Gan & Lee Pharmaceuticals Announces U.S. FDA Clearance of the IND application for the innovative Bi-weekly GLP-1RA GZR18 Injection, Bofanglutide, with chronic weight management Indication (A Phase 2 head-to-head with Tirzepatide clinical trial)
Gan & Lee Pharmaceuticals announced FDA clearance of their IND application for GZR18 Injection, a bi-weekly GLP-1 receptor agonist, to conduct a Phase 2 clinical trial. The trial will be a head-to-head comparison with Eli Lilly's Tirzepatide for chronic weight management in obese or overweight patients, with or without T2DM.
According to the World Obesity Federation's 2024 report, approximately 2.2 billion adults worldwide were overweight in 2020, with projections reaching 3.3 billion by 2035. GZR18, as the first bi-weekly GLP-1 mono-agonist formulation, works by delaying gastric emptying and suppressing appetite. Current clinical data suggests weight loss effects comparable to or better than multi-target once-weekly GLP-1 formulations.
Gan & Lee Pharmaceuticals ha annunciato l'approvazione da parte della FDA della loro domanda IND per GZR18 Injection, un agonista del recettore GLP-1 somministrato ogni due settimane, per condurre uno studio clinico di Fase 2. Lo studio sarà un confronto diretto con Tirzepatide di Eli Lilly per la gestione del peso cronico in pazienti obesi o in sovrappeso, con o senza T2DM.
Secondo il rapporto 2024 della World Obesity Federation, circa 2,2 miliardi di adulti in tutto il mondo erano in sovrappeso nel 2020, con proiezioni che raggiungono i 3,3 miliardi entro il 2035. GZR18, essendo la prima formulazione mono-agonista GLP-1 somministrata ogni due settimane, funziona ritardando lo svuotamento gastrico e sopprimendo l'appetito. I dati clinici attuali suggeriscono effetti di perdita di peso comparabili o migliori rispetto alle formulazioni GLP-1 multi-target somministrate una volta a settimana.
Gan & Lee Pharmaceuticals anunció la aprobación de la FDA de su solicitud IND para GZR18 Injection, un agonista del receptor GLP-1 administrado cada dos semanas, para llevar a cabo un ensayo clínico de Fase 2. El ensayo será una comparación directa con Tirzepatide de Eli Lilly para la gestión crónica del peso en pacientes obesos o con sobrepeso, con o sin T2DM.
Según el informe 2024 de la Federación Mundial de Obesidad, aproximadamente 2.2 mil millones de adultos en todo el mundo estaban con sobrepeso en 2020, con proyecciones que alcanzan los 3.3 mil millones para 2035. GZR18, como la primera formulación mono-agonista GLP-1 administrada cada dos semanas, actúa retrasando el vaciamiento gástrico y suprimendo el apetito. Los datos clínicos actuales sugieren efectos de pérdida de peso comparables o mejores que las formulaciones GLP-1 de múltiples objetivos administradas una vez a la semana.
Gan & Lee Pharmaceuticals는 GZR18 Injection의 IND 신청서가 FDA의 승인을 받았다고 발표했습니다. 이는 2주마다 투여되는 GLP-1 수용체 작용제로, 2상 임상 시험을 실시할 예정입니다. 이 시험은 비만 혹은 과체중 환자의 만성 체중 관리에 대해 Eli Lilly의 Tirzepatide와의 정면 비교를 진행할 것입니다.
2024년 세계 비만 연맹 보고서에 따르면, 2020년 전 세계에서 약 22억 명의 성인이 과체중이었으며, 2035년까지 33억 명에 이를 것으로 예상됩니다. GZR18은 2주마다 투여되는 최초의 GLP-1 단일 작용제 제형으로, 위 배출을 지연시키고 식욕을 억제하는 작용을 합니다. 현재의 임상 데이터는 주 1회 투여되는 다중 표적 GLP-1 제형과 비슷하거나 더 나은 체중 감소 효과를 제시하고 있습니다.
Gan & Lee Pharmaceuticals a annoncé l'approbation par la FDA de leur demande IND pour GZR18 Injection, un agoniste des récepteurs GLP-1 administré toutes les deux semaines, afin de réaliser un essai clinique de Phase 2. L'essai sera une comparaison directe avec Tirzepatide de Eli Lilly pour la gestion chronique du poids chez des patients obèses ou en surpoids, avec ou sans T2DM.
Selon le rapport 2024 de la Fédération Mondiale de l'Obésité, environ 2,2 milliards d'adultes dans le monde étaient en surpoids en 2020, avec des projections atteignant 3,3 milliards d'ici 2035. GZR18, en tant que première formulation mono-agoniste GLP-1 administrée toutes les deux semaines, agit en retardant la vidange gastrique et en supprimant l'appétit. Les données cliniques actuelles suggèrent des effets de perte de poids comparables ou meilleurs que ceux des formulations GLP-1 multi-cibles administrées une fois par semaine.
Gan & Lee Pharmaceuticals gab die Genehmigung durch die FDA für ihren IND-Antrag auf GZR18 Injection bekannt, einen alle zwei Wochen verabreichten GLP-1-Rezeptor-Agonisten, um eine Phase-2-Studie durchzuführen. Die Studie wird einen direkten Vergleich mit Tirzepatide von Eli Lilly zur chronischen Gewichtsmanagement bei fettleibigen oder übergewichtigen Patienten, mit oder ohne T2DM, darstellen.
Laut dem Bericht der World Obesity Federation 2024 waren im Jahr 2020 weltweit etwa 2,2 Milliarden Erwachsene übergewichtig, mit Prognosen, die bis 2035 3,3 Milliarden erreichen werden. GZR18, als erste alle zwei Wochen verabreichte GLP-1-Mono-Agonisten-Formulierung, wirkt, indem es die Magenentleerung verzögert und den Appetit unterdrückt. Aktuelle klinische Daten deuten auf Gewichtsverlust-Effekte hin, die vergleichbar oder besser sind als bei einmal wöchentlich verabreichten Multi-Ziel-GLP-1-Formulierungen.
- FDA clearance received for Phase 2 clinical trial
- First bi-weekly GLP-1 mono-agonist formulation in development
- Preliminary data shows comparable or better weight loss effects than existing weekly formulations
- Early-stage development (Phase 2) indicates long path to potential commercialization
- Will face strong competition from established products like Tirzepatide (LLY)
Insights
The FDA clearance for GZR18's Phase 2 trial represents a significant development in the competitive GLP-1 landscape. This bi-weekly formulation's head-to-head trial against Tirzepatide (Eli Lilly's blockbuster drug) could potentially disrupt the current market dynamics. Early clinical data suggesting comparable or superior weight loss effects to existing weekly GLP-1s is particularly noteworthy, as it could indicate a meaningful therapeutic advancement. The bi-weekly administration schedule could offer a significant competitive advantage, potentially improving patient compliance while reducing the frequency of injections by 50% compared to weekly formulations. However, the trial must demonstrate both superior efficacy and safety to compete with established players in this
This development poses a potential competitive threat to Eli Lilly's dominant position in the GLP-1 market. While Gan & Lee's Phase 2 trial announcement doesn't immediately impact LLY's market position, successful trial results could eventually challenge LLY's Mounjaro/Zepbound franchise. The
According to the latest data released by the World Obesity Federation (WOF) Global Obesity Report (2024), approximately 2.2 billion adults worldwide were overweight (referring to BMI ≥ 25kg/m2) in 2020, accounting for about
GZR18, as a GLP-1 receptor agonist, can delay gastric emptying by activating GLP-1 receptors expressed on the gastrointestinal tract; and enhance satiety and suppress appetite by activating GLP-1 receptors in the hypothalamus and other parts, thereby reducing the patient's weight. GZR18 injection is the first bi-weekly GLP-1 mono-agonist formulation. Current clinical data has demonstrated weight loss effects comparable to or even better than multi-target once-weekly GLP-1 formulations, providing new insights for the future development of GLP-1 drugs. The development of the bi-weekly GZR18 injection is expected to offer more flexible treatment options for obese patients , leading to improved long-term weight management efficacy and adherence.
About GZR18
GZR18 is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (RA) being developed by Gan & Lee Pharmaceuticals. The indications currently under development are type 2 diabetes and chronic weight management for obese or overweight patients. Clinical data shows that administering GZR18 injection once a week and every two weeks can achieve good hypoglycemic or weight loss effects2.
References:
1. World Obesity Alliance 2024 World Obesity Report [EB/OL].
2. LINONG JI, WEI CHEN, RUIHUA DONG, MINGXIA YUAN, DONG ZHAO, SHUGUANG PANG, LIYUAN ZHAO, JING ZHAO, ZHONG-RU GAN; 1858-LB: A Novel GLP-1 Analog, GZR18, Induced an
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™), fast-acting aspart injection (Rapilin®), mixed protamine zinc lispro injection (25R) (Prandilin™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 first among all selected 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)
info.medical@ganlee.com (Medical Information)
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FAQ
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