Ascentage Pharma, a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, and Tanner Pharma Group, a global pharmaceutical services provider of specialty access solutions, have jointly launched an innovative Named Patient Program (NPP) for olverembatinib.

This collaboration will allow access to Ascentage Pharma's novel drug candidate, olverembatinib on a named patient basis in over 100 countries and regions where the drug is not yet commercially accessible. Olverembatinib is currently approved by the National Medical Products Administration (NMPA) for use in China for adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation as confirmed by a validated diagnostic test.

Named Patient Programs are a mechanism through which physicians can legally and ethically prescribe investigational or approved drugs for patients in need prior to their commercial availability. Under the terms of the agreement, Tanner will be the supplier of olverembatinib to healthcare providers on a named patient basis in countries where the drug is not commercially available. The NPP is being launched globally, giving patients the opportunity to access olverembatinib.

CML is a hematologic malignancy of the white blood cells. The introduction of tyrosine kinase inhibitors (TKIs) targeting BCR-ABL have significantly improved the clinical management of CML. However, despite clinical benefits offered by the first- and second-generation TKIs, many patients develop drug resistance.

Developed by Ascentage Pharma, olverembatinib is a novel third-generation BCR-ABL inhibitor that can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation. Currently, olverembatinib is recommended by both the Guidelines of the Chinese Society of Clinical Oncology (CSCO) and the China Anti-Cancer Association's (CACA) Guidelines for the Holistic Integrative Management of Cancers, for the treatment of patients with TKI-resistant CML harboring the T315I mutation (while the CACA Guidelines also recommend olverembatinib for the treatment of patients with CML intolerant/resistant to at least two TKIs). As the first approved third-generation BCR-ABL inhibitor in China and the second in any country globally, olverembatinib is currently being evaluated in a Phase Ib study in the US for the treatment of drug-resistant CML. To date, olverembatinib has been granted one Fast Track designation and three Orphan Drug designations by the US FDA, and one Orphan Drug designation by the European Medicines Agency (EMA).

Olverembatinib has potential in several other indications as well. It has been included in the CSCO Guidelines for the treatment of patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Besides, in an ongoing clinical trial, preliminary results suggest potential of olverembatinib in the management of gastrointestinal stromal tumors (GIST)1 and in a preclinical study published recently, olverembatinib has shown potential in the management of Covid-19 patients.

"There is enormous unmet medical need in the treatment of CML globally. As the world's second 3rd-generation BCR-ABL inhibitor entering clinical development in the US, and one of the few China-developed novel drug candidates positioned for the global market from the very beginning, olverembatinib has demonstrated excellent efficacy and safety, leading to the marketing authorization in China last year," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. 

He added "Tanner Pharma is a world-leading pharmaceutical services provider with extensive experience in enabling access to innovative therapies when no other treatment options exist. We look forward to partnering with Tanner Pharma to provide this named patient program and expand the access to olverembatinib to patients with CML around the world."

"We are pleased to expand the work we do globally to give hope to CML patients through our partnership with Ascentage Pharma for olverembatinib," said Robert Keel, Executive Vice President at Tanner Pharma Group. "The named patient program will help ensure patients who have no alternative therapeutic options for their disease, receives access to olverembatinib in a manner that is reliable, responsible, ethical and in accordance with all country-specific regulatory requirements."