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Innovent and Etana jointly announce the approval of Bevagen® (biosimilar bevacizumab) by the Indonesian Food and Drug Authority (BPOM)

SAN FRANCISCO and SUZHOU, China, June 13, 2022 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and markets high-quality drugs for the treatment of oncology, autoimmune, metabolic diseases , Ophthalmology and Others and PT Etana Biotechnologies Indonesia (“Etana”), today jointly announced that the Indonesian Food and Drug Authority (BPOM) has approved Bevagen® (biosimilar bevacizumab), a recombinant humanized monoclonal antibody anti-VEGF, for five indications, including metastatic colorectal cancer (mCRC), locally recurrent or metastatic triple negative breast cancer (mTNBC), advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), epithelial cancer of the ovary, fallopian tube and primary peritoneum (CO) and cervical cancer (CC). Etana will market Bevagen® in Indonesia under the current license agreement with Innovent. Bevagen® will potentially be the first Chinese antibody to be marketed and produced locally in South East Asia.

dr. Michael YuFounder, Chairman and CEO of Innoventsaid “We are delighted that as part of the strategic collaboration with Etana, the approval of Bevagen® in Indonesia marked a significant step towards bringing Innovent’s innovative portfolio to the global marketplace, benefiting patients around the world. By combining Etana’s commercial expertise in the local Indonesian market with the clinical profile of Bevagen®, high quality production and a relatively affordable price, we are confident that Bevagen® will be brought to market quickly and will benefit many many cancer patients. »

Nathan Tirtana, CEO of Etana said, “Etana appreciates BPOM’s support for the approval of Bevagen® for cancer patients in Indonesia. With this product, we believe we can provide greater access to a high-quality, affordable biosimilar medicine to meet the needs of cancer patients by Indonesia. Our next step is to implement technology transfer and local production of Bevagen® by Indonesia, through a collaboration with Innovent. According to GLOBOCAN 2020 data, breast cancer (16.6%), cervical cancer (9.2%), lung cancer (8.8%), liver cancer (5. 4%) and colorectal cancer (4.4%) are the most common types of cancer in France. Indonesiaand Bevagen® is approved for most of these indications.”

Approval of Bevagen® with the active ingredient Bevacizumab (humanized anti-VEGF monoclonal antibody) was granted by BPOM on June 13, 2022. Each single-use Bevagen® vial contains 100 mg of bevacizumab in a 4 ml vial (25 mg/ml). The approval in Indonesia confirms that Bevagen® has met the drug safety and efficacy standards set by the Indonesian government, both in terms of product quality and production process.

Since January 18, 2021, Etana entered into a strategic collaboration with Innovent Biologics. Currently, Innovent’s biosimilar bevacizumab injection, known as BYVASDA® in mainland China, has been approved by the National Medical Product Administration (NMPA) for six indications, including advanced non-small cell lung cancer, metastatic colorectal cancer, recurrent glioblastoma in adults, advanced or unresectable hepatocellular cancer. carcinoma, advanced ovarian cancer and advanced cervical cancer.

About Bevagen® (biosimilar bevacizumab)

Bevagen® is a biosimilar to the recombinant humanized anti-VEGF monoclonal antibody bevacizumab. Vascular endothelial growth factor (VEGF) is a critical factor in promoting angiogenesis and is highly expressed by endothelial cells in most tumors. An anti-VEGF antibody selectively binds to VEGF, preventing their binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting key signaling pathways, such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK, and producing anti-tumor effects. Since its launch, bevacizumab has been approved for the treatment of patients with multiple malignancies worldwide, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cancer cervical and epithelial ovary, fallopian tube or primary peritoneum cancer. The efficacy and safety of bevacizumab have been well documented and recognized worldwide.

About Innovent

Inspired by the spirit “Begin with Integrity, Succeed with Action”, Innovent’s mission is to develop, manufacture and market high-quality biopharmaceutical products that are affordable for everyday people. Founded in 2011, Innovent is committed to developing, manufacturing and marketing high quality, innovative medicines for the treatment of cancer, autoimmune, metabolic, ophthalmological and other major diseases. On October 31, 2018Innovent was listed on the main board of the Stock Exchange of Hong Kong Limited with stock code: 01801.HK.

Since its creation, Innovent has developed a fully integrated multifunctional platform that includes R&D, CMC (chemistry, manufacturing and controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a strong pipeline of 32 valuable assets in cancer, autoimmunity, metabolism, ophthalmology and other major therapeutic areas, with 7 products approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), Pemazyre® (oral pemigatinib inhibitor) and olverembatinib (BCR-ABL TKI) and Cyramza ® (ramucirumab), 3 assets under NMPA NDA review, 3 assets in phase 3 or pivotal clinical trials, and 19 additional molecules in clinical studies.

Innovent has assembled an international team with advanced talents in the development and commercialization of high-end biologic drugs, including many global 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 many collaborators to advance China the biopharmaceutical industry, improve the availability of drugs and improve the quality of life of patients. For more information, please visit: www.innoventbio.com and www.linkedin.com/company/innovent-biologics/.

To note:

TYVYT® (sintilimab injection) is not an approved product in the United States.

BYVASDA® (biosimilar bevacizumab injection), SULINNO® and HALPRYZA® (biosimilar rituximab injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (biosimilar injection of bevacizumab, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (biosimilar injection of adalimumab, Innovent)

Pemazyre® (oral pemigatinib inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in mainland China, Hong Kong, Macao and Taiwan.

CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in mainland China.

About Etana

Founded in 2014, Etana is an Indonesian biopharmaceutical company that researches, produces and markets biological therapies for the Southeast Asian market. With a mission to serve patients by providing high quality, affordable and innovative therapeutic products, the company has built state-of-the-art local production facilities that meet international and Indonesian FDA standards. These facilities have the capacity to produce organic therapeutic products certified as halal by the Indonesian Ulema Council (MUI). Etana aspires to be the leading biopharmaceutical company in the ASEAN region through aggressive expansion of manufacturing capacity and pipeline development, primarily focusing on oncology products and vaccines.

Etana is led by a local management team with various international backgrounds and strong experiences in the biopharmaceutical industry, with the support of a team of international investors and a leading biopharmaceutical company. Etana aims to provide innovative yet affordable treatments through local production, in support of Indonesian government programs and increased market demands. Etana is currently the leading biotechnology company in Indonesia engaged in the research and manufacture of monoclonal antibodies, mRNA and other biological platforms. For more information about Etana, please visit www.id.etanabiotech.com.

Innovent Forward-Looking Statements

This press release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, with respect to Innovent Biologics, Inc. (“Innovent” or “Company”), are intended to identify some of such forward-looking statements. The Company does not intend to regularly update these forward-looking statements.

These forward-looking statements are based on the Company’s management’s existing beliefs, assumptions, expectations, estimates, projections and understandings regarding future events at the time such statements are made. These statements are not guarantees of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company’s control and are difficult to predict. Accordingly, actual results may differ materially from the information contained in the forward-looking statements due to changes or future developments in our business, the Company’s competitive environment and political, economic, legal and social conditions.

The Company, the directors and employees of the Company assume no (a) obligation to correct or update any forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements do not materialize or prove to be incorrect.

SOURCE Innovative Biologics