On 10^th October, Beijing Holley-Cotec Pharmaceuticals Co., Ltd., a wholly-owned export subsidiary of KPC pharmaceuticals, Inc. (KPC) has received prequalification approval from the World Health Organization (WHO) for its antimalarial product, dihydroartemisinin/Piperaquine phosphate 40mg/320mg film-coated tablet (DHA/PQP tablet, under the proprietary name of Duo-Cotecxin) .

Previously, the artemisinin and its derivatives from KPC have been prequalified by the WHO as active pharmaceutical ingredients. With these foundations, KPC has initiated the project for WHO prequalification of the DHA/PQP tablet on 2018, with support obtained from the Bill & Melinda Gates Foundation. After 5 years of relentless efforts, the DHA/PQP tablet manufactured by KBN-Zhejiang Pharmaceutical Co., Ltd., which is also a wholly-owned subsidiary of KPC has acquired its requalification approval successfully via application filed by the Beijing Holley-Cotec Pharmaceuticals Co., Ltd.

At present, KPC has seven artemisinin-based products, and has participated in the drafting and establishment of quality specifications on five artemisinin-based products (artemisinin, artemether, artemether tablets, artemether capsules, artemether injections),and these standards have been collected into the international pharmacopoeia monographs. The DHA/PQP tablet prequalified is one of the core products of KPC artemisinin series, and the prequalification indicates that KPC is now a qualified supplier for the international public procurement market, which also provides a powerful support and guarantee for the expansion of the KPC's international public market. This prequalification experience would also benefit other KPC’s products by accelerating the process of internationalization.

Malaria is a global public health issue that has attracted extensive attention from the international community, since nearly half of the world's population was at risk of malaria according to statistic done by WHO in 2021. As the discoverer of artemisinin, Professor Tu Youyou became China’s first Nobel Prize laureate in medicine, and have made extraordinary contributions to the progression of the global anti-malaria work. KPC, as the world’s first company who manufactures artemisinin, is honored to work collaboratively with Tu Youyou's team, the Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, the Academy of Military Medical Sciences of China and other units, who are participating in and witnessing the global popularization journey of artemisinin, and KPC will continue the research and exploration in the field of anti-malaria, and on the new indications of artemisinin-related products.

Artemisinin is a gift of Chinese medicine to the world. In the future, KPC would promptly implement its mission of "From Nature, For Human Health", fulfil its social responsibility, show its commitment as a state-owned enterprise. Taking advantage of the internationalization of Artemisinin, KPC commits to put in more resources and efforts continuously to bring the excellent culture of traditional Chinese medicine to the world, and to make traditional Chinese medicine benefit the health of people around the globe, in order to contribute to the internationalization of traditional Chinese medicine.

Please refer to the link below for more information on prequalification of DHA/PQP tablet:

https://extranet.who.int/prequal/news/beijing-holley-cotecs-dhapiperaquine-tablet-prequalified