Author | Zhu Ping
Editor | Lin Hong
Picture source | Tu Chong
On July 11, the Gansu Provincial Public Resources Trading Center issued a notice on the " new crown epidemic prevention and control treatment drugs" ambavirimab injection and rothenium Misvevirumab injection has been put on the Internet for emergency use and will be introduced into the drug and medical consumables procurement management subsystem of the Gansu Province National Medical Security Information Platform from July 12, 2022 for procurement by public medical institutions across the province. The publicity period is July 2022. From July 12th to July 14th.
Gansu Province information shows that the online unit price of these two monoclonal antibodies is "not higher than the national lowest price of 2,417 yuan" each. The drug is a subsidiary of Tengsheng Boyao , Tengsheng Huachuang Pharmaceutical Technology ( The new coronavirus treatment drug developed by Beijing) Co., Ltd. (hereinafter referred to as Tensheng Huachuang) was officially launched in China on July 8.
On July 13, Luo Yongqing, President of Tengsheng Boyao and General Manager of Greater China, pointed out to 21 Century Economic Report reporter that the price of this drug is set by taking into account various factors such as dosage and pharmacoeconomic value. It is understood that it takes about half a year from approval to commercial launch. Tengsheng Boyao has been preparing for commercialization. Luo Yongqing said that there are currently two main commercialization paths for this product. One is to distribute it nationwide through distributors. Where there is demand in various places, the second is through government procurement. We are currently communicating with relevant ministries and commissions to discuss matters related to the national strategic reserve.
Luo Yongqing pointed out that the accessibility of COVID-19 drugs is still basically led by the government. "We are discussing with our partners how to speed up the commercialization of the product. Currently, we have received requests from more than 20 provinces and cities. The final advancement depends on policy support, but it also requires recruitment like Gansu Province before it can enter the hospital; In terms of production capacity, we cooperate with CDMOs and will formulate production plans based on the needs of domestic and foreign markets, which will be affected by changes in the COVID-19 epidemic. "
Domestic COVID-19 drugs will be commercialized on July 7. , Tengsheng Boyao announced that its long-acting new coronavirus neutralizing antibody ambavirumab and romisevirumab combination therapy has been commercially launched in China, and the first batch of antibody drug has achieved commercial release.
Ambavirumab and romisevirumab combination therapy received marketing approval from the National Medical Products Administration (NMPA) in December 2021 for the treatment of mild and common forms with progression to severe disease (including hospitalization) or death) adults and adolescents (12-17 years old, weighing ≥40 kg) with high risk factors for novel coronavirus infection (COVID-19). Among them, the indication group for adolescents (12-17 years old, weight ≥40 kg) is subject to conditional approval. This combination therapy was approved by the National Health Commission in March 2022 to be included in the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Ninth Edition)".
Since March 22, 2022, many provincial and municipal medical security bureaus have successively implemented the instructions of the "Notice on Effectively Doing Medical Security Work for Current Epidemic Prevention and Control" (hereinafter referred to as the "Notice") issued by the National Medical Security Administration , the combination therapy of ambavirimab and romisevirimab will be included in the payment scope of the local medical insurance fund.
’s previous global phase 3 clinical trial data showed that the combination of ambavirumab and romisevirumab reduced the risk of hospitalization and death by 80% in outpatients with COVID-19 who were at high risk of clinical progression compared with placebo. Statistical significance.
Luo Yongqing told the 21st Century Business Herald reporter that on December 8 last year, the drug was approved through the green channel during the epidemic and was approved quickly. "We must produce high-quality drugs in accordance with the highest global standards, that is, comply with the Good Manufacturing Practice (GMP), verify the production process, etc. This work usually takes more than half a year to complete. During this period, we have at least gone through 5 inspections, including State Food and Drug Administration , review industrial park centers such as Jiangxi Food and Drug Administration, Wuxi Food and Drug Administration, US Food and Drug Administration (FDA), Shanghai Food and Drug Administration, Beijing Food and Drug Administration We. GMP verifications were conducted many times during the epidemic, and reports were issued according to very high standards each time.
Regarding the commercialization path, Luo Yongqing revealed that he is currently cooperating with several of the largest distributors in China such as China Resources Pharmaceutical , Shanghai Pharmaceuticals Holdings and Sinopharm Holdings ; in addition, he is also communicating with relevant national ministries and commissions, Discussing matters regarding the national strategic reserve. "As for the situation that BA.5 has appeared in some areas of the country, there are already demands from regions including Macau. We will also deliver the drugs to these places in need through the dealers mentioned above. "
Regarding the price of the above-mentioned drugs, the Gansu Provincial Public Resources Trading Center information shows that "Gansu sales companies promise not to be higher than the national lowest price of 2,417 yuan per pill." Regarding the pricing principles, Luo Yongqing pointed out to the 21st Century Business Herald reporter that currently in China It is independent pricing; overseas, the business model of similar neutralizing antibody drugs is to adopt government procurement.
"For example, in the United States, when the government purchases millions of doses, the government procurement price per person is between 1,500 and 2,000 US dollars. The pricing in China, taking into account all the factors mentioned above, the pricing of one gram of ambavirumab plus one clomisvirma will be lower than the U.S. pricing because we believe this product has a strong public It is a hygiene issue, so we try to reduce costs and give the maximum profit to the market.
Is it effective against mutant strain BA.4/5?
It is understood that this new drug has been first used in Shenzhen Third People’s Hospital . This is a domestic new coronavirus specific drug that will be supplied to the market after its commercialization. The first batch of drugs, a total of 100 people,
According to Liu Lei, Secretary of the Party Committee of Shenzhen Third People’s Hospital, an 82-year-old confirmed case in the hospital has successfully received the new coronavirus neutralizing antibodies ambavir and romisovir. The monoclonal antibody combination therapy drug has become the first clinical user of the drug after its commercialization. The above-mentioned patient suffers from various basic diseases such as hypertension, coronary heart disease, and chronic heart failure, and has a high viral load and is prone to disease. It is developing into severe disease. At present, the old man's immune mechanisms have been effectively improved, the viral load has dropped sharply, and the medication effect is obvious. Yan Li, chief medical officer of
Teng Sheng Bo Yao, pointed out to the 21st Century Business Herald reporter that this combination therapy. It maintains neutralizing activity against the Omicron subtype BA.2 live new coronavirus variant currently prevalent in China and all previously widely watched new coronavirus variants. In addition, in vitro chimeric virus experimental data show that the The half inhibitory concentration (IC50) of the combination therapy for neutralizing the BA.4/5 subtype variant of Omicron is about 2ug/ml. Combined with the pharmacokinetics model data, a single intravenous injection of 1000 mg of ambavir was performed. The plasma concentration of monoclonal antibody and 1000 mg of clomisvir at one week was 126 times the corresponding IC50 or more than 21 times the 90% inhibitory concentration (IC90) against BA.4/5
" according to US FDA guidelines. (Plasma concentration is 10-30 times higher than IC90), we judge that this combination therapy continues to maintain neutralizing activity against BA.4/5. "Yan Li pointed out.
Lu Hongzhou, director of Shenzhen Third People's Hospital, told the 21st Century Business Herald reporter that at present, further experiments are underway to confirm the neutralizing activity of this combination therapy on BA.4/5 and BA.2.12.1 , including live virus analysis, is in progress.
Regarding the antiviral activity against the BA.5 subtype mutant strain, Zhu Qing, senior vice president and head of the biopharmaceutical department of Tengsheng Biopharmaceuticals, further explained to the 21st Century Business Herald reporter, The current experimental results, using chimeric viruses, are very similar to the antiviral activity against BA.2, suggesting a single intravenous administration of 1,000 mg of ambavirumab plus 1,000 mg of clomisvir. During one week of resistance, the blood drug concentration must be at least one hundred times greater than the value that maintains 50% inhibition of activity. According to FDA guidelines, if the blood drug concentration is higher than 50% or 90%, the inhibitory value must be at least ten times greater. The experimental results show that the inhibition rate of 50% is greater than 100 times, and the inhibition rate of 90% is greater than 20 times. Through these calculations, we judge that the combination therapy is effective for Omicron BA.5 and Omicron, which is still popular in many areas. BA.2 will remain effective.
"As for the development of drugs against the second-generation variant of Omicron, we are continuing to focus on some broad-spectrum antibodies.However, the development of these broad-spectrum antibodies is not only aimed at Omicron, but may also remain active in similar and large virus families, which can inhibit the reproduction of mutant virus strains to a greater extent. These studies are currently ongoing collaborations. " Zhu Qing pointed out.
Editor of this issue Li Yutong Intern Wu Ziying
