Shanghai, December 3, 2024 - Luye Pharma Group today announced that the innovative drug Zepzelca® (lurbinectedin for injection) has been approved for marketing by China’s National Medical Products Administration (NMPA) through the priority review program. The drug is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Zepzelca is a selective inhibitor of oncogenic transcription. While inhibiting oncogenic transcription, it regulates the microenvironment for tumors and leads to the apoptosis of tumor cells. The drug was also approved by the U.S. Food and Drug Administration (FDA) through its Accelerated Approval Program in 2020. For 27 years, it has been the only new chemical entity approved by the FDA for the treatment of relapsed SCLC since 1997.
Lung cancer has the highest incidence and highest mortality rates among all cancers in China, with over 1.06 million new cases reported in 20221. SCLC, accounting for 13-17% of all lung cancers2, is one of the most aggressive subtypes with a 5-year overall survival rate of less than 10%3. Most patients would experience a relapse or develop drug resistance after the initial treatment, and the median overall survival (mOS) is only 4-5 months after receiving further chemotherapy2.
“Relapsing and drug resistance are inevitable challenges in the treatment of SCLC, unfortunately,” said Professor Cheng Ying, Director of Jilin Cancer Center. “The lack of effective therapies after a relapse leaves SCLC patients in the lurch. Zepzelca has eliminated a 20-year bottleneck in the second-line treatments for SCLC, offering a new option to patients. The overseas Phase 2 clinical trial of Zepzelca demonstrated that it was superior over the existing standard second-line treatment for SCLC in terms of both antitumor activity and safety based on the historical data. The bridging study in the Chinese population demonstrated even better survival outcomes. We look forward to its clinical application as soon as possible.”
The approval of Zepzelca by the NMPA was based on the results of two clinical studies. One of them was a pivotal study conducted overseas, an open-label, multicenter, and single-arm study (a Phase 2 basket trial) in adult patients with SCLC (including both platinum-sensitive and platinum-resistant patients) who experienced disease progression after receiving platinum-based chemotherapy. In this study, they were treated with Zepzelca alone through intravenous infusion of the drug every 3 weeks at a dose of 3.2 mg/m2. The study was published in The Lancet Oncology, which demonstrated an overall response rate (ORR) of 35.2%, a median duration of response (mDoR) of 5.3 months, a median progression-free survival (mPFS) of 3.5 months, and an mOS of 9.3 months for all patients treated with Zepzelca . The other study was a single-arm, bridging clinical study with dose escalation and expansion for Zepzelca to evaluate its safety, tolerability, pharmacokinetics (PK), and preliminary efficacy in Chinese patients with advanced solid tumors, including recurrent SCLC. The study showed an ORR of 45.5%, an mDoR of 4.2 months, an mPFS of 5.6 months and an mOS of 11.0 months for SCLC patients treated with Zepzelca through intravenous infusion every 3 weeks at a dose of 3.2 mg/m2.
The two studies above demonstrated significant antitumor activity for Zepzelca as a second-line treatment for SCLC with a manageable safety profile. In addition, the study conducted in the Chinese population demonstrated better patient outcomes.
Additionally, Zepzelca is also being investigated in multiple international clinical trials. In a Phase 1/2 study, Zepzelca in combination with atezolizumab demonstrated an ORR of 66.67%, an mPFS of 4.7 months, and an mOS of 14.5 months when used as a second-line treatment for patients with extensive-stage SCLC. In another Phase 1/2 study, Zepzelca combined with pembrolizumab showed an ORR of 46.4%, an mPFS of 5.3 months, and an mOS of 11.1 months as a second-line treatment for patients with relapsed SCLC. Furthermore, clinical studies involving Zepzelca in combination with an immune checkpoint inhibitor as the first-line maintenance therapy for SCLC, in combination with chemotherapy for the treatment of relapsed SCLC, and for the treatment of leiomyosarcoma are also underway. These studies are designed to continue exploring the clinical application and therapeutic potential of the drug.
Zepzelca has been recommended by the NCCN Clinical Practice Guidelines in Oncology for Small Cell Lung Cancer, the Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, and the CSCO Guidelines for the Diagnosis and Treatment of Small Cell Lung Cancer for the treatment of relapsed SCLC as a single agent. Furthermore, the CSCO Guidelines for the Diagnosis and Treatment of Small Cell Lung Cancer has included the combination of Zepzelca and immune checkpoint inhibitors for the treatment of SCLC in its 2024 edition for the first time2.
To date, Zepzelca has been approved for marketing in 17 countries and regions worldwide. Luye Pharma has been granted the rights to develop and commercialize this drug in the Chinese mainland, Hong Kong, and Macao, and has received marketing approval for the drug in these three regions.
"We believe that Zepzelca will be able to address the urgent treatment needs of Chinese SCLC patients, of which the number is huge,” said Yang Rongbing, President of Luye Pharma Group. “The drug has received positive feedback after its launch in Hong Kong and Macao in March this year. Our oncology team is now working full steam ahead to commercialize it in the Chinese mainland. Meanwhile, several clinical studies of Zepzelca are also being conducted overseas. We will continue to explore the therapeutic potential of this drug in China, hoping to benefit as many patients as possible."
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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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Shanghai, December 3, 2024 - Luye Pharma Group today announced that the innovative drug Zepzelca® (lurbinectedin for injection) has been approved for marketing by China’s National Medical Products Administration (NMPA) through the priority review program. The drug is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Zepzelca is a selective inhibitor of oncogenic transcription. While inhibiting oncogenic transcription, it regulates the microenvironment for tumors and leads to the apoptosis of tumor cells. The drug was also approved by the U.S. Food and Drug Administration (FDA) through its Accelerated Approval Program in 2020. For 27 years, it has been the only new chemical entity approved by the FDA for the treatment of relapsed SCLC since 1997.
Lung cancer has the highest incidence and highest mortality rates among all cancers in China, with over 1.06 million new cases reported in 20221. SCLC, accounting for 13-17% of all lung cancers2, is one of the most aggressive subtypes with a 5-year overall survival rate of less than 10%3. Most patients would experience a relapse or develop drug resistance after the initial treatment, and the median overall survival (mOS) is only 4-5 months after receiving further chemotherapy2.
“Relapsing and drug resistance are inevitable challenges in the treatment of SCLC, unfortunately,” said Professor Cheng Ying, Director of Jilin Cancer Center. “The lack of effective therapies after a relapse leaves SCLC patients in the lurch. Zepzelca has eliminated a 20-year bottleneck in the second-line treatments for SCLC, offering a new option to patients. The overseas Phase 2 clinical trial of Zepzelca demonstrated that it was superior over the existing standard second-line treatment for SCLC in terms of both antitumor activity and safety based on the historical data. The bridging study in the Chinese population demonstrated even better survival outcomes. We look forward to its clinical application as soon as possible.”
The approval of Zepzelca by the NMPA was based on the results of two clinical studies. One of them was a pivotal study conducted overseas, an open-label, multicenter, and single-arm study (a Phase 2 basket trial) in adult patients with SCLC (including both platinum-sensitive and platinum-resistant patients) who experienced disease progression after receiving platinum-based chemotherapy. In this study, they were treated with Zepzelca alone through intravenous infusion of the drug every 3 weeks at a dose of 3.2 mg/m2. The study was published in The Lancet Oncology, which demonstrated an overall response rate (ORR) of 35.2%, a median duration of response (mDoR) of 5.3 months, a median progression-free survival (mPFS) of 3.5 months, and an mOS of 9.3 months for all patients treated with Zepzelca . The other study was a single-arm, bridging clinical study with dose escalation and expansion for Zepzelca to evaluate its safety, tolerability, pharmacokinetics (PK), and preliminary efficacy in Chinese patients with advanced solid tumors, including recurrent SCLC. The study showed an ORR of 45.5%, an mDoR of 4.2 months, an mPFS of 5.6 months and an mOS of 11.0 months for SCLC patients treated with Zepzelca through intravenous infusion every 3 weeks at a dose of 3.2 mg/m2.
The two studies above demonstrated significant antitumor activity for Zepzelca as a second-line treatment for SCLC with a manageable safety profile. In addition, the study conducted in the Chinese population demonstrated better patient outcomes.
Additionally, Zepzelca is also being investigated in multiple international clinical trials. In a Phase 1/2 study, Zepzelca in combination with atezolizumab demonstrated an ORR of 66.67%, an mPFS of 4.7 months, and an mOS of 14.5 months when used as a second-line treatment for patients with extensive-stage SCLC. In another Phase 1/2 study, Zepzelca combined with pembrolizumab showed an ORR of 46.4%, an mPFS of 5.3 months, and an mOS of 11.1 months as a second-line treatment for patients with relapsed SCLC. Furthermore, clinical studies involving Zepzelca in combination with an immune checkpoint inhibitor as the first-line maintenance therapy for SCLC, in combination with chemotherapy for the treatment of relapsed SCLC, and for the treatment of leiomyosarcoma are also underway. These studies are designed to continue exploring the clinical application and therapeutic potential of the drug.
Zepzelca has been recommended by the NCCN Clinical Practice Guidelines in Oncology for Small Cell Lung Cancer, the Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, and the CSCO Guidelines for the Diagnosis and Treatment of Small Cell Lung Cancer for the treatment of relapsed SCLC as a single agent. Furthermore, the CSCO Guidelines for the Diagnosis and Treatment of Small Cell Lung Cancer has included the combination of Zepzelca and immune checkpoint inhibitors for the treatment of SCLC in its 2024 edition for the first time2.
To date, Zepzelca has been approved for marketing in 17 countries and regions worldwide. Luye Pharma has been granted the rights to develop and commercialize this drug in the Chinese mainland, Hong Kong, and Macao, and has received marketing approval for the drug in these three regions.
"We believe that Zepzelca will be able to address the urgent treatment needs of Chinese SCLC patients, of which the number is huge,” said Yang Rongbing, President of Luye Pharma Group. “The drug has received positive feedback after its launch in Hong Kong and Macao in March this year. Our oncology team is now working full steam ahead to commercialize it in the Chinese mainland. Meanwhile, several clinical studies of Zepzelca are also being conducted overseas. We will continue to explore the therapeutic potential of this drug in China, hoping to benefit as many patients as possible."
###
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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