Innovent Announces the NMPA Granted Marketing Approval for BYVASDA® (Bevacizumab Biosimilar) in China

SUZHOU, China, June 19, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that BYVASDA® (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug independently developed by Innovent, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China. BYVASDA® is Innovent's second monoclonal antibody drug approved by the NMPA following TYVYT® (sintilimab injection, officially approved for treatment of patients with Hodgkin's lymphoma in December 2018).

In recent years, the cancer burden in China has been continuously increasing. According to the report of Cancer Today from the WHO's International Agency for Cancer Research, there were 4.285 million newly diagnosed cancer patients and 2.865 million deaths from cancer in China in 2018. Among the malignant tumors in China, lung cancer ranks first both in incidence rate (0.774 million newly diagnosed patients) and mortality rate (0.691 million deaths). Colorectal cancer ranks second in incidence rate (0.517 million newly diagnosed patients) and fifth in mortality rate (0.245 million deaths). Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer, and in China it was approved for the treatment of patients with advanced non-small cell lung cancer and metastatic colorectal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide. Currently there still remains huge unmet clinical demand for bevacizumab treatment in China, as many ordinary Chinese patients cannot afford for it. BYVASDA® is an anti-VEGF humanized monoclonal antibody and a bevacizumab biosimilar independently developed by Innovent. The launch of BYVASDA® will provide Chinese patients with high-quality and relatively more affordable bevacizumab biosimilar injection.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "BYVASDA® is another example of our success with the National Major New Drug Innovation and Development Projects and the second monoclonal antibody drug approved by the NMPA following TYVYT® (sintilimab injection). We hope to bring this high-quality and cost-saving drugs to more patients in need in China as soon as possible. In January 2020, Innovent out-licensed the commercial rights of BYVASDA® in the United States and Canada to Coherus BioSciences, a leading biosimilar company, demonstrated an international recognition of the quality of BYVASDA®. We are looking forward to working together to make BYVASDA® benefit more patients globally."

About BYVASDA®

BYVASDA® is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA® produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, metabolic, autoimmune and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully-integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 18 in clinical development, 5 in Phase 3 or pivotal clinical trials, 3 under NDA reviews by the NMPA (2 under priority review status), while 2 products, TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab biosimilar), officially approved for marketing in China. TYVYT® has been the only PD-1 inhibitor included in the NRDL since 2019.

Innovent has built an international team of advanced talents in cutting-edge biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly, Roche, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.

SOURCE Innovent Biologics, Inc.

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