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.

The Named Patient Program aims to allow patients with small cell lung cancer (SCLC) and no other treatment options immediate access 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 of the 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 Clinical Oncology 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, General Manager, 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.