EkaLore has previously released looks at the rise of mRNA vaccines as the global nSars-Covid-19 pandemic has run across the globe in multiple waves. This release is a brief look and Alien Sighting report on some of the developments looking at the competition for Pfizer/BioNTech and Moderna in global markets.
Fosun Pharma’s agreement with BioNTech for mRNA products and a manufacturing license actually predates Pfizer. BioNTech’s agreement with Fosun provided exclusive access to the markets in China, Hong Kong, and Macau in return for a investment position and other terms. Almost three years later there is no approval for Fosun’s imported BioNTech product nor for domestic Chinese production of the BioNTech BNT162b2 Covid-19 vaccine. Chinese regulatory approval has not been forthcoming with even limited access by expatriates and foreigners subject to limits.
Chinese hopes for an mRNA vaccine focused on Suzhou Abogen Biosciences, founded in 2019 by a Moderna alumnus, which has developed AwCorna. AwCorna was developed cooperatively with the PLA Academy of Military Sciences, and Walvax Biotechnology Co. Ltd. Abogen has raised more than USD$1.7B to fund the development and establish a manufacturing plant targeted for 120M doses per year. The manufacturing plant development was specifically to provide a domestic production source and technology. Trials begun in 2020 had Phase III readouts in peer-reviewed form in early 2022 with continued work on targeting Omnicron and subsequent VOC’s. The vaccine has received EUA approvals in Indonesia with work continuing for China.
Indian hopes for an mRNA vaccine (GEM-COVAC19) focused on Pune-based Gennova Biopharmaceuticals. Further development showed only a short timeline was needed to tweak the novel preparation for Omnicron and subsequent VOC’s. GEM-COVAC19 was novel using self-amplifying RNA and a freeze-dried preparation method enabling transport and storage at merely refrigerator (not CO2 ice) temperatures. After trials, GEM-COVAC19 has received EUA in India though not a high volume.
In Germany Curevac’s CVnCoV mRNA-technology vaccine did not show high efficacy in clinical trials with many different variants a problem. Continued research (in cooperation with GSK) in ongoing for a next-generation product.
In Japan, Takeda did import the Moderna product into the Japanese market. Takeda’s manufacturing efforts were focused on NovaVax’s TAK-019 vaccine. Though a highly capable biopharma contract manufacturer Takeda has not taken on mRNA technology. Moderna has subsequently acquired a Japanese concern, OriCiro Genomics, where it will focus on next-generation manufacturing development. Takara has announced intentions to provide components and production elements for mRNA vaccine production though no products have been to market in over 12 months.
In Korea mRNA vaccine production of the Moderna mRNA-1273 product was undertaken by Samsung Biologics manufacturing under license. Even though only started as a product line in May 2021 there was the approval of the product in December 2021 for Korea. Samsung is also able to export production volumes to other countries.
Across highly capable markets in China, Japan, Korea, and India production of mRNA vaccines has been unsuccessful at scale at all plants except Samsung Biologics. The rigorous supply chain development, difficult manufacturing process steps, and need for highly qualified manufacturing talent has shown how exceptionally successful manufacturing at Pfizer, Moderna, and BioNTech has been. The continued need for rapid turnaround of new products meeting emergent requirements for VOCs strains the demonstrated requirements of adaptive flexible manufacturing.
Alien Sightings is a regular feature of EkaLore’s Alien Invader series where we spot organizations that are entering new markets and taking share and profit almost immediately from incumbent market players. If you are looking to expand to new markets, or if you are worried about defending against such invaders, you’ll find our Alien Invader series informative – www.Ekalore.com/alien-invaders
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