China's first self-developed 3CL target neo-crown drugs approved 5 neo-crown oral drugs approved in China

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On January 29, 2023, Centrum Pharmaceutical Group Limited announced that the company’s innovative anti-neo-coronavirus class 1 drug Centronoxin (centronavir/ritonavir combination package) was approved by the State Drug Administration (NMPA) on January 28 for conditional marketing in China, with the approved indication of “mild to moderate novel coronavirus infection (COVID-19) in adult patients. 19) in adult patients”. It is also the first 3CL target anti-neo-coronavirus innovative drug with independent intellectual property rights developed in China, filling the gap in this field in China.

On the same day, Junshi Biologicals’ Rimivir Hydrobromide Tablets (“Mindvir”) were also approved, making a total of five oral NICs approved for marketing in China, including three domestic NICs: Real Biologicals’ Azivudine, Junshi Biologicals’ Mindvir, and Centrum Pharmaceuticals’ Centrum, and two imported NICs: Pfizer Paxlovid and Mercer’s Molnupiravir capsules, initially forming a market pattern of “3+2”.

3CL target “highly conservative”

No fear of new coronavirus mutations

3CL protease is the main protease of coronavirus, which is indispensable in the process of virus replication, and the site is highly conserved, not easily affected by virus mutation, and has broad-spectrum anti-coronavirus activity. Because there is no 3CL homologous protein in the human host, it is more selective and specific, with less risk of side effects.

The 3CL protein is unique to viruses and there is no protein similar to 3CL in humans, so drug development targeting the 3CL protein has certain specificity and safety advantages.

In layman’s terms, anti-neo-coronavirus drugs targeting 3CL have broad-spectrum anti-coronavirus activity and will remain effective even if the neo-coronavirus continues to mutate from Omicron in the future. Also, compared to other target anti-neo-coronaviruses, humans are at less risk of side effects when taking this class of drugs because there is no 3CL homologous protein in the human body.

Pfizer Paxlovid (P-drug) is the world’s first marketed 3CL oral small molecule drug, which has been widely used during the global neo-coronavirus epidemic. According to Pfizer Paxlovid clinical trial data, the risk of hospitalization or death was reduced by 89% when the drug was taken within 3 days of the onset of symptoms. in April 2022, the World Health Organization updated its Guidelines for the Treatment of New Coronavirus, and P-drug was recommended as the only option for mild to moderate treatment.

Centronoxin (X) and Pfizer Paxlovid (P) are the same 3CL target, as China’s self-developed “national” 3CL oral small molecule drugs, X and P and Japan’s Ensitrelvir target the same.

Cianoxin (cianotretinoin/ritonavir combination package) clinical trial lead expert, academician Wang Chen of the Chinese Academy of Engineering said in an interview, as China’s first independently developed 3CL target new crown innovative drugs, cianotretinoin/ritonavir clinical trials adhere to the standardization and high standard requirements. Clinical data showed that early dosing of the drug in patients with mild to moderate disease improved respiratory and systemic symptoms significantly. “The launch of the drug is significant and will hopefully bring clinical benefit to vulnerable, high-risk populations at risk of developing severe and critical illness after contracting neo-crown, and provide an effective means to combat the next phase of the neo-crown epidemic in China.”

Will automatically enter temporary health insurance

Initial priority to be guaranteed for areas with severe epidemics

According to clinical study information released by Centrum Pharmaceuticals, the study was led by Academician Wang Chen of the Chinese Academy of Medical Sciences and the National Center for Respiratory Medicine, Academician Fan Jia of Zhongshan Hospital of Fudan University, Professor Cao Bin of China-Japan Friendship Hospital, and Professor Hu Bijie, Director of the Department of Infectious Diseases of Zhongshan Hospital of Fudan University.

The Phase II/III clinical study included a large sample of Chinese patients and targeted the currently prevalent Omicron strain, and was the first study at home and abroad to achieve the primary endpoint of complete elimination (score of 0) of 11 new coronary symptoms including “cough, fever or fever, headache, diarrhea, muscle or body pain (or soreness)” for 2 days. The Phase III registration clinical study.

It is reported that Cianoxin will be put into production immediately after being approved for marketing. After entering the distribution chain, it will serve the needs of patients through hospitals, online Internet hospitals and other channels. It is understood that, as a domestic innovative drug with fully independent intellectual property rights, its price will be significantly lower than that of “similar drugs” with the same target.

According to China’s previously released “New Coronavirus Infection Treatment Protocol (10th Edition)” and the “Notice on Optimizing Medical Coverage for Patients with New Coronavirus Infection after the Implementation of “Class B B Control” issued by the National Health Insurance Bureau recently, Cianoxin will automatically enter the latest version of the “New Coronavirus Prevention and Control Guidelines” after approval. After approval, Cianxin will automatically enter the latest version of the “New Coronavirus Prevention and Control Guide” and be included in the temporary medical insurance drug catalog, and purchasers will only have to pay the personal out-of-pocket portion after medical insurance reimbursement.

The reporter learned from Centrin Pharmaceuticals that the company will follow the arrangement of the relevant state departments to coordinate and guide, and give priority to guarantee the supply to the areas with serious epidemic in China at the initial stage of production capacity, and be ready to increase the production dynamically to guarantee the supply depending on the progress of the domestic epidemic.