The clinical acceleration of domestic new crown oral drugs is accelerating, but the difficulty of obtaining approval is increasing | Jianzhi Research – Wall Street News


Kexing Pharmaceutical announced on June 23 that it received the “Notice of Acceptance” issued by the State Drug Administration. The company and Shenzhen Antaiwei Biopharmaceutical Co., Ltd. jointly developed the new crown small molecule oral drug SHEN26 Capsules. The clinical trial registration application has won the national drug Accepted by the Supervision Administration.

SHEN26 is a small-molecule oral drug developed by Sinovac Pharma in cooperation with Professor Zhang Xumu, Dean of Pingshan Biomedical Research Institute of Southern University of Science and Technology, and Professor Guo Deyin of Sun Yat-Sen University School of Medicine.

Previously,Wall Street News & Wisdom ResearchIn the article “Kexing Pharmaceuticals Annual Report Discloses the Progress of New Crown Oral Drugs, and Plans to Raise 300 Million to Rapidly Advance Clinical Research | Jianzhi Research”, it is mentioned that SHEN26 is aNovel coronavirus polymerase (RdRp) inhibitor, can achieve antiviral effect by inhibiting viral nucleic acid synthesis. Preclinical studies have shown that SHEN26 exhibits significant anti-SARSCoV-2 effects in vitro and in vivo, has significant inhibitory activity against the new coronavirus and its variants, and exhibits antiviral activity against both the original strain and known important variants. The mechanism is clear, the oral bioavailability is good, and the safety of repeated administration in animals is good.No mutagenic risk and no off-target effects.

At present, this project is a key promotion project of the Ministry of Science and Technology of the People’s Republic of China on public safety risk prevention and control and emergency technical equipment. Biopharmaceutical industry key projects, key enterprises, key regions) innovation projects.

Shenzhen Kexing Pharmaceuticals, a wholly-owned subsidiary of Kexing Pharmaceuticals, signed the “SHEN26 Project Cooperation Agreement” with Shenzhen Antaiwei Biopharmaceuticals on February 18, 2022.Globally, Antaiwei exclusively licenses the intellectual property rights of SHEN26 obtained or held by it to Shenzhen Kexing, and transfers the follow-up research and development rights and commercialization rights of the products to Shenzhen Kexing.

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At present, no domestic oral drug has been approved in China

In the new crown oral medicine,At present, in addition to the RdRp inhibitor VV116 jointly developed by Junshi Bio and Wangshan Wangshui in China, Azvudine from Real Pharmaceuticals is applying for emergency use for new crown indications.

in,VV116The domestic and Paxlovid head-to-head Phase III clinical trial was announced in May 2022 to achieve the primary clinical endpoint and secondary efficacy endpoint, and the overall incidence of adverse events was lower than that of Paxlovid.The primary endpoint was time to improvement in patient symptoms. Two other international multicenter Phase III clinical trials are in progress.Husband AsaAt the end of 2020, the new crown phase III clinical trial will be carried out in Brazil, and the clinical results have not yet been announced.The company’s chosen clinical endpoint is viral load

Previously, it was rumored in the market that the approval results of these two new crown oral drugs will be released at the end of May and early June, but there is still no further news.

Wisdom researchnote,Not only domestic new crown oral drug approvals tend to be cautious, but also internationally.. June 22,Japan’s Ministry of Health, Labour and Welfare announced that it will decide on Shionogi’s new crown drug (whether or not to approve it) at a later date, and the Japanese government group will conduct further discussions on the necessary data.

In response to the delayed approval of Shionoyi’s new crown oral drug, the market speculates that there are two willingness.First, there is a risk of teratogenicity to the fetus. Second, although this drug can rapidly reduce the viral load of patients and alleviate respiratory symptoms in clinical practice, there is no statistical difference in improving the systemic symptoms of patients compared with the control group.

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As for Pfizer’s new crown oral drug Paxlovid, it is receivingvaccinated healthy adults, vaccinated adults with risk factors for progression to severe diseasePfizer announced on June 15Phase 3 clinical failureThis means that paxlovid does not reduce the risk of severe illness or death in general risk populations

The study enrolled 1,153 subjects with standard risk, and each subject was randomized to receive Paxlovid or a placebo orally twice a day for five days.

The latest analysis showed that Paxlovid reduced the relative risk of hospitalization or death by 51 percent. Specifically, 5 of the 576 patients in the treatment group died or were hospitalized, and 10 of the 569 patients in the placebo group died or were hospitalized. However, this data is not statistically significant.

In a subgroup of 721 vaccinated adults with at least one risk factor for progression to severe COVID-19, Paxlovid reduced the relative risk of hospitalization or death by 57%, which was also not statistically significant .

For the statistical results not significant, there is a reason or because of the currently circulating omicron strainsThe rate of severe disease itself is low, so the proportion of severe disease progression in the control group is inherently lowso the data in this clinical trial were not statistically significant.

Pfizer’s clinical results will also have some impact on Junshi’s VV116, although the primary endpoint of vv116 in head-to-head clinical is clinical recovery time,But severe mortality remains one of the secondary endpoints, and Pfizer’s failure means the head-to-head secondary endpoint is not relevant

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The clinical trial of domestic oral drugs is still accelerating

In the clinical stage, the 3CLpro inhibitor developed by Simcere and Shanghai Pharmaceuticals has completed the clinical phase I on June 1, 2022, and the two phase II/III clinical studies of mild to moderate disease treatment and close contact prevention have been launched rapidly, which are the first in China. The fastest progressing oral inhibitor of 3CL. Sinovac’s clinical progress followed closely.

Wisdom researchIt is believed that from the perspective of clinical indication selection, Simcere Pharmaceuticals has shown different paths, instead of high-risk groups, it has chosen mild and moderate diseases, and has found a new way to use close prevention indications. However, Pfizer’s clinical phase 3 post-exposure prophylaxis also ended in failure. therefore,After the vaccine is widely vaccinated and the scope of use is expanded, it is more difficult to obtain statistically significant results of clinical benefits for the new crown oral drugs currently in the clinical stage.

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