News>Press Releases
Boan Biotech’s Nivolumab Injection LY01015 to Start Clinical Trials in China, As the first applied biosimilar to Opdivo® according to Registration Classification 3.3 of Biological Product
February 25,2021

Luye Pharma Group announced that the clinical trial application for LY01015 (Nivolumab Injection) developed by the Group's subsidiary Boan Biotech, has been accepted by the Center for Drug Evaluation of the China National Medical Products Administration.

 

As the first applied biosimilar to Opdivo® according to Registration Classification 3.3 of Biological Product, LY01015 is used for the treatment of patients with Melanoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma, Renal Cell Carcinoma, Classical Hodgkin Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Squamous Cell Carcinoma and Advanced Gastric or Gastroesophageal Junction Cancer.

 

Immuno-oncology represented by PD-1 inhibitors has become one of the main therapies for cancer throughout the world. A PD-1 inhibitor resists cancer cells by activating the autoimmune system. It achieves this by blocking the pathway through which cancer cells induce the dormancy of human immune cells (T-cells), so as to partially restore the ability of T-cells to kill cancer cells. As a result, it succeeds in controlling or eliminating cancer on a long-term basis, and provides hopes of a cure for cancer.

 

As the world's first PD-1 immune checkpoint inhibitor approved by the regulators, the Nivolumab Injection has become a key option for treating multiple types of cancers, with over ten indications globally. Publicly available financial data shows that the worldwide sales of Opdivo® (the reference drug for LY01015) reached USD 7.204 billion in 2019, growing 7.0% YoY. The industry expects that PD-1 inhibitor drugs will continue to play a major role in the growth of the global market for oncology drugs. Given the huge number of cancer patients in China as well as the wide indications coverage of PD-1 inhibitor drugs, such products will continue to grow quickly in China and abroad.

 

"We are optimistic about the market prospects of LY01015, and are planning to register this drug in other countries and regions," said Jiang Hua, CEO of Boan Biotech. "We are striving to make progress in the development of various candidates in our pipeline, hoping to provide high-quality and affordable biological antibody products to benefit more patients, in China and around the world."

 

Luye Pharma is increasing its investment into biopharmaceutical R&D and accelerating the worldwide development of its biopharmaceutical business through Boan Biotech. Boan Biotech already has a product portfolio consisting of more than 10 innovative antibodies protected by international intellectual property rights and 8 biosimilars.

 

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About Boan Biotech


Established in 2013 as a subsidiary of Luye Pharma Group, Boan Biotech is a fully integrated biopharmaceutical company. It specializes in therapeutic antibody development with a focus on oncology, immunology, pain, and endocrine diseases. Boan Biotech's antibody discovery work is based on four technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology, ADC Technology, and Nanobody Platform. Boan Biotech has expertise in the full industry chain: antibody generation, lead optimization, cell line development, upstream and downstream process development, analytical development, technology transfer, pilot production, and commercial manufacturing. Outside of China, Boan Biotech also conducts biopharmaceutical development in the US and European markets.

News>Press Releases
Boan Biotech’s Nivolumab Injection LY01015 to Start Clinical Trials in China, As the first applied biosimilar to Opdivo® according to Registration Classification 3.3 of Biological Product
February 25,2021

Luye Pharma Group announced that the clinical trial application for LY01015 (Nivolumab Injection) developed by the Group's subsidiary Boan Biotech, has been accepted by the Center for Drug Evaluation of the China National Medical Products Administration.

 

As the first applied biosimilar to Opdivo® according to Registration Classification 3.3 of Biological Product, LY01015 is used for the treatment of patients with Melanoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma, Renal Cell Carcinoma, Classical Hodgkin Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Squamous Cell Carcinoma and Advanced Gastric or Gastroesophageal Junction Cancer.

 

Immuno-oncology represented by PD-1 inhibitors has become one of the main therapies for cancer throughout the world. A PD-1 inhibitor resists cancer cells by activating the autoimmune system. It achieves this by blocking the pathway through which cancer cells induce the dormancy of human immune cells (T-cells), so as to partially restore the ability of T-cells to kill cancer cells. As a result, it succeeds in controlling or eliminating cancer on a long-term basis, and provides hopes of a cure for cancer.

 

As the world's first PD-1 immune checkpoint inhibitor approved by the regulators, the Nivolumab Injection has become a key option for treating multiple types of cancers, with over ten indications globally. Publicly available financial data shows that the worldwide sales of Opdivo® (the reference drug for LY01015) reached USD 7.204 billion in 2019, growing 7.0% YoY. The industry expects that PD-1 inhibitor drugs will continue to play a major role in the growth of the global market for oncology drugs. Given the huge number of cancer patients in China as well as the wide indications coverage of PD-1 inhibitor drugs, such products will continue to grow quickly in China and abroad.

 

"We are optimistic about the market prospects of LY01015, and are planning to register this drug in other countries and regions," said Jiang Hua, CEO of Boan Biotech. "We are striving to make progress in the development of various candidates in our pipeline, hoping to provide high-quality and affordable biological antibody products to benefit more patients, in China and around the world."

 

Luye Pharma is increasing its investment into biopharmaceutical R&D and accelerating the worldwide development of its biopharmaceutical business through Boan Biotech. Boan Biotech already has a product portfolio consisting of more than 10 innovative antibodies protected by international intellectual property rights and 8 biosimilars.

 

###

 

About Boan Biotech


Established in 2013 as a subsidiary of Luye Pharma Group, Boan Biotech is a fully integrated biopharmaceutical company. It specializes in therapeutic antibody development with a focus on oncology, immunology, pain, and endocrine diseases. Boan Biotech's antibody discovery work is based on four technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology, ADC Technology, and Nanobody Platform. Boan Biotech has expertise in the full industry chain: antibody generation, lead optimization, cell line development, upstream and downstream process development, analytical development, technology transfer, pilot production, and commercial manufacturing. Outside of China, Boan Biotech also conducts biopharmaceutical development in the US and European markets.