Nuocheng Jianhua is a commercial-stage biomedical high-tech company focusing on the development of new drugs in the field of malignant tumors and autoimmune diseases. The company currently has a number of new drug products in the commercialization, clinical and preclinical development stages. The company has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong and the US.
Obutinib tablets have been promoted and sold within the national health insurance catalogue across the country, quickly covered the Chinese hematoma market, penetrated 300+ cities and 1,500+ hospitals, and were included in the CSCO lymphoma diagnosis and treatment guidelines. They are recommended for r/r CLL/SLL, r/r MCL, r/r DLBCL and pCNSL. There is huge potential for growth in expanding multiple indications and increasing the length of medication in the future.
Sales of obutinib increased 163.6% from RMB 214.7 million up to 2021 to RMB 565.9 million in the year ending 2022. Total revenue for the year ending 2022 was RMB 625.4 million, compared to RMB 1,043.0 million for the previous year. Total revenue decreased by RMB 417.6 million, mainly due to a decrease in revenue generated from business partnerships from RMB 776.0 million as of 2021 to 0 as of 2022.
As of the announcement date, top-line data from the 12-week mid-term analysis of the multiple sclerosis (“MS”) global phase II trial had reached the main end point. The company's brain-penetrating BTK inhibitor obutinib significantly reduced disease activity in a phase II trial in patients with relapsed remission of MS. Compared with placebo, a significant decrease in the cumulative number of neodymium (“Gd”) +T1 lesions was detected at week 12, and this main goal was achieved in a dose-dependent manner in all three active treatment groups. The biggest drop was in the 80 mg QD group, reaching 92.1% (p=0.0006), supporting further research and development. In the mid-term analysis of the plan, data from a total of 136 patients were analyzed. Compared with placebo, the cumulative number of new Gd+T1 lesions decreased by 71.1% (p=0.0238) in the obutinib 50 mg QD group, 80.8% (p=0.0032) in the 50 mg obutinib BID group, and 92.1% (p=0.0006) in the Obutinib 80 mg QD group, which showed a trend of improving dose dependence. Week 24 results will be available in May 2023.
Risk warning: Obutinib's R&D progress and sales fell short of expectations, progress in internationalization fell short of expectations, and R&D progress of other varieties fell short of expectations.