CR Double-Crane subsidiary secures drug registration certificate for hypertension treatment

China Resources Double-Crane Pharmaceutical Co., Ltd. (CR Double-Crane) announced that its wholly-owned subsidiary, China Resources Saike Pharmaceutical Co., Ltd. (CR Saike), has obtained a drug registration certificate from the National Medical Products Administration for Bisoprolol Fumarate and Amlodipine Besilate Tablets. The Class 4 chemical medicine is approved for domestic production and is intended as an alternative therapy for hypertension. The certificate, received on November 18, 2025, signifies the product meets registration requirements and has passed consistency evaluation.

CR Saike initiated the generic drug's research and development in November 2022, submitting its application on June 14, 2024. Total R&D investment for this drug by CR Double-Crane amounts to 10,791,300 yuan. The company anticipates this new registration will enhance its product line and market competitiveness, while also providing valuable experience for future product development.

Globally, the original Bisoprolol and Amlodipine tablets, developed by Merck Kft, were approved in the EU in November 2017 and in China in May 2021 under the brand "Concor AMLO®." Global sales for Bisoprolol and Amlodipine tablets reached $74,049,300 in 2024, with "Concor AMLO®" accounting for $44,294,600. In China, 14 manufacturers, including CR Saike, have received approval for the drug. The domestic medical and retail market for Bisoprolol and Amlodipine tablets was 42,860,000 yuan in 2024.