On December 8, my country approved the first new coronavirus neutralizing antibody combination therapy with independent intellectual property rights.
According to the website of the National Medical Products Administration, Tengsheng Huachuang Medical Technology (Beijing) Co., Ltd. approved the new coronavirus neutralizing antibody combined therapy drug Ambavirimab Injection (BRII-196) and Romisvirimab Injection in an emergency (BRII-198) Registration application.
In accordance with the relevant provisions of the National Drug Administration in accordance with the "Drug Administration Law", in accordance with the special drug approval procedures, emergency review and approval are carried out, and the above two drugs are approved to be used in combination to treat 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 new coronavirus infection.
Among them, adolescents with indications are subject to conditional approval.
The major shareholder of Tengsheng Huachuang Company is the listed company Tengsheng Biopharma, with a shareholding ratio of more than 72.77%.
Other shareholders include the Shenzhen National Infectious Diseases Clinical Medical Research Center and Professor Zhang Linqi of Tsinghua University, with a shareholding ratio of 6.8% and 4.17%, respectively.
Chen Zhu, an academician of the Chinese Academy of Sciences, said at the 2021 World Life Science and Technology Conference held recently: "To deal with the epidemic, there must be both a'miao' and a'medicine'."
The approval of the first neutralizing antibody in China has sparked heated discussions.
The price of the drug has not yet been announced. According to a reliable person familiar with the matter, the price of the neutralizing antibody is about RMB 8,000 per dose. The average price of the neutralizing antibody drug in the United States is US$2,000 per dose.
How to distribute neutralizing antibody drugs in the future has also aroused discussion in the industry.
"I think antibody drugs may be purchased by the country like vaccines. If they are bought, the price is really not cheap." A relevant person from a Zhonghe antibody drug research and development company told CBN reporters.
The indications for expensive neutralizing antibody drugs are mild and common types, accompanied by patients who are at risk of progressing to severe illness.
Tengshengbo Pharmaceutical earlier released news that the drug has been clinically treated in some areas of China.
There is currently no data to verify the effectiveness of domestic neutralizing antibodies against the new variant of the new crown "Omi Keron".
According to an unpublished research data seen by a reporter from CBN, the effectiveness of multiple drugs, including Tengshengbo and AstraZeneca’s neutralizing antibodies, has declined significantly in response to Ome Keron. Eli Lilly and Regeneron’s neutralizing antibody is almost ineffective against "Omi Keron", and Vir's neutralizing antibody is still effective against "Omi Keron".
"At present, there is no'Omi Keron' mutant strain in China, so the effect on the effectiveness of neutralizing antibodies is not significant." The above-mentioned company related person told the CBN reporter.
In addition to Tengshengbo, a number of companies in China are also developing new coronavirus neutralizing antibodies.
At present, China has deployed three major technical routes in the research and development of new crown neutralizing antibody drugs, including blocking viruses from entering cells, inhibiting virus replication, and regulating the human immune system.
Junshi Biology issued an announcement last month that the company's JS026 injection clinical trial application was approved by the State Food and Drug Administration, and the drug is expected to fight against most of the currently known variants of the new coronavirus.
In addition, another injection, JS016, jointly developed by Junshi and the Institute of Microbiology, Chinese Academy of Sciences, has also completed a phase II clinical trial last month. The results show that it can reduce the patient's viral load and the risk of serious illness. JS016 is currently being actively promoted. Phase III clinical trial.
A reporter from China Business News learned that JS026 and JS016 also have the potential for joint use, which is expected to greatly increase the effectiveness of dealing with unknown new crown variants in the future, and provide a "Chinese solution" for the global fight against the epidemic.
Xie Xiaoliang, Professor Li Zhaoji of Peking University, said in an exclusive interview with a reporter from China Business News that the single-use new crown neutralizing antibody DXP-604 developed by his team is undergoing phase II clinical trials in China and has been approved in Beijing Ditan Hospital as sympathy Medication is used for emergency treatment, mainly suitable for mild and ordinary patients.
Xie Xiaoliang said that the data of patients who have received treatment showed that the drug showed good safety, the patient's viral load dropped sharply, and some patients recovered and were discharged from the hospital. The average nucleic acid conversion was shortened by 11 days.
He believes that the new coronavirus neutralizing antibody has achieved the goal of quickly controlling the development of the disease in patients. From this perspective, "vaccine + neutralizing antibody drugs" will help end the epidemic.
The mutation of the virus also makes the effectiveness of neutralizing antibodies face uncertain.
If "Omi Keron" does occur immune escape, it will be a blow to the effectiveness of neutralizing antibodies.
Xie Xiaoliang told CBN reporters that the escape of antibodies caused by virus mutations is currently the biggest challenge.
"Because of the high cost of research and development and production of neutralizing antibodies, if the antibody fails, it means that the previous investment will be wasted." He said.
Author: Qian Tongxin