Shanghai, China, December 4, 2023 -- Luye Pharma Group today announced that Lurbinectedin for injection has been approved by the Pharmaceutical Administration Bureau in Macao for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy.

"SCLC is a type of lung cancer that is highly malignant and relatively difficult to treat, characterized by poor prognosis and a high relapse rate," said Yang Rongbing, President of Luye Pharma Group. "The main challenge in treating this disease today is the lack of new drugs to treat it after a relapse. We're excited to see the approval of Lurbinectedin in Macao. This will also allow SCLC patients beyond Macao to benefit from the drug and improve their survival via relevant policies adopted in the Guangdong-Hong Kong-Macao Greater Bay Area."

Lurbinectedin is a selective inhibitor of oncogenic transcription. Its unique dual-action mechanism allows it to regulate the microenvironment for tumors while inhibiting oncogenic transcription and causing the apoptosis of cancer cells. In 2020, Lurbinectedin received the Accelerated Approval from the U.S. Food and Drug Administration (FDA). It was the only new chemical entity approved by the FDA for the treatment of metastatic SCLC in more than 20 years before 2020.

The approval of Lurbinectedin in Macao is mainly based on data from two clinical studies of the drug conducted in China and overseas. The study conducted overseas was an open-label, multicenter, and single-arm Phase II clinical study of the drug in 105 adult patients with SCLC whose disease progressed after receiving platinum-based chemotherapy. In this study, patients treated with Lurbinectedin demonstrated an overall response rate (ORR) of 35.2%. Among them, the ORR of those who were chemotherapy-sensitive (CTFI ≥90 days) was 45%, the median Progression Free Survival (mPFS) was 4.6 months, and the median Overall Survival (mOS) was 11.9 months.

The study conducted in China was a single-arm, dose-escalation, and dose-expansion clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Lurbinectedin in Chinese patients with advanced tumors, including relapsed SCLC. In this study, an Independent Review Committee confirmed that the ORR was 45.5% in subjects with relapsed SCLC, the mPFS was 5.6 months, and the mOS was 11.0 months. The study also demonstrated a promising efficacy and a manageable safety profile of the drug as a second-line treatment in Chinese SCLC patients. Besides, its efficacy in Chinese patients was found to be comparable to or even better than that in the SCLC cohort of the Phase II clinical trial conducted overseas.

Lung cancer is number one among all cancers in China in terms of incidence and mortality. In 2020, there were about 815,000 new cases of lung cancer and 714,000 deaths caused by it¹, of which SCLC accounted for 13-17%². SCLC patients are often already in an advanced stage upon diagnosis, resulting in poor prognosis, with a five-year survival rate of only 7% and only 3% for those with extensive SCLC³. Although SCLC is very sensitive to the initial treatment, most patients would develop drug resistance and see a relapse after the initial treatment. According to statistics, about 75% of the patients with locally advanced SCLC and more than 90% of those with metastatic SCLC have relapsed within 2 years after the initial treatment⁴. The high recurrence rate of SCLC poses a huge challenge to its treatment, and an innovative therapy is urgently needed in clinical practice.

In addition to its approval in Macao, Lurbinectedin is also under review for launch in Hong Kong and mainland China respectively. Moreover, the drug has been granted priority review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Lurbinectedin has also been recommended by multiple authoritative guidelines in China and abroad. For example, the NCCN Guidelines for SCLC (V1. 2024) recommends this drug as a preferred treatment for SCLC patients with CTFI shorter than 6 months, and the 2023 CSCO Guidelines for SCLC recommends it as a second-line treatment for relapsed SCLC after ≤6 months or >6 months.

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About Lurbinectedin

Lurbinectedin is an analog of the marine compound ET-736 isolated from sea squirt Ecteinascidia 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 tumors.

In 2020, Lurbinectedin received the Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy. After that, the drug was also approved in several other countries worldwide. Luye Pharma 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. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has also achieved multiple innovations in new chemical entities and antibodies, and is actively making strategic developments in the fields of cell therapies and gene therapies.

Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. 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., Europe and Japan, as well as in fast growing emerging markets.

 

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