Innovent Announces an Out-license Agreement with PT Etana Biotechnologies Indonesia to Launch BYVASDA® (Bevacizumab Biosimilar) in Indonesia

Innovent Biologics, Inc., 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 an agreement with PT Etana Biotechnologies Indonesia (Etana) to out-license BYVASDA® (Bevacizumab Biosimilar)'s development and commercialization rights in Indonesia to Etana. Etana is committed to launch BYVASDA® in the local market. In return, Innovent will receive milestones for development and commercialization as well as double-digit royalties on net sales. The specific financial terms were not disclosed.

BYVASDA®(Bevacizumab Biosimilar) was firstly approved by China NMPA on June 17, 2020. In January 2020, Innovent entered into an out-license agreement with Coherus BioSciences, Inc. to commercialize BYVASDA® (Bevacizumab Biosimilar) in the United States and Canada.

"We are excited to establish a strategic collaboration with Etana. Following BYVASDA® (Bevacizumab Biosimilar)'s breaking into the North America market in 2020, this collaboration will enable BYVASDA® to penetrate into a Southeast Asian market quickly and marked another solid step toward getting Innovent's innovative portfolio into the global market," said Blake Salisbury, Vice President of Business Development of Innovent, "We are confident that pairing Etana's commercial expertise in the local Indonesian market with BYVASDA's clinical profile will further accelerate our mission, benefitting patients globally."

Mr. Nathan Tirtana, Co-founder and CEO of Etana, stated: " We are excited to enter into the collaboration with Innovent, a premier biopharmaceutical company which has a fully-integrated multi-functional platform. We have been impressed with Innovent's achievements in its innovation and globalization strategies. Through this collaboration, we hope to make BYVASDA® accessible to patients in Indonesia."

This transaction is subject to customary closing conditions.

About BYVASDA® (Bevacizumab Biosimilar)

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.

BYVASDA® was firstly approved by China NMPA on June 17, 2020. Previous approved indications of BYVASDA® include advanced non-small cell lung cancer and metastatic colorectal cancer. In December 2021, it was further approved by NMPA for the indication of adult recurrent glioblastoma.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture 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, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong, S.A.R., China 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 4 products - TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection) and HALPRYZA® (rituximab biosimilar injection) - officially approved for marketing in China, four assets in Phase 3 or pivotal clinical trials, and additional 15 molecules in clinical trials. TYVYT® was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, 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.

About PT Etana Biotechnologies Indonesia

Founded in 2015, Etana Biotechnologies is an Indonesia-based biotechnology company with dedicated focus on the manufacturing and commercialization of biologics in the oncology space for the Southeast Asian market. The company is currently commercializing EPO in Indonesia for the treatment of anemia in patients with chronic kidney disease. The company was co-founded by Nathan Tirtana, a veteran in the Indonesian healthcare industry, and a major Southeast Asian pharmaceutical partner.