02137.HK announced that its holding company, Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd. (hereinafter referred to as "Tengsheng Huachuang"), announced in the Beijing Municipal Drug Administration on Tengsheng Huachuang and its entrusted producers, Wuxi Yaoming Biotechnology Co., Ltd and Shanghai Yaoming Biotechnology Co., Ltd. The formal inspection conclusion was obtained after the production quality management standard ("GMP") conformance test was carried out for the original solution and preparation workshop of new crown neutralization antibody ambavirin injection and romisciumab 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.
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. According to the final results of the Phase 3 clinical trial of the ACTIV-2 study under the Global access to COVID Therapeutic Vaccine accelerated Program ("ACTIV") supported by the US National Institutes of Health, the combination of ambavirin and romisovir reduced the risk of hospitalization and death of COVID-19 outpatients with high risk of clinical progression by 80 per cent. The combination therapy was approved by the State Drug Administration (SDA) of China on December 8, 2021 for the treatment of mild and ordinary adults and adolescents (12-17 years old, weight ≥ 40kg) with novel coronavirus infection (COVID-19) who developed into severe (including hospitalization or death) high risk factors. Among them, adolescents (12-17 years old, weight ≥ 40kg) were conditionally approved. The combination therapy was approved by the National Health Commission to be included in COVID-19 's diagnosis and treatment Plan (trial Ninth Edition) on March 15, 2022.
The data of live virus and chimeric virus tests in several independent laboratories showed that the patient received intravenous injection of 1000 mg ╱ 1000 mg ambavirin and romisovir combination therapy to maintain neutralization activity against novel coronavirus Omicron BA.2 subtype mutant and all previous widely concerned novel coronavirus mutants.
Since the COVID-19 epidemic first appeared in China in 2020, the company and Teng Shenghua have taken fighting COVID-19 as their responsibility, practicing the company's social responsibility, and cooperating with the third people's Hospital of Shenzhen and Tsinghua University. a lot of manpower and resources have been invested in the development of ambavirin and romisovir monoclonal antibodies. Relying on the company's strong R & D capabilities and international cooperation capabilities, the clinical development of ambavirin and romisovir combination therapy has been promoted rapidly in China and around the world. In less than 20 months, the company rapidly promoted the combination therapy of ambavirin and romisovir from the initial laboratory research to the completion of international phase 3 clinical trials, which was finally approved by the State Drug Administration of China.
In order to quickly benefit patients in need after the clinical effectiveness of the antibody has been verified, the company has partnered with contract research and production organizations to expand the production of ambavirin and romisvir monoclonal antibodies in the clinical phase. These pre-produced antibodies, which also began in May 2021, can be used in the fight against the local COVID-19 epidemic in China. So far, the company has donated about 3000 copies of ambavirin and romisovir combination therapy in cooperation with government departments and hospitals, and supported 22 hospitals in 21 regions to carry out patient treatment. A total of nearly 1000 patients received ambavirin and romisovir combination therapy, including mild, common, severe and critically ill patients. The maximum age of patients receiving treatment was 92 years old, so the outbreak of Delta mutants was effectively controlled. After the success of the third phase of the clinical trial, the company invested additional funds and resources to promote the registration and commercialization of ambavirin and romisovir combination therapy, and strive to bring this clinically proven and effective treatment option to the majority of patients.