(Source: China Medical News)
Reposted from: China Medical News
□?Reported by this reporter, Chang Ruibo
On June 7, at the 86th Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, USA, the venue was packed. An oral presentation from China drew attendees from around the world—the Phase III clinical research data on tirzepatide in Chinese patients with severe obesity were unveiled publicly for the first time. The results showed that among Chinese obese participants with BMI ≥ 30 kg/m², after 60 weeks of treatment with a 9 mg dose of tirzepatide, the average body weight decreased by 18.55% from baseline, and 44.0% of participants achieved a weight reduction of ≥ 20%. On the same day, the study findings were published in (Journal of the American Medical Association) (JAMA). This marked the third appearance of tirzepatide-related clinical trial results in an international top academic journal, following earlier features on the main issues of (The New England Journal of Medicine) (NEJM) and (Nature).
Zhao Lei, Senior Vice President of Cind Bioscience (Suzhou) Co., Ltd. (hereinafter referred to as Cind Bioscience), said with pride: “From a single molecule in the lab to the highest international academic stage in the field of metabolism, every step of Massito peptide embodies the hard work and wisdom of the R&D team.”
Massito peptide is the first glucagon (GCG)/glucagon-like peptide-1 (GLP-1) dual-receptor agonist approved globally. Its two indications—weight loss and type 2 diabetes—were approved in China in June and September 2025, respectively.
Delving into the unknown molecule
The R&D story behind Massito peptide begins with a molecule that, at the time, was not favored by the industry.
Time goes back to 2018. That April, Cind Bioscience’s self-developed PD-1 inhibitor Sindili Immuno injection (toripalimab) had just submitted a new drug application (NDA). The company’s strategic focus then turned toward the oncology field.
At that moment, Enrique Conterno, then head of global diabetes at Eli Lilly, found Cind Bioscience’s founder and Board Chair, Yu Dechao, to discuss the possibility of Cind Bioscience taking over the subsequent R&D work for Massito peptide.
At the time, Cind Bioscience’s R&D focus was in oncology. Whether it was weight loss or diabetes, both were areas the company had never entered before. More realistically, at that time Massito peptide was merely a new molecule that had completed early-stage clinical studies, with data from only a dozen healthy participants—its R&D prospects were unclear.
But in Yu Dechao’s view, behind this “unfavored” molecule lurked enormous clinical value.
Data from the China Chronic Disease and Risk Factor Monitoring Project of the Chinese Center for Disease Control and Prevention show that from 2004 to 2018, the obesity rate among Chinese adults increased from 3.1% to 8.1%. Based on this, in 2018 China had approximately 85 million people with obesity.
“Such a vast and year-by-year growing population with obesity not only poses health risks for individuals, but also brings a massive economic burden to society.” Zhao Lei said. (The consensus of experts on obesity prevention and treatment among Chinese residents) shows that by 2030, China’s medical expenditures attributable to overweight and obesity could reach 418 billion yuan, accounting for 21.5% of the nation’s total medical spending.
Of course, for Cind Bioscience’s Board of Directors, launching a new R&D project requires more than just market demand—it must also demonstrate that its mechanism of action can stand up to scientific validation.
To this end, Cind Bioscience’s research team spent more than a year conducting in-depth research and repeated argumentation on the mechanism of action and R&D feasibility of Massito peptide, and subsequently presented queries to the Board three times.
“GLP-1 receptor agonists have been repeatedly validated in clinical practice. They can suppress appetite by activating the receptor; whereas GCG receptor agonists act on the liver and adipose tissue to promote fat burning and energy metabolism.” Zhao Lei explained, “With the two targets working in synergy, it may produce a ‘1+1>2’ effect against metabolic diseases such as obesity and type 2 diabetes.”
Based on its judgment of clinical needs and a clear understanding of Massito peptide’s mechanism, Cind Bioscience finally made the decision. In August 2019, Cind Bioscience entered into a strategic cooperation with Eli Lilly, obtaining the rights for development and commercialization of Massito peptide in China.
Climb over the “invisible” mountains
From a brand-new molecule newly confirmed in the lab, to a safe and effective drug in patients’ hands, the R&D team behind Massito peptide had to climb one “invisible” mountain after another.
Although Eli Lilly’s early work had already completed preclinical studies for Massito peptide, including pharmacology, toxicology, and pharmacokinetics, for Massito peptide to move from the lab to large-scale production, the R&D team still needed to solve the challenge of formulation process development.
In August 2022, the R&D team launched pharmaceutical research on scaled-up production processes for Massito peptide.
The structure of Massito peptide determines that it is suitable for a chemical synthesis route. But getting the route right doesn’t mean the road is easy. “Because Massito peptide is a new molecule, there are almost no existing synthesis process parameters to refer to. Every step has to be explored by the R&D staff themselves—essentially crossing the river by feeling the stones,” Zhao Lei said.
According to the introduction, the structure of Massito peptide is like a precision necklace: a backbone composed of 34 amino acids, with a fatty acid side chain attached externally at the second amino acid position. The synthesis process is like stringing together individual “beads” into a necklace. And each “bead” takes a long time to synthesize: side-chain synthesis takes half a month, backbone synthesis takes nearly one month, and subsequent steps such as cleavage, purification, and lyophilization each require about half a month. These processes are tightly linked—any deviation in any step would wipe out all the prior work.
After about a year of sustained breakthroughs, through the unremitting efforts of team members, the bottlenecks in the production process were tackled one by one, ultimately enabling the batch-wise, stable production of Massito peptide.
In November 2022, the Phase III clinical trials for Massito peptide’s two indications—weight loss and diabetes—were launched simultaneously for participant enrollment. Initially, the clinical medicine team estimated that recruitment would take 12 months. But with the full push from team members, the actual recruitment period for the weight-loss indication was far shorter than expected.
This made the clinical medicine team feel firsthand that the clinical demand for weight loss had been seriously underestimated. After internal discussions, the company ultimately decided to prioritize submitting the NDA for Massito peptide’s weight-loss indication.
Prioritizing submission for market approval meant that clinical trial management work—which could originally have been carried out at a more relaxed pace—had to be completed within a much shorter timeframe.
One of the most challenging tasks was to design energy intake plans for 610 participants across 23 hospitals nationwide. Dietary patterns vary widely from place to place, making it difficult to have a one-size-fits-all plan. To address this, the team consulted a large amount of literature, repeatedly refined their approach, and developed tailored plans for participants in different regions—plans that both met the requirements of the trial protocol and aligned with local eating habits.
On December 18, 2023, with the last patient completing follow-up, the Phase III clinical trial of Massito peptide was officially concluded.
The results of the clinical trials did justice to the team’s efforts. The findings showed that at Week 32, the weight reduction in the Massito peptide 4 mg and 6 mg groups was 10.09% and 12.55%, respectively, while the proportion of patients achieving a weight reduction of ≥5% was 73.9% and 82.0%, respectively. In addition, Massito peptide also comprehensively improved metabolic indicators—by Week 48, the waist circumference of participants decreased significantly, systolic blood pressure dropped, and blood lipid measures such as triglycerides and low-density lipoprotein cholesterol were also clearly optimized.
In late 2023, the NDA for the weight-loss indication of Massito peptide was formally submitted. On June 27, 2025, that indication was officially approved.
Charge toward the next starting point
Since Massito peptide was approved for commercialization in June 2025, its pace of commercialization has accelerated steadily.
According to the introduction, after Massito peptide was launched, a multi-channel sales network was quickly established, with public hospitals as the main channel, complemented by e-commerce platforms, offline retail pharmacies, and non-public medical institutions.
“The growth momentum after Massito peptide’s launch has exceeded expectations.” Deng Mengqing, Deputy General Manager of Commercial Strategy Planning at Cind Bioscience, said happily, “Behind this are the urgent clinical needs in weight loss and metabolism, as well as market recognition of the differentiated clinical value of Massito peptide.”
Cind Bioscience’s focus was not limited to immediate performance. While Massito peptide achieved rapid volume ramp-up, a differentiated positioning strategy around the product’s “metabolic comprehensive benefits” was also put in place in parallel.
This strategic layout has already shown phased achievements recently. At the just-concluded ADA Scientific Sessions, Massito peptide had three clinical trials selected for oral presentations, including studies in people with moderate-to-severe obesity, people with type 2 diabetes combined with obesity, head-to-head research versus semaglutide, and a Phase Ib study in Chinese adolescents with obesity—broadening the research scope to different types of individuals with metabolic abnormalities.
In addition, Phase III clinical trials for Massito peptide targeting indications such as obstructive sleep apnea (OSA) combined with obesity or overweight, obesity or overweight combined with metabolic-associated fatty liver disease (MAFLD), and hypertension combined with obesity are also progressing steadily.
While continuously expanding the indications for Massito peptide, Cind Bioscience is also planning next-generation innovative products in the weight-loss, glucose-lowering, and metabolism fields. According to the introduction, Cind Bioscience’s self-developed next-generation candidate drugs, including the oral small-molecule GLP-1 daily formulation IBI3032, the novel amylin analog IBI3040, and the weekly oral small-molecule GLP-1 IBI3042, have all achieved initial research results. Zhao Lei revealed that Cind Bioscience is also exploring new targets and new mechanisms for weight-loss and metabolism drugs, striving to provide patients with more diversified treatment options.
Innovation has no finish line—only the drive to keep reaching the next starting point. Zhao Lei said candidly that the R&D cycle for innovative drugs is longer and that commercial returns involve more uncertainty. However, Cind Bioscience’s DNA determines it will not choose the safer path.
“Only by adhering to differentiated innovation can we start from patient needs and better address clinical problems that remain unmet.” Zhao Lei said.