From Bio Journal - May 2022

Trend: mRNA vaccines create huge market for the pharmaceutical industry

In the recently released pharmaceutical industry's sales rankings for FY2021, Pfizer took the top spot with sales of $81.288 billion (8.9217 trillion yen), far above any of the other pharmaceutical companies and up 94% from last year. Pfizer earned $35.6 billion in revenue in FY2020, ranking eighth globally. In FY2021, coronavirus vaccine sales totaled $36.781 billion. The COVID-19 pandemic has provided a tailwind for the global pharmaceutical industry, which has grown into a huge market with increased sales for many companies. However, Japanese companies that failed to get onboard have struggled, and Takeda, which had been among the top ten companies in the past, was left out in the cold this time.

Moderna, Inc., a US company that stepped into the limelight as a venture company developing mRNA vaccines along with BioNTech AG of Germany, announced a new strategy on March 7. At the top of the new strategy was the development of mRNA vaccines against the 15 most closely watched pathogens, as identified by the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI), in preparation for future pandemics, and the initiation of clinical trials by 2025.

To compete with multinationals who are boosting their sales and developing new strategies, the Japanese government has moved to develop new vaccines. The Japan Agency for Medical Research and Development (AMED) established the Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response (SCARDA), which will play the role of a control tower for the development projects. On April 4, SCARDA held its first strategic promotion meeting aimed at creating research and development bases for advanced vaccine development.

In a separate move, the Japanese Ministry of Education, Culture, Sports, Science and Technology (MEXT) designated six national universities as research centers for infectious diseases, three of which are designated as research centers for vaccine development; the Institute of Medical Science at the University of Tokyo, Osaka University, and Shimane University. On April 1, Shimane University launched the Research and Development Center for Vaccines and Therapeutic Antibodies for Emerging Infectious Diseases. Researchers at the university are already working with Asahi Kasei Corp. and others to develop a coronavirus vaccine, for which a patent was applied in December 2021.

Japanese companies have also reported achievements during this period. Mitsubishi Tanabe Pharma Corp. announced on February 24 that a COVID-19 vaccine developed in collaboration with its Canadian subsidiary Medicago has been approved for use in Canada. This is the first COVID-19 vaccine to use plant cells to produce virus-like particles (VLP). VLP vaccines include the HPV (human papillomavirus - cervical cancer) vaccine in Japan, but all VLP vaccines developed thus far, including the COVID-19 vaccine, have used moth cells.

The plant used is problematic, as tobacco leaves are used. Mitsubishi Tanabe Pharma Corp. holds a 78.68% stake in Medicago, while the remainder is held by Philip Morris, a major US tobacco company. In a press conference on March 16, WHO stated that it has a strict policy concerning the tobacco industry and that the vaccine is not expected to be approved.

NEC also announced on April 8 that it has initiated development of mRNA vaccines that are effective against all types of coronavirus infections, including COVID-19. The initiative, in collaboration with its Norwegian subsidiary NEC OncoImmunity AS, was adopted after a public call by CEPI, an international organization for vaccine development. Experiments employing AI will be conducted to find antigens that have broad reactivity against coronaviruses.

Crafton Biotechnology Co., Ltd., a company developing mRNA drugs, was established in Nagoya on March 1. The company, a venture company established by Nagoya University Graduate School Professor Hiroshi Abe and Kyoto Prefectural University of Medicine Graduate School Professor Tomoshi Uchida, plans to conduct joint research with Waseda University, Yokohama City University, the Institute of Physical and Chemical Research (RIKEN) and others. It has already been selected by AMED as an ginnovative advanced research and development support project.h

Further, construction of a plant for Arcalis, Inc. which will serve as a manufacturing base for mRNA vaccines and pharmaceuticals, began on March 12 at an industrial park in Minamisoma City, Fukushima Prefecture. The plant is scheduled to manufacture vaccines and pharmaceuticals under contract from pharmaceutical companies and drug discovery ventures around the world. The industrial park is based on the Fukushima Innovation Coast Framework, which takes reconstruction from the March 2011 earthquake disaster as its pretext. Large numbers of LDP lawmakers and bureaucrats from the Ministry of Health, Labor and Welfare are said to have attended the Shinto ground-breaking ceremony to pacify the local guardian spirits. Arcalis is a subsidiary of Axcelead, Takeda's flagship investment firm, jointly established by Takeda and Whiz Partners, with Hitachi also being involved. (Nikkei Biotech Online Edition 2022/3/29 and others)

Nissin Foods holds cultured meat sampling party with the University of Tokyo

Aiming to make steaks from cell culture, a research team led by Professor Shoji Takeuchi of the graduate school of the University of Tokyo and Nissin Foods Holdings held a sampling party for the cultured meat on March 31. Since cultured meat has not yet been approved as a food, there is no mechanism for sampling it, but the sampling party was approved by the University of Tokyo ethics committee. The research team has been successful in creating three-dimensional structures using bovine muscle cells, but for this sampling they claim to have made the meat entirely from edible materials. The keys to this are a culture liquid that contains edible serum used to grow the cells, and a gel made from edible blood plasma used to create three-dimensional structures. (Nisshin Foods Holdings 2022/3/31)

Gryllus enters the edible cricket and feed markets

Gryllus, a Tokushima University venture company developing genome-edited crickets and the largest producer of edible crickets, has established a production and processing base in Mima City, Tokushima Prefecture, and is currently set up to produce 10 tons/year of cricket powder. The plant aims at 60 tons/year by the end of 2023. On April 15, the company established a new brand of animal feed using crickets as the basic material and launched sales of feed for reptiles. The company says it is also considering marketing crickets as feed for marine and livestock animals. (Gryllus 2022/4/15)

Launch of university-originated gene-editing plant venture

Gra&Green (gGrand Greenh) Inc., a university-based venture company (representative, Yuki Tanba) that improves plant varieties using genome editing technology, is going into full swing after completing financing. The company will be located in Nagoya University and a research farm is due to be established in Toyohashi City. (Gra&Green 2022/4/13)

Osaka University and Shimadzu Corporation jointly develop cultured meat

On March 28, Professor Noriya Matsuzaki at Osaka University's Graduate School of Engineering, announced that he would develop a technology to automatically produce cultured meat using a 3D printer in cooperation with Shimadzu Corporation and Sigmaxyz Holdings Inc., a consulting company. Cultured meat is still expensive, and the company plans to initially target the development of high-quality meat costing more than 10,000 yen per 100 grams. (Osaka University 2022/3/28)

Using plant-derived sugars as materials for bio-plastics applications

The Green Earth Institute, a bio-venture, announced that it would team up with Mitsui Chemicals to conduct research and development for the production of biomass plastics, sending the stock price of Green Earth soaring. Using plant-derived sugars as raw material, a substance produced from bio-isopropanol by fermentation has been used, for example, as a cleaning agent, but Mitsui Chemicals now plans to produce polypropylene from this raw material. (Nikkei Biotech Online Edition 2022/4/1)

Moderna, Inc. sued for patent infringement

Moderna, Inc., the venture company that developed mRNA vaccines, has been sued for patent infringement over lipid nanoparticles used to envelop mRNA. The patent belongs to Arbutus Biopharma Corp., a Canadian company that licensed it to Acuitas Therapeutics. Acuitas then issued a sublicense to Moderna, Inc. However, the scope of the license to Moderna, Inc. was limited when the Swiss Genevant was spun off from Arbutas and Genevant licensed it to BioNTech. On February 28, Arbutas and Genevant filed a patent infringement lawsuit in the US District Court for the District of Delaware, though it did not appear that an injunction or claim would be issued until the pandemic was contained. (Nikkei Biotech Online Edition 2022/3/10, and others)

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