Adults taking Mounjaro in a clinical trial lost on average 48 lb. at the highest dose1,2

Mounjaro delivered superior A1C reductions versus all comparators in phase 3 SURPASS clinical trials6-12

Mounjaro represents a new class of obesity and diabetes medicines and is expected to be available in Hong Kong as early as the end of this year

HONG KONG,Oct. 28,2024 --Hong Kong's Department of Health approved Eli Lilly Asia,Inc.'s Mounjaro® (tirzepatide) in KwikPen® presentation,the first and only obesity and type 2 diabetes treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors.1

Mounjaro is indicated for adults with obesity (with a BMI of 30 kg/m2or greater),or those who are overweight (with a BMI of 27 kg/m2or greater) and also have weight-related medical problems such as hypertension,dyslipidemia,type 2 diabetes mellitus,obstructive sleep apnea or cardiovascular disease,to lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.Mounjaro is alsoindicated as an adjunct to diet and exercise to improve glycemic control in adults with insufficiently controlled type 2 diabetes mellitus as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsor in addition to other medicinal products for the treatment of diabetes.1

Obesity and diabetes are chronic diseases that can result in serious health complications,including heart disease,hypertension and stroke 3,4.As the first and only Hong Kong-approved,once-weekly GIP and GLP-1 receptor agonist,Mounjaro is a single molecule that activates the body's receptors for GIP and GLP-1,which are natural incretin hormones.

The approval was based on results from the phase 3 SURMOUNT and SURPASS trials. In SURMOUNT-1,a study in 2,539 adults with obesity,or excess weight and weight-related medical problems not including diabetes,people taking Mounjaro as an adjunct to diet and exercise experienced substantial weight loss compared with placebo at 72 weeks. At the highest dose (15 mg),people taking Mounjaro lost on average 48 lb.,while at the lowest dose (5 mg),people lost on average 34 lb. (compared to 7 lb. on placebo).1,2

Additionally,1 in 3 patients taking Mounjaro at the highest dose lost over 58 lb. (25% of body weight),compared to 1.5% on placebo,according to data not controlled for type 1 error.1,2

In phase 3 SURPASS program,efficacy was evaluated for Mounjaro5 mg,10 mg and 15 mg used alone or in combination with commonly prescribed diabetes medications,including metformin,SGLT2 inhibitors,sulfonylureas and insulin glargine. Participants in the SURPASS program achieved average A1C reductions between 1.8% and 2.1% for Mounjaro 5 mg and between 1.7% and 2.4% for both Mounjaro 10 mg and Mounjaro 15 mg.6-12

"Mounjaro delivered superior and consistent A1C reductions against all of the comparators throughout the SURPASS program,which was designed to assess Mounjaro's efficacy and safety in a broad range of adults with type 2 diabetes who could be treated in clinical practice," said Juan Pablo Frías,M.D.,Medical Director,National Research Instituteand Investigator in the SURPASS program.

Side effects reported in at least 5% of patients treated with Mounjaro include nausea,diarrhea,decreased appetite,vomiting,constipation,indigestion (dyspepsia),and stomach (abdominal) pain. In studies,most nausea,diarrhea and vomiting occurred when people increased their dose – but the effects generally decreased over time.6-12

According to the Department of Health's Population Health Survey 2020-2022,32.6% of persons aged 15-84 in Hong Kong had obesity (i.e. BMI ≥ 25.0 kg/m2) and another 22.0% were overweight (i.e. 23.0 kg/m2≤ BMI < 25.0 kg/m2)13,while around 1 in 10 people live with type 2 diabetes.14

Yuko Mizuma,General Manager,Hong Kong & Macau,Eli Lilly Asia,Inc. stated: "Obesity and type 2 diabetes are chronic diseases that affect a significant number of Hong Kong citizens and put them at increased risk of over 200 health complications." 3-5

"Approval of Mounjaro,an innovative medical treatment,is an exciting news and Lilly is committed to tackling obesity and diabetes together with Hong Kong citizens."

Mounjaro is approved in Hong Kong in six doses (2.5 mg,5 mg,7.5 mg,10 mg,12.5 mg,15 mg) and will come inLilly's KwikPen. A multi-dose,pre-filled pen first launched by Lilly in 2008,the KwikPen is already used to deliver different Lilly diabetes medicines for patients around the world. Mounjaro is expected to be available in Hong Kong as early as the end of this year.

About Mounjaro

Mounjaro is used in addition to diet and exercise for the treatment of insufficiently controlled type 2 diabetes,and for chronic weight management in people living with obesity (BMI ≥30) or overweight (BMI ≥27) with a related health condition (such as high blood pressure,high cholesterol,heart disease,prediabetes or sleep apnoea).1

Mounjaro works to mimic two hormones which regulate blood sugar levels and satiety.1

It belongs to a class of medicines called incretins and is injected under the skin once a week.Mounjaro is available in six doses. The recommended starting dose is 2.5mg once a week for four weeks.1

As with all medicines,Mounjaro may be associated with some side-effects. The most commonly occurring side effects can include an upset stomach,injection site-related side effects,and low blood sugar.1

Issued by Sandpiper on behalf of Eli Lilly Asia,Inc.

References:

1. Mounjaro. Prescribing Information. Eli Lilly Asia,Inc.

2. Jastreboff AM,Aronne LJ,Ahmad NN,et al; SURMOUNT-1 Investigators.Tirzepatide Once Weekly for the Treatment of Obesity.N Engl J Med. 2022;387(3):205-216.

3. Horn DB,et al. Postgrad Med. 2022;134(4):359-375

4. Fitch AK,et al. Obes Pillars. 2022;15:1:100004

5. Yuen MMA. Health complications of obesity: 224 obesity-associated comorbidities from a mechanistic perspective. Gastroenterol Clin N Am 2023;52(2):363–80. 10.1016/j.gtc.2023.03.006.

6. Rosenstock,J,et. al. Efficacy and Safety of Once Weekly Tirzepatide,a Dual GIP/GLP-1 Receptor Agonist Versus Placebo as Monotherapy in People with Type 2 Diabetes (SURPASS-1). Abstract 100-OR. Presented virtually at the American Diabetes Association's 81st Scientific Sessions; June 25-29.

7. Rosenstock,et. al. (2021). Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind,randomised,phase 3 trial. Lancet. 2021;398(10295):143-155. doi: 10.1016/S0140-6736(21)01324-6.

8. Frías JP,Davies MJ,Rosenstock J,et al; for the SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6)(suppl):503-515. doi: 10.1056/NEJMoa2107519

9. Frias,J.P. Efficacy and Safety of Tirzepatide vs. Semaglutide Once Weekly as Add-On Therapy to Metformin in Patients with Type 2 Diabetes. Abstract 84-LB. Presented virtually at the American Diabetes Association's 81st Scientific Sessions; June 25-29.

10.Ludvik B,Giorgino F,Jódar E,et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised,open-label,parallel-group,phase 3 trial. Lancet. 2021;398(10300):583-598. doi: 10.1016/S0140-6736(21)01443-4

11.Del Prato S,Kahn SE,Pavo I,et al; for the SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised,multicentre,phase 3 trial. Lancet. 2021;398(10313):1811-1824. doi: 10.1016/S0140-6736(21)02188-7

12.Dahl D,Onishi Y,Norwood P,et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545. doi:10.1001/jama.2022.0078

13.Population Health Survey 2020-22,Department of Health

14.Hong Kong Reference Framework,Diabetes Care for Adults in Primary Care Settings,Revised Edition 2023

About Lilly

Lilly is a medicine company making life better for people around the world. We've turned science into pioneering new discoveries for nearly 150 years,and today our medicines support more than 51 million people across the globe. Harnessing the power of biotechnology,chemistry and genetic medicine,our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: treating obesity,redefining diabetes and obesity care; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and targeting the most difficult-to-treat cancers. With each step towards a healthier world,we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more,visitHome | Lilly Hong Kong.