China-Singapore Jingwei, December 10 (Wang Yuling, Lin Wansi) "In the pharmaceutical industry, the approval of BRII-196 and BRII-198 is of great significance. In the past, we only had vaccines to control the epidemic, but now we have monoclonal antibodies. So fast, this is a landmark event in China's biopharmaceutical industry." A preparation practitioner who came to Tengsheng Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as Tengsheng Biopharma) for an interview told Sino-Singapore Jingwei.
At the beginning of 2020, Tengsheng Biopharmaceuticals, Tsinghua University and Shenzhen Third People’s Hospital jointly established Tengsheng Huachuang Medical Technology (Beijing) Co., Ltd. (hereinafter referred to as Tengsheng Huachuang) to jointly develop BRII-196 and BRII-198 Xinguanzhonghe antibody.
On December 8, the official website of the National Medical Products Administration issued a message, emergency approval of Tengshenghua's innovative coronavirus neutralizing antibody combination therapy drug Ambavirimab Injection (BRII-196) and Romisvirimab Injection ( BRII-198) registration application.
This is the first domestically approved new coronavirus neutralizing antibody combination therapy drug with independent intellectual property rights.
Who are the first domestically-made new crown "special effects" suitable for?
Is it effective against mutant viruses?
Do you still need a vaccine if you have a "special effect medicine"?
On December 9th, Tengsheng Huachuang CEO Luo Yongqing and CFO Li Ankang gave answers one by one at the media conference on the new coronavirus neutralizing antibody combination therapy.
How effective is the medicine?
For the public, what is most concerned about is the effect of the new crown "special medicine".
Luo Yongqing introduced that ambavirumab and rotamisvirumab are non-competitive new severe acute respiratory syndrome virus 2 (SARS-CoV- 2) Monoclonal neutralizing antibody, 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.
The Phase III clinical trial of Tengshengbo Pharmaceutical is a randomized double-blind controlled study from a large global sample of 837 patients with new coronary pneumonia in 6 countries on 4 continents and 6 countries. One group uses antibody drugs and the other group uses placebo control.
Data show that
among COVID-19 outpatients with a high risk of disease progression, the relative risk of the composite endpoint of hospitalization and death is reduced by 80%.
The analysis showed that the number of deaths in the treatment group was 0 within 28 days, while the number of deaths in the placebo group was 9 people. No serious drug-related adverse reactions or infusion reactions were found.
It is understood that after a single injection of Tengsheng Huachuang's neutralizing antibody, the blood concentration can reach 300 times that of inhibiting 90% of the virus growth. 9 months after the injection, the serum concentration can still achieve 90% of inhibiting the growth of the virus. 40 times.
"So Tengsheng Huachuang's neutralizing antibody can provide continuous protection for more than 9 months or even 12 months." Luo Yongqing pointed out.
Who can use it? how to use?
According to the relevant provisions of the "Drug Administration Law", the above two drugs are used in combination to treat adults and adolescents (12-17 years old, 12-17 years old, Weight ≥40kg) patients with new coronavirus infection (COVID-19).
Among them, adolescents (12-17 years old, weight ≥40kg) indication population are conditional approval.
In terms of use, Li Ankang introduced that the dose of the drug is
1 gram each
of
ambavirumab and rotavirumab. At present, a single course of treatment is only used for a single dose. Each bottle of the drug is 500 mg and requires four injections. Bottle, the injection time is about 1 hour.
"According to the current study, after one injection, the dose has sufficient antiviral efficacy and protection. Whether the dose will be changed in the future requires further exploration." Li Ankang said.
Do I still need a vaccine if I have a special medicine?
Regarding the relationship between the new crown treatment drugs and the new crown vaccine, Li Ankang said that the first step in the establishment of large-scale prevention is to use the vaccine first.
"At present, ambavirumab/romisvirimab is a therapeutic drug, and the indications for prevention are under study. In the future, it will be able to provide more preventive evidence and clinical data." Li Ankang said.
"The new crown drug and the new crown vaccine are'dual insurance' and cannot replace each other." Xu Fujie, deputy director of health innovation and cooperation at the Gates Foundation Beijing Representative Office and former professor at the First Affiliated Hospital of Zhejiang University, once accepted an interview with Sino-Singapore Jingwei It is pointed out that the vaccine plays a preventive role and reduces the possibility of infection. If you are unfortunately infected, by taking the new crown drug, you can reduce the probability of severe illness and death.
Is it effective against Omi Keron mutants?
The sudden outbreak of the new coronavirus mutant strain "Omi Keron" has made the global epidemic situation confused. In particular, the impact of Omi Keron on new crown testing reagents, vaccines and drugs has also attracted considerable attention.
So, is the domestically produced new crown therapeutic drug effective against the Omi Keron mutant strain that people are concerned about?
Luo Yongqing revealed that there are currently four laboratories undergoing tests, and results will be available within two weeks.
"When we screened antibodies in March last year, the strategy was to choose a pair of antibodies, not just one." Looking back at the antibody screening phase, Luo Yongqing admitted frankly that the R&D team predicted that RNA viruses would produce mutations. The characteristics of this pair of antibodies It is a different epitope that binds to the receptor binding region RBD of the new coronavirus spike glycoprotein. It is in a highly conserved region and is not prone to mutation and escape. During the mutant pandemic from January to July this year, according to the current In vitro chimeric virus experimental data, the combination therapy of bavirimab and romisvirimab maintains neutralizing activity against major virus variants that have received widespread attention.
How about the price and capacity?
Regarding the price issue that the public is concerned about, some experts have previously stated to Zhongxin Jingwei that the production cost of neutralizing antibody drugs is high and requires low-temperature refrigeration, and the cost is relatively high.
"China's pricing is not yet clear, and it is currently actively communicating with the government."
Li Ankang said that during the second phase of clinical trials, the team was communicating with relevant government departments to discuss strategic reserves and procurement matters.
In addition, in addition to entering the national strategic reserve, there will be another commercialization plan for ambavirumab/romisvirumab.
On the production side, is the supply and production of new crown drugs sufficient?
Luo Yongqing bluntly said, "There is no need to worry.
" "We entrust WuXi Biologics, a CDMO organization, to produce. The latter's production scale and production capacity can be expanded flexibly. From the current demand, the supply of drugs can be guaranteed."
New crown treatment drugs are being developed to accelerate the sprint
It is understood that the domestic new coronary pneumonia drugs mainly focus on the three technical routes of inhibiting virus replication, blocking virus entry into cells, and regulating the human immune system. Among them, many therapeutic drugs are expected to have new progress in December.
In addition to ambavirumab injection and romisvirimab injection, the neutralizing antibody therapy JS016 jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and the Junshi Biological team also belongs to the class of neutralizing antibody drugs.
Previously, the drug completed the enrollment of all patients in international multi-center phase Ib/II clinical trials in mainland China, Hong Kong, the Philippines, Ukraine and other places, and the clearance and statistics of all observation periods and all clinical data. The clinical trial is expected to be completed in December in conclusion.
Azivudine developed by Henan Normal University is an oral new crown treatment drug, which is undergoing phase III clinical trials in China, Brazil, and Russia.
It is reported that the drug strives to apply for domestic conditional approval for listing in December.
The pioneering pharmaceutical industry's proclulamide is another oral new crown treatment drug. Currently, three international multi-center phase III clinical trials are being carried out in China, the United States, Brazil and other countries. The group work is being carried out in an orderly manner.
The fastest progress is the Phase III clinical trials for patients with mild and moderate COVID-19 in the United States and other countries. Interim data is expected to be released in December.
Talking about the difference with several overseas neutralizing antibody combination therapy drugs that have been urgently authorized, Luo Yongqing said, "First of all, whether the patient will be enrolled for treatment within 5 days, or will be treated within 5 to 10 days, the clinical effect is It is consistent and closer to the real-world situation; secondly, the experiment of Tengsheng Huachuang team is in the global mutant pandemic period, and most of the patients in the group are infected with the new coronavirus mutant strain. Therefore, the neutralizing antibody of Tengsheng Huachuang may be It is the only antibody combination that has evidence of beneficial effects on mutant strains; third, the neutralizing antibody of Tengsheng Huachuang is a long-acting antibody combination. The other three companies may not have made this long-acting genetic engineering modification. Can provide long-term protection." (Zhongxin Jingwei APP)
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