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2024 ADA | HANSOH PHARMA RELEASED THE PHASE II CLINICAL STUDY DATA OF THE NOVEL DUAL GIP AND GLP-1 RECEPTOR AGONIST
Release Date：2024/07/03
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The 2024 ADA Meeting was held in Orlando, USA, from June 21st to 24th, this year. Hansoh Pharma's HS-20094 (a novel Dual GIP and GLP-1 Receptor Agonist) Phase II clinical Study Data were presented in the form of a poster + e-poster live Q&A at the conference.


The American Diabetes Association (ADA) Meeting is one of the largest and most prestigious diabetes academic conferences in the world, attracting over 10,000 participants from around the globe each year, including physicians, clinicians, nurses, and researchers. The conference provides attendees with opportunities to interact and exchange views with diabetes experts, as well as keep up with the latest advancements in diabetes research, treatment, and care.


Recent reports indicate that around 537 million adults worldwide (aged 20-79) had diabetes in 2021 (about 1 in 10 people), and it is estimated that this number may rise to 643 million by 2030 and to 783 million by 2045. During this period, the world population is projected to grow by 20%, while the number of diabetes patients is expected to increase by 46%[1]. The prevalence of type 2 diabetes in China also shows an increasing trend year by year. The prevalence rate had climbed up to 11.2% during the period from 2015 to 2017, with type 2 diabetes accounting for over 90% of the total morbidity population[2], demonstrating a significant unmet clinical need.


HS-20094, independently developed by Hansoh Pharma, is a novel Dual GIP and GLP-1 Receptor Agonist. It promotes insulin secretion, slows gastric emptying, and suppresses appetite to reduce food intake, thereby exerting biological effects such as glycemic control, weight loss, and metabolic improvement. The drug is administered subcutaneously once a week.

 

The recently published Phase II study results of HS-20094 demonstrate that HS-20094 exhibits excellent safety and tolerability profiles in type 2 diabetes patients, along with superior glucose-lowering and weight-loss effects.


Study Profile


Safety and Efficacy of HS-20094 in Patients with Type 2 Diabetes: A Randomized, Double-blind, Placebo-controlled, Phase 2 Study


Poster number：733-P

STUDY DESIGN

• This was a randomized, double-blind, placebo-controlled, active referenced trial (NCT06118008).

• In this phase 2 study, we further explored the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-20094 in patients with type 2 diabetes mellitus (T2DM).

• were enrolled and randomized at 4：1：1 to double-blind HS-20094 (5 mg, 10 mg or 15 mg), placebo and open-label semaglutide (1.0 mg) once-weekly with rapid titration methods.

• Administration: Injection was given subcutaneously once a week for 4 weeks.


RESULTS


Participants

A total of 54 participants received at least one dose, including 36, 9, and 9 in the HS-20094 group, semaglutide group, and placebo group, respectively.


Safety

•  HS-20094 was well-tolerated in patients with T2DM.Most (98%) adverse events (AEs) reported were mild or moderate. The most common AEs were gastrointestinal AEs,with no apparent dose-dependency observed (Table 1).One SAE unrelated to the study drug occurred in HS-20094 5mg group; No SAE occurred in HS-20094 10mg group, HS-20094 15mg group, placebo group and Semaglutide group during the study.

• No drug-related serious AEs, no AEs leading to discontinuation,no death, and no severe hypoglycemia events were reported.


PK Profile

• After a 4-week period of titrated administration：The median Tmax was between 16h and 24h.

• The geometric mean of t1/2 was estimated to be between 142h and 168h.

•Exposure (Cmax and AUC) increased in an approximately dose-proportionally manner.


PD (Blood Glucose Lowering)

• OGTT Glucose AUC0-2h on Day 23 was significantly decreased with HS-20094 compared with placebo, in a dose-dependent manner. On Day23, insulin AUC0-2h and C-peptide AUC0-2h were significantly increased by all doses of HS-20094 treatment compared with placebo. HS-20094 15 mg showed statistically greater reduction than semaglutide 1.0 mg .

• A significant decrease in HbA1c was observed on Day 29 in all HS-20094 dose groups and semaglutide group compared to placebo.


PD (Weight Loss)

• Mean body weight reduced in a dose-dependent manner in the HS-20094 dose groups, with up to 4.8% of weight loss in the 15 mg group.

• The change from baseline was statistically greater with HS- 20094 15 mg compared with semaglutide 1.0 mg.


CONCLUSION


The above data showed that each dose of HS-20094 was significantly better than that of the placebo group in terms of glucose reduction and weight loss.More data for the comparison of HS-20094 and semaglutide will be published later.


At present, Hansoh Pharma has initiated and accelerated a further study of HS-20094 in patients with type 2 diabetes, and overweight/obesity in China. It is hoped that the drug will bring benefits to these patients.


About Hansoh Pharma

Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).

Statements

1. This announcement is intended for healthcare professionals only and not for advertising purposes.2. Hansoh Pharma does not recommend the use of any unapproved drugs or off-label indications, nor does it make recommendations regarding any drug or indication.3. The information provided in this announcement is for reference only; please follow the advice or guidance of a physician or other healthcare professional. Any treatment-related decisions made by healthcare professionals should be based on the specific circumstances of the patient and should be used in accordance with the instructions for the drug.4. For more detailed information about any company products, medical treatments, or diseases, please consult a healthcare professional.

Forward-Looking Statements

This press release is intended to provide information about Hansoh Pharmaceutical Group Co., Ltd. and its affiliates, including their subsidiaries (collectively referred to as "Hansoh Pharma"). It does not constitute a disclosure of information about Hansoh Pharma or any investment recommendations.The information contained in this release may include forward-looking statements related to Hansoh Pharma's business and product prospects, as well as its plans, beliefs, expectations, and strategies. These statements are predictions based on speculative assumptions and are not guarantees of future performance. They are subject to risks and uncertainties, such as scientific, commercial, political, economic, financial, legal factors as well as competitive environment and social conditions, many of which are beyond Hansoh Pharma's control and difficult to predict, thus actual results may differ significantly from what is stated here, and past securities price trends should not be used as a guide for future market conditions. As such, investors should exercise caution when using this information to make investment decisions. Phrases such as "commit," "expect," "believe," "predict," "anticipate," "forecast," "intent,"“project,” “may,” “will,” “should,” “plan,” “could,” “continue,” “target,” “contemplate,” “estimate,” “guidance,” “possible,” “potential,” “pursue,”“likely,”and words and terms of similar terms substance used in connection with any discussion of future plans, actions or events indicate forward-looking statements.Hansoh Pharma does not commit to or guarantee the accuracy, timeliness, or completeness of forward-looking information and assumes no obligation to update or revise these forward-looking statements. Neither Hansoh Pharma nor any of its directors, employees, or agents will be responsible for any forward-looking statements that prove to be inaccurate or unachievable and any losses or damages incurred by users due to reliance on the information provided herein, including but not limited to direct, incidental, indirect, or punitive damages.All information in this press release is current as of the date of release. Hansoh Pharma assumes no responsibility to update or revise this information in light of new developments, future events, or other circumstances, except as required by law. Additionally, Hansoh Pharma reserves the right to make changes, corrections, or discontinuations to all or part of the content of this press release at any time without notice. For information specifically related to the listed company, investors are encouraged to refer to the announcements and financial reports of Hansoh Pharma (03692.HK).