It can effectively reduce the mortality rate of new crown patients! Pioneering pharmaceutical stock price doubled, chairman: promote the application for emergency medication

Source of this article: Time Weekly Author: Du Sumin

Due to the publication of the results of the third phase of the clinical key data of the new crown oral drug pkrutamine global multicenter, pioneering pharmaceutical industry (09939. HK) opened on April 6 and rose in a straight line, rising more than 200% in 2 minutes, and finally fell back to 106.37%, closing at HK$28.85 per share.

Pkrutamine is a new generation of androgen receptor (AR) antagonists independently developed by the pioneering pharmaceutical industry, which can block the combination of androgens and AR, and was originally developed for the treatment of prostate cancer and breast cancer. During the COVID-19 pandemic, pioneering pharmaceutical studies have found that pkrutamine not only blocks AR signaling, but also reduces the expression of two key proteins (ACE2 and TMPRSS2) that the new coronavirus enters the host cell.

According to the clinical trial data released by pioneering pharmaceuticals, pkrutamine can effectively reduce the hospitalization/mortality rate of patients with new crown, especially for all patients who have been taking the drug for more than 7 days, the corresponding protection rate is 100%, and in subjects with high risk factors (especially in the middle and high age group), it can significantly reduce hospitalization/mortality. In addition, pkrutamine can significantly and sustainably reduce THE CARRIER and improve COVID-19-related symptoms.

On April 6, a relevant person from the pioneering pharmaceutical industry said in an interview with the Times Weekly reporter, "We have also just got the data and are preparing to communicate with the regulator to see if we can apply for emergency medication, and the specific timetable cannot be given at present." ”

The new crown oral special drug "returns", with an annual production capacity of up to 50 million copies

On the evening of December 27, 2021, Pioneering Pharmaceutical released a progress report on the global multicenter clinical trial of the new crown oral drug pruneutamine for the treatment of non-hospitalized patients with new crown, but the situation was not ideal.

At that time, this result was widely interpreted by the market as "research and development failure". The share price of Pioneering Pharmaceutical also went all the way down, with the lowest point only 6.91 Hong Kong dollars per share, down 80% from the highest point.

The key data results released today have reversed pkrutamine. Commenting on the results of the trial, Tong Youzhi, founder, chairman and CEO of Pioneering Pharmaceuticals, said: "These data rigorously prove the clinical efficacy of pkrutamine in the new crown population (mainly infected by Delta and Omicron variants), and at the same time have statistical significance. ”

Tong Youzhi also stressed that the company will actively promote the application for emergency drug use EUA licenses from the national drug regulatory agencies in China, the United States and other countries and regions.

The newly released clinical trial data has excited the market, and the progress of pkrutamine pricing and production capacity has also attracted much attention. Not long ago, Pfizer's new crown oral drug Paxlovid (nematvir tablets / ritonavir tablets) was priced in China, and the price of 2300 yuan a box can be taken for five consecutive days, that is, a course of treatment.

The relevant person in the pioneering pharmaceutical industry told the Times Weekly reporter that pkrutamine has not yet been priced, "because this product has not been approved whether it is used as a new crown oral drug or an indication for the treatment of prostate cancer, so there is no price for this drug." ”

However, Tong Youzhi revealed in an interview with the media a few days ago that pkrutamine is a small molecule oral drug, its medication time is short, the treatment cycle is 1 to 2 weeks, it can play a role in the early stage of medication, and the speed of the new crown virus is accelerated. In terms of price, the synthesis of small molecules of pkrutamine is easier to put in volume and easy to control costs.

In terms of production capacity, the relevant people in the development of the pharmaceutical industry said that the company currently has a production capacity of 1 million people / month of pkrutamine, and reached 50 million copies / annual production capacity at the end of this year.

According to its introduction, the previous production capacity of pkrutamine was set for prostate cancer, and the production capacity of new crown drugs is completely different, "so we start from two aspects, one is from expanding our own production capacity, and the other is to expand production capacity by cooperating with external CDMO to fully guarantee the supply of puklamide, so there is no need to worry." ”

Domestic manufacturers compete for the 100 billion yuan new crown oral drug market

The market is also paying increasing attention to the progress of domestic new crown oral drugs. Huachuang Securities believes that it is expected that the market of developed countries in Europe and the United States for new crown oral drugs is expected to be at the level of 30 billion US dollars, and the annual (reserve) demand for domestic new crown oral drugs in the future is expected to reach the level of 100 million servings.

In addition, some analysts pointed out that with reference to the pricing of approved new crown oral drugs, the market size of new crown oral drugs will increase by more than 50 billion US dollars in the next three months, equivalent to about 317.4 billion yuan.

According to public information, at present, there are three main technical routes for the research and development of new crown therapeutic drugs: blocking the virus from entering the cell, inhibiting viral replication and regulating the human immune system.

According to media statistics, there are currently 17 small molecule new crown drugs in The country in the emergency research and development, in addition to the development of pharmaceuticals, Junshi Bio (01877.HK; 688180. SH), real organisms of the new crown oral drug has entered the clinical phase III trial.

Among them, Junshi Bio's VV116 is a new oral nucleoside anti-SARS-CoV-2 drug, which is different from the antiviral technology route used by prunamide, the former is to regulate the human immune system, and the latter is to block the virus from entering the cell.

On March 16, Junshi Bio announced that it initiated an international multicenter, randomized, double-blind, controlled Phase III clinical study for the treatment of moderate to severe COVID-19, with the primary endpoint being the percentage of participants who progressed to (critical) severe COVID-19 or all-cause deaths as of day 29. The study has completed the enrollment and administration of the first patient. Junshi Bio said that VV116 has been approved for the treatment of patients with moderate to severe novel coronavirus pneumonia in Uzbekistan.

As the number one seed player of domestic new crown oral drugs, a number of securities institutions have predicted that Junshi Bio's VV116 will apply for listing in the second half of this year.

As an approved anti-HIV drug, a real-life azifriculture, a real-life adjudicated, is currently undergoing phase III trials in China, Brazil and Russia. Among them, the phase III trial for patients with moderate to severe COVID-19 in Brazil is expected to be completed in April 2022, and the trial for patients with mild disease is expected to be completed in July 2022.

In addition, the new crown oral drugs of Frontier Biologics (688221.SH), Cerise Pharmaceuticals-B (01672.HK), and Simcere Pharmaceuticals (02096.HK) have recently been approved for clinical trials. Guangshengtang (300436.SZ), Genting Xinyao-B (01952.HK), Kexing Pharmaceutical (688136.SH) and other pharmaceutical companies are also actively promoting products to enter clinical trials.