Home News Two days, four new crown vaccines announced that they have been approved for emergency use, and many companies are competing for new crown treatment drugs – yqqlm

Two days, four new crown vaccines announced that they have been approved for emergency use, and many companies are competing for new crown treatment drugs – yqqlm

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While the epidemic prevention and control measures continue to be optimized, a number of new crown vaccines have been approved for emergency use, and the development of new crown drugs is also accelerating.

In two days from December 4 to 5, four companies, China Cell (688520), Wantai Bio (603392), Clover Bio (02197.HK) and Wesker Bio announced that the new crown vaccine was approved for emergency use. On December 6, Wantai Bio-certification representative told The Paper that the company has built a production capacity of 100 million nasal spray new crown vaccines per year, and the follow-up production capacity depends on market conditions. Hanyu Pharmaceutical (300199), which owns the HY3000 anti-new crown polypeptide nasal spray drug, said that the specific time to market needs to be determined according to the progress of clinical trials. “The expected output can basically meet market demand.”

On December 6, the concept of new crown prevention and control fell the most, and vaccine stocks fell. As of the close, CanSino (688185) fell 3.25% to 180.80 yuan per share; Wantai Bio (603392) fell 8.20% to 137.45 yuan per share; Shenzhou Cell (688520) fell 8.40% to 68.15 yuan/share; Kangtai Bio (300601) fell slightly 0.23% to 34.08 yuan/share; Watson Bio (300142) fell 0.56% to 39.21 yuan/share. In terms of Hong Kong stocks, Clover Bio (02197.HK) fell 9.69% to HK$4.1/share; CanSino Bio (06185.HK) fell 5.82% to HK$82.6/share.

The concept stocks of new crown special medicines are also in the doldrums. As of the close, Tuoxin Pharmaceutical (301089) fell 2.55% to 75.61 yuan per share; Hanyu Pharmaceutical (300199) fell 5.65% to 17.55 yuan per share; Zhongsheng Pharmaceutical (002317 ) fell 5.62% to 28.69 yuan per share; Cheung Kong Health (002435) fell 5.42% to 5.24 yuan per share; Fosun Pharma (600196) fell 4.45% to 34.81 yuan per share.

 Four COVID-19 vaccines approved for emergency use in two days

On November 11, the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council in response to the Novel Coronavirus Pneumonia Epidemic issued the “Notice on Further Optimizing the Prevention and Control Measures of the Novel Coronavirus Pneumonia Epidemic Prevention and Control in a Scientific and Accurate Way”. It mentions “promoting the vaccination of the new coronavirus in an orderly manner. Accelerate the development of monovalent or multivalent vaccines with broad-spectrum protection, and promote approval in accordance with laws and regulations.”

According to the Securities Times, with the approval of the aforementioned four new crown vaccines for emergency use, 13 new crown vaccines in China have been approved by the State Food and Drug Administration for conditional marketing or included in emergency use.

On December 5, Wantai Bio announced that the nasal spray influenza virus carrier COVID-19 vaccine developed in cooperation with Xiamen University and Hong Kong University was recommended by the National Health and Medical Commission, and the State Food and Drug Administration organized demonstrations and agreed to emergency use. Wantai Bio said that this is the first nasal spray COVID-19 vaccine approved for emergency use in China, and it is also the first mucosal immune COVID-19 vaccine in the world to enter clinical trials and so far the only one that has verified safety and broad-spectrum effectiveness in Phase III clinical trials.

On December 6, a reporter from The Paper asked Wantai Biological about the annual production capacity of the new crown vaccine for nasal spray as an investor. The vaccine industry base construction project is one of the company’s non-public stock offerings to raise investment projects, with a production capacity of 240 million tubes per year.

“The follow-up production capacity depends on the market situation. We and CanSino have different technical paths. From various data, our vaccines are still very secure in terms of safety and other aspects. The protection rate of people over 60 years old is not low. For young and middle-aged groups.” The person said.

Clover Bio is a clinical-stage global biopharmaceutical company developing novel vaccines and biological therapies.

Clover Bio told The Paper that its company’s new crown vaccine SCB-2019 (CpG1018/aluminum adjuvant) was included in emergency use after being evaluated by relevant state departments. The data show that compared with placebo subjects, vaccination with the SCB-2019 new crown vaccine can reduce the risk of transmission of the new crown virus among family members.

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Clover Biology did not disclose the specific production capacity of the vaccine. Judging from the company’s official website, Clover Biology has two production bases, namely the Changxing Commercial Production Base and the Chengdu Pilot Production Base. According to its prospectus disclosed last year, the potential maximum production capacity of Clover Bio can independently produce more than 1 billion doses of SCB-2019 per year.

Shenzhou Cell focuses on the R&D and industrialization of monoclonal antibodies, recombinant proteins, vaccines and other biopharmaceutical products. It announced on the evening of December 4 that the company’s self-developed recombinant new coronavirus bivalent (Alpha/Beta variant) S trimer protein vaccine (project code: SCTV01C) was put into emergency use. Shenzhou Cell’s semi-annual report disclosed that the company has invested 150 million yuan in the research and development of the vaccine.

On the evening of December 3, Beijing released the WeChat public account “Four Measures of Beijing Economic and Technological Development Zone to Coordinate Epidemic Prevention and Control and Economic and Social Development”, which mentioned that the Shenzhou cell vaccine has been approved for emergency use and is speeding up the organization of production. However, the news did not point out the specific vaccine species.

Shenzhou Cell announced that SCTV01C is still in the clinical research stage. “Although SCTV01C is included in emergency use, its future market sales will still face relatively fierce competition. At the same time, it will be affected by various factors such as the development and changes of domestic and foreign epidemics, the new crown vaccination rate, and the company’s production capacity. There are still uncertainties.” Shenzhou Cell said.

It is worth noting that, in addition to the above-mentioned three listed companies’ new crown vaccines being approved for emergency use, the recombinant new coronavirus vaccine (Sf9 cells) developed by Wesker Biotech/Sichuan University Huaxi Weikexin is also included in emergency use, which is also the first one approved in China Recombinant protein novel coronavirus vaccine produced by the insect cell technology platform for emergency use.

According to the information on the official website, Wesker Bio is an innovative biopharmaceutical company integrating vaccine research and development, production and sales. ), new oral anti-new coronavirus drugs, and research and development of mRNA new crown vaccines. The current test results show that the three products all have good in vivo safety and in vivo activity.

A vaccine practitioner told The Paper that the inclusion of the new crown vaccine for emergency use does not mean that it can replace the formal review and approval process. Referring to the past experience of the industry, enterprises need to go through the guidance and access process of relevant government agencies from obtaining emergency use approvals to launching them on the market for grassroots use. “For example, setting prices, entering the disease control information system, how to vaccinate, bidding and purchasing, etc. all take time.” The person said.

According to Article 20 of the “Vaccine Administration Law of the People’s Republic of China“, in the event of a particularly major public health emergency or other emergency that seriously threatens public health, the competent health department of the State Council proposes emergency use of vaccines based on the needs of infectious disease prevention and control. It is suggested that it can be used urgently within a certain range and within a certain period of time after being approved by the drug regulatory department of the State Council.

  A number of pharmaceutical companies promote the listing process of the new crown vaccine

In addition to the COVID-19 vaccine approved for emergency use mentioned above, CanSino Biologics (688185.SH) recombinant novel coronavirus vaccine for inhalation is also being promoted nationwide. Since the launch of the inhaled new crown vaccine in Shanghai on October 26, Beijing, Tianjin, Jiangsu, Zhejiang and Hainan have also successively introduced the inhaled new crown vaccine to the entire population.

In terms of production capacity, CanSino mentioned in the announcement released on November 25 that after the company’s inhaled recombinant new coronavirus vaccine Keweisha® Wuyou® was included in emergency use as a booster injection, the company’s production capacity has reached 1.5 million per day. servings, the potential maximum capacity is 1 million servings per day, and the implementation of specific shipments is subject to the instructions of the country and local disease control.

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On the investor interaction platform, CanSino stated that according to the product instructions of the company’s new crown vaccine for inhalation, the 0.5mL/bottle product is 3 human doses; the 1.5mL/bottle product is 14 human doses. As of November 18, the number of public vaccination sites for the inhaled new crown vaccine exceeded 1,000, and the commercialization process of the inhaled new crown vaccine is currently advancing.

Kangtai Biological (300601.SZ) has 5 new crown vaccine products approved for marketing with conditions in China, 4 of which have been approved for emergency use, and 3 of which have been included in the emergency use list of the World Health Organization. On November 18, Kangtai Bio announced that the new coronavirus inactivated vaccine (Vero cells) it developed has completed the key data analysis of phase III clinical trials. This product was included in the country for emergency use in May 2021.

Kangtai Bio explained in the announcement that according to the relevant national regulations on vaccine registration management, after completing the phase III clinical research of the new coronavirus inactivated vaccine, it still needs to go through comprehensive review, production site inspection and other procedures, and then apply for new drugs for the vaccine Factors such as the progress and results of marketing and drug review and approval have certain uncertainties.

On December 1, Watson Bio (300142.SZ) stated on the investor question-and-answer platform that the data compilation and statistical analysis of the phase III clinical trial of the new crown mRNA vaccine jointly developed by the company and Aibo Bio Bio was in progress. According to the regulations and requirements of the regulatory authorities, actively promote the listing process of related new crown vaccines.

Guosen Securities pointed out in the research report that referring to the promotion process of enhanced vaccination policies in developed countries, my country generally follows the gradual progress of the three groups of “elderly/high-risk groups→adults→children and adolescents”, and the vaccination rate of people in various age groups in China is still rising space. Recently, a number of domestic new crown vaccines have made clinical/approval progress. It is recommended to pay attention to the promotion of new crown vaccine booster injections and the progress of the research pipeline.

Kaiyuan Securities pointed out that under the new situation of precise prevention and control, medical consumption is expected to usher in an industry recovery. Kaiyuan Securities believes that the pharmaceutical industry will be severely disturbed by the epidemic in 2022, and the performance of consumer medical care, medical services, and traditional Chinese medicine will be damaged. With the policy margins improving, 2023 is expected to usher in a recovery market.

However, some analysts believe that, judging from the industry lines of some enterprises, there are few commercialized products. If it is not approved for strengthening immunity, the market share may not be optimistic.

  The development of new crown therapeutic drugs accelerates

Not only the new crown vaccine, but also the development of new crown therapeutic drugs is also accelerating. According to a research report released by Southwest Securities on December 5, 5 new crown oral drugs have been approved for marketing in the world, and 10 drugs are in clinical phase III (including new use of old drugs and phase II/III, of which 2 drugs have obtained EUA).

From the perspective of the domestic market, Pfizer’s new crown oral drug Paxlovid (Nimatevir Tablets/Ritonavir Tablets) was approved to be launched in China in February this year, and then Aziv, a real biological drug, was approved to be launched in July, becoming the first The first approved domestic oral drug for new crown. In addition, Merck has submitted NDA for Molnupiravir, Junshi Biotech (688180.SH)’s oral nucleoside anti-SARS-CoV-2 drug VV116 (JT001), Kintor Pharmaceuticals (9939.HK)’s proxalutamide, Simcere The new crown small molecule drug SIM0417 of the industry (2096.HK) is conducting phase III clinical trials.

With the optimization of the epidemic prevention policy, new progress has been made in aerosolized inhalants and small molecule oral drugs against the new coronavirus, and many companies have successively won clinical trial approvals.

On November 30, Yuekang Pharmaceutical (688658.SH) announced that its broad-spectrum coronavirus membrane fusion inhibitor peptide drug (YKYYO17 aerosol inhalation) has been approved by the State Drug Administration for clinical trials. The application indication for this product is Treat novel coronavirus infection. According to Yuekang Pharmaceuticals, peptide drug inhalation preparations are innovative high-end preparations, which realize efficient utilization of peptide drugs through inhalation and lung delivery, so that peptide drugs can exert systemic curative effect and have broad application prospects. According to the company’s semi-annual report, as of June 2022, Yuekang Pharmaceutical has invested about 19.04 million yuan in the research and development of this product.

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On the same day, China Resources Double Crane (600062.SH) announced that its wholly-owned subsidiary Beijing Double Crane Runchuang Technology Co., Ltd. received the CX2101A “Notice of Approval of Drug Clinical Trials” issued by the State Food and Drug Administration, approving the drug to be used for the treatment of Clinical trials for novel coronavirus pneumonia. CX2101A is a small molecule compound that acts on RdRp (RNA-dependent RNA polymerase) of the new coronavirus, using the latest generation of prodrug technology BEPro. Preliminary studies have found that this technology can effectively improve the oral availability and pharmacokinetic properties of drugs. In the future, this technology can be used as the core technology to further develop new antiviral and antitumor products.

On November 29, Ascletis Pharmaceuticals (1672.HK) announced on the Hong Kong Stock Exchange that the application for a new drug clinical trial of the new crown oral candidate drug protease (3CLpro) inhibitor ASC11 has been accepted by the State Food and Drug Administration. According to Ascletis Pharmaceuticals, ASC11 is an oral small molecule drug candidate independently developed by using a variety of proprietary technologies including molecular simulation docking.

In addition, new crown preventive drugs have also attracted attention. Recently, many companies have been approved for clinical trials and are preparing for listing.

On December 5, the public account of Hanyu Pharmaceutical (300199.SZ) announced that the phase II clinical trial of the anti-new crown broad-spectrum preventive peptide drug HY3000 nasal spray was officially launched. On the same day, Hanyu Pharmaceutical stated on the investor question-and-answer platform that the company will work with the clinical lead unit Zhujiang Hospital of Southern Medical University, as well as the sub-center Nanfang Hospital of Southern Medical University and Sun Yat-sen Memorial Hospital of Sun Yat-sen University to quickly promote, and strive to launch HY3000 nasal spray as soon as possible .

At noon on December 6, a reporter from The Paper asked about the progress of Hanyu Pharmaceutical’s related products as an investor. The other party stated that the specific time to market of HY3000 nasal spray needs to be determined according to the progress of clinical trials. In terms of production, “In addition to self-built production lines, the company also signed a production scheduling plan with external partners. It is estimated that the output can basically meet market demand.” The other party also stated that after the Phase II clinical trial of HY3000 nasal spray is completed, it can apply for emergency listing, but the final result still depends on whether the Food and Drug Administration approves it.

On November 28, China Biotech (1177.HK) announced that its recombinant fully human anti-new coronavirus monoclonal antibody nasal spray (F61 nasal spray) was approved by the State Drug Administration for clinical trials on November 25 , for the prevention of people at high risk of exposure to the new coronavirus. According to the company’s introduction, the F61 nasal spray has broad-spectrum and high neutralizing activity against all mutant strains of the new coronavirus, and can directly act on the upper respiratory tract of the nasopharynx to form a protective film on the nasal mucosa. When the new coronavirus invades, this protective film can prevent it from binding to the host cell and specifically block the invasion of the new coronavirus.

(Editor in charge: Tan Mengtong)

Disclaimer:The purpose of reprinting this article by China Net Finance is to convey more information, and it does not represent the views and positions of this website. Article content is for reference only and does not constitute investment advice. Investors operate accordingly at their own risk.

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