On the afternoon of October 2, the Karolinska Institute in Sweden announced that the 2023 Nobel Prize in Physiology or Medicine was awarded to Katalin Karikó.（Katalin Karikó）and Drew Weissman（Drew Weissman）, in recognition of their contributions to messenger ribonucleic acid（mRNA）The discovery of nucleoside base modifications has enabled the development of anti-COVID-19 mRNA vaccines at an unprecedented speed.

On September 12, the FDA announced the emergency authorization of two COVID-19 vaccines targeting the XBB variant, aimed at preventing severe outcomes of COVID-19, including hospitalization and death. These two COVID-19 vaccines are updated mRNA vaccines developed by BioNTech as well as Moderna and Pfizer.

In addition to preventing COVID-19, mRNA technology is mainly applied in the fields of infectious diseases and tumors. The field of infectious diseases includes influenza, HIV, RSV, shingles, tuberculosis, bacterial meningitis, etc.; tumor vaccines and drugs, protein replacement therapy.(Often used for some rare diseases), which is the main development direction in the mRNA field in recent years and also the field with the most expectations from major pharmaceutical companies.Research reports predict that the non-COVID mRNA market size is expected to reach 28.1 billion US dollars by 2025, indicating broad market prospects for the mRNA industry chain.

According to incomplete statistics, more than 10 Chinese companies have entered the mRNA vaccine research and development field, includingCSPC, Abogen, AIM Vaccine, Stemirna Therapeutics, Shanghai Rnacure Biopharma, CanSinoBIO, Olymvax, INNORNA, Immornaetc.

On March 22 this year,CSPC Pharmaceutical Group LimitedCSPC's COVID-19 mRNA vaccine (SYS6006) included in emergency use in ChinaThe first domestically produced COVID-19 mRNA vaccine in China. This vaccine coversThe core mutation sites of Omicron BA.5 variant provide a good cross-protection effect against the Omicron strain.5On the 13th,SYS6006The first shot in China was administered in Shijiazhuang, officially starting the vaccination campaign.

In the 4,000-subject sequential booster immunization clinical study conducted during the pandemic (December 10, 2022 - January 18, 2023), with a recombinant protein vaccine as the control, the protective efficacy of SYS6006 was 70.2% (95% CI: 53.6%-80.9%) within 7-28 days after the booster dose; the protective efficacy of SYS6006 was 85.3% (95% CI: 56.9%-95.0%) within 14-28 days after the booster dose.

Earlier, the mRNA COVID-19 vaccine frontrunners were Abogen andWalvax BiotechnologyThe mRNA COVID-19 vaccine, which is a collaborative effort, has long been in the phase III clinical trial stage. The vaccine is currently only available inIndonesiaGranted emergency use authorization, but not yet approved in China.

In January 2022, *The Lancet Microbe* published the phase 1 clinical trial data of Abogen Biosciences' COVID-19 mRNA vaccine. The results showed that, in terms of safety, no serious adverse events were reported within 56 days after vaccination with Abogen’s COVID-19 mRNA vaccine, but a series of mild or moderate adverse events occurred.

In addition, Walvax BiotechAlso withShanghai Rnacure Biopharma Co., Ltd.Cooperation has been established.mRNA Vaccine（RQ3013）。The 2023 semi-annual report mentioned that the company is actively promoting the vaccine's marketing authorization and drug registration application.Related Work.

According toRQ3013 is an innovative broad-spectrum mRNA vaccine against COVID-19. The vaccine incorporates key mutation sites of the S protein from the Alpha and Beta variants and includes multiple critical immune escape sites from the Omicron variant. It is the world’s first chimeric design to enter clinical research.. The drug'sStage IIIbClinical TrialThe main results showed that no serious adverse events occurred after the administration of RQ3013 or the control vaccines. Moreover, RQ3013 demonstrated significantly superior performance in terms of virus neutralizing antibodies and protective efficacy compared to the two control vaccines. These findings indicate that a single dose of RQ3013 as a sequential booster in healthy individuals aged 18 years and above, who have previously received three doses of inactivated COVID-19 vaccine, exhibits good safety and effectiveness.

CanSinoBIO earlierGained attention due to the adenovirus vector COVID-19 vaccine, meanwhile, the companyAlso laying out mRNA vaccines. The 2023 half-year report shows that its mRNA COVID-19 vaccine has completed the Phase 2b clinical trial.According to media reports, in January 2023, the phase one production project of CanSinoBIO's COVID-19 mRNA vaccine CS-2034 was also established in Shanghai, with a designed capacity of 100 million doses. It has currently entered the verification stage and started trial production.

On August 7 this year, CanSinoBIO andAstraZenecaCanSinoBIO announced that the collaboration, under the "Product Supply Cooperation Framework Agreement," will focus on leveraging the company's mRNA production platform to support the development of specific vaccines.

Stemirna Therapeutics Co.,Ltd.Also a star company in China's mRNA sector.It was established in 2016 and is a platform-based innovative pharmaceutical company in China that pioneered the research and development, production of mRNA innovative vaccines, and nanoliposome encapsulation delivery technology services.In December 2022, SW-BIC-213, a product of Stemirna Therapeutics Co., Ltd., received Emergency Use Authorization (EUA) in Laos. This marked the first time that a Chinese mRNA vaccine targeting a COVID-19 variant strain had been granted an EUA. On May 25, 2023, Stemirna Therapeutics announced that the Phase III clinical trial for this vaccine has been completed in Laos, meeting its primary endpoint. Relevant data has been submitted on a rolling basis to the National Medical Products Administration (NMPA) for the application of domestic Emergency Use Authorization.

In addition to the COVID-19 vaccine, Stemirna Therapeutics Co., Ltd. is also developing an mRNA tumor vaccine. Its most advanced mRNA personalized tumor vaccine has entered Phase I clinical trials in Australia, making it the first personalized cancer vaccine in China to reach clinical trials, comparable to those developed by Moderna and BioNTech.

However, in July this year, it was reported that the Tianci Factory of Stemirna Therapeutics Co., Ltd. suspended trial operations starting from July 21, 2023.Okay. In this regard,Stemirna Therapeutics Co., Ltd. responded to the media, stating that the main reason is the existence of objective factors in the general environment. As there will be no immediate demand for the production of COVID-19 vaccines recently, they have decided to temporarily suspend trial operations and refocus their main efforts on research and development.On August 24th, Stemirna Therapeutics Co.,Ltd.RawThe company announced on its WeChat Official Account that it would launch CDMO business, namely contract manufacturing.

AIM VaccineIn the 2023 semi-annual report, it was mentioned that the company is developing a bivalent mRNA COVID-19 vaccine. As of now, a clinical trial application has been submitted in China, and a Phase III clinical trial commenced on March 25, 2023, in Pakistan. This clinical trial is currently in its final stages.

As early as December 7, 2020,Trillion-Dollar Private Vaccine GiantZhiFei BioAnnounced that the company plans to subscribe with its own funds of RMB 35 million.INNORNAWith 10.189% equity, INNORNA has built a leading technology platform in the field of mRNA, particularly in LNP delivery technology. However, the 2023 semi-annual report only mentioned INNORNA as an equity-participating company without providing any other information.

In July 2022, INNORNABeiGeneReach Global Strategic Cooperation. According to the terms of the agreement, INNORNA willBeiGeneReceive an upfront payment and are entitled to additional payments and tiered royalties based on the research and development progress, regulatory progress, and commercialization milestones achieved in the mRNA-LNP collaborative research project.BeiGeneWill have the global exclusive rights to develop and commercialize the jointly developed mRNA-LNP products. Additionally, through grantingBeiGeneUnder the non-exclusive license for the use of its proprietary LNP technology platform, INNORNA will receive an additional upfront payment and is entitled to receive further milestone payments.

In addition, there areBaike Biotech, CR PharmaceuticalPharmaceutical companies, in the form of commercial cooperation, are entering the layout of the mRNA field.

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