Asian Tech Press -- Fosun Pharma may receive approval for the BioNTech-developed mRNA COVID-19 vaccine in China, unveiling the tip of the iceberg of China's thriving capital market for mRNA vaccines.
On July 5, the healthcare recruitment platform Yimaitongdao showed that Jiangsu Fosun Pharmaceutical Sales Co. Ltd., a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", 02196: HK), began recruiting for the Senior Medical Information Communication Specialist for Vaccines and Regional Sales Manager for Vaccines, with locations in Shanghai and three cities in Guangdong Province, namely Shenzhen, Zhanjiang and Maoming.
The staff needed for the above positions are responsible for the COVID-19 vaccine product, developed in collaboration with China and Germany, which is based on a third-generation mRNA technology.
The above information means that China may soon approve the mRNA vaccine, the COVID-19 vaccine developed by Fosun Pharma and German company BioNTech SE (NASDAQ: BNTX), which is called Fubitai in Chinese.
1. Fubitai, the mRNA vaccine produced by Fosun Pharma in cooperation with BioNTech
Fosun Pharma is one of the first investors to focus on the development of mRNA technology. Dr. Aimin Hui, President of Global R&D Center and Chief Medical Officer of Fosun Pharma, once said that the company closely followed this market in the early stage of the pandemic.
After visiting three leading companies, Moderna Inc, CureVac N.V., and BioNTech, Fosun targeted BioNTech for cooperation in late January 2020.
Fosun Pharma introduced the new mRNA COVID-19 developed by BioNTech in collaboration with America-based Pfizer Inc. (NYSE: PFE), named Fubitai. It has been mass vaccinated in Europe, the US, and other developed countries.
At the Fosun Pharma's annual general meeting held on June 11, 2021, Beijing time, the company said that Fubitai is still waiting for approval. At present, the approval process regarding pharmacology is basically completed, and the company has basically sorted out the subsequent approval requirements and information.
At the meeting, Fosun Pharma revealed that it has been working with BioNTech on technology transfer and equipment ordering, and that BioNTech has sent experts to Fosun Pharma's Jinshan plant in Shanghai to work with the Chinese firm's team. It is expected that the localized production line will be completed in August and start normal production.
Some industry insiders have made the point that in the cooperation between Fosun Pharma and BioNTech to establish a joint venture, the former acts as the latter's agent in China, and its nature is to exchange the market for technology.
As early as May 9, Fosun Pharma issued an important announcement that one of its wholly-owned subsidiaries, Shanghai Fosun Pharmaceutical Industry Development Co. Ltd., proposed to invest in a joint venture with BioNTech to localize the production and commercialization of mRNA COVID-19 vaccine products.
According to the announcement, both parties will respectively subscribe 50% of the registered capital of the joint venture. Fosun's subsidiary intends to contribute up to $100 million in cash and/or tangible or intangible assets, and BioNTech plans to invest up to $100 million in intangible assets such as its relevant production technology and proprietary technology licenses.
The parties also agreed that Fosun Pharma Industry shall provide production facilities with an annual capacity of up to 1 billion doses of mRNA COVID-19 vaccine as part of the registered capital.
2. Development of mRNA vaccine in China
Since the outbreak of COVID-19 in 2020, among the five technical routes for vaccine development worldwide, mRNA technology has attracted much attention for its advantages of precision treatment.
According to media reports, three pharmaceutical companies in China have already received approvals for clinical trials, namely Suzhou Abogen Biosciences (AbogenBio), Shanghai-based Stemirna Therapeutics Co., Ltd. (Stemirna Ther), and Zhuhai Lifanda Biotechnology Co (Lifanda Bio).
ARCoV, an mRNA COVID-19 vaccine jointly developed by AbogenBio, the PLA Academy of Military Science, and Walvax Biotechnology Co., Ltd. (Walvax), is the first mRNA vaccine approved for clinical trials in China, and is currently the most advanced mRNA vaccine developed locally in China.
On May 11, Mexica's foreign minister Marcelo Ebrard confirmed that ARCoV, planned to begin Phase III trials in the country on May 30, with an expected 6,000 volunteers involved.
In a previous media interview, AbogenBio's head revealed that if everything goes well, there will be an all-year manufacturing capacity for 120 million doses from the third quarter of 2021, allowing for hundreds of millions of multi-dose vials of vaccines for foreign export.
In addition to AbogenBio, Stemirna Ther and Lifanda Bio are also getting approvals for clinical trials.
On January 5, 2021, Hong Kong-based Tibet Pharmaceuticals Inc. announced that it had been informed that Stemirna Ther had received approval from the National Medical Products Administration (NMPA) to conduct clinical trials of mRNA COVID-19 vaccine.
Lifanda Bio is registered in the Guangdong-Macao Co-operation Traditional Chinese Medicine Science and Technology Industrial Park (GMTCM Park) in Hengqin, and has its own mRNA production and drug delivery platform.
In February 2020, Dr. Yucai Peng, founder of Lifanda Bio, revealed that antibodies were found in animal experiments. However, it was not until March 2021 that news emerged that clinical approvals were obtained.
In terms of the public schedule, Fosun Pharma and AbogenBio (jointly with Walvax) are progressing faster and may be the first group of Chinese companies to enter production for mRNA COVID-19 vaccines.
3. Prospects of mRNA vaccines in China
To date, there are two mRNA vaccines available worldwide that have been approved for marketing or emergency use in over 60 countries and regions, namely Fosun Pharma/BioNTech/Pfizer BNT162b2, and mRNA-1273 developed by American company Moderna Inc. The two vaccines have demonstrated protection rates of over 90% in Phase III clinical trials.
Since the outbreak, there have been a number of cases of Chinese pharmaceutical companies collaborating with mRNA vaccine makers, in addition to Fosun Pharma.
On May 20, 2020, CanSino Biologics Inc (6185: Hong Kong) and Canada's Precision NanoSystems (PNI) jointly developed a vaccine based on mRNA lipid nanoparticle (mRNA-LNP) technology.
On December 7, 2020, Chongqing Zhifei Biological Products Co., Ltd announced that it intended to subscribe 10.189% equity of Shenzhen-based biotech firm Innorna with self-owned capital of 35 million yuan, becoming the third-largest shareholder of the latter. Zhifei Bio has hoped to venture into the mRNA vaccine field in this way.
It can be said that the outbreak of the COVID-19 has pushed the mRNA pharmaceutical industry to an unprecedented climax, and the Chinese mRNA pharmaceutical industry has finally ushered in the spring of development.
Large financing for mRNA technology companies has also received attention. AbogenBio announced to the public in April this year that it had completed a Series B financing totaling 600 million yuan.
On May 31 this year, AIM Biotech Pte. Ltd. announced to complete the acquisition of Lifanda Bio with a holding of 50.1546%. Industry insiders believe this move will also accelerate the production and marketing of China-made mRNA COVID-19 vaccines.
In early June, Stemirna Ther said the formal completion of a new round of financing of $200 million, which set a new record for a single round of financing for Chinese mRNA vaccine companies.
With the promotion of multiple capitals, the mRNA vaccine has become a cross-over track in the vaccine field. An industry insider said, "The epidemic has increased the cooperation between companies, such as joint R&D. People are also often communicating together about COVID-19 and (vaccine) developments. As of now, it is still crucial to control the epidemic."
Who is the final winner on the track of mRNA vaccines? Everything will have to wait for the test of time.
