NMPA Accepts New Drug Application for IBI-305, a Biosimilar Product Candidate of Bevacizumab (Avastin®)

SUZHOU, China, Jan. 28, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, announced today that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for a biosimilar product candidate of bevacizumab (Avastin^®). This NDA by Innovent is the third that has been accepted by the NMPA following Tyvyt^® (sintilimab injection, marketing approval granted on December 24, 2018) and IBI-303 (a biosimilar product candidate of adalimumab).

IBI-305 is a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody independently developed by Innovent for the treatment of non-small cell lung cancer (NSCLC), colorectal cancer and other malignant tumors. Bevacizumab (marketed under the trade name Avastin^® in China) has been approved globally for the treatment of multiple types of malignant tumors including NSCLC and has a favorable safety and efficacy profile. Despite the huge demand for effective cancer therapies in China, the adoption rate of bevacizumab (Avastin^®) is relatively low due to its rather low affordability. Innovent's biosimilar product candidate of bevacizumab, IBI-305, is expected to offer a high-quality and affordable alternative to patients in China.

The NDA is based on clinical data generated from two clinical studies, namely a Phase 3 comparative study of efficacy and safety in advanced non-squamous NSCLC patients and a pharmacokinetics (PK) study in healthy subjects. Both studies directly compare IBI-305 to bevacizumab and have met their pre-defined primary endpoints.

"Two clinical studies have been conducted with bevacizumab injection as the control drug. Based on the high-quality clinical data, the NDA application of IBI-305 has been accepted by NMPA. We believe that the high quality bevacizumab biosimilar will improve drug availability and benefit more patients and their families," said Professor Li Zhang from Cancer Hospital of Sun Yat-sen University.

"We are delighted that IBI-305 has become our third NDA successfully accepted by the NMPA. At the present time we have thirteen products in clinical development stage and four products in Phase 3 clinical trials. Tyvyt^®, our first commercial product, was recently approved by NMPA and our team will continue to deliver high quality biopharmaceutical drugs from our rich pipeline to benefit more ordinary people in China and globally," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About NSCLC and Colorectal Cancer

The report on the development of malignant tumors in China (2017), compiled by China Anti-Cancer Association, points out that the incidence of malignant tumors in China accounts for about 22% of the world's incidences, and the number of cases of malignant tumors ranks first in the world. Moreover the incidence and mortality of lung cancer in China accounted for 35.78% and 37.56% of the world, respectively. China has become the country with the largest incidence of lung cancer in the world and lung cancer is the fastest growing malignant tumor in China. NSCLC, accounts for 80% of all lung cancer cases. The incidence of advanced colorectal cancer is also relatively high and continues rising.

Basic and clinical research has shown that angiogenesis plays an important role in pathogenesis of malignant tumors. The good efficacy and safety of the branded bevacizumab in seven solid tumors including NSCLC and colorectal cancer have been confirmed in multiple clinical studies. Branded bevacizumab was approved for the treatment of NSCLC and colorectal cancer by NMPA in China.

About IBI-305 (bevacizumab biosimilar)

IBI-305 has been designed as a biosimilar to bevacizumab and is a recombinant humanized anti-VEGF monoclonal antibody for injection. 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. Bevacizumab produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking the blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells.

About Innovent

Innovent was established in 2011. Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. These capabilities have enabled the company to build a robust pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune, and cardiovascular diseases. Leveraging the platform, the company has built up a pipeline of 20 innovative medicines in the last seven years, led by four core products that are in late-stage clinical development in China. From a pipeline of 20 innovative medicines, thirteen have entered into clinical development, four have entered Phase 3 clinical trials, two monoclonal antibodies have their New Drug Application (NDA) under review and one, Tyvyt^® (sintilimab injection), is now approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL).

Innovent has built a biopharmaceutical production facility that operates under global standards. The design and operation of the clinical and commercial facilities are in compliance with the cGMP standards of NMPA, FDA and EMA. The existing production lines have already passed GMP audits by an international pharmaceutical company. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, Incyte, Hanmi and other biopharmaceutical companies. 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. Innovent wishes to work with all relevant parties helping the advancement of China's biopharmaceutical industry, improving the drug availability to ordinary people and enhancing the quality of the patients' life. Innovent is listed on the main board of the Hong Kong Stock Exchange with the stock code of HK 01801. For more information, please visit: www.innoventbio.com.

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SOURCE Innovent Biologics, Inc.

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