Soochow Securities Maintains "Buy" Rating on ASCLETIS-B (01672): ASC30 Expected to Launch Quarterly Formulation

Stock News
09/10

Soochow Securities issued a research report stating that ASCLETIS-B (01672) has made smooth progress across its pipeline in 2025, meeting the firm's expectations. The timeline for future clinical data disclosure is relatively clear, and the firm believes the probability of successful market launch is high. The firm maintains its revenue forecasts for 2025-2027 at 0.02/0.64/2.03 billion yuan and reiterates its "Buy" rating.

On September 9, the company announced that its small molecule GLP-1R agonist ASC30, formulated as an ultra-long-acting subcutaneous depot for weight maintenance, demonstrated a 75-day apparent half-life in obese subjects. This indicates that ASC30 has the potential to develop into a long-term weight management maintenance solution with quarterly dosing cycles.

Soochow Securities' main viewpoints are as follows:

**ASC30 Injectable Shows Promising Half-Life, Making Quarterly Formulation Possible**

In previous Phase Ib clinical trials, ASC30's ultra-long-acting subcutaneous depot formulation for weight maintenance showed a 75-day apparent half-life following a single 100mg subcutaneous injection in obese subjects (BMI ≥ 30 kg/m²), with peak plasma concentration reached 17 days after the single 100mg injection. Long-term weight management remains a significant unmet clinical need, and a longer-acting quarterly dosing regimen would provide patients with a weight maintenance solution after achieving target weight.

**Excellent Safety Data and Tolerability Support Long-Term Use**

No serious adverse events (SAEs) were reported in ASC30's Phase Ib clinical study, nor were any Grade 3 or higher adverse events (AEs) observed. Among obese subjects treated with 100mg ASC30, GI-related AEs were minimal and only Grade 1. No elevation in liver enzymes (including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBL)) was observed. The excellent tolerability enables the possibility of higher dosing for ASC30. The company is currently evaluating clinical trial design (including ASC30 weight maintenance dose selection) and communicating with regulatory agencies.

**ULAP Long-Acting Platform Enables Diversified Subcutaneous Injectable Formulations**

ASC30's weight maintenance formulation was developed using Ascletis' Ultra-Long-Acting Platform (ULAP). The company has multiple pipeline programs utilizing this platform to develop long-acting formulations, potentially meeting various clinical needs. The formulation currently being used in the ongoing Phase IIa subcutaneous injection clinical trial of ASC30 in the United States has already incorporated this technology.

Based on the characteristics of small molecules, peptides, and proteins/antibodies, the company designs various release constants (k) for subcutaneous depot drugs through ULAP technology, achieving precise controlled release of subcutaneous injection drugs within preset dosing intervals, reducing peak-to-trough plasma concentration ratios, and improving clinical efficacy. Future development may include combination formulation pipelines based on this platform for ASC47 with ASC30 or other GLP-1 drugs.

**Multiple Catalysts Expected in Second Half, Several Important Clinical Data Readouts Imminent**

Based on clinical trial progress and company announcements, the firm expects Phase II topline data for oral ASC30, Phase I data for ASC47, and Phase I data for ASC50 to be released in Q4 2025, with Phase II topline data for subcutaneous ASC30 expected in Q1 2026. The company also expects to submit IND applications for 2-3 new pipeline programs to the FDA within the next 6-9 months, including dual-target peptide weight loss programs.

**Risk Factors:** New drug development and approval progress may fall short of expectations; drug sales may underperform expectations; intensified product competition landscape; uncertainty in drug approval policies.

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