Can Ascletis’ obesity pipeline redefine oral and monthly peptide therapy in 2026?

Ascletis Pharma Inc. (HKEX: 1672) has formally selected ASC37, its first oral GLP-1R/GIPR/GCGR triple peptide agonist, as a clinical development candidate for obesity treatment. The Hong Kong–listed biotechnology company expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration by the second quarter of 2026, following strong preclinical performance powered by its Peptide Oral Transport ENhancement Technology, or POTENT.

The oral formulation of ASC37 demonstrated a bioavailability of 4.2 percent in non-human primate studies, far exceeding comparative levels seen with semaglutide, tirzepatide, and retatrutide when delivered using SNAC-based formulations. According to Ascletis Pharma Inc., ASC37’s area under the curve for drug exposure was 57 times greater than retatrutide, with an observed half-life of 56 hours. These pharmacokinetics support potential once-daily or even less frequent oral dosing.

The announcement follows Ascletis’ earlier disclosure this month of a successful co-formulation of two other once-monthly injectable peptide drug candidates, ASC36 and ASC35. The dual updates show that Ascletis Pharma Inc. is now actively building out a delivery-flexible pipeline aimed at reshaping how obesity and other metabolic conditions are treated over the next decade.

Why the high bioavailability of ASC37 could set a new benchmark for oral peptides

Among the most notable findings from Ascletis Pharma Inc.’s announcement is the sharp leap in oral bioavailability achieved by ASC37. The firm’s proprietary POTENT platform appears to have overcome one of the most difficult problems in peptide drug delivery—efficient absorption across the gastrointestinal tract. While traditional peptides often degrade before systemic circulation, POTENT has enabled a formulation that maintains stability and performance through oral administration.

In comparative studies, ASC37’s bioavailability was approximately nine times greater than semaglutide, thirty times greater than tirzepatide, and sixty times greater than retatrutide, each delivered via SNAC, a commonly used oral absorption enhancer. These improvements were also reflected in overall exposure, where ASC37’s AUC profile significantly outpaced that of oral retatrutide. With an average half-life approaching 56 hours, the compound may allow for reduced dosing frequency while maintaining therapeutic levels.

The preclinical data, generated in non-human primates, builds a compelling case for ASC37’s advancement into human trials. The molecule was developed entirely in-house using the company’s Artificial Intelligence-Assisted Structure-Based Drug Discovery platform, known as AISBDD. Early in vitro activity comparisons also suggested that ASC37 was five times more potent on GLP-1R, four times on GIPR, and four times on GCGR compared to retatrutide.

How the injectable ASC36 and ASC35 combination enhances Ascletis’ long-acting portfolio

Ascletis Pharma Inc.’s second major announcement this month centered on the co-formulation of ASC36 and ASC35, designed for once-monthly subcutaneous injection using the firm’s Ultra-Long-Acting Platform, or ULAP. ASC36 is a next-generation amylin receptor peptide agonist, while ASC35 is a GLP-1R and GIPR dual peptide agonist. Together, they are intended to deliver multi-pathway metabolic regulation in a depot formulation.

In preclinical trials involving diet-induced obese rats, the co-formulated therapy delivered a 14.5 percent reduction in body weight over a 7-day period. This performance was approximately 51 percent greater than a comparable co-formulation of eloralintide and tirzepatide. Each compound also showed strong results as a monotherapy, with ASC36 showing a 32 percent improvement over eloralintide and ASC35 showing 71 percent greater weight reduction compared to tirzepatide in separate rodent models.

The pharmacokinetic profile of the co-formulated ASC36 and ASC35 mirrored that of each compound administered individually, suggesting no compromise in drug behavior due to formulation. Chemical and physical stability also remained intact, with no evidence of aggregation, fibrillation, or precipitation at neutral pH. This is critical, as many long-acting peptide formulations tend to destabilize under physiological conditions, impacting both efficacy and safety.

Ascletis Pharma Inc. intends to submit an IND for the co-formulated ASC36 and ASC35 therapy to the U.S. Food and Drug Administration by the second quarter of 2026, in parallel with ASC37’s regulatory path.

What Ascletis’ platforms reveal about its dual-delivery metabolic strategy

The dual announcements mark a strategic inflection point for Ascletis Pharma Inc., whose evolving obesity portfolio now spans both oral and injectable formats. The firm’s AISBDD, POTENT, and ULAP platforms form a vertically integrated pipeline engine that enables both route flexibility and molecular diversity. With ASC30, ASC35, ASC36, ASC37, and the potentially upcoming ASC47—a targeted thyroid hormone receptor beta agonist—Ascletis Pharma Inc. is rapidly positioning itself as a platform-rich innovator within the obesity and cardio-metabolic therapeutic landscape.

Executives at Ascletis Pharma Inc. suggested that combining high-efficacy monotherapies with advanced co-formulations could lead to differentiated products that are superior to current standard-of-care GLP-1 therapies. CEO Jinzi Jason Wu said the firm’s pipeline is designed to address multiple angles of metabolic disease, noting that both ASC37 and the ASC36/ASC35 combo may offer superior convenience, compliance, and efficacy profiles over single-pathway agents.

The company’s broader vision includes combining peptides with distinct mechanisms, such as amylin receptor targeting and adipose-tissue specific hormone modulation, in ways that could optimize clinical outcomes across different patient subtypes and disease severities.

How investors and analysts are viewing Ascletis’ U.S. regulatory push

Analysts covering the metabolic disease sector noted that the upcoming U.S. IND filings could be pivotal in shifting perception of Ascletis Pharma Inc. from a regional biotech player to a globally competitive innovator. The oral delivery success of ASC37, in particular, could place Ascletis in contention with large-cap players such as Novo Nordisk and Eli Lilly, especially as demand continues to surge for oral and injectable weight loss therapies with improved convenience and tolerability.

However, much will depend on human pharmacokinetic data from the Phase 1 trial of ASC37. Investors are likely to focus on whether the bioavailability seen in non-human primates can translate into similar systemic exposure and efficacy in human subjects. Safety, tolerability, and gastrointestinal side effects will also be key metrics of interest, especially in a market where side effect profiles can impact long-term adherence.

For the monthly injectable ASC36/ASC35 combination, the investor lens will likely zoom in on durability of weight loss, dose linearity, and tolerability across injection cycles. The ability to maintain monthly dosing without triggering immune or formulation-related issues could set a new precedent for once-a-month peptide regimens.

The Hong Kong–listed shares of Ascletis Pharma Inc. (1672.HK) have seen renewed interest following the announcements, with institutional investors now awaiting firm timelines for IND submissions and Phase 1 trial initiations. A successful U.S. regulatory entry could mark a new chapter for the biotechnology firm in the global obesity therapeutics market.

What is the broader market context for Ascletis’ dual-track obesity innovation?

The timing of Ascletis Pharma Inc.’s pipeline acceleration aligns with a rapidly growing market for GLP-1 receptor agonists and their combinations. As global obesity prevalence rises, so does demand for non-invasive, long-acting, and multi-modal therapies. With many patients seeking alternatives to weekly injections or injectable-only options, oral therapies like ASC37 could meet a growing gap in convenience and compliance.

Similarly, once-monthly injectables that combine GLP-1, GIP, and amylin pathways offer the promise of greater therapeutic durability and weight loss efficiency. Companies like Eli Lilly and Novo Nordisk have already validated the GLP-1 and GIP classes, but few players have succeeded in triple or co-formulated agents with long-acting performance and neutral pH stability.

Ascletis Pharma Inc. now finds itself at the intersection of these needs—armed with proprietary delivery technology, multiple optimized compounds, and regulatory momentum. If successful, its dual-track strategy could make it one of the most versatile developers of metabolic disease treatments out of Asia, with global commercialization potential on the horizon.

Key takeaways on Ascletis’ dual obesity drug strategy and upcoming U.S. filings

• Ascletis Pharma Inc. has selected ASC37, its first oral GLP-1R/GIPR/GCGR triple peptide agonist, for clinical development targeting obesity.
• Preclinical studies show ASC37 has up to 60x higher oral bioavailability than leading peptide analogs in SNAC formulations.
• A separate once-monthly injectable co-formulation of ASC36 and ASC35 achieved 14.5% weight loss in obese rats, outperforming tirzepatide combinations.
• Both candidates are expected to enter the U.S. regulatory pathway by Q2 2026.
• Ascletis is leveraging proprietary platforms (AISBDD, POTENT, ULAP) to create differentiated, long-acting, and high-bioavailability therapeutics.
• The Chinese biotechnology firm is positioning itself as a multi-format innovator in the metabolic disease space.