Novartis Establishes New Radiopharmaceutical Base in China to Advance Radioligand Therapy Access

Due to radioactivity, nuclear medicine products become a special high-threshold category:Research and development, clinical trials, production, and use are all subject to strict regulation.Clinical trials require professional qualifications, extensive experience in nuclear medicine diagnosis and treatment, ethical committee safeguards, and scientific and standardized management of trial institutions. More effective collaboration between hospitals and enterprises is also needed to promote the development and transformation of radiopharmaceuticals.

By utilizingRadiation Energy of Radionuclidesand apply it to advanced cancer,NovartisA new concept in cancer treatment for patients with advanced cancer – Radioligand Therapy (RLT), theoretically RLT (radioligand therapy) Can deliver therapeutic radionuclides to target tumor cells anywhere in the body. Novartis has established global expertise, specialized supply chains, and policy capabilities within its network of radioligand therapy manufacturing sites.

Under the PharmacirclePharnex Cloud Database www.pharnexcloud.comDisplay:Novartis' radioligand therapy Pluvicto (177Lu-PSMA-617) (INN: lutetium(177Lu)vipivotide tetraxetan) reported Q3 2023 revenue of $256 million, representing a 217% year-over-year increase.Performance in the first three quarters was $7.07 billionSince its launch in March 2022, Pluvicto has experienced production shortages.

▲Distributed by:Advanced Accelerator Applications USA, Inc.

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Pharnex Cloud Database www.pharnexcloud.com

In 2018, Novartis acquired Endocyte for a total price of $2.1 billion (a 54% premium), obtaining 177Lu-PSMA-617. Previously, Endocyte had acquired this product from the German company ABX for a down payment of $12 million (while retaining partial rights). This product was originally invented by scientists at the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ). Relevant patents:WO-2015055318。

▲ OpenHair Plan

On October 26, 2023, Novartis announced that the U.S. FDA had resolved the drug shortage status classification issue for Pluvicto® (lutetium Lu 177 vipivotide tetraxetan). This decision was achieved by significantly increasing the production of Pluvicto since May this year.

1.In 2018, Novartis' Lutathera (lutetium 177Lu dotatate) was approved by the FDA for marketing. It is used to treat gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs) that are positive for somatostatin receptors, marking their first radiopharmaceutical drug. In 2017, Novartis acquired Advanced Accelerator Applications (AAA) for $3.9 billion, gaining access to Lutathera. Advanced Accelerator Applications was originally established in France in 2002 as a spin-off from the European Organization for Nuclear Research (CERN). Through independent research and acquisitions, the company has built a pipeline encompassing eight diagnostic radiopharmaceuticals and one therapeutic radiopharmaceutical, along with several advanced production bases.

2. In March 2023, Novartis obtained 3B in Germany. PharmaceuticalsThe FAP-targeted peptide technology includes the exclusive licensing rights for the development and commercialization of FAP-2286 for therapeutic and imaging applications, while 3BP retains the rights to develop the FAP-targeted peptide technology for diagnostic purposes.

3BP Receives $40 Million Upfront Payment and Potential Development and Commercial Milestone Payments of Up to $425 Million (Previously Acquired Partial Rights to FAP-2286 from Clovis)