets. The cost disparity between Phase III clinical trials in China and the United States can reach 5- to 10-fold. Innovent Bio’s net cash reserves have currently risen to $2 billion, providing financial assurance for high-cost multinational trials.
At the 2025 ASCO Annual Meeting, Innovent Bio presented Phase I clinical data of IBI363 in solid tumors such as lung cancer, colorectal cancer, and melanoma, fully demonstrating its breakthrough potential. IBI363 is a globally first-in-class PD-1/IL-2α-biased bispecific antibody fusion protein independently developed by Innovent. The released data revealed a significant “tail effect” of IBI363 in lung cancer, with overall survival (OS) outcomes across multiple tumor types substantially surpassing those of existing standard therapies, highlighting its immense potential as a next-generation immunotherapy agent. Leveraging its dual mechanism of action, IBI363 has demonstrated breakthrough efficacy in several major indications, and its first-in-class status positions it as a leader in next-generation immunotherapy. Currently, IBI363 has been granted Fast Track Designation by the U.S. FDA.
In addition to IBI363, Innovent Bio’s two other molecules, IBI343 and IBI354, have also garnered significant attention. Notably, IBI343 (an anti-CLDN18.2 ADC) has demonstrated breakthrough potential in the treatment of pancreatic cancer and has received Breakthrough Therapy Designation in both China and the United States; meanwhile, IBI354 (an anti-HER2 monoclonal antibody–camptothecin derivative conjugate) has shown substantial promise in treating various advanced solid tumors, with particularly outstanding performance in ovarian and breast cancers.
Capital reserves will also support a differentiated business development (BD) strategy. The company has clearly stated that it will advance its oncology pipeline to a “more licensable stage” in exchange for higher upfront payments and royalty rates. Furthermore, with mazdutide facing competition from Eli Lilly’s tirzepatide and pressure from national reimbursement listings upon its market launch, sufficient cash flow will enable mazdutide to adopt a price-for-volume strategy during the early commercialization phase, while avoiding R&D gaps caused by compressed profit margins.
Innovent Bio’s $550 million financing not only provides strong support for international multicenter trials of innovative drugs such as IBI363, but also strengthens the capital foundation of its global strategy, ushering in a new chapter for China’s innovative pharmaceutical industry.