The first domestically-produced new crown drug approved: a dose of US$2,100 per dose, the Chinese price is undetermined-Economic Observer Network-Professional Financial News Website

Economic Observer Network reporter Qu Yixian On the evening of December 8, the State Food and Drug Administration urgently approved Tengshengbo Pharmaceutical (02137.HK)’s holding company Tengshenghua’s innovative coronavirus neutralizing antibody combination therapy drug Ambavirimab Injection (BRII-196) and Romi Application for registration of svirimab injection (BRII-198). This is China’s first self-developed new coronavirus-neutralizing antibody combination therapy that has been proven to be effective through a rigorous randomized, double-blind, placebo-controlled study.

Li Ankang, Chief Financial Officer of Tengshengbo Pharmaceutical, said on the afternoon of December 9 that because government orders and supply are related to pricing, the domestic price of the combination therapy has not yet been determined, and discussions with the government are in progress. The purchase price is USD 2,100 per person.

Tengsheng Huachuang CEO Luo Yongqing said that the CDMO company WuXi Biologics has been commissioned to produce this drug. The channel is divided into two parts, one is the national strategic reserve, and the other is the procurement of the epidemic situation. The latter will follow the distribution channels of prescription drugs to manage. “This product is not like our ordinary products. Its main model is government procurement. We will also have a commercial team, mainly for promotion and doctor education.”

Luo Yongqing introduced that the therapeutic dose of the combination therapy is one dose, specifically BRII-196/BRII-198 each 1g, respectively placed in 100ml saline infusion, and the infusion can be completed within one hour. After a single injection, it can provide protection for more than 9 months or even 12 months.

“This is a long-acting antibody that can exist in the human body for a long time after being injected, and there is no need for a second treatment.” Li Ankang said.

Has been used in more than 870 cases in China

In response to the domestic new crown epidemic that began in May this year, Tengshengbo Pharmaceutical has cooperated with Chinese government agencies and hospitals to provide BRII-196/BRII- to Guangzhou, Shenzhen, Ruili, Kunming, Nanjing, Yangzhou, Zhangjiajie, Zhengzhou, Manzhouli and other places. 198 Carry out clinical treatment.

Luo Yongqing said on the afternoon of the 9th that this was recommended and used by relevant ministries and commissions. At present, BRII-196/BRII-198 has been used in the treatment of more than 870 confirmed patients in China. The feedback from clinicians was relatively positive. After the medication, the patient’s symptoms were relieved, the virological index improved, and the antibody index increased. Among them, the data of Shenzhen Third People’s Hospital and Guangzhou Eighth Hospital have been submitted. The safety is good, and immunological and kinesiology indexes are all improve.

“These data are not a rigorous randomized double-blind controlled study, so it is not a confirmation. The feedback we currently get is that there are no adverse events and the safety is very good. Academician Zhong Nanshan also led the second phase of clinical trials in the Chinese population in China. The preliminary result is also good safety.” Luo Yongqing said.

According to reports, Ambavirimab/Romisvirimab is a non-competitive new severe acute respiratory syndrome virus 2 (SARS-CoV- 2) Monoclonal neutralizing antibodies, especially using bioengineering technology to reduce the risk of antibody-mediated dependence enhancement, and to extend the plasma half-life to obtain a more lasting therapeutic effect. Their non-overlapping epitope binding regions provide a high degree of neutralizing activity against SARS-CoV-2.

The so-called neutralizing antibody, in simple terms, after a pathogen invades the human body, it will stimulate the human body to produce a variety of antibodies, but only some of the antibodies can quickly identify the pathogen, and at the same time “catch” the pathogen before the invasion to protect the human body from infection. This process is It is called neutralization, and the antibody that plays a role is the neutralizing antibody.

In addition to traditional public health methods, vaccines play a preventive role in epidemic prevention and control, and antibody drugs play a therapeutic role.

Reduce the risk of hospitalization and death by 80%

The State Food and Drug Administration stated that in accordance with the relevant provisions of the Drug Administration Law and in accordance with the special drug approval procedures, emergency review and approval will be conducted to approve the combined use of the above two drugs for the treatment of mild and common types with progression to severe (including hospitalization or Death) Adults and adolescents (12-17 years old, weight ≥40kg) with high-risk factors, patients with novel coronavirus infection (COVID-19). Among them, adolescents (12-17 years old, weight ≥40kg) indications are subject to conditional approval.

This approval is based on the Phase 3 clinical trial of ACTIV-2 supported by the National Institutes of Health (NIH), including the positive interim and final results of 847 enrolled patients.

The final results showed that compared with placebo, the combination therapy of ambasavirumab/romisvirimab reduced the risk of hospitalization and death for outpatients with high risk of clinical progression by 80% (interim result was 78%), with statistics Learn saliency. As of the 28-day clinical endpoint, there were zero deaths in the treatment group and 9 deaths in the placebo group, and its clinical safety was better than that of the placebo group.

At the same time, subjects who started treatment at an early stage (within 5 days after the onset of symptoms) or at a late stage (within 6 to 10 days after the onset of symptoms) had a significant reduction in hospitalization and mortality, which provided more opportunities for patients with new coronary disease. Long treatment window.

The current experimental test data of chimeric viruses in vitro show that the new coronavirus monoclonal neutralizing antibody ambavirumab/romisvirimab combination therapy maintains neutralizing activity against the major SARS-CoV-2 variant strains that have received widespread attention, including : Alpha, Beta, Gamma, Ipsilon, Delta, Delta+, Lambda and Miu.

Luo Yongqing also stated that several laboratories of Tengsheng Biopharmaceuticals are testing the recently emerged B.1.1.529 (Omi Keron) variants, and data is expected to be available within 2 weeks.

Research and development lasted less than 20 months

It is worth noting that it took less than 20 months from the initial laboratory study to the completion of the international phase 3 clinical trial for the ambavirumab/romisvirimab combination therapy.

In May 2020, Tengsheng Bo Pharmaceutical, Shenzhen Third People’s Hospital and Tsinghua University formally signed an investment agreement to establish Tengsheng Huachuang Company in Beijing to jointly develop and own this combination therapy.

From the perspective of division of labor, Tsinghua University and Shenzhen Third People’s Hospital provide professional skills to ensure that all necessary tests, screenings, virological tests, biochemical and cell culture characteristics are completed. Tengshengbo Pharmaceutical provides professional knowledge of drug development, antibody optimization, intellectual property protection, project management, contract development and production organization (CDMO) management, and supervision of clinical trials and drug registration.

Luo Yongqing said that in the early days, Shenzhen Third People’s Hospital isolated more than 200 kinds of antibodies from the sera of recovered patients. Later, Tsinghua University identified the antibodies together and did a lot of virological and biochemical experiments to find the characteristics of these antibodies. Some screening work was done.

Tengshengbo Pharmaceutical also participated in the precise screening of antibodies. After the two antibodies were screened, they were optimized and genetically engineered. The subsequent construction of cell lines, production of clinical samples, phase I, II, and III clinical trials, and China-US approval are mainly undertaken by Tengshengbo Pharmaceutical.

In early October, Tengshengbo Pharmaceutical submitted an emergency use authorization application for BRII-196/BRII-198 combination therapy to the U.S. FDA for the treatment of COVID-19 outpatients with a high risk of clinical progression to severe disease.

Li Ankang said that he is currently communicating with US regulatory agencies and is expected to be approved in the near future. The preventive indications of the drug are also being further studied.

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