Genexine and KGbio received the first market approval for novel long-acting Erythropoietin, Efepoetin alfa, from The Indonesian Food and Drug Authority (BPOM)

Rhea-AI Summary

Genexine receives market approval for its long-acting erythropoietin drug Efepoetin alfa for the treatment of chronic kidney disease-induced anemia in non-dialysis patients. Further approvals for dialysis patients expected. Multinational Phase 3 clinical trial planned for label expansion.

Positive

• Genexine receives first market approval for Efepoetin alfa, a drug for CKD-induced anemia. Potential for increased sales and revenue.
• Approval opens up opportunities for commercialization in other Asian countries.
• Multinational Phase 3 clinical trial targeting dialysis patients planned for label expansion.

Negative

• None

• First market approval for Genexine discovered and developed therapeutic drug, Efesa (Efepoetin alfa), a long-acting erythropoietin (EPO) for the treatment of Chronic Kidney disease Induced anemia
• Label expansion ongoing in dialysis patients

SEOUL, South Korea--(BUSINESS WIRE)-- Genexine (KQ 095700, CEO Sungjune Hong), a publicly-listed clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, together with PT Kalbe Genexine Biologics (KGbio), a joint venture clinical-stage biotechnology company between Genexine and PT Kalbe Farma that focused on bringing biologics medical innovation to international markets, announced the approval of its long-acting erythropoietin, Efepoetin alfa (GX-E4), by the Indonesian Ministry of Food and Drug Safety (BPOM) for the treatment of chronic kidney disease induced anemia in non-dialysis patients. This milestone marks the first market approval for a drug originating from Genexine's research and development with KGbio.

Genexine, in collaboration with KGbio, has been co-developing Efepoetin alfa for CKD patients in both non-dialysis and dialysis settings. While this BPOM approval specifically pertains to the treatment of CKD-induced anemia in non-dialysis patients, it is anticipated that further approvals for dialysis patients with CKD-induced anemia will be secured in due course.

Furthermore, a multinational Phase 3 clinical trial targeting dialysis patients is set to commence in the Q4 of 2023, spearheaded by Genexine and KGbio. This study will be conducted across 11 countries in Europe and Asia to facilitate a label expansion including both dialysis and non-dialysis patient populations.

“We are thrilled to have our first-ever product approval,” said Sungjune Hong, CEO of Genexine. “This is a landmark result for everyone at Genexine and our partner KGbio and represents our first market approval of therapeutic drugs that have been discovered, developed, and commercialized by a Korean BioPharma company. Our efforts to focus on commercialization over the past year have been successful and we now look to roll out this product in several other Asian countries and expand the indication to include dialysis patients. Efepoetin alfa was one of the products developed using our proprietary hyFc® fusion platform and demonstrates our ability to deliver a novel long-acting EPO drug to patients suffering from CKD-induced anemia.”

And President Director of PT Kalbe Genexine Biologics, Sie Djohan said “Kalbe believes by receiving market approval for anemia treatment Efepoetin alfa, It is easier for patients to get access to medicines for their recovery."

In 2020, Genexine and KGbio initiated phase 3 clinical trials for non-dialysis patients in a multinational setting, spanning seven countries across Asia and Oceania. These countries included Korea, Australia, Taiwan, as well as Southeast Asian nations such as Indonesia, Malaysia, Thailand, and the Philippines. As of the latest results in April 2023, Efepoetin alfa has demonstrated non-inferiority when compared to Roche's Mircera®, exhibiting a good safety and tolerability profile. It successfully met the primary endpoint, achieving a response rate 69.6% in patients whose hemoglobin levels increased by more than 1g/dL, surpassing the 63.2% for Mircera®.

About Efepoetin alfa (GX-E4)

Efepoetin alfa (GX-E4) is a bio-better drug for CKD-induced anemia, developed based on hyFc^®, Genexine's proprietary long-acting platform technology. As kidney function declines patients with CKD suffer anemia due to a lack of EPO(Erythropoietin), a hormone that stimulates red blood cell production, approximately 90% of EPO is produced by the kidney. GX-E4 is a long-acting drug that extends the half-life of EPO in the body, that is developed for once every two weeks or once every four weeks injection, compared to the first-generation short-acting EPO product that needs to be injected once every 2 to 3 days.

About Genexine

Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on developing and commercializing immunotherapeutic and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFc® fusion technology. The Company has multiple products in clinical development including several undergoing Phase 3 registration trials. The Company's proprietary pipeline includes GX-188 (tirvalimogene teraplasmid) for cervical cancer, GX-I7 (efineptakin alfa) for multiple cancers, GX-H9 (eftansomatropin alfa) for Pediatric Growth Hormone Deficiency and GX-E4 for CKD-induced anemia, among others. Genexine has established multiple partnerships with global companies in order to expedite product development and commercialization and create significant value. Genexine is listed on the Korean exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea. Genexine is committed to the well-being and care of patients worldwide.

About KGbio

KGbio is a clinical-stage biotechnology company established in 2016, focused on bringing biologics medical innovation to markets outside the US/Canada, Western Europe, and China. The business model revolves around in-licensing novel biologics and select biosimilars in oncology and high-specialty therapeutic areas (typically pre-IND or early clinical stage), with the objective to out-license them in target geographies after finishing clinical development as well as regulatory and reimbursement approvals.

Platforms of interest include Fc-fusion proteins, antibodies, bi-specifics, ADCs, cell therapies and therapeutic vaccines. The company is backed by Asian pharma companies Kalbe, Genexine and US private equity giant General Atlantic.

For more information, kindly visit: https://www.kg-biologics.com/

About Kalbe

PT Kalbe Farma Tbk. (“Kalbe”) was established in 1966 and is one of the largest publicly-listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions managing a broad and strong portfolio of brands; Prescription Pharmaceuticals Division, Consumer Health Division comprising over-the-counter drugs, as well as supplement drink and ready to drink products, Nutritional Division, and Distribution & Logistics Division. Kalbe currently has more than 40 subsidiaries and 14 production facilities with international standards, employed around 16,000 employees and have 72 branches of distribution & logistics across Indonesia. Since 1991, Kalbe’s shares have been listed on the Indonesia Stock Exchange (IDX: KLBF). As of 31 December 2022, Kalbe has IDR 28.9 trillion total consolidated revenue and IDR 98.0 trillion market capitalization.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231022313600/en/

For further information, please contact:

Mr. Jongsoo Lee

Investor Relations, Genexine, Inc.

jongsoo.lee@genexine.com

Source: Genexine, Inc.

FAQ

What drug did Genexine receive market approval for?

Genexine received market approval for its long-acting erythropoietin drug Efepoetin alfa.

What is Efepoetin alfa used for?

Efepoetin alfa is used for the treatment of chronic kidney disease-induced anemia in non-dialysis patients.

Will there be further approvals for dialysis patients?

Yes, it is anticipated that further approvals for dialysis patients with CKD-induced anemia will be secured in due course.

What is the plan for label expansion?

A multinational Phase 3 clinical trial targeting dialysis patients is planned for label expansion.

What were the results of the clinical trials for Efepoetin alfa?

Efepoetin alfa demonstrated non-inferiority to Roche's Mircera®, achieving a response rate of 69.6% in patients whose hemoglobin levels increased by more than 1g/dL.