Ascentage Pharma and Tanner Pharma Group Initiate a Global Innovative Named Patient Program

SUZHOU,China and ROCKVILLE,Md. and CHARLOTTE,N.C.,July 25,2022 -- Ascentage Pharma (6855.HK),a global biopharmaceutical company engaged in developing novel therapies for cancers,chronic hepatitis B (CHB),and age-related diseases,and Tanner Pharma Group ("Tanner Pharma"),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 basisin 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 Programsare 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) targetingBCR-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. Such acquired resistance to TKIs is a major challenge in the treatment of CML. BCR-ABL kinase mutations represent a key mechanism of acquired drug resistance; T315I,which is the most- common drug-resistant mutation,occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors,hence presenting an urgent and high unmet medical need for third-generation BCR-ABL inhibitors to more effectively and safely target the T315I mutation.

Developed by Ascentage Pharma,olverembatinib is a novel third-generation BCR-ABL inhibitorthat 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 patients2.

Tanner Pharma Group is a specialist pharmaceutical services provider based in Charlotte North Carolina,USA with offices in Europe and Latin America. Through its Managed Access Programs division,Tanner supports manufacturers by providing ethical,controlled and compliant access to their innovative medicines in countries where they are not commercially accessible. Tanner has been enabling patient access to medicines for more than 20 years in over 130 countries and has extensive experience supporting CML 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 topatients withCML 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."

References:

1. Qiu H,Zhou Z,Zhou Y,et al. Promising antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor- (TKI-) resistant succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST). J Clin Oncol 40,2022 (suppl 16; abstr 11513).

2. Chan M,Holland EC,Gujral T. Olverembatinib inhibits SARS-CoV-2-Omicron variant-mediated cytokine release in human peripheral blood mononuclear cells. EMBO Mol Med. 2022 May 17;e15919.

Healthcare professionals can obtain details about the Olverembatinib Named Patient Program by contacting Tanner Pharma at:

Telephone: +1 704 552 8408

Email: olverembatinib@tannerpharma.com

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers,chronic hepatitis B,and age-related diseases. On October 28,2019,Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.

Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis,or programmed cell death. The company has built a pipeline of eight clinical drug candidates,including novel,highly potent Bcl-2,and dual Bcl-2/Bcl-xL inhibitors,as well as candidates aimed at IAP and MDM2-p53 pathways,and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 50 Phase I/II clinical trials in the US,Australia,Europe,and China. To date,Ascentage Pharma has obtained a total of 15 ODDs,2 FTDs,and 2 Rare Pediatric Disease (RPD) designations from the FDA and 1 ODD from the EU for four of the company's investigational drug candidates.

Leveraging its robust R&D capabilities,Ascentage Pharma has built a portfolio of global intellectual property rights and has entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology,MD Anderson Cancer Center,Mayo Clinic,Dana-Farber Cancer Institute,Merck,AstraZeneca,and Pfizer. The company has built a talented team with global experience in discovering,developing,launching,and commercializing innovative drugs and is setting up world-class commercial manufacturing and sales & marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs,in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

About Tanner Pharma Group

Tanner Pharma Group is a specialist pharmaceutical services provider based in Charlotte North Carolina,USA with offices in Europe and Latin America. Tanner provides a portfolio of service offerings focused on improving the global access to medicines. Through its Tanner MAP division,Tanner supports manufacturers with ethical,controlled,and compliant access to their innovative medicines in countries where they are not commercially accessible. For more information,visit www.tannerpharma.com and connect with us on LinkedIn and Twitter.

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