Jia Xuan, a reporter from China Economic Weekly
Up to now, two new crown oral drugs have been approved for marketing in the world, and there is still a blank in China. Once this product is approved for domestic listing, it will become the first domestic new crown oral special drug.
Affected by this, the stock price of Pioneering Pharmaceutical rose by more than 200% within one minute after the opening of the market, soaring by 106.37% on the day, closing at HK$28.85 per share.
The first domestic new crown oral drug is coming?
On April 6, Pioneering Pharmaceuticals announced that pkrutamine, as an ACE2 (angiotensin-converting enzyme 2) and TMPRSS2 (transmembrane protease serine 2), can be used in the clinical treatment of the new crown.
In the process of treating non-hospitalized COVID-19 patients with mild and moderate illness, pkrutamine can effectively reduce hospitalization and mortality; pkrutamine can significantly reduce hospitalization and mortality in subjects with high risk factors (especially in the middle and high age group); it can significantly and continuously reduce the load of the new crown virus; and can improve COVID-19-related symptoms.
It is understood that the phase III clinical trial of pkrutamine for non-hospitalized COVID-19 patients with mild to moderate illness is a double-blind, placebo-controlled, randomized (1:1), global multicenter registered clinical trial.
In this trial, enrolled subjects first developed COVID-19 symptoms for no more than five days, regardless of whether there were risk factors or not, and subjects who had been vaccinated against COVID-19 were not excluded.
The first participant enrolled on April 24, 2021, and completed the enrollment of 733 participants worldwide on December 24, 2021 (727 from the United States and the rest from other countries). The last interview with the last subject was completed on February 3, 2022.
During the trial period, subjects were given oral pkrutamine 200 mg once a day plus standard therapy ("prunamide group") or placebo + standard therapy ("control group") for a period of 14 days.
Clinical trial results have shown that pkrutamine is effective in reducing hospitalization/mortality. Among the subjects who completed the drug for more than 7 days, the number of hospitalization events in the control group and the pkrutamide group were 6 (including one death) and 0 cases (p<0.02, respectively, and the corresponding protection rate was 100%.
Pkrutamine significantly reduces hospitalization/mortality in subjects with high-risk factors, particularly in the middle to high age group. For example, in subjects aged ≥ 60 years with at least one underlying medical condition (e.g., obesity, diabetes, hypertension, etc.), pkrutamine significantly reduced hospitalization/mortality (p<0.02) with a corresponding protection rate of 100%; there was no hospitalization or death in the pkrutamine group.
Pkrutamine significantly and sustainably reduces COVID-19 load. Compared with the control group, the pkrutamine treatment group significantly and consistently reduced the viral load from day 3 to day 28 (days 3 and 28, p<0.01).
In addition, in terms of symptom improvement, the pkrutamine group was better able to improve some of the symptoms associated with COVID-19 such as fever, shortness of breath, and cough than the control group, and the improvement continued to be better than that of the control group until at least the 28th day.
Dr. Tong Youzhi, founder, chairman and CEO of Pioneering Pharmaceuticals, said that these data not only rigorously prove the clinical efficacy of pkrutamine in the new crown population (mainly infected by Delta and Omicron variants), but also effectively reduce the hospitalization/mortality of patients, especially for all patients who have taken the drug for more than 7 days, as well as the middle and high-aged new crown patients with high risk factors to achieve a 100% protection rate, which is statistically significant.
On March 25, Pioneering Pharmaceutical announced the highlights of the 2021 annual performance, which mentioned that the sales revenue of the year achieved a breakthrough from 0 to 1, reaching RMB34.23 million, which was derived from the down payment authorized by the external authorization of the new crown indications of pkrutamine.
It is worth noting that the interim analysis data released by the Phase III clinical trial last year was not ideal.
On December 27, 2021, Pioneering Pharmaceuticals released a progress report on the global multicenter clinical trial of pkrutamine for the treatment of non-hospitalized COVID-19 patients. It was shown that the interim analysis of the Phase III clinical trial did not achieve statistical significance. The company plans to adjust its clinical trial protocol and seek the consent of regulatory agencies such as the US FDA to continue to recruit high-risk COVID-19 patients with only underlying diseases and/or no history of COVID-19 vaccination.
In response, Tong Youzhi responded that this is related to the great change in the situation of new crown pneumonia patients in the United States. It was emphasized that there was no problem with the safety of the oral drug, and although there was no statistical difference in efficacy, a trend in efficacy was seen.
Compared with last year, the three phases of data blindness have a "reversal" effect.
As for when the drug will be listed, Tong Youzhi said: "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." ”
Up to now, two new crown oral drugs have been approved for marketing in the world, including Merck's Molnupiravir and Pfizer's Paxlovid, and there has not been a self-developed new crown oral drug approved in China. Once this product of the pioneering pharmaceutical industry is approved for domestic listing, it will become the first domestic new crown oral special drug.
A number of new coronavirus drugs have made new progress, and some of them have been included in medical insurance
At present, many domestic new crown drugs have made good progress, and a number of drugs and clinical trials have been approved.
On December 8 last year, the State Drug Administration (NMPA) urgently approved the joint therapy of the new coronavirus monoclonal neutralizing antibody ampherolumab/romimavir monoclonal antibody (formerly known as BRII-196/BRII-198 combination therapy) jointly developed by the National Clinical Medical Center for Infectious Diseases, the Third People's Hospital of Shenzhen, Tsinghua University and Tengshengbo Pharmaceutical Biotechnology Co., Ltd. (hereinafter referred to as "Tengshengbo Pharmaceutical", 2137.HK). This is the first drug with independent intellectual property rights to neutralize antibodies for the new coronavirus.
The drug is used to treat adults and adolescents (12-17 years, weighing ≥40 kg) with mild and ordinary types and with a high risk factor for progression to severe (including hospitalization or death) in patients with novel coronavirus infection (COVID-19), of which adolescents (12-17 years, ≥ 40 kg) are conditionally approved.
It is worth noting that the combination therapy lasted less than 20 months from the initial laboratory research advancement, to the completion of international Phase 3 clinical trials, and finally obtained the listing approval of the Mainland State Food and Drug Administration, setting a Chinese record.
On March 15 this year, the National Health Commission issued the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Version 9)" (hereinafter referred to as the "Diagnosis and Treatment Plan") to further standardize antiviral treatment.
Two specific anti-coronavirus drugs were written into the diagnosis and treatment plan, including the domestically produced neo-coronavirus monoclonal neutralizing antibody amphavir monoclonal/romimab combination therapy.
On March 21, China's National Medical Security Bureau issued the Notice on Effectively Doing a Good Job in the Medical Security Work of the Current Epidemic Prevention and Control, which pointed out that for the new drugs added to the "Diagnosis and Treatment Plan", the provincial medical security departments referred to the relevant requirements of the Notice of the Ministry of Finance of the State Medical Security Bureau on Medical Security for the Pneumonia Epidemic Caused by the Novel Coronavirus Infection (National Medical Insurance Electricity [2020] No. 5) and temporarily included them in the scope of payment of the medical insurance fund in their provinces.
In addition, on March 30, the Jiangsu Provincial Food and Drug Administration announced that Simcere Pharmaceutical's new crown oral drug SSD8432 (SIM0417) was approved by IND. The drug targets 3CL protease, which plays a key role in the replication of the new coronavirus, and has strong inhibitory activity against a variety of new coronavirus strains such as the South African strain, the Delta strain, and the Omikeron strain, and has obvious clinical potential. This is also the first domestic 3CL new crown oral drug to enter the clinical stage.
Editor-in-charge: Guo Jiyao
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