Innovent and Etana Jointly Announce the Approval of Bevagen® (Bevacizumab Biosimilar) by the Indonesian Food and Drugs Authority (BPOM)

Rhea-AI Summary

Innovent Biologics and PT Etana Biotechnologies Indonesia announced the approval of Bevagen®, a bevacizumab biosimilar, by the Indonesian Food and Drugs Authority (BPOM) on June 13, 2022. This approval allows for five cancer treatment indications, including colorectal and breast cancer. Bevagen® will be the first Chinese antibody drug produced in Southeast Asia. The collaboration aims to leverage Etana's local market expertise to enhance patient access to affordable cancer treatments. Innovent's portfolio includes 32 assets, with several approved in China, showcasing its commitment to global market expansion.

Positive

• Approval of Bevagen® for five cancer indications enhances market potential.
• First Chinese antibody drug to be produced locally in Southeast Asia, expanding Innovent's footprint.
• Strategic collaboration with Etana expected to improve access to affordable treatments.
• Innovent's robust pipeline with 32 assets highlights growth potential.

Negative

• None.

SAN FRANCISCO and SUZHOU, China, June 13, 2022 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and PT Etana Biotechnologies Indonesia ("Etana"), today jointly announced that the Indonesian Food and Drugs Authority (BPOM) has approved Bevagen® (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug, 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 ovarian, fallopian tube, and primary peritoneal cancer (OC), and cervical cancer(CC). Etana will commercialize Bevagen® in Indonesia under the current licensing agreement with Innovent. Bevagen® will potentially be the first Chinese antibody drug to be marketed and locally produced in Southeast Asia.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, said "We are pleased that under the strategic collaboration with Etana, the approval of Bevagen® in Indonesia marked a meaningful step toward bringing Innovent's innovative portfolio into the global market, benefitting patients globally. Pairing Etana's commercial expertise in the local Indonesian market with Bevagen®'s clinical profile, high-quality production and relative affordability, we are confident that Bevagen® will launch to the market quickly and benefit many cancer patients."

Nathan Tirtana, President Director of Etana said, "Etana appreciates the support of BPOM for approving Bevagen® for cancer patients in Indonesia. With this product, we believe we can provide better access to high quality and affordable biosimilar drug to meet the need of cancer patients in Indonesia. Our next step is to implement the technology transfer and local Bevagen® production in Indonesia, via 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 frequent cancer types in Indonesia, and Bevagen® is approved for most of these indications."

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

Since January 18, 2021, Etana has entered into strategic collaboration with Innovent Biologics. Currently, Innovent's bevacizumab biosimilar 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, adult recurrent glioblastoma, advanced or unresectable hepatocellular carcinoma, advanced ovarian cancer and advanced cervical cancer.

About Bevagen® (Bevacizumab Biosimilar)

Bevagen® is a biosimilar of 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 the 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 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 documented and recognized worldwide.

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, ophthalmology 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 32 valuable assets in the fields of cancer, autoimmune, metabolic, 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® (pemigatinib oral inhibitor) and olverembatinib (BCR-ABL TKI) and Cyramza® (ramucirumab), 3 asset under NMPA NDA review, 3 assets in Phase 3 or pivotal clinical trials, and an additional 19 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, 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 help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com and www.linkedin.com/company/innovent-biologics/.

Note:

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

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

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab biosimilar injection, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (adalimumab biosimilar injection, Innovent)

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

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

About Etana

Established in 2014, Etana is an Indonesian biopharmaceutical company that researches, produces and commercializes biologicals therapies for the Southeast Asian market. With the mission to serve patients by providing high quality, affordable, and innovative therapeutics, the company has constructed the state-of-the-art local production facilities that meet international and Indonesian FDA standards. These facilities have the capability to produce biological therapeutics with halal certification from the Indonesian Ulema Council (MUI). Etana aspires to be the leading biopharmaceutical company in ASEAN region through aggressive expansion in production capacity and pipelines development, with primary focus on oncology products and vaccines.

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

Innovent's Forward-Looking Statements

This news 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, as they relate to Innovent Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee 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. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

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SOURCE Innovent Biologics

FAQ

What is Bevagen® approved for in Indonesia?

Bevagen® is approved for five indications including metastatic colorectal cancer, triple negative breast cancer, advanced non-small cell lung cancer, ovarian cancer, and cervical cancer.

When was Bevagen® approved by BPOM?

Bevagen® was approved by the Indonesian Food and Drugs Authority (BPOM) on June 13, 2022.

What role does Etana play in the commercialization of Bevagen®?

Etana will commercialize Bevagen® in Indonesia under a licensing agreement with Innovent, handling local production and distribution.

How does Innovent's pipeline look as of June 2022?

Innovent has developed a robust pipeline of 32 assets, with 7 products approved for marketing in China.

What significance does the approval of Bevagen® hold for Innovent?

The approval marks a significant step in Innovent's strategy to bring its innovative portfolio to the global market, benefiting patients in Southeast Asia.