Tonghua Dongbao: Clinical trial application for BC Combo accepted


Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company" or "Tonghua Dongbao") received the notification of acceptance 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 CXSL2101513 Guo.


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?).


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 212 million for the first three quarters of 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, dual insulin is expected to 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.


The R&D of BC Combo keeps in step with that of BC Lispro — the ultra-rapid-acting insulin lispro, which was approved in October for parallel Phase III and Phase I clinical trials. This indicates that the Company's R&D pipeline is making significant headway. Tonghua Dongbao has been accelerating its transformation toward a high-tech biomedical innovator over the past year. Dedicated to the R&D of diabetes drugs, the Company has ventured into the field of gout treatment to expand its R&D pipeline of treatments for endocrine diseases.


The Company has been building up a strong talent team, which, so far, has consisted of about 400 professionals with a doctorate or master's degree. Since Dr. Du Zhiqiang joined the Company as the deputy general manager of R&D, the Company has sorted out and optimized the existing R&D pipelines and channeled superior resources into high-quality projects, demonstrating the Company's capabilities in novel drug R&D. In the future, the Company will expand the novel drug R&D team and build a laboratory in Shanghai. While ensuring the approval of new products every year, Tonghua Dongbao will continue to expand the R&D pipeline of novel drugs for the treatment of endocrine diseases, so as to boost the sustainable growth of the Company.

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