Gan & Lee Pharmaceuticals' Bi-weekly (twice a month) GLP-1 Receptor Agonist GZR18 Injection Achieved 17.29% Weight Loss at 30 Weeks in a Phase IIb Clinical Trial

BEIJING, July 22, 2024 /PRNewswire/ -- Recently, Gan & Lee Pharmaceuticals(Gan & Lee, Shanghai Stock Exchange: 603087) announced that its independently developed long-acting GLP-1 receptor agonist (GLP-1 RA), GZR18 injection, has achieved positive results in a clinical trial for adults with obesity/overweight in China.

Statement:

1. GZR18 injection is an investigational drug and has not yet been approved in China.

2. Gan & Lee Pharmaceuticals does not recommend the use of any unapproved drugs/indications.

The phase IIb clinical trial (CTR20231695) is a multi-center, randomized, double-blind, placebo-controlled study conducted at 25 clinical trial centers in China, recruiting a total of 340 participants. The participants were overweight (BMI≥24 kg/m²) with at least one weight-related comorbidity or obese (BMI≥28 kg/m²) adults with poorly controlled diet and exercise. They were randomized to receive bi-weekly (Q2W) doses of 12 mg, 18 mg, 24 mg, 48 mg, and once-weekly (QW) dose of 24 mg GZR18 injection or placebo for 30 weeks (including a dose escalation period). The primary efficacy endpoint of the study was the percent change in body weight from baseline after 30 weeks of treatment. The study assessed changes from baseline in average weight, waist circumference, waist-to-hip ratio, body mass index (BMI), glycemic parameters, and the safety and tolerability of the drug.

After 30 weeks of treatment, compared to the placebo group, participants receiving different doses and frequencies of GZR18 injection (12 mg, 18 mg, 24 mg, and 48 mg Q2W; 24 mg QW) had a significant reduction in the percent change in body weight from baseline. The mean percent changes in body weight from baseline was -11.15% (12 mg group, Q2W), -13.22% (18 mg group, Q2W), -14.25% (24 mg group, Q2W), -17.29% (48 mg group, Q2W), and -17.78% (24 mg group, QW), all more effective than the placebo group (reduced by 0.99%). There was no significant difference in mean percent change in body weight between the 48 mg Q2W group and the 24 mg QW group (one-sided test, P > 0.025).

In this study, the bi-weekly GZR18 injections were generally safe and well tolerated, consistent with the known safety signals of GLP-1 receptor agonists. The most common adverse events were gastrointestinal reactions, most of which were mild to moderate in severity, comparable to other GLP-1 RAs.

The comprehensive results of this phase IIb study are planned to be announced later this year and will be published in a peer-reviewed journal.

About Gan & Lee

Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin^®), fast-acting lispro injection (Prandilin^â„¢), fast-acting aspart injection (Rapilin^®), mixed protamine zinc lispro injection (25R) (Prandilin^â„¢25), aspart 30 injection (Rapilin^®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin^®30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine^®).

In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked second overall and first among domestic companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine^®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets.

In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.

Further Information:
BPRD@ganlee.com (Media)
BD@ganlee.com (Business Development)

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Gan & Lee Pharmaceuticals' Bi-weekly (twice a month) GLP-1 Receptor Agonist GZR18 Injection Achieved 17.29% Weight Loss at 30 Weeks in a Phase IIb Clinical Trial

Gan & Lee Pharmaceuticals' Bi-weekly (twice a month) GLP-1 Receptor Agonist GZR18 Injection Achieved 17.29% Weight Loss at 30 Weeks in a Phase IIb Clinical Trial

Gan & Lee Pharmaceuticals' Bi-weekly (twice a month) GLP-1 Receptor Agonist GZR18 Injection Achieved 17.29% Weight Loss at 30 Weeks in a Phase IIb Clinical Trial

TIANJIN, China, Dec. 24, 2024 /PRNewswire/ -- On December 7, 2024, AIMA Technology Group warmly invited a delegation of five top-performing U.S. IBD dealers to visit its headquarters. Accompanying the group was Angela Zheng, CEO of AIMA's U.S. subsidiary, AIMA EBIKE, along with her sales, marketing, and customer service teams. This visit not only marked a deepened connection between AIMA and the mainstream U.S. market but also provided U.S. dealers with a valuable opportunity to witness AIMA Technology's globally leading capabilities in research, development, and manufacturing of electric mobility solutions.

The delegation first toured AIMA's state-of-the-art factory in Tianjin. Aima Technology possesses production factories with extremely high levels of intelligent manufacturing Additionally, AIMA has integrated advanced technologies such as AI visual recognition and established a CNAS-certified R&D laboratory, maintaining its industry leadership in intelligent transformation. During the tour, the dealers were deeply impressed by AIMA's cutting-edge technology, large-scale production capabilities, and relentless pursuit of excellence in product development and manufacturing. They expressed that this rare visit not only enhanced their understanding of AIMA but also strengthened their confidence in promoting AIMA products as a symbol of outstanding performance and exceptional quality to their customers.

Furthermore, AIMA Technology's R&D team engaged in in-depth discussions with the dealers regarding the new models AIMA EBIKE plans to launch in 2025. The dealers test-rode prototypes of the latest models and shared their innovative insights. They expressed high praise for AIMA's product innovation capabilities and market acumen, recognizing these as key factors that distinguish AIMA in the industry.

Later, the dealers joined AIMA Technology's team to witness the rollout of the 10,000th AIMA E-Bike. This milestone moment showcased AIMA's exceptional manufacturing strength and market influence. The dealers were inspired and expressed strong confidence in the promising future of their partnership with AIMA.

This visit from the top-tier U.S. dealer delegation not only deepened mutual trust and friendship but also injected new momentum into AIMA's ambition to become a leader in the U.S. E-Bike industry by focusing on the IBD channel. Looking ahead, AIMA Technology will continue to strive to provide market-leading performance and quality, enhancing its product development and manufacturing capabilities while working hand-in-hand with global dealers to create an even brighter future.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

AIMA Technology Welcomes Top U.S. Dealers to Shape the Future Together

AIMA Technology Welcomes Top U.S. Dealers to Shape the Future Together