The first domestic COVID-19 specific drug was listed.
Ambaviruzumab injection
Romisevir monoclonal antibody injection
● This is the first approved Covid-19 neutralizing antibody combination therapy drug with independent intellectual property rights in China.
● It can reduce the risk of hospitalization and death of COVID-19 patients with high clinical progression by 80%.
On July 7th, Tengshengbo Pharmaceutical and its holding company Tengsheng Huachuang announced that the combination therapy of COVID-19 neutralizing antibody Anbavir monoclonal antibody and Romisvir monoclonal antibody was commercialized in China, and the first batch of antibody drugs had been released commercially. This drug is also the first approved domestic COVID-19 neutralizing antibody combination therapy drug.
How effective is this COVID-19 specific medicine? Can ordinary families afford the cost of treatment? On July 8th, Luo Yongqing, president and general manager of Tengshengbo Pharmaceutical in Greater China, disclosed the pricing and production capacity of neutralizing antibody drugs in COVID-19.
Luo Yongqing said that overseas similar products generally adopt the mode of government procurement, and each person is in the range of 1,500-2,000 US dollars. The combination therapy of Tengsheng Bo Medicine will be priced within 10,000 yuan, which is lower than the global level.
It is reported that the first batch of thousands of medicines were sent to Shenzhen Third People’s Hospital. The next step will be to distribute the drugs to the whole country through three distributors: China Resources Medicine, Shanghai Medicine and Sinopharm Holdings.
Why are new drugs?
Pricing is so expensive?
According to reports, at present, the combination therapy of Ambroxobin and Romisvir is listed in China and adopts the independent pricing model. Overseas, the business model of the drug is the government procurement model. For example, if the US government purchases millions of people, the government procurement price for each person is between 1,500 and 2,000 US dollars. The domestic price of this specific drug made in COVID-19 is lower than the purchase price in the United States, basically within 10,000 RMB.
Luo Yongqing, President and CEO of Tengshengbo Pharmaceutical, revealed that the company invested more than US$ 200 million before and after the research and development of Anbavir monoclonal antibody and Romisvir monoclonal antibody to ensure the smooth development and commercialization. He said that the price of new drugs should comprehensively consider many factors such as dosage and pharmacoeconomic value. When Tengshengbo first designed the COVID-19 neutralizing antibody, it considered the possible mutation of the virus in the future, so it designed a pair of antibodies instead of one antibody.
"Our current dosage is 1000 mg of Ambavirumab plus 1000 mg of Romisvir, a total of 2,000 mg, which is the highest dosage among all approved neutralizing antibodies at home and abroad." Luo Yongqing said.
This specific medicine
Can I take medical insurance?
The price of this COVID-19 specific medicine is close to 10,000 yuan, which is a heavy burden for many low-income families. However, the good news is that patients can take medical insurance to settle accounts.
Since March 22 this year, several provincial and municipal medical insurance bureaus have successively included the combination therapy of Ambavirumab and Romisimab into the payment scope of local medical insurance funds. In contrast, another neutralizing antibody that has been approved for marketing in the world — — AstraZeneca Evusheld was also used in the pioneer area of international medical tourism in Boao Lecheng, Hainan this month through relevant policies. The indication is prevention before exposure of COVID-19, and the price of two injections at one time is 13,300 yuan, which cannot be settled by medical insurance.
In terms of production capacity, Tengshengbo Pharmaceutical said that it will make production plans according to the needs of domestic and foreign markets, and has reached cooperation with Yaoming Bio, a leading global biopharmaceutical contract development and production (CDMO) enterprise, which can match production capacity according to global and domestic epidemic prevention needs.
This new drug has been first used in Shenzhen Third People’s Hospital. At the same time, Tengshengbo Pharmaceuticals has entrusted three major distributors, namely China Resources Medicine, Sinopharm Holdings and Shanghai Pharmaceuticals. "They have the ability to cover any part of the country. Once there is demand, they can deliver it quickly. Coverage is not a problem." Luo Yongqing said.
After vaccination
Do you need a specific medicine?
At present, vaccines, small molecule drugs and neutralizing antibody drugs play different roles in COVID-19 epidemic response.
"Neutralizing antibodies can make up for the shortcomings faced by vaccines and small molecular drugs when used in immunocompromised people." Li Yan, chief medical officer of Tengshengbo Medicine, said that some people with weak immunity may not be suitable for COVID-19 vaccine, and even if they are vaccinated, they can’t produce enough antibodies because of their weak immune response, so the vaccine can’t play a preventive role. For this part of the population, injecting neutralizing antibody can produce "immediate" effect.
At present, Tengshengbo Pharmaceutical has received demand from more than 20 provinces and cities. However, the future market space of drugs mainly depends on the change of epidemic prevention policy and the influence of future epidemic evolution. "As BA.5 and BA.4 become the dominant Covid-19 (strain) overseas, it may also spread to China. I think this will create an application demand. " Luo Yongqing said.
According to national business daily and Beijing Daily client.
Special surprise
Double antibody+large dose
Studies have shown that it is effective for the "worst mutant"
On July 6th, WHO Director-General Tan Desai said that Omicron mutant strain BA.5 has been detected in 83 countries and regions, and BA.4 has been detected in 73 countries and regions. At present, BA.5 has replaced BA.2 as the main strain in the world. The latest weekly report on the global COVID-19 epidemic released by WHO shows that the number of COVID-19 cases in the world has increased for the fourth consecutive week, reaching the highest level since March this year.
Happily, the first domestic COVID-19 specific drug showed broad spectrum in the face of constantly changing viruses. "The results just obtained on the 7 th show that the combination therapy of Ambavirumab/Romisvir has shown a good virus inhibition effect on Omicron mutants BA.4 and BA.5." Lu Hongzhou, president of the Third People’s Hospital of Shenzhen, said that laboratory pseudovirus research shows that the antibody concentration required for the drug to inhibit 90% of BA.4 or BA.5 virus is very low, which can meet the effective standards set by the US Food and Drug Administration.
Zhang Linqi, the head of the R&D team and a professor at Tsinghua University Medical College, told reporters that everyone uses the method of screening "antibody pairs" to avoid virus escape, but they are particular about screening "antibody pairs". The two antibodies must cooperate with each other and be able to play a combination boxing, for example, to identify different positions of the virus. Based on the detailed study of the interaction process between virus and antibody, the team finally screened out the "antibody pair" that can inhibit the virus in time and space from 206 candidate antibodies and found the "best partner".
Luo Yongqing said that when the antibody was originally designed, the possible virus mutation in the future was considered, so it was not a single antibody, but a pair of antibodies; At the same time, considering the efficacy of the combination therapy, the dosage of "Anbavir monoclonal antibody (1000 mg)+Romisvir monoclonal antibody (1000 mg)" was finally determined, which is also the highest dose of neutralizing antibodies approved at home and abroad.
"Even if there are further virus mutations in the future, we can consider other methods, such as continuing to increase the dose to achieve the antiviral effect." Luo Yongqing said.