With the end of the Spring Festival holiday, the first long holiday after the new crown "Class B and B control", small molecule oral drugs, which are the focus of attention of new crown therapeutic drugs, will also usher in a market competition after the Spring Festival.

　　A reporter from the Beijing Youth Daily learned that a week before the Spring Festival this year, two new crown oral drugs had submitted applications for marketing and had been accepted.

　　On January 16, Simcere Pharmaceuticals announced the new drug listing application (NDA) for the innovative drug Xiannuoxin (cenotevir tablet/ritonavir tablet combination packaging) jointly developed with Shanghai Institute of Materia Medica, Chinese Academy of Sciences and Wuhan Institute of Virology. ) was accepted by the State Food and Drug Administration under the special approval procedure for drugs, and it is intended to be used for the treatment of adult patients with mild to moderate novel coronavirus infection.

　　Cenoxin is an innovative oral small molecule anti-new coronavirus drug, which targets the 3CL protease of SARS-CoV-2 virus replication, and combined with low-dose ritonavir can help slow down the metabolism or decomposition of cenotevir in the body , Improve the antiviral effect.

　　On January 18, Junshi Biology announced that it received the "Notice of Acceptance" approved and issued by the State Food and Drug Administration, and the oral nucleoside anti-new coronavirus drug Deuterium Remidevir Hydrobromide Tablets (Project Code: JT001 /VV116) The new drug marketing application for the treatment of new coronavirus infection has been accepted.

As of now, VV116 has been approved in Uzbekistan for the treatment of moderate to severe COVID-19 patients.

　　It is understood that more than 30 domestic companies are in the research and development stage of oral small molecule new crown drugs.

In addition to Simcere Pharmaceuticals and Junshi Biotechnology, whose new drug listing applications have been accepted, Zhongsheng Pharmaceutical RAY1216, Frontier Biotech FB2001, and Guangshengtang GST-HG171 have successfully entered the new crown oral drug market competition because they are already in Phase III clinical stage. Fast second echelon.

　　Immediately behind the second echelon, Sinovac SHEN26 is in the successful stage of phase II clinical research and has completed the enrollment of all subjects; Xinlitai SAL0133 has just been approved to carry out phase I clinical trials of indications; Cheung Kong Health acquired Jianghe The pharmaceutical industry has entered the new crown oral drug track.

　　In addition, as the former first echelon, Kintor Pharmaceuticals disclosed in April last year the key data of its Phase III clinical trial of its new crown oral drug Proxalutamide in the treatment of non-hospitalized new crown patients with mild and moderate symptoms, but there has been no update since then.

The drug has been questioned by the industry because of the mechanism of action of the androgen receptor.

　　Essence Securities believes that according to the progress of clinical development of new crown drugs related to pharmaceutical companies, multiple drugs will be approved for marketing in the first half of the year.

In general, Simcere Pharmaceuticals Xiannuoxin, Junshi Biotech VV116, and Zhongsheng Pharmaceutical RAY1216 have become promising seed players in the industry.

According to previous news from the WeChat official account of "Jiangsu Drug Administration", "Cennuoxin's phase III clinical progress ranks first among domestic 3CL target drugs, and it is expected to be launched in February 2023 at the earliest."

　　In addition, a reporter from the Beiqing Daily learned that there are a variety of 3CL protease inhibitors under research in China, including Xiannuoxin from Simcere, RAY1216 from Zhongsheng Pharmaceutical, FB2001 from Frontier Bio, and GST-HG171 from Guangshengtang. .

For the RdRp target, Junshi Biotech’s oral nucleoside anti-new coronavirus drug VV116, and Sinovac’s SHEN26 are also under development.

　　background

　　In addition to new crown small molecule oral drugs

　　A variety of therapeutic drugs and devices have been approved intensively

　　In fact, the country has been working hard to expand the types and quantities of new crown treatment drugs.

In the last week of 2022, the State Food and Drug Administration approved 12 symptomatic drugs for the treatment of new coronavirus infection, and urgently approved the import of Merck's new crown oral drug monogravir capsules.

　　In the more than half a month before the Spring Festival, the State Food and Drug Administration continued to approve a number of novel coronavirus symptomatic drugs and medical oxygen for marketing; Lung Oxygenation Therapy (ECMO) products have been approved for marketing successively; the State Food and Drug Administration approved the supplementary application for increasing production and capacity expansion of 5 varieties including ibuprofen tablets through the fast-track review channel; the State Food and Drug Administration approved 2 types of bead beads within 2 days The monoclonal antibody injection biosimilar drug was launched, and the drug was included in the "Diagnosis and Treatment Program for Novel Coronavirus Infection (Trial Version 10)" and "Diagnosis and Treatment Program for Severe Cases of New Coronavirus Infection (Trial Version 4)"...

　　In addition, some overseas drug companies are also trying to enter the Chinese market.

A reporter from the Beiqing Daily learned that the Japanese company Shionogi’s new 3CL protease inhibitor and the new crown oral drug Ensitrelvir (Enstrelvir) also officially submitted a listing application to the State Food and Drug Administration in January this year.

The drug was urgently approved by the Japanese Ministry of Health, Labor and Welfare on November 22 last year. It is Japan's first domestically produced oral drug for new crowns.

On December 23 last year, Shionogi Pharmaceutical Company revealed that it had signed an "Import Distribution Agreement" with a Chinese company.

Sino Biopharmaceutical Co., Ltd. announced on the evening of December 29 that its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Ping An Shionogi Co., Ltd. signed a promotion agreement for the new coronavirus infection treatment drug Ensitrelvir in mainland China. The cooperation period is 5 years .

　　Beijing Youth Daily/Reporter Zhang Xin Coordinator/Chi Haibo