Why investors are watching Ascletis Pharma’s monthly obesity shot as a potential GLP-1 disruptor

Ascletis Pharma Inc. (HKEX: 1672) has announced the co-formulation of ASC36 and ASC35, two novel once-monthly subcutaneous peptide therapies, as part of its broader push to reshape the global obesity treatment landscape. The move represents a significant milestone for the Hong Kong-listed biotechnology company, which is leveraging its proprietary Ultra-Long-Acting Platform and Artificial Intelligence-Assisted Structure-Based Drug Discovery technologies to create advanced weight management therapeutics.

ASC36 is a next-generation amylin receptor agonist, while ASC35 is a dual GLP-1R and GIPR agonist. Both compounds are administered via monthly subcutaneous injection and were designed in-house. By combining these agents into a single ultra-long-acting formulation, Ascletis Pharma aims to deliver enhanced weight loss efficacy compared to monotherapy regimens or competing drug combinations currently under development or on the market. The company stated that it plans to submit an Investigational New Drug application to the United States Food and Drug Administration in the second quarter of 2026 to advance the ASC36–ASC35 combination into clinical development.

How did the dual formulation perform in head-to-head preclinical studies?

Ascletis Pharma reported encouraging results from preclinical studies involving diet-induced obese rodents and non-human primates. In these studies, the co-formulation of ASC36 and ASC35 demonstrated pharmacokinetic profiles comparable to their respective monotherapy regimens, supporting the feasibility of monthly subcutaneous administration.

In diet-induced obese rats, ASC36 monotherapy achieved a 9.6 percent reduction in body weight over a seven-day treatment cycle, outperforming eloralintide, which achieved a 7.3 percent reduction. This represented a 32 percent relative improvement in weight loss efficacy. Meanwhile, ASC35 monotherapy demonstrated approximately 71 percent greater relative body weight reduction versus tirzepatide in a separate mouse model.

Notably, the combination of ASC36 and ASC35 outperformed the combination of eloralintide and tirzepatide, delivering a 14.5 percent reduction in body weight. This translated to a 51 percent greater weight loss compared to the eloralintide–tirzepatide group, and nearly 99 percent higher than eloralintide monotherapy. These statistically significant improvements in weight reduction were observed within a short seven-day treatment window, underscoring the potency of the dual agent strategy.

The co-formulation also displayed robust chemical and physical stability, with no aggregation or precipitation under neutral pH conditions. This is a crucial development consideration, as many amylin receptor agonists are known to aggregate or form fibrils, which can lead to loss of drug potency, device clogging, increased turbidity, and elevated immunogenicity risk.

What platform technologies support the development of once-monthly peptide therapies?

Ascletis Pharma has built its pipeline on two core proprietary technologies. The first is its Artificial Intelligence-Assisted Structure-Based Drug Discovery platform, which allows the optimization of peptide and small molecule candidates for selectivity, stability, and bioavailability. The second is the Ultra-Long-Acting Platform, which enables the design of subcutaneous depot formulations with tailored release kinetics.

By engineering peptides to release slowly over extended periods, Ascletis Pharma can reduce the peak-to-trough ratio seen with many traditional injectables. This approach supports more consistent plasma levels and may reduce adverse events, while also improving patient adherence. In the case of ASC36 and ASC35, the Ultra-Long-Acting Platform has enabled a once-monthly dosing profile, which compares favorably to currently available therapies requiring weekly or more frequent administration.

The biotechnology firm also confirmed that ASC36 is being positioned as the cornerstone agent in its broader cardio-metabolic disease strategy. Beyond the current co-formulation with ASC35, the company is also evaluating ASC47, an adipose-targeted thyroid hormone receptor beta agonist, for potential future combinations.

How is Ascletis Pharma positioning itself in the competitive obesity treatment market?

With global attention focused on the commercial success of GLP-1-based therapies such as semaglutide and tirzepatide, Ascletis Pharma is positioning itself as a second-generation innovator in the obesity space. Analysts covering the obesity therapeutics market have noted that the convenience of once-monthly dosing and the potential for combination efficacy could give Ascletis Pharma an edge in emerging markets and long-term maintenance therapy strategies.

Unlike established players such as Novo Nordisk and Eli Lilly, Ascletis Pharma has adopted a modular approach to peptide formulation. This allows it to rapidly design and combine agents with distinct but complementary mechanisms of action, enhancing both efficacy and metabolic impact. The company’s experience in peptide chemistry, together with its integrated discovery-to-commercialization model, supports rapid progression from bench to clinic.

Its lead program, ASC30, a small molecule GLP-1R agonist, is also under development in once-daily oral and monthly-to-quarterly injectable formats, showcasing the company’s focus on flexible and patient-friendly treatment modalities.

What is the clinical and regulatory roadmap for the ASC36–ASC35 combination?

Ascletis Pharma has announced plans to file an Investigational New Drug application with the United States Food and Drug Administration in the second quarter of 2026. The filing will mark the formal transition of the ASC36–ASC35 combination into clinical development for obesity and potentially related cardio-metabolic disorders.

The company also hosted a conference call in Mandarin on November 13, 2025, to discuss the preclinical results and strategic roadmap. During the call, Ascletis Pharma emphasized its commitment to leveraging ULAP-enabled peptides across multiple indications and combination strategies.

Although human trials have not yet commenced, the strong preclinical signals have drawn early attention from institutional observers who are closely monitoring next-generation obesity treatment pipelines. Future updates may include additional animal model results, IND-enabling studies, and possible partnership discussions with multinational pharmaceutical companies interested in co-developing the ASC36–ASC35 combination for global markets.

How are investors reacting to Ascletis Pharma’s obesity pipeline momentum?

Ascletis Pharma Inc. is listed on the Hong Kong Stock Exchange under the ticker 1672.HK. The company’s obesity pipeline has attracted growing interest in recent quarters as market momentum builds around GLP-1 agonists and related classes. While share price activity has remained modestly volatile, investor sentiment has gradually strengthened following major pipeline disclosures.

Some institutional investors are viewing Ascletis Pharma’s once-monthly platform as a differentiated play in the metabolic disease category, particularly as concerns mount over long-term adherence and cost-effectiveness of current blockbuster treatments. Ascletis Pharma’s ability to show statistically significant weight loss advantages over eloralintide and tirzepatide in short-duration studies has added credibility to its dual-agent strategy.

Analysts expect investor attention to intensify in the lead-up to the 2026 IND submission. The company’s continued transparency around its pipeline progress, including potential developments with ASC47 and other ULAP-enabled peptides, will likely shape investor confidence over the next 12 to 18 months.

What are the most important highlights from Ascletis Pharma’s next‑generation once‑monthly obesity therapy announcement?

• Ascletis Pharma Inc. has announced the co-formulation of ASC36, an amylin receptor agonist, and ASC35, a GLP-1R/GIPR dual agonist, into a once-monthly subcutaneous therapy for obesity.

• The co-formulation demonstrated a 14.5% body weight reduction in diet-induced obese rats, showing a 51% improvement over the eloralintide and tirzepatide combination.

• ASC36 alone achieved 32% greater weight loss than eloralintide, while ASC35 outperformed tirzepatide by 71% in separate monotherapy studies.

• Preclinical pharmacokinetic data in non-human primates showed the co-formulated therapy matched the individual dosing profiles of ASC36 and ASC35.

• The formulation exhibited excellent chemical and physical stability at neutral pH, avoiding common issues like aggregation and fibrillation linked to amylin-based therapies.

• Ascletis Pharma plans to submit an Investigational New Drug application to the United States Food and Drug Administration in Q2 2026.

• The therapy was developed using Ascletis Pharma’s proprietary Ultra-Long-Acting Platform and Artificial Intelligence-Assisted Structure-Based Drug Discovery technologies.

• The ASC36–ASC35 combination is part of a broader pipeline strategy that includes additional once-monthly or once-quarterly agents like ASC30 and ASC47.

• Analysts believe the once-monthly platform could be a second-generation contender in the global obesity treatment market, offering improved adherence and efficacy.

• Ascletis Pharma (HKEX: 1672) is gaining institutional attention as it prepares to scale its ultra-long-acting peptide programs for cardio-metabolic diseases.