Zitong Financial App News$Tengshengbo Medicine-B (02137.HK) $It was announced that its holding company Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd. (hereinafter referred to as "Tengsheng Huachuang") in Beijing Drug Administration, Wuxi Yaoming Biotechnology Co., Ltd. And Shanghai Yaoming Biotechnology Co., Ltd. The formal inspection conclusion was obtained after the production quality management specification (GMP) conformance test was carried out for the original solution and preparation workshop of new crown neutralizing antibody ambavirin injection and romisovir monoclonal antibody injection.

The conclusion shows that the production of ambavirin and romisovir injection is basically in line with the Drug production quality Management Standard (revised in 2010) and its appendix requirements, the company needs to further do a good job in risk control, and after working with the entrusted manufacturer to complete the specific rectification requirements, start the commercial production and sale of ambavirin and romisovir combination therapy. The completion of GMP compliance testing is the last regulatory requirement before the commercial sale of ambavirin and romisovir combination therapy. The company will consult with relevant government agencies and work with other partners to study how to benefit Chinese patients as soon as possible.

It is reported that the combination of ambavirin and romisovir is the first anti-novel coronavirus drug independently developed in China and proved to be effective in an international multicenter, randomized, double-blind, placebo-controlled study.