China's first new crown drug NDA is coming soon!

On May 23, Junshi Bio released a corporate announcement announcing the success of the head-to-head Phase III clinical trial between VV116 and Pfizer's P dr.

The Phase III registrational clinical study of VV116 versus PAXLOVID in the early treatment of mild to moderate COVID-19 met the primary endpoi.

It is reported that on April 19 this year, VV116 was registered to start the head-to-head Pfizer Paxlovid Phase III clinical trial (NCT05341609) for the treatment of mild to moderate new coronary pneumon.

The announcement shows that the NCT05341609 study is a multi-center, single-blind, randomized, controlled phase III clinical study to evaluate VV116 versus Nematevir/Ritonavir (PAXLOVID) for the early treatment of patients with mild to moderate COVID19 effectiveness and safe.

According to the documents of the China Clinical Trial Registration Center, there are 5 research purposes in this head-to-head trial, including comparing the effects of the two drugs on the clinical status and safety characteristics of the subjects, evaluating the two drugs in 10 days and 14 days respective.

Image source: Minsheng Securities Research Report

The announcement on May 23 showed that the study was conducted by Academician Ning Guang of Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine as the principal investigator, and 822 patients were actually enroll.

Priced at $185 in Uzbekistan

Priced at $185 in Uzbekistan

Multiple bed phase III trials are underway

Multiple bed phase III trials are underway

It is worth mentioning that in 2021, VV116 will complete the phase 2 clinical trial of moderate to severe disease in Uzbekist.

At present, VV116 is in the phase III clinical research phase in an international multi-center, and a number of clinical studies for patients with mild to moderate and moderate to severe COVID-19 are in progre.

At present, VV116 is in the phase III clinical research phase in an international multi-center, and a number of clinical studies for patients with mild to moderate and moderate to severe COVID-19 are in progre.

Image source: Minsheng Securities Research Report

An international multicenter, double-blind, randomized, placebo-controlled, Phase II/III clinical study (NCT05242042) for mild to moderate COVID-19 was initiated in February this year to evaluate the use of VV116 in mild to moderate COVID-19 Efficacy, safety and pharmacokinetics of early treatment in 19 patients, the primary endpoint is the proportion of patients who converted to severe/critically ill COVID-19 and died from all causes within 29 da.

In March this year, an international multi-center, randomized, double-blind, controlled phase III clinical study for the treatment of moderate to severe COVID-19 was launched, with the aim of confirming the efficacy of VV116 compared with standard treatment in international multi-center subjects with moderate to severe COVID-1 The primary endpoint was the percentage of subjects who progressed to (critical) severe COVID-19 or all-cause death by day 2

VV116 significantly shortens the nucleic acid conversion time of confirmed patients within 5 days

VV116 significantly shortens the nucleic acid conversion time of confirmed patients within 5 days

In addition, on May 18, the journal Emerging Microbes & Infections published the clinical study data of Junshi VV116 on Omicron-infected subjec.

It is understood that the research team of the trial conducted this open-label, prospective cohort study from March 8, 2022 to March 24, 2022 to evaluate its safety and efficacy in Chinese subjects infected with Omicron s.

This study included 136 hospitalized patients diagnosed with COVID-19, of which 60 patients in the treatment group received VV116 treatment (300 mg, BID5 days), and 76 patients in the control group received standard treatment on.

Median time from first positive test to first dose was 5 days

In addition, the nucleic acid conversion time of patients who received VV116 treatment within 5 days after the first positive test was shorter than that of the control group (56vs 113 days), and cox regression analysis showed that the adjusted HR was 37 [95%CI 50-75, P＜ 00

According to the trial data, VV116 is a safe and effective oral antiviral drug with better efficacy in the early stage of Omicron infecti.

VV116 is a safe and effective oral antiviral drug with better efficacy in the early stage of Omicron infecti.

100 billion market space

Hisun Pharmaceutical becomes VV116 raw material manufacturer

Hisun Pharmaceutical becomes VV116 raw material manufacturer

Just after the test data was made public, on May 19, Hisun Pharmaceutical and Wangshi Biological reached a contracted production agreement on the production of VV116 produc.

The two parties intend to establish a strategic partnership in the fields of product processing, production, international registration, and market development of the small molecule innovative drug VV116, so as to achieve the strategic goal of complementary advantages, mutual benefit and common developme.

The agreement only reached a framework agreement on the cooperation principle of the entrusted production of VV116 produc.

The specific quantity, price, special requirements, e.

will be signed separately based on the entrusted production framework agreeme.

The main shareholders of Wangshi Bio are Shanghai Juntuo, e.

Shanghai Juntuo is a subsidiary of Wangshi Bio, and Shanghai Juntuo is a holding subsidiary of Junshi B.

The agreement only reached a framework agreement on the cooperation principle of the entrusted production of VV116 produc.

The specific quantity, price, special requirements, e.

will be signed separately based on the entrusted production framework agreeme.

Image source: Minsheng Securities Research Report

According to the latest phase III clinical administration of VV116, two tablets of 300 mg on the first day, twice a day; on days 2-5, one tablet of 300 mg twice a day; according to the plan, each person needs 12 tablets of 300 mg per course of treatme.

Tablets, a total of 6g of APIs are required; every 100 million servings corresponds to 360 tons of API and about 500 tons of key intermediate 49-

According to the analysis of the research report of Soochow Securities, according to the assumptions under prudent/neutral/optimistic conditions, it is estimated that the reserve demand of VV116 is 1/2/300 million people respectively; the corresponding API market space is about 72/144/26 billion yuan; corresponding to The market space of key intermediate 49-1 is about 50/100/15 billion yuan respective.

Referring to the national drug reserve during the 2009 H1N1 influenza period and the recommended plan in the WHO's influenza pandemic plan, it is expected that the domestic new crown drug is expected to reserve 100-300 million doses per ye.

With reference to the price of VV116 in Uzbekistan, it is estimated that the price for one person in China may be 600-1000 yu.

Under a prudent forecast, the domestic sales of VV116 is about 60-100 billion yuan, and under an optimistic forecast, the sales are expected to reach 180-300 billion yuan

The corresponding key intermediate 49-1 market space is about 50/100/15 billion yuan respective.

Domestic VV116 sales are about 60-100 billion yuan, and under optimistic forecasts, sales are expected to reach 180-300 billion yuan

References:

References: References:

Minsheng Securities: VV116 is approaching, pay attention to the opportunities in the domestic new crown drug industry chain

Minsheng Securities: VV116 is approaching, pay attention to the opportunities in the domestic new crown drug industry chain

Soochow Securities: VV116 preparation and its industrial chain have a large market space

Soochow Securities: VV116 preparation and its industrial chain have a large market space