News>Press Releases
Luye Pharma’s Anti-tumor Biological Drug LY01008 Completes Primary Endpoint Observation for Phase III Clinical Trials in China
November 04,2019

Luye Pharma Group has announced that it has completed enrollment for a 648 patient Phase III clinical trial in China for the cancer treatment product LY01008 (a biosimar for Avastin) in May 2019. The trial is an efficacy and safety comparative study of LY01008 with the reference drug of Avastin. Currently, the observation of the Overall Response Rate (ORR) for the primary endpoint in a blinded state has already been completed.

Luye Pharma has a number of investigational oncology drugs at different clinical testing stages in China and other countries, with smooth development progress in each. Enrichment of the oncology product pipeline will continue to strengthen the company's competitiveness in this field of treatment, as well as lay solid foundations for rapid expansion into the global market.

LY01008 is a recombinant anti-VEGF humanized monoclonal antibody injection indicated for non-small-cell lung cancer or colorectal cancer. According to public financial reports, Avastin® (which is a market comparable of LY01008) achieved sales of 6,849 million Swiss francs globally in 2018, while its sales in China totaled RMB 1,740 million in 2018, according to IQVIA.

Lung cancer and colorectal cancer have become the most common and the third most common cancers in China, respectively. There were approximately 774,000 new lung cancer cases in China in 2018, with non-small-cell lung cancer accounting for around 80% of these. Colorectal cancer is the third most common cancer in China after lung cancer and gastric cancer, with an estimated 429,000 new cases and 281,000 deaths in 2018. The patient population is extremely large and constantly growing, which generates huge unmet needs in this therapeutic area.

"We are accelerating the R&D and launch progress of LY01008, to address treatment needs for more patients. The company's strong marketing capabilities and broad market coverage in the oncological field will also provide healthy support for the launch of LY01008," said a Luye Pharma Group management representative. “Oncology is one of the core therapeutic areas of focus for the company’s long-term development. We will continue to increase investment to further enrich our oncology product pipeline through in-house R&D innovation as well as external partnerships.”

In addition to LY01008, the company has several other innovative formulations and treatments targeting the oncology field, currently at different clinical stages of clinical development in China and other countries. These include the innovative drug Zepsyre® (Lurbinectedin), innovative formulation Goserelin Acetate Extended-release Microspheres for Injection, a biosimilar for Denosumab, an IDO/TDO dual-target inhibitor, CAR-T therapy, and other R&D projects.

News>Press Releases
Luye Pharma’s Anti-tumor Biological Drug LY01008 Completes Primary Endpoint Observation for Phase III Clinical Trials in China
November 04,2019

Luye Pharma Group has announced that it has completed enrollment for a 648 patient Phase III clinical trial in China for the cancer treatment product LY01008 (a biosimar for Avastin) in May 2019. The trial is an efficacy and safety comparative study of LY01008 with the reference drug of Avastin. Currently, the observation of the Overall Response Rate (ORR) for the primary endpoint in a blinded state has already been completed.

Luye Pharma has a number of investigational oncology drugs at different clinical testing stages in China and other countries, with smooth development progress in each. Enrichment of the oncology product pipeline will continue to strengthen the company's competitiveness in this field of treatment, as well as lay solid foundations for rapid expansion into the global market.

LY01008 is a recombinant anti-VEGF humanized monoclonal antibody injection indicated for non-small-cell lung cancer or colorectal cancer. According to public financial reports, Avastin® (which is a market comparable of LY01008) achieved sales of 6,849 million Swiss francs globally in 2018, while its sales in China totaled RMB 1,740 million in 2018, according to IQVIA.

Lung cancer and colorectal cancer have become the most common and the third most common cancers in China, respectively. There were approximately 774,000 new lung cancer cases in China in 2018, with non-small-cell lung cancer accounting for around 80% of these. Colorectal cancer is the third most common cancer in China after lung cancer and gastric cancer, with an estimated 429,000 new cases and 281,000 deaths in 2018. The patient population is extremely large and constantly growing, which generates huge unmet needs in this therapeutic area.

"We are accelerating the R&D and launch progress of LY01008, to address treatment needs for more patients. The company's strong marketing capabilities and broad market coverage in the oncological field will also provide healthy support for the launch of LY01008," said a Luye Pharma Group management representative. “Oncology is one of the core therapeutic areas of focus for the company’s long-term development. We will continue to increase investment to further enrich our oncology product pipeline through in-house R&D innovation as well as external partnerships.”

In addition to LY01008, the company has several other innovative formulations and treatments targeting the oncology field, currently at different clinical stages of clinical development in China and other countries. These include the innovative drug Zepsyre® (Lurbinectedin), innovative formulation Goserelin Acetate Extended-release Microspheres for Injection, a biosimilar for Denosumab, an IDO/TDO dual-target inhibitor, CAR-T therapy, and other R&D projects.