Luye Pharma's Innovative Anti-Cancer Therapy Lurbinectedin to Benefit "Named Patients" in Hong Kong

HONG KONG,Jan. 9,2023 -- Luye Pharma Group today announced the launch of the Named Patient Program (NPP) in Hong Kong,China,providing eligible local patients immediate access to the innovative anti-cancer therapy Lurbinectedin. Luye Pharma has signed an agreement with Abacus Medicine Pharma Services (AMPS),an international healthcare and pharmaceutical services company,the terms of which grant AMPS exclusive distribution rights of the drug for the NPP in Hong Kong.

William Van,General Manager,Abacus Medicine Pharma Services Asia Limited and Andy Siow,APAC Regional Director of Luye Pharma (International) signing distribution agreement for Named Patient Program of Lurbinectedin in Hong Kong

The Named Patient Program aims to allow patients with small cell lung cancer (SCLC) and no other treatment options immediateaccess to Lurbinectedin,supported by professional clinical assessments and in accordance with local laws,regulations and ethical requirements. The program covers all hospitals in Hong Kong.

Lurbinectedin is a selective inhibitor of oncogenic transcription. It was granted accelerated approval in 2020 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic SCLC with disease progression on or after receiving platinum-based chemotherapy. Lurbinectedin is the only new chemical entity to be approved by the FDA for the treatment of relapsed SCLC during the past 25 years. Its New Drug Application is under review by the local health authority in Hong Kong.

SCLC is a high-grade neuroendocrine carcinoma,accounting for approximately 15% of all lung cancer cases1. Most SCLC patients are already in the advanced stage upon diagnosis,resulting in poor prognosis. Their five-year survival rate is only 7%,or as low as 3% for those in the extensive stage2. Most patients with SCLC will experience a relapse or develop drug resistance after initial treatments. The high relapse rate ofthe disease poses a significant challenge to its treatment,and innovative therapies are urgently needed in clinical practice.

Dr. Leung Kwong Chuen,Specialist in Clinical Oncology and Clinical Associate Professor (Honorary) at the Department of Medicine and Therapeutics of the Chinese University of Hong Kong said:" SCLC is a relatively difficult subtype of lung cancer to treat and is characterized by a high degree of malignancy,poor prognosis,and high recurrence. A lack of new treatment options after recurrence of the disease is a major challenge faced in current clinical application. We are very pleased to see eligible patients are able to receive this innovative therapy through this program and improve their prognosis."

Dr. Au Siu Kie,Specialist in ClinicalOncology and President of the Hong Kong Precision Oncology Society said:" Lung cancer is the leading cause of cancer deaths in Hong Kong. For the last 3 decades. SCLC has been notorious due to the lack of available medications. We believe that Lurbinectedin is a breakthrough and will be able to provide a better treatment option for patients with relapse SCLC."

Andy Siow,APAC Regional Director of Luye Pharma (International),said:" Luye Pharma has been committed to developing,manufacturing and commercializing innovative anticancer drugs to address unmet clinical needs. The Named Patient Program will help to provide immediate access to Lurbinectedin for those with urgent healthcare needs,bringing hope to patients with SCLC who are suffering from the disease."

William Van,Abacus Medicine Pharma Services Asia Limited,said:" We are glad to enter into this distribution partnership with Luye Pharma for Lurbinectedin and the Named Patient Program in Hong Kong. Leveraging extensive experience in running such programs,in addition to our comprehensive local business network and channel strengths,we are looking forward to working closely with each other to provide better service to local patients."

In addition to Hong Kong,Lurbinectedin is also available to patients in the Chinese mainland for urgent clinical use at designated medical institutions in the Hainan Boao Lecheng International Medical Tourism Pilot Zone.

About Lurbinectedin

Lurbinectedin is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells,Lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages,downregulating the production of cytokines that are essential for the growth of the tumor.

To date,Lurbinectedin has received marketing authorizations in the U.S.,Australia,UAE,Canada,Singapore and other countries for the treatment of adult patients with metastatic SCLC whose disease has progressed during or after receiving platinum-based chemotherapy. Lurbinectedin is also recommended by Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis,treatment and follow-up (published in 2021) and the NCCN Guidelines for Small Cell Lung Cancer (2022). Luye Pharma Group owns the rights to develop and commercialize Lurbinectedin in China.

About Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D,manufacturing and sale of innovative medications. The company has established R&D centers in China,the U.S. and Europe,with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Along with a number of new drugs and new formulations in the central nervous system and oncology therapeutic areas understudyin the U.S.,Europe and Japan,Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres,liposomes,and transdermal drug delivery systems.The company has achieved multiple innovations in new chemical entities and antibodies,and is also actively makingstrategic developments in the fields of cell therapies and gene therapies.

Luye Pharmais developing a global supply chain of 8 manufacturing sites with over 30 production lines in total,establishing GMP quality management and international standard control systems. With more than 30 products covering the central nervous system,oncology,cardiovascular,metabolism and other therapeutic areas,business is conducted in over 80 countries and regions around the world,including the largest pharmaceutical markets - China,the U.S.,as well as in fast growing emerging markets.

About Abacus Medicine Pharma Services

Abacus Medicine Pharma Services (AMPS) is part of the Abacus Medicine Group,a fast-growing supplier of original prescription medicines. 1,100 employees service thousands of customers in Europe and the rest of the world. With a customised ERP system,a bespoke global distribution centre and a leadership team with decades of experience,AMPS is evolving into the next-generation healthcare and pharma services company by combining the infrastructure and skills at Abacus Medicine with the experience and expertise within AMPS.

References:

1. Rudin CM,et al. Nat Rev Dis Primers. 2021 Jan 14;7(1):3.

2. Cancer.Net. Lung Cancer - Small Cell. Available at https://www.cancer.net/cancer-types/33776/view-all. Accessed in October 2022.