News>Press Releases
The NDA for Luye Pharma’s Imported Drug Lurbinectedin Accepted by NMPA for Treating Relapsed Small Cell Lung Cancer in China
June 06,2023
Shanghai, June 6, 2023 – Luye Pharma Group today announced that the New Drug Application (NDA) for Lurbinectedin has been accepted by China's National Medical Products Administration (NMPA). This is an imported drug indicated for treating adult patients with metastatic small cell lung cancer (SCLC) who have disease progression on or after receiving platinum-based chemotherapy. Previously, the drug was granted priority review by the NMPA.

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 leading to the apoptosis of cancer cells. In 2020, Lurbinectedin received the Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the above indication. 

The NDA is based on data from a single-arm, dose-escalation, and dose-expansion clinical study conducted in China. The study was designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Lurbinectedin in Chinese patients with advanced solid tumors including relapsed SCLC. The results of the study show promising efficacy and a manageable safety profile of the drug as a second-line therapy at a dose of 3.2mg/m2 in Chinese SCLC patients. An Independent Review Committee confirmed the Overall Response Rate (ORR) was 45.5% in subjects with relapsed SCLC.

Lung cancer was China’s No.1 cancer in 2020 in terms of morbidity and mortality, with approximately 815,000 new cases and 714,000 deaths that year1. Specifically, SCLC accounted for 13%-17% of all lung cancer cases2. Most SCLC patients were already in the advanced stage upon diagnosis, resulting in poor prognosis. Their five-year survival rate was only 7% or as low as 3% for those in the extensive stage3. Although SCLC is very sensitive to initial treatments, most patients would experience a relapse or develop drug resistance after initial treatments. According to statistics, approximately 75% of the patients with locally advanced SCLC and more than 90% of those with metastatic SCLC would relapse within two years after receiving treatments4. The high relapse rate of SCLC poses a significant challenge to its treatment, and innovative therapies are urgently needed in clinical practice. 

Lurbinectedin has been the only new chemical entity approved by the FDA for the treatment of relapsed SCLC during the past 26 years since 1997. The approval of Lurbinectedin in the U.S. was based on data from an open-label, multicenter, and single-arm Phase II clinical study of the drug in 105 adult patients with SCLC (including platinum-sensitive and platinum-resistant ones) whose disease progressed after receiving platinum-based chemotherapy. In this study, patients treated with Lurbinectedin demonstrated an ORR of 35% and a median Duration of Response (DoR) of 5.3 months.

The clinical study conducted in China was the first study evaluating the efficacy and safety of Lurbinectedin in Chinese patients. The results show that the efficacy of Lurbinectedin in Chinese patients with relapsed SCLC who had experienced progression after receiving the first-line platinum-based chemotherapy was comparable to its efficacy in the Phase II clinical study conducted overseas, and the response rate was even higher in Chinese patients. The preliminary results of the Chinese study were presented at the 2022 annual meeting of the American Society of Clinical Oncology as well as the 25th National Clinical Oncology Conference and the 2022 annual meeting of the Chinese Society of Clinical Oncology, attracting extensive attention from both Chinese and overseas experts.

In addition to the Chinese mainland, Lurbinectedin is also being reviewed for its NDA in the Hong Kong SAR of China. Moreover, the drug is available to Chinese patients for urgent clinical use at designated medical institutions in the Hainan Boao Lecheng International Medical Tourism Pilot Zone and through the Named Patient Program in Hong Kong. 

Yang Rongbing, President of Luye Pharma Group, said: “SCLC is a subtype of lung cancer the treatment of which is relatively challenging. It is highly malignant and prone to relapse. Patients often have a poor prognosis. The main challenge in treating SCLC is the lack of new treatment options for patients with relapsed SCLC. We’re excited to see that the NDA for Lurbinectedin has been accepted by the NMPA. We hope that this innovative medicine can reach patients in need and improve their survival as soon as possible.”

Lurbinectedin was originally developed by Luye Pharma’s partner PharmaMar. Luye Pharma was granted the exclusive rights to develop and commercialize the drug in China. 

###

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.

Lurbinectedin has also been approved in 9 other countries, in addition to its accelerated approval by the U.S. FDA for the treatment of metastatic SCLC. The drug is recommended by Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (published in 2021), the NCCN Guidelines for Small Cell Lung Cancer (2022) and the 2023 Chinese Society of Clinical Oncology Guidelines for Small Cell Lung Cancer. 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. 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 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., Europe and Japan, as well as in fast growing emerging markets.

About PharmaMar

PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation.

PharmaMar has developed and now commercializes Yondelis® in Europe by itself, as well as Zepzelca® (Lurbinectedin), in the US and China; and Aplidin® (Plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: Lurbinectedin and Ecubectedin. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland and the United States. PharmaMar also wholly owns Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com

————

References:
  1. International Agency for Research on Cancer – Population Fact Sheets – China. Available at https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed in June 2023.
  2. The 2022 Guidelines of the Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Small Cell Lung Cancer. People’s Medical Publishing House. 2022
  3. Cancer.Net. Lung Cancer - Small Cell. Available at https://www.cancer.net/cancer-types/33776/view-all. Accessed in June 2023.
  4. Rudin CM, et al. Nat Rev Dis Primers. 2021 Jan 14;7(1):3.
News>Press Releases
The NDA for Luye Pharma’s Imported Drug Lurbinectedin Accepted by NMPA for Treating Relapsed Small Cell Lung Cancer in China
June 06,2023
Shanghai, June 6, 2023 – Luye Pharma Group today announced that the New Drug Application (NDA) for Lurbinectedin has been accepted by China's National Medical Products Administration (NMPA). This is an imported drug indicated for treating adult patients with metastatic small cell lung cancer (SCLC) who have disease progression on or after receiving platinum-based chemotherapy. Previously, the drug was granted priority review by the NMPA.

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 leading to the apoptosis of cancer cells. In 2020, Lurbinectedin received the Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the above indication. 

The NDA is based on data from a single-arm, dose-escalation, and dose-expansion clinical study conducted in China. The study was designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Lurbinectedin in Chinese patients with advanced solid tumors including relapsed SCLC. The results of the study show promising efficacy and a manageable safety profile of the drug as a second-line therapy at a dose of 3.2mg/m2 in Chinese SCLC patients. An Independent Review Committee confirmed the Overall Response Rate (ORR) was 45.5% in subjects with relapsed SCLC.

Lung cancer was China’s No.1 cancer in 2020 in terms of morbidity and mortality, with approximately 815,000 new cases and 714,000 deaths that year1. Specifically, SCLC accounted for 13%-17% of all lung cancer cases2. Most SCLC patients were already in the advanced stage upon diagnosis, resulting in poor prognosis. Their five-year survival rate was only 7% or as low as 3% for those in the extensive stage3. Although SCLC is very sensitive to initial treatments, most patients would experience a relapse or develop drug resistance after initial treatments. According to statistics, approximately 75% of the patients with locally advanced SCLC and more than 90% of those with metastatic SCLC would relapse within two years after receiving treatments4. The high relapse rate of SCLC poses a significant challenge to its treatment, and innovative therapies are urgently needed in clinical practice. 

Lurbinectedin has been the only new chemical entity approved by the FDA for the treatment of relapsed SCLC during the past 26 years since 1997. The approval of Lurbinectedin in the U.S. was based on data from an open-label, multicenter, and single-arm Phase II clinical study of the drug in 105 adult patients with SCLC (including platinum-sensitive and platinum-resistant ones) whose disease progressed after receiving platinum-based chemotherapy. In this study, patients treated with Lurbinectedin demonstrated an ORR of 35% and a median Duration of Response (DoR) of 5.3 months.

The clinical study conducted in China was the first study evaluating the efficacy and safety of Lurbinectedin in Chinese patients. The results show that the efficacy of Lurbinectedin in Chinese patients with relapsed SCLC who had experienced progression after receiving the first-line platinum-based chemotherapy was comparable to its efficacy in the Phase II clinical study conducted overseas, and the response rate was even higher in Chinese patients. The preliminary results of the Chinese study were presented at the 2022 annual meeting of the American Society of Clinical Oncology as well as the 25th National Clinical Oncology Conference and the 2022 annual meeting of the Chinese Society of Clinical Oncology, attracting extensive attention from both Chinese and overseas experts.

In addition to the Chinese mainland, Lurbinectedin is also being reviewed for its NDA in the Hong Kong SAR of China. Moreover, the drug is available to Chinese patients for urgent clinical use at designated medical institutions in the Hainan Boao Lecheng International Medical Tourism Pilot Zone and through the Named Patient Program in Hong Kong. 

Yang Rongbing, President of Luye Pharma Group, said: “SCLC is a subtype of lung cancer the treatment of which is relatively challenging. It is highly malignant and prone to relapse. Patients often have a poor prognosis. The main challenge in treating SCLC is the lack of new treatment options for patients with relapsed SCLC. We’re excited to see that the NDA for Lurbinectedin has been accepted by the NMPA. We hope that this innovative medicine can reach patients in need and improve their survival as soon as possible.”

Lurbinectedin was originally developed by Luye Pharma’s partner PharmaMar. Luye Pharma was granted the exclusive rights to develop and commercialize the drug in China. 

###

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.

Lurbinectedin has also been approved in 9 other countries, in addition to its accelerated approval by the U.S. FDA for the treatment of metastatic SCLC. The drug is recommended by Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (published in 2021), the NCCN Guidelines for Small Cell Lung Cancer (2022) and the 2023 Chinese Society of Clinical Oncology Guidelines for Small Cell Lung Cancer. 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. 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 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., Europe and Japan, as well as in fast growing emerging markets.

About PharmaMar

PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation.

PharmaMar has developed and now commercializes Yondelis® in Europe by itself, as well as Zepzelca® (Lurbinectedin), in the US and China; and Aplidin® (Plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: Lurbinectedin and Ecubectedin. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland and the United States. PharmaMar also wholly owns Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com

————

References:
  1. International Agency for Research on Cancer – Population Fact Sheets – China. Available at https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed in June 2023.
  2. The 2022 Guidelines of the Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Small Cell Lung Cancer. People’s Medical Publishing House. 2022
  3. Cancer.Net. Lung Cancer - Small Cell. Available at https://www.cancer.net/cancer-types/33776/view-all. Accessed in June 2023.
  4. Rudin CM, et al. Nat Rev Dis Primers. 2021 Jan 14;7(1):3.