Ascletis Announces ASC37 Once-Monthly Triple Peptide Agonist Shows Superior Weight Loss vs Tirzepatide in Obese Mouse Model

Ascletis Pharma Announces Breakthrough Preclinical Results for ASC37 Triple Peptide Agonist

Ascletis Pharma Unveils Promising Preclinical Data for Once-Monthly ASC37 Triple Peptide Agonist

Key Highlights

ASC37, a next-generation GLP-1R/GIPR/GCGR triple peptide agonist, has demonstrated significantly superior weight loss compared to tirzepatide in a diet-induced obese (DIO) mouse model.
ASC37 achieved 88% greater relative body weight reduction than tirzepatide at the same dose (1 nmol/kg), with dose-dependent effects reaching up to 41.5% weight loss.
Both subcutaneous (SQ) once-monthly and oral formulations of ASC37 are planned for U.S. FDA submission via Biologics License Applications (BLA) following Phase III completion.
ASC37’s SALD formulation exhibited a 7-fold longer half-life than retatrutide in non-human primate studies, supporting once-monthly or less frequent dosing.
ASC37’s qualification as a biologic provides extended statutory exclusivity (13 years post-approval), enhanced protection from government price negotiation, and immunity from pharmacy compounding.

Detailed Report

Ascletis Pharma Inc. has announced a significant advancement in its obesity drug pipeline, reporting robust preclinical results for its triple peptide agonist, ASC37. In a voluntary disclosure aimed at keeping shareholders and potential investors informed, the company revealed that ASC37—targeting GLP-1R, GIPR, and GCGR receptors—surpassed tirzepatide (a leading obesity drug) in weight loss efficacy in diet-induced obese (DIO) mice.

Preclinical Results

ASC37 delivered a statistically significant 88% greater weight reduction compared to tirzepatide (1 nmol/kg, SQ, QD), with a p-value of 0.0279 confirming significance.
At higher doses, ASC37’s impact increased dramatically, with up to 41.5% total body weight loss at 30 nmol/kg (p < 0.0001 versus tirzepatide).
The effect was dose-dependent, underscoring the potential for tailored treatment regimens.

Regulatory Pathway and Market Exclusivity

ASC37 is engineered with 41 alpha amino acids, qualifying it as a biologic for regulatory purposes.
Both once-monthly SQ and oral formulations are scheduled for FDA submission via BLA, with IND applications planned for Q3 2026.
Biologics benefit from a 13-year exemption from government price negotiation (vs. 9 years for small molecules), per the Inflation Reduction Act.
No regulatory pathway exists for third-party pharmacy compounding of biologics, protecting ASC37 from generic competition by compounding pharmacies.

Competitive Advantage

Compared to retatrutide (another triple peptide agonist in development), ASC37’s SALD formulation offers a substantially longer half-life (17 days vs 2.5 days), supporting once-monthly dosing and potentially improved patient compliance.
ASC35, a dual peptide agonist with similar molecular structure, will also be submitted as a BLA.

Management Commentary

Jinzi Jason Wu, Ph.D., Founder, Chairman, and CEO of Ascletis, highlighted the strong preclinical results and regulatory advantages, stating that ASC37 could become a first-in-class once-monthly triple peptide agonist for severe obesity. The biologics pathway offers strategic benefits, including longer exclusivity and protection from price controls and compounding threats.

Potential Impact for Shareholders

ASC37’s superior efficacy and unique dosing profile may position it as a leading obesity therapy candidate, potentially accelerating commercial success and market share.
The extended exclusivity period and regulatory protections could translate to sustained revenue streams and pricing power post-launch.
Upcoming IND and BLA milestones (starting Q3 2026) will be critical events for investor monitoring.
Any positive clinical developments or regulatory progress could be highly price sensitive and impact the company’s share value.

Cautionary Statement

Ascletis Pharma cautions that there is no guarantee of successful development, manufacturing, or commercialization of ASC37 and/or ASC35. Preclinical results are not necessarily indicative of clinical outcomes. Investors should consider the inherent risks of pharmaceutical development.

亞盛醫藥公布ASC37三重肽激動劑突破性前臨床結果

亞盛醫藥披露ASC37三重肽激動劑一個月一次注射突破性前臨床數據

報告重點

ASC37（新一代GLP-1R/GIPR/GCGR三重肽激動劑）在飲食誘導肥胖（DIO）小鼠模型中，減重效果顯著優於司美格魯肽（tirzepatide）。
ASC37於相同劑量（1 nmol/kg）下，比司美格魯肽高出88%減重效果，最高可達41.5%減重（隨劑量遞增）。
ASC37每月一次皮下注射（SQ）及口服配方，均預計以生物製劑許可申請（BLA）方式向美國FDA提交。
ASC37注射型式（SALD）在非人靈長類中半衰期為17天，遠高於retatrutide（2.5天），支持每月一次或更少的給藥頻率。
ASC37作為生物製劑，享有更長獨佔期（FDA批准後13年），並受價格談判保護及免於藥房配製競爭。

詳細報導

亞盛醫藥有限公司宣布其肥胖藥物管線取得重大進展，ASC37三重肽激動劑前臨床數據表現強勁。公司自願披露，ASC37（靶向GLP-1R、GIPR和GCGR受體）在飲食誘導肥胖小鼠中減重效果超越現有領先藥物司美格魯肽。

前臨床結果

ASC37在1 nmol/kg皮下注射（SQ，QD）下，減重幅度較司美格魯肽高88%，統計顯著（p=0.0279）。
高劑量下，ASC37效果更明顯，最高達41.5%減重（30 nmol/kg，p<0.0001）。
減重效果隨劑量遞增，顯示可針對不同患者量身訂製療程。

監管路徑及市場獨佔

ASC37含41個α氨基酸，符合生物製劑身份規範。
每月一次皮下注射和口服配方，均計劃以BLA方式提交FDA，預計2026年第三季提交IND申請。
生物製劑享有13年價格談判豁免期（小分子僅9年），根據美國《通脹削減法案》。
生物製劑無藥房配製合規渠道，避免第三方低價競爭。

競爭優勢

與retatrutide（三重肽激動劑）相比，ASC37 SALD配方半衰期長7倍（17天 vs 2.5天），利於每月一次給藥與患者依從性。
ASC35（雙肽激動劑）結構相似，也將以BLA方式申請。

管理層評論

創辦人兼董事長CEO吳勁梓博士表示，ASC37有望成為首創每月一次三重肽激動劑治療嚴重肥胖。生物製劑監管路徑帶來更長獨佔期、價格保護及配製競爭屏障，具戰略優勢。

對股東的潛在影響

ASC37減重療效及獨特給藥頻率，或使其成為肥胖治療領先候選藥物，推動商業成功及市場份額。
長獨佔期及監管保護，有望帶來持續收入及定價權。
未來IND及BLA里程碑（2026起）為投資者關注重點。
臨床進展或監管動態均具價格敏感性，或影響公司股價。

風險提示

亞盛醫藥提醒，ASC37及ASC35未必能成功開發、製造或商業化。前臨床結果不代表臨床最終成果。投資者需評估醫藥研發固有風險。