More than 30 companies in China are developing new crown small molecule drugs

Read Time:4 Minute, 33 Second

With the end of the Spring Festival holiday, the first long holiday after the new crown “B class B”, as the focus of attention of the new crown treatment drugs, small molecule oral drugs, will also usher in the end of the Spring Festival listed race.

Beijing Youth Daily reporter learned that a week before this year’s Spring Festival, there are two new crown oral drugs submitted to the market application, and has been accepted.

On January 16, Centrum Pharmaceuticals announced that the new drug marketing application (NDA) for Centronoxin (centronavir tablets/ritonavir tablets combination package), an innovative drug jointly developed with the Shanghai Institute of Pharmaceutical Sciences of the Chinese Academy of Sciences and Wuhan Institute of Virus Research, was accepted by the State Drug Administration under the special drug approval procedure, intended for the treatment of adult patients with mild to moderate novel coronavirus infection.

Centronavir is an innovative oral small molecule anti-new coronavirus drug, targeting the 3CL protease of SARS-CoV-2 virus replication. Combining with low-dose ritonavir helps to slow down the metabolism or breakdown of centronavir in the body and improve the antiviral effect.

On January 18, Junshi Biologicals announced that it had received the Notice of Acceptance from the State Drug Administration (SDA), and the new drug marketing application for the oral nucleoside anti-new coronavirus drug deuterium rimivir hydrobromide tablets (project code: JT001/VV116) for the treatment of new coronavirus infection was accepted. So far, VV116 has been approved in Uzbekistan for the treatment of patients with moderate to severe COVID-19.

It is understood that more than 30 domestic companies are in the development stage of new oral small molecule coronaviruses. In addition to Centrum Pharmaceuticals and Junshi Biologicals, which have already received new drug applications, Zongsheng Pharmaceuticals RAY1216, Frontier Bio FB2001 and GST-HG171 are in the Phase III clinical stage, and have successfully entered the second echelon of the race to market new oral crown drugs.

Immediately behind the second tier, Kexing Pharmaceuticals SHEN26 is in the successful phase II clinical study stage and has completed enrolling all subjects; Reliant SAL0133 has just been approved to carry out phase I clinical trials for the indication; Yangtze River Health has entered the new oral drug track by acquiring Jianghe Pharmaceuticals.

In addition, as the former first tier, Pioneer Pharmaceuticals disclosed key data from its Phase III clinical trial of its investigational new crown oral drug pucrutamide for the treatment of patients with mild to moderate ambulatory new crown in April last year, but there has been no update since then. The drug has also been questioned by the industry for its androgen receptor mechanism of action.

Anxin Securities believes that, according to the clinical development progress of drug companies’ related new crown drugs, several drugs will be approved for listing in the first half of the year. In general, Centrum Pharmaceuticals Xianoxin, Junshi Biologicals VV116, and Zhongsheng Pharmaceuticals RAY1216 have become the industry’s bullish seed players. According to the previous news of “Jiangsu Drug Regulatory” WeChat public number, “the phase III clinical progress of Xianoxin is in the first place of domestic 3CL target drugs, and is expected to be listed in February 2023 at the earliest”.

In addition, the North China Youth Daily reporter learned that there are a number of 3CL protease inhibitors under development, including Centrin, RAY1216, FB2001, and GST-HG171. SHEN26 are also in development.

Background

In addition to the new coronavirus small molecule oral drug

A number of therapeutic drugs and devices have been approved intensively

In fact, the state has been focusing on expanding the variety and number of new coronavirus therapeutic drugs. in the last week of 2022, the State Drug Administration (SDA) centrally approved 12 new coronavirus infection symptomatic treatment drugs, and urgently approved the import of Merzadone’s new coronavirus oral drug Monoravir capsules.

In the half month or so before the Spring Festival, the State Drug Administration continued to approve a number of new coronavirus symptomatic treatment drugs as well as medical oxygen to market; as a salvage treatment device for patients with critical new coronavirus pneumonia, two of China’s domestic extracorporeal membrane pulmonary oxygenation (ECMO) products have been approved to market; the State Drug Administration through the fast review channel, approved five varieties of ibuprofen tablets to increase production and expand the capacity of the relevant supplement The State Drug Administration approved 2 tolimumab injection biosimilars within 2 days, which were included in the “Treatment Plan for Novel Coronavirus Infection (Trial 10th Edition)” and “Treatment Plan for Severe Cases of Novel Coronavirus Infection (Trial 4th Edition)” ……

In addition, some overseas drug companies are also trying to enter the Chinese market. Beiqing News reporter learned that Japanese company Shionoyi’s new 3CL protease inhibitor, new coronary oral drug Ensitrelvir (Ensitrelvir) also submitted a formal listing application to the State Drug Administration in January this year. The drug was urgently approved by Japan’s Ministry of Health, Labour and Welfare on November 22 last year, and is the first domestically produced new crown oral drug in Japan. On December 23 last year, Shionogi Pharmaceutical Co. revealed that it had signed an Import Distribution Agreement with a Chinese company. China Biopharmaceuticals Ltd. announced in the evening of Dec. 29 that its subsidiary Zhengda Tianqing Pharmaceutical Group Ltd. signed a promotion agreement for the new coronavirus infection treatment drug Ensitrelvir in mainland China with Ping An Shionoyi Co. for a five-year cooperation period.