On September 24, 2024, Newland Pharmaceutical Co., Ltd. (hereinafter referred to as "the Company") received the Approval Notices for the Marketing Application of Chemical Active Pharmaceutical Ingredients for Esomeprazole Sodium and Tadalafil, approved and issued by the National Medical Products Administration (NMPA).

  Drug Introduction

  Esomeprazole Sodium is a proton pump inhibitor. By inhibiting the H⁺/K⁺-ATPase of gastric parietal cells, it suppresses both basal and stimulated gastric acid secretion. It is indicated for gastroesophageal reflux disease, gastric ulcer and duodenal ulcer caused by excessive gastric acid secretion, and can also be combined with antibacterial agents for the treatment of Helicobacter pylori infection of the stomach, showing remarkable efficacy in the treatment of gastric acid-related diseases.

  Tadalafil is a phosphodiesterase inhibitor. By inhibiting PDE5 on vascular smooth muscle, it increases the level of cyclic guanosine monophosphate (cGMP) in the body, demonstrating significant efficacy in the treatment of male erectile dysfunction. As it also exerts a vasodilatory effect on the cardiovascular system and pulmonary arteries, it can additionally be used in the treatment of pulmonary arterial hypertension.

  The Company has obtained the Approval Notices for Esomeprazole Sodium and Tadalafil, with their statuses shown as "A" on the CDE registration platform for APIs, excipients and packaging materials.

  Impact on the Company

  The Approval Notices for Esomeprazole Sodium and Tadalafil obtained by the Company confirm that these APIs comply with the relevant Chinese drug review and technical standards and are approved for use in formulations marketed in China. The approvals will further enrich the Company's product portfolio.