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On December 16, China Resources 39 and Oncoceutics reached a authorized partnership to obtain exclusive development, production and commercialization rights for onC201, an innovative glioma drug product in Greater China (Chinese mainland, Hong Kong, Macau and Taiwan).
under the licensing agreement, China Resources will make down payments, milestones and sales credits to Oncoceutics.
will also be responsible for the clinical development of ONC201 in China to obtain listing licenses and commercialization in the Chinese market.
ONC201, a core product developed by Oncoceutics, is currently at a critical clinical stage and is a new small molecule with a unique mechanism of action that has proven its anti-cancer activity and safety in a number of clinical trials, including in adult and child patients with high-level gliomas.
these trials focused primarily on gliomas containing the H3 K27M mutation, which can be identified by immunogroupization or gene sequencing, including FDA-approved companion diagnostic technique FoundationOne CDx.
H3 K27M mutated glioma is a subsysm of cerebral glioma, defined by molecular parting, with poor prognosis.
, the FDA recently awarded ONC201 fast-track qualification for the treatment of adult relapsed H3 K27M mutant high-level gliomas, orphan drug qualification for the treatment of glioblastomas and H3 K27M mutant gliomas, and identification for rare pediatric diseases for the treatment of H3 K27M mutant gliomas. Dr Lee Schalop, CEO of
Oncoceutics, said: "We are delighted to partner with China Resources 39, which is committed to innovative therapies, and China Resources 39 is the ideal partner to bring ONC201 to patients in China with H3 K27M mutant gliomas and other related adaptations.
agreement will drive the development of ONC201 in the global market, enough to give Chinese patients with serious illnesses better treatment options.
, ONC201 has the potential to expand to other cancers that have similar responses to the paths involved.
are excited about the drug's promise to introduce a truly innovative treatment model for dopamine-signaled tumors.
Huawei, President of China Resources 39, said,
We are confident that with the assistance of Oncoceutics' excellent team, this new treatment can be brought to China to bring better treatment options to patients.
""ONC201 is expected to promote China's pediatrics and adult cerebral glial tumor treatment breakthrough, in line with China Resources 39 strategic direction, help the company to expand product layout, promote the company's innovation and transformation.
we are pleased to be working with Oncoceutics and have the potential to develop a wide range of cancers that are responsive to ONC201 in the future.
" About China Resources 39 China Resources 39 is a large state-controlled pharmaceutical listed company of China Resources Pharmaceutical Group, mainly engaged in pharmaceutical product research and development, production, sales and related health services.
listed on the Shenzhen Stock Exchange on March 9, 2000 and officially entered China Resources Pharmaceutical Group in 2008.
company's products cover a wide range of products, product lines, including prescription drug business varieties covering pediatrics, oncology, anti-infection, cardiovascular, digestive system, orthopaedic and other therapeutic fields.
China Resources 39 to "care for the public health, create a better life" as the mission, is committed to become the leader of the mass medical and health industry.
About Oncoceutics Inc., a clinical-stage drug discovery and development company, has a new class of compounds called imipridones that selectively target G-protein coupled subjects for tumor therapy.
ONC201, an orally active small molecule DRD2 antagonist and ClpP astrogen, is conducting post-clinical trials for H3 K27M mutant gliomas, as well as developing other adaptations.
onC206 is the second clinical phase of the imipridones, which is currently undergoing clinical studies for the treatment of central nervous system tumors.
the company received funding from the NCI, FDA, Musella Foundation, Michael Mosier Defeat DIPG Foundation, Dragon Master Foundation, Chad Tough Foundation, National Brain Tumor Association, and a number of private and public partners.
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