On April 6, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that it has entered into a memorandum of understanding for a partnership with China Resources Pharmaceutical Group Limited (HKEX 3320.HK, "CR Pharma") with the intent to establish an independent company ("the mRNA Co.") focused on the discovery, development and commercialization of messenger RNA ("mRNA") vaccines (Press release, Everest Medicines, APR 6, 2022, View Source [SID1234611541]).

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CR Pharma is a subsidiary of China Resources (Holdings) Co., Ltd, a key state-owned enterprise overseen by China’s State-owned Assets Supervision and Administration Commission of the State Council (SASAC). CR Pharma is an integrated pharmaceutical company in China, engaging in the R&D, manufacturing, and distribution of pharmaceutical products. Their products include chemical drugs, traditional Chinese medicine, biological drugs and supplements, which cover a wide range of treatment fields, including the cardiovascular system, digestive tracts, metabolism, large-volume intravenous infusion, pediatrics, the respiratory system, Coagulation disorders and immune diseases, etc.

Through this proposed partnership with CR Pharma, the mRNA Co. will be well-positioned to advance its potentially best-in-class mRNA vaccine candidates through Chinese regulatory pathways and into commercialization. Under the terms of the MOU, the mRNA Co. will be a fully functional, independent operating company, by assuming the rights under the existing collaboration with Providence Therapeutics Holdings Inc. ("Providence"), including the full technology platform, as well as Everest’s mRNA manufacturing infrastructure. Everest will be the majority and controlling shareholder of the mRNA Co.

The mRNA Co. will accelerate the late-stage development and registration of its potentially best-in-class mRNA COVID-19 vaccine candidate, PTX-COVID19-B, and continue the development of a second-generation COVID-19 vaccine with broad spectrum activity designed to be effective against but not limited to the Omicron variants, as well as two Collaboration Project with Providence that target new mRNA based vaccines. The mRNA Co. will also continue to advance the construction of Everest’s global GMP manufacturing site in Jiashan, Zhejiang Province, which is expected to be operational by the end of 2022. Once complete, the first phase of manufacturing will be dedicated to PTX-COVID19-B, with an expected annual capacity of 700-800 million doses.

CR Pharma comments that through this cooperation with Everest Medicines, the two companies intend to work together in the development of mRNA COVID-19 vaccine and the development of other potential products using the mRNA technology platform, so as to contribute to China’s public health.

"We are pleased with Everest’s ability to continually grow the business, as well as its industry leadership and reputation, by executing strategic collaborations and partnerships with key stakeholders like CR Pharma, which provide valuable expertise and resources to critical ventures such as this," said Wei Fu, Chairman of Everest Medicines and Chief Executive Officer of CBC Group. "This potential collaboration propels forward the development of Everest’s mRNA vaccines, and shows our commitment to bring highly sought-after mRNA vaccines to China."

The lead vaccine candidate for development under Everest’s mRNA technology platform is PTX-COVID19-B, a potentially best-in-class lipid nanoparticle formulated mRNA vaccine with strong immunogenicity and tolerability profiles and has been shown to generate high titer neutralization against the original and variant strains of SARS-CoV-2 in an S protein-typed pseudovirus assays. Based on data from the Phase 1 trial, neutralizing antibody levels at Day 42 were 8.6 times and 23 times higher than convalescence sera in the 40μg and 100μg dose levels, respectively.

Everest’s licensing partner Providence is currently evaluating PTX-COVID19-B in a head-to-head clinical trial against Pfizer-BioNTech’s Comirnaty COVID-19 vaccine. Everest and Providence expect to report top line data in mid-2022, and if positive, this study together with a required safety dataset can support emergency marketing authorization with a stringent Western regulatory authority. Everest and Providence also plan to initiate a registrational booster vaccine trial in 2022 to further expand the indication of PTX-COVID19-B.

About PTX-COVID19-B

PTX-COVID19-B is an mRNA vaccine in Phase 2 development for the treatment of COVID-19, which encodes the full-length S protein of SARS-CoV-2 encapsulated in a lipid nanoparticle (LNP). Interim data from Providence’s Phase 1 study showed that PTX-COVID19-B generated strong virus neutralization activity and produced a level of antibodies in participants in the treatment arm that compare favorably to those produced by other mRNA vaccines that have been approved for use against COVID-19. The treatment was generally safe and well tolerated.

In September 2021, Everest entered into a strategic partnership with Providence Therapeutics Holdings Inc. ("Providence") to advance mRNA vaccines and therapies. Under the terms of the agreement, Everest owns the rights Providence’s mRNA vaccine candidates, including PTX-COVID19-B, in Greater China, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Pakistan, Philippines, Singapore, Thailand, Timor-Leste and Vietnam. Everest and Providence also entered into a 50/50 global collaboration under which Everest is enabled to create and develop products using Providence’s mRNA platform for product discovery across a broad range of other prophylactic and therapeutic areas.