Omicron is still spreading wildly, with a surge of confirmed cases worldwide. Many places in China have also reported cases of infection with Omicron mutant strain.
According to the real-time statistics of worldometer, as of about 6:30 on January 17, Beijing time, 66.8786 million cases of covid-19 pneumonia and 87000 deaths had been confirmed in the United States. Compared with the data at 6:30 the previous day, there were 1209800 new confirmed cases and 2886 new deaths in the United States. In addition, on January 16, France added more than 270000 confirmed cases and Britain added more than 70000 confirmed cases.
According to the data of the U.S. Department of health, as of January 13, there were more than 155000 hospitalized patients with covid-19 pneumonia in the United States, a new high since the outbreak of the epidemic in the United States. With the surge of patients and the loss of medical staff, many hospitals have to suspend the reception of non emergency patients and train National Guard personnel to care for patients.
Under the background of the continuous spread of covid-19 virus, the market once again focused on covid-19 therapeutic drugs, and the stock prices of relevant companies soared one after another.
is China's first covid-19 oral drug expected to be on the market within this year? Covid-19 drug sector soared
On January 17, Hong Kong stock Geli pharmaceutical-b soared by 27%, reaching a new high in recent two years; Covid-19 pharmaceutical sector of A-Shares also soared by 13%, Xinxiang Tuoxin Pharmaceutical Co.Ltd(301089) , Fujian Cosunter Pharmaceutical Co.Ltd(300436) , Staidson(Beijing) Biopharmaceuticals Co.Ltd(300204) , Hybio Pharmaceutical Co.Ltd(300199) 20cm limit, Jinghua Pharmaceutical Group Co.Ltd(002349) , Zhejiang Hisun Pharmaceutical Co.Ltd(600267) 10cm limit; Shanghai Junshi Biosciences Co.Ltd(688180) soared 17% in the session and ended up 11%. Bull stocks Aba Chemicals Corporation(300261) were suspended for verification from the 17th due to abnormal growth.
The sharp rise of covid-19 drug sector is related to the progress of two covid-19 oral drugs. One is from Shanghai Junshi Biosciences Co.Ltd(688180) and the other is from Gelly pharmaceutical-b.
On the same day, according to surging news reports, China's only covid-19 small molecule drug vv116 approved for clinical trials is expected to submit a new drug listing (NDA) application in the second half of 2022 after passing the clinical trials within this year. For the above news, Shanghai Junshi Biosciences Co.Ltd(688180) replied to the media that it is actively promoting the clinical trial of vv116 and is currently preparing the phase II and phase III clinical trials of the drug in the international multi center. The company did not give a clear reply to the specific listing schedule of the drug in China.
At the end of last year, Shanghai Junshi Biosciences Co.Ltd(688180) disclosed that the Ministry of health of Uzbekistan had approved the emergency use authorization of small molecule covid-19 oral drug vv116 for the treatment of covid-19 pneumonia. It is understood that vv116 is jointly developed by Shanghai Institute of pharmacy, Chinese Academy of Sciences, Wuhan Institute of Virology, Chinese Academy of Sciences, Xinjiang Institute of physical and chemical technology, Chinese Academy of Sciences, Wangshan wangshui and Central Asia drug R & D center, Chinese Academy of Sciences. In October 2021, the A-share listed company Shanghai Junshi Biosciences Co.Ltd(688180) announced that it had reached cooperation with Wangshan wangshui to jointly undertake the clinical development and industrialization of the drug worldwide (except five Central Asian countries, Russia, North Africa and the Middle East). At present, vv116 is undergoing clinical research in China.
In addition, on January 3 this year, Gelly pharmaceutical-b announced on the Hong Kong stock exchange that the annual production capacity of ritonavir, the listed anti covid-19 oral drug product of the company, has been expanded to 100 million tablets, which can be further and rapidly expanded according to the market demand in the future. The company's oral direct anti covid-19 virus drug pipeline includes listed ritonavir oral tablets (100mg); Oral polymerase (RdRp) inhibitor asc10; Oral protease (3clpro) inhibitor asc11.
Among them, ritonavir oral tablets of Gelly pharmaceutical-b were approved for marketing by the State Drug Administration of China in September 2021; ASC10 is an oral direct anti COVID-19 drug candidate targeting polymerase (RdRp) for the treatment of New Coronavirus (SARS-CoV-2) infection. The company plans to submit clinical trials in China in the first half of 2022 to countries such as China and the United States. ASC11 is an oral direct anti COVID-19 drug candidate targeting protease (3CLpro). It is combined with Lito Bernard Vee's oral tablet to treat New Coronavirus (SARS-CoV-2) infection. The company plans to submit clinical trials to China, the United States and other countries in the second half of 2022.
several companies prompt risks
In fact, covid-19 concept stocks related to therapeutic drugs have been rising since late December last year, Aba Chemicals Corporation(300261) and Jinghua Pharmaceutical Group Co.Ltd(002349) are the "leading brothers".
According to the statistics of , in the 20 trading days since December 20, 2021, Aba Chemicals Corporation(300261) and Jinghua Pharmaceutical Group Co.Ltd(002349) have increased by 270% and 177% respectively; Hybio Pharmaceutical Co.Ltd(300199) also increased by 155%; Fujian Cosunter Pharmaceutical Co.Ltd(300436) , Zhejiang Jianfeng Group Co.Ltd(600668) , Staidson(Beijing) Biopharmaceuticals Co.Ltd(300204) increased by 76%, 67% and 57% respectively; Both Shanghai Junshi Biosciences Co.Ltd(688180) and Frontier Biotechnologies Inc(688221) increased by more than 41%.
Recently, due to the abnormal increase of share price, Aba Chemicals Corporation(300261) has been suspended for verification twice. The most recent one is January 17. The trading of the company's shares has been suspended since the opening of the market on that day. In the previous verification announcement, Aba Chemicals Corporation(300261) said that the company had not signed any cooperation agreement with Pfizer, had no cooperative relationship with Pfizer, and did not supply carlon anhydride and its derivatives to Pfizer. The customers of the company's carbonic anhydride and its derivatives are mainly Chinese customers and Indian customers. It is uncertain whether the company's carbonic anhydride and its derivatives are indirectly supplied to Pfizer.
According to the research results published in science magazine and the report on paying attention to Pfizer covid-19 Drug Intermediates - isopentenol and inulin published by China International Capital Corporation Limited(601995) chemical team on December 3, 2021, caronic anhydride and its derivatives can be used to synthesize Pfizer covid-19 oral drug parovid from the process flow. Aba Chemicals Corporation(300261) has a synthetic process patent for the synthesis of carbonic anhydride, and there are other synthetic processes for the synthesis of carbonic anhydride.
it is worth noting that on January 17, a number of covid-19 drug concept stocks issued stock price change announcements, suggesting relevant risks.
Fujian Cosunter Pharmaceutical Co.Ltd(300436) said that the anti covid-19 virus small molecule oral innovative drug project of Fujian Guangsheng Zhonglin Biotechnology Co., Ltd., a holding subsidiary of company, is still in the stage of preclinical research. In the follow-up, it is necessary to determine preclinical candidate compounds (PCC) through compound property characterization research, so as to complete preclinical pharmaceutical research and pharmacokinetic, pharmacodynamic Pharmacological and toxicological research, and carry out phase I, phase II and phase III clinical research after obtaining the clinical (implied) license of nmpa. After obtaining the corresponding safety and efficacy data, the drug registration application can be submitted to nmpa. After obtaining the drug registration certificate and passing the GMP compliance inspection of API, the project products can be produced and sold.
New drug research and development has the characteristics of high risk, high investment and long cycle, which draws the attention of investors to the risk.
Hybio Pharmaceutical Co.Ltd(300199) said that New Coronavirus's collaboration with the Institute of Microbiology of China Academy of Sciences has not yet reached the risk of clinical progress and effectiveness in developing New Coronavirus polypeptide nasal spray. At present, there are covid-19 preventive and therapeutic drugs in different R & D stages in the world. Many covid-19 vaccines have been listed in China, and many antibodies and small molecule drugs are also in different R & D stages. The new drug has uncertainty in the market competition pattern after listing.
Xinxiang Tuoxin Pharmaceutical Co.Ltd(301089) said that the company did not sign any cooperation agreement with MSD, the company was not in MSD's qualified supplier list system, the company did not sign any cooperation agreement with MSD, had no cooperative relationship with MSD, and did not supply uridine products to MSD. As a pharmaceutical intermediate, the production process of uridine is relatively mature, and there is no high technical barrier and market access threshold.
Staidson(Beijing) Biopharmaceuticals Co.Ltd(300204) suggests that many of the projects under research of company belong to innovative biological products. Innovative biomedicine has the characteristics of high technology, high risk and high added value. It has a long cycle and many links from development, clinical trial, application for approval to production. It is vulnerable to many factors such as technology, approval and policy. It is faced with many risks, such as the progress of clinical trial may not be as expected, the results of clinical trial may not be as expected, and the approval of drug application for listing may not be as expected, Please make careful decisions and pay attention to investment risks.
Zhejiang Hisun Pharmaceutical Co.Ltd(600267) said that after the company's self inspection, the company's current production and operation is normal, and there is no major information that should be disclosed but not disclosed. In two consecutive trading days on January 14 and January 17, 2022, the deviation of the company's stock closing price has reached more than 20%. Please pay attention to the trading risks in the secondary market, make rational decisions and invest prudently.
According to Frontier Biotechnologies Inc(688221) , company's product fb2001 is covid-19 pneumonia virus protease inhibitor for injection, and the target is covid-19 pneumonia virus 3CL main protease. As of the disclosure date of the announcement, Pfizer's oral covid-19 drug has been authorized by the U.S. FDA for emergency use to treat patients with adverse prognosis risk For non hospitalized patients with mild to moderate covid-19 pneumonia, the company's product fb2001 is a protease inhibitor for injection, which is intended to treat hospitalized patients with moderate and severe covid-19 pneumonia; At present, the drugs approved for the treatment of hospitalized patients with covid-19 pneumonia include redcivir of Gilead company. Please make rational decisions and invest prudently.
organization: domestic covid-19 oral drugs are in urgent need of independent control
Although the risk tips of listed companies are coming, from the point of view of many institutions, the prospect of covid-19 therapeutic drugs is still very promising, especially oral covid-19 drugs. Southwest Securities Co.Ltd(600369) it is considered that covid-19 vaccine, neutralizing antibody and small molecule oral medicine are effective combinations for anti epidemic. Among them, the global oral covid-19 drug market is expected to be billions to tens of billions of dollars.
Huachuang securities pharmaceutical team said that at present, covid-19 has replaced influenza in stages and become the largest infectious disease of human respiratory tract. Reviewing the 100 year history of influenza (1918-2020), the real means to protect human society from the impact of influenza is the "prevention + treatment" combination of "influenza vaccine + oral specific drugs". From the perspective of prevention and treatment paradigm, "covid-19 vaccine + oral anti-covid-19 drug" is also a better choice, which is more convenient and lower social cost, similar to "influenza vaccine + oseltamivir". Covid-19 epidemic prevention and control interpretation so far, relying on vaccines alone can not completely stop the spread of the virus. Oral specific drugs are the key to finally free people from the fear of covid-19 virus infection and the last puzzle to end the impact of the epidemic.
Huachuang securities pharmaceutical team pointed out that at present, two oral drugs of Pfizer and MSD have been approved by EUA overseas. Domestic covid-19 oral drugs are in urgent need of self-control. Many pharmaceutical companies in China have deployed a variety of oral anti covid-19 drugs, which are in different stages of clinical development: azvudine III clinical of real organisms; Shanghai Junshi Biosciences Co.Ltd(688180) / vv116 of Wangshan wangshui has entered clinical research and has been approved by EUA in Uzbekistan. Oral 3CL inhibitors of golly, Xiansheng, Zhongsheng and other companies are in the preclinical research stage and are expected to enter clinical practice in the next 6 months.
Zhongtai Securities Co.Ltd(600918) said that under the background of accelerating the spread of Omicron, the global daily diagnosis has reached a new high, the epidemic situation in China has broken out at many points, and the covid-19 theme is expected to trigger another investment boom. In terms of therapeutic drugs, focus on three logics: Chinese R & D and innovation enterprises with high progress; Cdmo industrial chain of new drugs created by large overseas pharmaceutical enterprises; And generic API applications in other parts of the world.
Zhang Wenhong on Chinese Anti covid-19 oral drugs and Omicron
On January 13, Zhang Wenhong, director of the national infectious diseases Medical Center and director of the infection department of Huashan Hospital Affiliated to Fudan University, published a long article on his microblog, talking about China's anti-covid-19 oral drugs, Omicron, etc.
Zhang Wenhong said that the clinical characteristics of Omicron mutant and delta mutant in the early stage were compared. Compared with Delta, Omicron is faster and more hidden, but it still has lethality that can not be ignored. Subsequently, we discussed with the scientific research team the recent progress of protective research on Omicron after booster vaccination, and also prepared for the clinical research of a new class of oral anti covid-19 oral drugs developed and innovated by China.
Zhang Wenhong said that vaccines and drugs will be the core scientific and technological support for us to tide over the pandemic and return to normal life in the future. Like the epidemic prevention forces, China's scientific and technological forces have been making unremitting efforts to tide over the pandemic smoothly and free our people from the fear of infectious diseases.
At the same time, the State Food and drug administration also attaches great importance to the research and development of covid-19 drugs. On December 8 last year, the State Drug Administration urgently approved the registration application of Tengsheng Huachuang covid-19 virus neutralizing antibody combined treatment drugs ambacizumab injection (brii-196) and romistumab injection (brii-198). This is the first approved covid-19 virus neutralizing antibody combination therapy drug with independent intellectual property rights in China.
According to the relevant provisions of the drug administration law, the State Food and drug administration shall carry out emergency review and approval according to the special approval procedures of drugs, and approve the combination of the above two drugs for the treatment of light and ordinary adults and adolescents (12 to 17 years old, weighing more than 40kg) with New Coronavirus infection (COVID-19) who are highly risk factors (including hospitalization or death). Among them, adolescents (12-17 years old, weight ≥ 40kg) with indications are subject to conditional approval.
On January 13 this year, Jiao Hong, director of the State Food and drug administration, led a team to Tengsheng Huachuang's on-site office to understand the construction of the enterprise's quality management system, the preparation of product production and supply, the implementation of the supervision and guidance of the Provincial Bureau, and study and deploy the key work in the next stage.
Jiao Hong affirmed that Tengsheng Huachuang company promoted the ambacizumab / romistuzumab combination therapy drug from the initial laboratory research to the completion of the international phase III clinical trial in a short time, and finally obtained the emergency approval of China. Jiao Hong stressed that we should fully understand the significance of innovative R & D and supervision of covid-19 virus treatment drugs, continue to summarize and improve early experience and practices, give full play to institutional advantages, and ensure product safety, effectiveness and controllable quality.
"Covid-19 medicine" has many concept stocks with a 20% limit, and the market space can reach 100 billion
Covid-19 small molecule drug China clinical is about to start, and the share prices of relevant enterprises soared
