China Resources Pharmaceutical Group (“CR Pharma”) Intends to Make Strategic Equity Investment for Everest’s mRNA Technology Platform
Partnership with CR Pharma will provide local support to navigate China regulatory pathways through mRNA vaccine platform, first in advancing Everest’s potentially best-in-class COVID-19 vaccine candidate
SHANGHAI, April 6, 2022 /PRNewswire/ — Everest drugs (HKEX 1952.HK, “Everest” or the “Company”), a biopharmaceutical company focused on the development and commercialization of transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that it has entered into a memorandum of understanding for a partnership with China Resources Pharmaceutical Group Limited (HKEX 3320.HK, “CR Pharma”) to establish an independent company (“the mRNA Co.”) focused on the discovery, development and commercialization of messenger RNA (“mRNA”) vaccines.
CR Pharma is a subsidiary of China Resources (Holdings) Co., Ltd, a key state-owned company overseen by China State Property Supervision and Administration Commission of the State Council (SASAC). CR Pharma is an integrated pharmaceutical company in China, engaged 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 areas, including cardiovascular system, digestive tract, metabolism, large volume intravenous infusion, pediatrics, the respiratory system, bleeding disorders and the immune system. illnesses, etc.
Through this proposed partnership with CR Pharma, 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 memorandum of understanding, mRNA Co. will be a fully functional and independent operating company, assuming the rights under the existing collaboration with Providence Therapeutics Holdings Inc. (“Providence“), including the complete technology platform, as well as Everest’s mRNA manufacturing infrastructure. Everest will be the majority and controlling shareholder of mRNA Co.
The mRNA Co. will accelerate late-stage development and registration of its potentially leading COVID-19 mRNA vaccine candidate, PTX-COVID19-B, and will pursue development of a COVID-19 vaccine by second-generation broad-spectrum activity designed to be effective against, but not limited to, Omicron variants, as well as two collaborative projects with Providence that target new mRNA-based vaccines. mRNA Co. will also continue to push forward the construction of Everest’s global GMP manufacturing site in Jiashan, zhejiang provincewhich should be operational at the end of 2022. Once completed, the first manufacturing phase will be dedicated to PTX-COVID19-B, with an expected annual capacity of 700 to 800 million doses.
CR Pharma comments that through this cooperation with Everest Medicines, the two companies intend to work together in the development of the COVID-19 mRNA vaccine and the development of other potential products using the mRNA technology platform, in order to contribute to China 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 such as CR Pharma, which provide valuable expertise and resources to critical businesses such as this,” said Wei Fu, President of Everest Medicines and CEO of CBC Group. “This potential collaboration propels the development of Everest’s mRNA vaccines and demonstrates our commitment to delivering highly sought-after mRNA vaccines. 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 profiles of immunogenicity and tolerability and has been shown to generate high titer neutralization against original and variant strains of SARS-CoV-2 in a protein S-like pseudovirus assay. Based on data from In the phase 1 trial, neutralizing antibody levels at day 42 were 8.6 times and 23 times higher than convalescent sera at the 40 μg and 100 μg doses, respectively.
Everest License 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 frontline data in mid-2022, and if positive, this study along with a required set of safety data may support emergency marketing authorization from a strict Western regulatory authority. Everest and Providence also plan to initiate a registration booster vaccine trial in 2022 to further expand the indication for 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 SARS-CoV-2 protein S encapsulated in a lipid nanoparticle (LNP). Provisional data from of Providence The phase 1 study showed that PTX-COVID19-B generated strong virus-neutralizing activity and produced a level of antibodies in participants in the treatment arm that compared favorably to those produced by other vaccines at mRNA that has been approved for use against COVID-19. Treatment was generally safe and well tolerated.
In September 2021Everest has entered into a strategic partnership with Providence Therapeutics Holdings Inc. (“Providence“) to advance vaccines and mRNA-based therapies. Under the terms of the agreement, Everest owns the rights of Providence mRNA vaccine candidates, including PTX-COVID19-B, in Greater China, Brunei, Cambodia, Indonesia, Laos, Malaysia, Burma, Pakistan, Philippines, Singapore, ThailandTimor-Leste and Vietnam. Everest and Providence also entered into a 50/50 global collaboration under which Everest is able to create and develop products using of Providence mRNA platform for product discovery in a wide range of other prophylactic and therapeutic areas.
About drugs Everest
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address the critical unmet medical needs of patients in Asian markets. Everest Medicines’ management team has deep expertise and extensive experience in high quality clinical development, regulatory affairs, CMC, business development and operations in both China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eleven potentially first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune diseases, cardio-renal diseases and infectious diseases. For more information, visit their website at www.everestmedicines.com.
This press release may contain statements that constitute forward-looking statements, including descriptions concerning the current intention, belief or expectations of the Company or its officers with respect to the Company’s business activities and financial condition. , which can be identified by terminology such as “will”, “expect”, “anticipate”, “future”, “intend”, “plan”, “believe”, “estimate”, ” trust” and similar statements. These forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the Company’s control and cannot be predicted. Therefore, actual results may differ from those in forward-looking statements due to various factors and assumptions, such as future changes and developments in our business, the competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives is under no obligation and does not undertake to revise any forward-looking statements to reflect new information, future events or circumstances after the date of this press release, except as required by law. .
SOURCE Everest Medicines