News 2025-07-30
Porton Provides Support for Mednovo's RDC Drug IND
Recently, Porton Pharma Solutions Ltd. (Porton) was awarded the "2024-2025 Excellent Supplier Award" by Mednovo Group Co., Ltd. (Mednovo Group) in recognition of Porton's professional support in the R&D of Radionuclide-Drug Conjugate (RDC). This not only highly affirms close collaboration between Porton and Mednovo Group over the past year, but also lays a solid foundation for deeper partnership in RDC and broader biopharmaceutical fields.
Previously,
Mednovo Group's RDC [177Lu]oxodotreotide injection was granted implied license
for CDE clinical trial. This marked a key milestone for Porton and Mednovo
Group's first collaborative project, validating the feasibility of industrial
chain collaboration in RDC, an innovative therapeutic field.
As Mednovo
Group's CDMO partner, Porton provided comprehensive end-to-end services for the
project, including IND of polypeptide precursor and cold drug, CMC research of
ANDA, GMP production, milligram-level filling, and preparation of CTD
documents. Since the launch of the project, Porton's team has swiftly completed
intellectual property evaluation, route design, and process development &
optimization. After process confirmation, Porton team did systematic research
on key parameters which significantly boosted process yield and stability,
ensuring smooth completion of engineering and validation batches. This laid a
solid foundation for the project's expedited regulatory application.
As
a cutting-edge carrier of the "diagnosis and therapy" concept, RDCs
leverage targeting molecules such as antibodies and polypeptides to precisely
anchor to diseased tissues. They then utilize radiation emitted by
radionuclides to deliver dual values: enabling diagnosis through the generation
of high-resolution imaging, while directly killing tumor cells. This seamless
integration of "diagnosis and therapy" has propelled their
application potential in oncology and other major disease areas from theory to
clinical practice, showcasing unique therapeutic advantages and promising
market prospects.
Porton
has established an RDC CDMO service platform, which covers small-molecule radiopharmaceuticals,
liquid/solid-phase synthesis of macromolecule radiopharmaceuticals and
biological macromolecule radiopharmaceuticals. With experience in serving IND,
NDA, and ANDA projects for dozens of types of RDC clients—including Cu-labelled
precursor, Ga-labelled precursor, Ac-labelled precursor, Lu-labelled precursor,
Tc-labelled precursor, and F-labelled precursor—the platform is capable of
providing global clients with CMC solutions for radiopharmaceutical precursors
and cold drugs.
“We
are glad to note that [177Lu]oxodotreotide injection has moved one step closer
to reaching patients. Throughout our collaboration over the past year and more,
Porton team has consistently upheld professional and customer-centric service
principles. This close partnership between our two parties has laid a solid
foundation for the project’s success,” stated Xiangsheng Kong, Chief Scientist
of Mednovo Group and Academician of the Russian Academy of Natural Sciences.
About Mednovo Group
Mednovo Group is a diversified group covers R&D, production, sales, investment and financing, focusing on the medical and health industry. By adopting a "self-research + acquisitions + equity" model, Mednovo Group has established multiple medical devices and pharmaceutical projects, laying out a diversified business track. Adhering to independent innovation, strict quality standards, and an international development path, Mednovo Group deeply integrates with industry needs to commit itself to researching, developing, and providing safe, effective, and accessible medical products and services. Its business covers four major aspects: Heart & Peripheral Vessels, Tumor MIS, Brain Science, and Women's Health. Mednovo Group is dedicated to driving leaps in the healthcare industry through innovative technologies and further advancing the development of China's mini-invasive interventional field.
About Porton
Founded in 2005, Porton Pharma Solutions Ltd. is an internationally recognized pharmaceutical contract development and manufacturing organization (CDMO) in enabling our global clients to optimize drug development and manufacturing. We provide customer development and manufacturing services for Small Molecules, Tides, Biologics and Conjugates (ADCs, AOCs, PDCs, RDCs, etc.), and Advanced Therapy Medicinal Products from pre-clinical to commercialization stages.
