On February 11, the launch and production ceremonies of the first domestically-made 3CL target anti-new crown innovative drug, Sennuoxin, were held in Jiangsu and Hainan.
From now on, Senoxin will gradually supply various medical institutions to meet the urgent needs of patients infected with the new crown.
The first domestically-made 3CL target anti-new crown innovative drug Cenoxin was put into production
On January 28, 2023, Simcere was approved by the National Medical Products Administration (NMPA) for conditional marketing in China. Simcere immediately started the production process and completed all production links quickly.
In the ramp-up stage of production capacity, Simcere Pharmaceuticals, with the support of relevant data, will prioritize the use of the first batch of Simcere in areas with greater domestic drug demand.
At the site of the launch and listing ceremony, clinical experts said that although the current domestic COVID-19 epidemic is in a "low level and sporadic in many places", it should not be taken lightly. When the herd immune barrier disappears with the decline of the antibody concentration in the body, there will still be a new wave of COVID-19 We must be prepared for the possibility of an epidemic.
It is expected that Senoxin® will become another effective means to fight against the new crown epidemic in the next stage.
Now that the economy is developing strongly and social life is gradually becoming normal, it is hoped that Sennosys will become a powerful scientific and technological force to help China's economic development flourish and relieve the public from worries.
Reduce viral load by more than 96%, Cenoxin's "anti-virus" is better than similar imported 3CL oral drugs
Sennuoxin® was approved by the National Medical Products Administration (NMPA) for special review and approval for conditional marketing in China on January 28, with the approval number Guoyao Zhunzi H20230001, becoming the first category 1 drug approved by the National Medical Products Administration in 2023 The innovative drug is also my country's first self-developed 3CL target anti-new coronavirus drug with independent intellectual property rights.
The drug was jointly developed by Simcere Pharmaceuticals, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Wuhan Institute of Virology. Clinical trials have been carried out in 43 hospitals across the country, including China-Japan Friendship Hospital, Fudan University Zhongshan Hospital, Wuhan Jinyintan Hospital, Shenzhen Third Hospital, and Shandong Qianfoshan Hospital. The research is the registered clinic covering the most extensive Chinese patient population infected with the new crown Omicron strain so far in China.
Senuoxin® was approved by the National Medical Products Administration (NMPA) for special review and approval in China on January 28, conditional marketing
According to the publicly disclosed clinical research data, Cenosys has similar safety and superior evidence of effectiveness to the imported 3CL anti-COVID-19 oral drug, which can rapidly and significantly reduce the viral load, shorten the course of the disease and turn negative Time, 3CL target is safer and more reliable.
After receiving a complete 5-day course of treatment, compared with the placebo group, the viral load in the Cenoxin group significantly decreased by 1.43log10 copies/mL (96.28%); The load decreased by 0.868log10 copies/mL (86.4%), nearly 10 percentage points lower than that of Cenoxin.
At the same time, the safety data also showed that Cenoxin was safe and well tolerated in Chinese patients with mild to moderate COVID-19.
Academician Rao Zihe of the Chinese Academy of Sciences introduced, "Cenoxin targets the key protease 3CL in the replication process of the coronavirus, taking it as soon as possible can quickly and significantly reduce the viral load, because of its strong antiviral activity, Cenoxin can help shorten the The course of the disease of the new crown infection helps the nucleic acid of the new crown infection to turn negative faster."
"Simcere State Key Laboratory of Pharmaceutical Industry" focuses on the achievements of major national strategic needs
The research and development of Sennuoxin is led by the State Key Laboratory of Simcere Pharmaceuticals.
It is understood that the laboratory is a national key laboratory approved by the Ministry of Science and Technology in 2015 and led by enterprises.
In recent years, the laboratory has focused on major national strategic needs, and continued to increase talent introduction and R&D investment. After the outbreak of the new crown epidemic, it immediately organized a scientific research team to conduct research on multiple anti-new crown virus targets, and identified 3CL protease inhibition as the The main research direction of the tackling plan.
After more than a year of scientific and technological research, a preclinical seed compound was developed through clinical phase I safety trials, phase Ib preliminary efficacy exploration trials, and phase II/III efficacy and safety confirmation trials, and finally developed Cenoxin. On January 28, 2023, it was conditionally approved by the State Food and Drug Administration for listing.
"It took only 14 months from the establishment of the project to the successful approval of Cenoxin, and it became the first domestically produced Class 1 innovative drug targeting 3CL, which shows that the innovation capability of China's biopharmaceutical industry is rapidly upgrading," analysts in the industry said. think.
Academician Wang Guangji of the Chinese Academy of Engineering also said that the State Key Laboratory of Simcere quickly responded to the country's major strategic needs, organized a scientific research team in a timely manner, and efficiently promoted the research and development of the Sennuoxin® project. "It is a vivid practice of writing papers on the motherland. ".
Yang Xuepeng, member of the Standing Committee of the Nanjing Municipal Party Committee and Secretary of the Party Working Committee of Jiangbei New Area, who participated in the listing and production ceremony, said, "Senoxin has broken the situation where imported drugs dominate the market and brought more effective treatment methods to the majority of new crown patients.".
Starting today, it will be gradually supplied to various medical institutions
The Centers for Disease Control and Prevention of Beijing, Hubei, Sichuan and many other provinces and cities recently issued a reminder that the local new crown is in a state of sporadic cases.
It is reported that after Simcere was approved, Simcere concentrated its pharmaceutical strength and completed production and listing within 12 days.
"The successful approval of Simcere and its quick launch into the market demonstrates the social responsibility and responsibility of Simcere Pharmaceuticals," Ding Hui, mayor of Haikou, said at the listing ceremony, hoping that the company will further tap the potential and expand production capacity guided by market demand. Do our best to serve and guarantee the market demand for anti-epidemic drugs in the next stage.
According to the clinical data of Cenoxin, it is better to use it as soon as possible.
In order to help patients use Cenoxin within the "golden 72 hours", especially the elderly, people with low immunity, patients with underlying diseases and other vulnerable groups, as well as the accessibility of drugs in areas with poor medical conditions and remote areas, the initial production capacity During the ramp-up phase, Simcere Pharmaceuticals, with the support of relevant data, prioritized the first batch of Cenoxin® for use in areas with greater domestic drug demand, and made every effort to increase the accessibility of Cenoxin®.
As the first domestically-made 3CL target anti-new crown innovative drug, Senoxin's medical insurance policy has received high attention.
On February 8, the National Medical Insurance Administration issued a notice: China-made new crown drugs such as Senuoxin belong to the scope of the tenth edition of the diagnosis and treatment plan.
Senuoxin entered the national temporary medical insurance and included in the payment scope of the basic medical insurance fund of the province, and the payment will be until March 31, 2023.
At present, the price of Sennuoxin is 750 yuan per box/course of treatment, and Pfizer Paxlovid, a similar target product, is 1890 yuan/course of treatment.
"The continuous mutation of the new crown Omicron strain has brought challenges to the prevention and control of the epidemic in my country. Because of its strong antiviral activity, Cenoxin can help shorten the course of the disease of the new crown infection and lay a solid foundation for the next stage of epidemic prevention in my country. Control provided an effective means of coping and enhanced our confidence," said Rao Zihe, academician of the Chinese Academy of Sciences.