Everest Medicines Enters into a Memorandum of Understanding to Partner with China Resources Pharmaceutical Group for its mRNA Vaccines Business
- China Resources Pharmaceutical Group (“CR Pharma”) Intends to Make Strategic Equity Investment for Everest’s mRNA Technology Platform
- The partnership with CR Pharma will provide local support to navigate China’s regulatory pathways across the mRNA vaccine platform, first in advancing the potentially best-in-class COVID-19 vaccine candidate from Everest
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 pharmaceuticals to address the critical unmet needs of Asia-Pacific markets, announced today today that it had concluded 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 enterprise supervised by the China State Council’s Public Assets Supervision and Administration Commission (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 MOU, mRNA Co. will be a fully functional, independent operating company, assuming rights under the existing collaboration with Providence Therapeutics Holdings Inc. (“Providence”), including the technology platform complete, as well as Everest 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 novel mRNA-based vaccines. 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. Upon completion, the first phase of manufacturing 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 an mRNA vaccine against COVID-19 and the development of other potential products using the technology platform of mRNA, in order 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 such as CR Pharma, which provide valuable expertise and resources to critical companies such as this,” said Wei Fu, President of Everest Medicines and Chairman and CEO of CBC Group. “This potential collaboration propels Everest’s mRNA vaccine development and demonstrates our commitment to bringing 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 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’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-notch data in mid-2022, and if positive, this study along with a required set of safety data may support emergency marketing authorization. with 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). Interim data from the Providence 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 mRNA vaccines approved for use against COVID-19. 19. Treatment was generally safe and well tolerated.
In September 2021, Everest entered into a strategic partnership with Providence Therapeutics Holdings Inc. (“Providence”) to advance vaccines and mRNA therapies. Under the terms of the agreement, Everest owns the rights to Providence’s mRNA vaccine candidates, including PTX-COVID19-B, in Greater China, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Pakistan, Philippines, Singapore, Thailand and Timor-Leste. and Vietnam. Everest and Providence have also entered into a 50/50 global collaboration under which Everest is able to create and develop products using Providence’s mRNA platform for product discovery in a wide range of other prophylactic and therapies.
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 China and with major 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. .
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SOURCE Everest Medicines
Company Codes: Hong Kong: 1952, Hong Kong: 3320