A new round of COVID-19 vaccine research and development competition seems to have begun. Around May Day, there are chinese biological, Kexing biological, Si microorganism and other new crown vaccines intensively approved for clinical trials, and there are currently more than 10 new generation of new coronavirus vaccines for Aomi Kerong in China. The COVID-19 pandemic is still in its development phase, and as the virus continues to mutate, the development of universal vaccines for various mutant strains is also on the way.
In the new release cycle from April 29 to May 5, the marketing application of Tuopeifiglestine Injection, a class 1 long-acting white drug of Tebao Biologics, was accepted, and a number of new coronavirus vaccines were approved for clinical trials, and the research and development progress of innovative drugs such as Beida Pharmaceutical, Aihin Dawei and Pumis was advanced.
As of May 5, the People's Finance Innovative Drug Index was at 2624.92 points, up 0.23% in the most recent release cycle. The performance was relatively flat, mainly affected by the holiday, and the progress of clinical declaration and clinical trials lagged behind.
The Omilon COVID-19 vaccine was intensively approved for clinical trials
Around May Day, there was continuous news in the field of domestic new crown vaccine research and development.
Since April 26, China Biologics and Kexing Biologics' Omicron mutant strain inactivated covid-19 vaccine, Smicrobial's new corona iteration mRNA vaccine, and Ruike Bio's new adjuvant recombinant protein new crown vaccine ReCOV have been approved for clinical trials by the State Food and Drug Administration, while The 2valent and 4-valent recombinant new coronavirus mutant S trimer protein vaccine of Shenzhou Cell has been approved for Phase III clinical trials in the United Arab Emirates.
In addition, China Biologics' inactivated COVID-19 vaccine for the Aumi kerong variant strain, which has just received clinical approval, quickly launched a clinical trial during the May Day period, becoming the first inactivated covid-19 vaccine for the Aomi kerong variant strain to enter the clinical trial.
It is worth noting that these vaccines are all mutant vaccines, and most of them are targeted at the Omikejung strain. Last November, the Omikejong variant emerged in South Africa and spread rapidly across the globe. A number of studies have shown that over time, the effectiveness of existing vaccines on infection and disease prevention is weakening, and there is immune escape in the Omiljung variant.
In response to this situation, global vaccine companies are working intensively to develop a mutant vaccine against Omi kerong.
At present, the COVID-19 vaccine jointly developed by Pfizer and BioNTech for Omicron is in Phase III clinical trials, and Moderna's divalent mRNA candidate vaccine mRNA-1273.214 for Michiron is in Phase 2/3 clinical trials, and the two vaccines are expected to be launched first this fall.
Last month, German Health Minister Carl Lauterbach told the media that Germany was scheduled to launch a vaccine against the new coronavirus variant, Omiljung, in September. "It is increasingly difficult for us to deal with these variants due to the constant emergence of new strains of the new coronavirus, and it is very likely that the highly contagious Omilkeron variant with a fatality rate similar to the Delta variant may become an absolute killer variant."
At the same time, the research and development of the Aomi Kerong variant vaccine with multiple technical routes in China is also accelerating. According to our incomplete statistics, there are currently more than 10 new generation of new coronavirus vaccines for Aumicron in China under study.
From the perspective of progress, SCTV01E, the quadrivalent vaccine of Shenzhou Cell, has obtained the approval of the UAE Phase III clinical trial at the end of April, and the progress is the fastest. According to the announcement of Shenzhou Cell, SCTV01E is a new generation of multivalent recombinant protein vaccine independently developed by the company, the active ingredients include Alpha+Beta+Delta+Omicron four recombinant S triper protein antigens, and at the same time, the use of new adjuvants that significantly enhance Th1 cells than traditional aluminum adjuvants.
From the perspective of technical routes, the new generation of COVID-19 vaccines against Opmi kerong mainly includes mRNA, recombinant proteins and inactivated vaccine routes. Among them, most of the mRNA route vaccines, a total of 7, CSPC Group, CanSino, Si Microbial 3 mRNA vaccines have been approved for clinical trials in China.
Since the beginning of this year, large-scale outbreaks have broken out in many parts of the country, and the research and development of mRNA vaccines is advancing rapidly. After obtaining clinical approval for the new crown variant mRNA vaccine SYS6006 at the beginning of last month, CSPC quickly launched two Phase I clinics that month. Recently, Academician Jiang Hualiang of the Institute of Pharmacology of the Chinese Academy of Sciences said at the "Healthy China" lecture of the China Europe Institute of Technology and Business, "The original progress in the research and development of mRNA vaccines in the mainland is backward, and in this Shanghai epidemic, 4 mRNA vaccines of CanSino, Si Microorganism, runze Biology and so on have entered the clinic, and the emergency moment of the epidemic has been used for clinical research." ”
In addition, the recently intensively approved COVID-19 vaccines have a certain broad spectrum and are trying to be used to fight a variety of NEW CORONAVIRUS variants.
According to reports, the new crown iterative mRNA vaccine of Slovak microorganisms includes D614G mutations in the research and development design of various new coronavirus variants such as Delta and Omicron, which has protective effect on the current new coronavirus epidemic strains and has a certain broad spectrum. CSPC also claims that its mRNA vaccine, SYS6006, has good immunoprotective efficacy against current mainstream mutant strains, including Ami kerong and Delta.
At present, the new generation of new coronavirus vaccines under research in the mainland can be divided into two categories, one is to develop vaccines specifically for mutant strains, and the other is to develop broad-spectrum vaccines for sites that are not easily mutated by the new crown virus. Because the virus mutates so quickly, researchers everywhere are targeting universal vaccines that can target a variety of mutant strains. If successfully developed, a generic vaccine will also be effective against coronaviruses other than COVID-19.
At present, domestic enterprises have begun to explore the development of such universal vaccines. It is reported that Shanghai Bowo Bio is cooperating with Fudan University and Furgent to develop a universal spectrum vaccine (that is, a large broad spectrum vaccine) for the B spectrum of the β coronavirus, which will be used to prevent various new coronavirus variants and MERS-CoV currently circulating in the Middle East and new highly pathogenic β-CoV variants in the future - SARS-CoV-3 or MERS-CoV-2.
Tebao Biologics Class 1 long-acting liter white medicine was declared for listing
On April 29, the listing application of Tebao Biology Class 1 long-acting white drug Tuopeifilgelstine Injection was accepted by the State Food and Drug Administration.
According to the announcement of Tebao Biologics, Topefiglioxine is a long-acting human granulocyte stimulating factor product independently developed by the company, using 40kD Y-type branch polyethylene glycol (PEG) molecules to modify human granulocyte stimulating factor, compared with the similar long-acting products currently on the market, it has a longer drug half-life, a lower drug dose, and the drug dose is about one-third of the long-acting products of the same kind that have been listed so far, which can better meet clinical needs.
It is reported that granulocytopenia is the most serious hematologic toxicity of chemotherapy, clinically pay special attention to the reduction of white blood cells during chemotherapy, often use some drugs that raise white blood cells, divided into general whitening drugs, hormone whitening drugs and whitening biologics - granulocyte colony stimulating factor (G-CSF) whitening drugs.
Some data show that in the domestic white-lipocy market, long-acting white-lipocy drugs occupy 70% of the market. In recent years, the scale of the domestic long-acting white medicine market has continued to rise, with terminal sales of public medical institutions in China exceeding 5 billion yuan in 2020.
At present, there are 4 enterprises in China that have obtained long-term G-CSF production approvals, including CSPC Baike, Qilu Pharmaceutical and Shandong New Era and Hengrui Pharmaceutical. At the end of last year, Shuanglu Pharmaceutical submitted a new drug listing application for polyethylene glycol recombinant human granulocyte stimulating factor injection, with a registration classification of 3.4 categories, which is expected to become the fifth domestic one. In addition, Yifan Pharma's innovative long-acting preparation Bergestine (F-627) is in the process of applying for marketing authorization in the United States, the European Union and China, and the domestic registration progress of Bergstromsting is slightly earlier than that of TuopeiFiglexin.
At present, Tebao Bio has a liter of white medicine Terjin for sale. For this declaration and listing, Tebao Bio said that Tuopeifegustine injection and the company's existing listed product Terjin (common name is "human granulocyte stimulating factor injection", short-acting preparation) are long- and short-acting product combinations, and if it can be approved for listing in the future, it will further enrich the company's product line structure and improve its competitiveness.
At the same time, during the new release cycle, the research and development progress of a number of innovative drugs such as Beida Pharmaceutical, Aihin Dawei, and Pumis has advanced forward. Among them, the two innovative drugs of Aihin Dawei and Pumis have entered the second phase of clinical stage.
Drug Clinical Trial Registration and Information Publicity Platform, on April 29, Aihin Dawei registered a phase II clinical trial evaluating AST-001 in the treatment of advanced pancreatic cancer with high expression of AKR1C3. According to reports, AST-001 is an innovative small molecule coupling drug with First-In-Class properties and global patent rights, which is activated by AKR1C3 enzyme to release effective drugs after entering the tumor cells overexpressed by the AKR1C3 enzyme to achieve accurate killing of tumor cells.
Pumis's PM8002 injection is a PD-L1/VEGF dual antibody, and the company registered two phase II clinical studies of PM8002 combined with chemotherapy for malignant mesothelioma and second-line treatment of small cell lung cancer with paclitaxel injection on May 5 and April 28, respectively. According to public information, at present, there are a number of bi-antibody or bispecific fusion protein products targeting PD-1/VEGF or PD-L1/VEGF in the world that have entered the clinical research stage, and in China, Kangfang Bio's AK112 injection has made the fastest progress and is already in the third phase of clinical stage.