Contact:
4008465777
Tonghua Dongbao: Clinical trial application for BC Combo approved
Date：2022-03-11
Author：東寶
Views：4
Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (the "Company" or "Tonghua Dongbao") received the notification of approval (No. 2022LP00393) from the National Medical Products Administration (NMPA) on the clinical trial application for BC Combo (THDB0207 injection), a soluble insulin glargine and insulin lispro injection. The acceptance number is CXSL210151.
BC Combo is one of the international cooperation projects of the Company with SA ADOCIA ("Adocia"), a French company. Their cooperation and licensing agreement allows Tonghua Dongbao to use BioChaperone, Adocia's proprietary technological platform, and its patent for a fee. Tonghua Dongbao is thereby granted the exclusive right to carry out clinical development, production, and commercialization of the licensed product BC Combo in the Greater China region, Malaysia, Singapore, and other countries and regions.
BC Combo is a leading and unique product available in the market. It is the only compound preparation that can combine the long-acting insulin glargine and the rapid-acting insulin lispro. At present, the only dual insulin product in the world is insulin degludec and insulin aspart injection from Novo Nordisk (trade name: Ryzodeg?). Ryzodeg? has been launched in countries and regions such as Japan, Europe, and the US since 2012. It was approved for marketing in China in May 2019.
The dual insulin market is lucrative. According to information published on Novo Nordisk's official website, Ryzodeg has seen substantial growth in sales revenue since it was approved in China in 2019. Specifically, Novo Nordisk reported Ryzodeg sales revenue of about RMB 42 million for 2020 and about RMB 291 million for 2021, signaling a rosy prospect for the dual insulin product. According to IQVIA, sales of insulin degludec and insulin aspart injection in China are expected to rocket to RMB 3 billion by 2025. In the future, the soluble insulin glargine and insulin lispro injection will provide more treatment options for patients and will also advance the development of the Company.
Dual insulin injection features better efficacy than pre-mixed insulin, which is composed of a single active insulin ingredient. Combined with new excipients, the soluble insulin glargine and insulin lispro injection can form a stable dual insulin compound preparation at a neutral pH value. It shows a rapid and efficacious onset of action in the prandial phase, little superposition in the transition phase, and long-lasting effects in the basal phase in terms of pharmacokinetics and pharmacodynamics. Compared with basal insulin, it can better control fasting and postprandial blood sugar in a balanced manner. Compared with pre-mixed insulin, it can better control fasting blood sugar, reduce the risk of hypoglycemia caused by the "shoulder effect", and is easier to use.
BC Combo will be a better medication option for patients with type 2 diabetes in China. It is typical of Chinese patients with type 2 diabetes to have elevated postprandial blood sugar, poor fasting blood sugar control, and a risk of hypoglycemia. However, few of these clinical needs are satisfied. Above all, Chinese patients have insufficient insulin secretion in the early postprandial phase, compared with patients in other countries. A new generation of dual insulin compound preparations, including BC Combo (THDB0207 injection), is expected to become a more effective, convenient and safer alternative to the existing pre-mixed insulin products, expanding treatment options for Chinese patients.
The R&D of BC Combo keeps in step with that of BC Lispro—the ultra-rapid-acting insulin lispro, which was approved last October for parallel Phase III and Phase I clinical trials. The Company's R&D pipeline is also making significant headway. Tonghua Dongbao has been optimizing its market development strategy for greater depth and breadth over the past year. Dedicated to the R&D of diabetes drugs, the Company has also ventured into the field of gout and hyperuricemia treatment to expand its R&D pipeline of treatments for endocrine diseases.
At present, the Company offers the broadest portfolio in China's diabetes treatment sector, able to meet the medication needs of patients of different stages and characteristics. In the future, the Company will continue to accelerate its development into an innovative pharmaceutical company through further innovation and transformation. While ensuring a steady stream of new products approved for marketing every year, Tonghua Dongbao will continue to improve R&D efficiency and expand the R&D pipeline of drugs for the treatment of endocrine diseases, so as to boost the sustainable growth and value of the Company.
