HD1916 (semaglutide biosimilar) / CSPC Pharma - LARVOL DELTA

…CSPC Pharmaceutical Group Limited…is pleased to announce that the second marketing authorisation application for Semaglutide Injection (the ‘‘Product’’) developed by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd., a subsidiary of the Company, has been accepted by the National Medical Products Administration (the ‘‘NMPA’’) of the People’s Republic of China (CSPC Press Release) - "The indication for this application is long-term weight management in overweight adults or obese patients, in conjunction with diet control and increased physical activity....This application is based on a Phase III clinical trial."

China filing • Obesity

Efficacy and Safety of Semaglutide Injection (HD1916) in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=506 | Completed | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Feb 2026 ➔ May 2025 | Trial primary completion date: Aug 2025 ➔ May 2025

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Semaglutide in Treatment of Obesity (clinicaltrials.gov) - P3 | N=462 | Active, not recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Behind BCVI: Encouraging Results From the STEP-HFpEF-DM Trial (YouTube) - "... interviews Sanjiv J. Shah, MD, on the groundbreaking results from the recent STEP-HFpEF-DM trial, including semaglutide use leading to over 70% reduction in heart failure hospitalization in patients with heart failure with preserved ejection fracture. Dr. Shah discusses the implications of these promising results and the future of using weight loss drugs to treat cardiovascular disease."

Interview • Video

Semaglutide in Treatment of Obesity (clinicaltrials.gov) - P3 | N=458 | Not yet recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

New P3 trial • Genetic Disorders • Obesity