Efepoetin alfa

SEOUL, South Korea I October 23, 2023 I 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. SOURCE: Genexine

Phase 3 clinical trial in China meets primary endpoint On track to in China in 2024 SEOUL, South Korea--(BUSINESS WIRE)-- Genexine Co. Ltd. (KOSDAQ:095700, CEO Neil Warma), a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, today announced positive topline results from the multi-center, randomized, open-label, active-controlled pivotal phase 3 study (CTJ101PGHD301) being conducted in China to evaluate the efficacy and safety of eftansomatropin alfa (Genexine’s proprietary long-acting growth hormone, also known as GX-H9) in children with growth hormone deficiency. The study being conducted by Genexine’s partner in China, I-Mab, met its primary endpoint of annualized height velocity (AHV) at week 52 and demonstrated that eftansomatropin alfa was non-inferior to Norditropin®. Eftansomatropin alfa was given by weekly injection vs. Norditropin® given by daily injection. The mean AHV was 10.76 (cm/year) for eftansomatropin alfa vs. 10.28 (cm/year) for Norditropin®, with a difference of 0.47 [95% CI -0.06,1.00] and non-inferiority p-value <0.0001. Eftansomatropin alfa was well tolerated and no drug discontinuation was reported due to treatment related adverse events. The safety pro eftansomatropin alfa was comparable to Norditropin®. The Company is planning to BLA submission in China in 2024. “We are pleased with the results from this registration trial as this demonstrates clear safety and efficacy in this potential best-in-class drug to treat children with growth hormone deficiency,” said Neil Warma, Genexine President and CEO. “This is a significant milestone for Genexine as we demonstrate our ability to bring our novel products to market and the value of our proprietary long-acting hyFc® platform. We are excited to be preparing to submit the BLA in 2024 and advancing this product to market and to patients in China. We remain committed to our efforts to commercialize our leading products in various key markets.” About Eftansomatropin alfa (long-acting recombinant human growth hormone) GX-H9 has been developed utilizing Genexine’s hyFc® platform as a treatment for growth hormone deficiency (GHD). GX-H9 is currently being evaluated in a phase 3 registration trial in pediatric GHD in China with a BLA submission expected in 2024. GX-H9 is a potential best-in-class product that is differentiated by its extended half-life resulting in significantly fewer injections (weekly versus daily) and its improved safety profile. Patient compliance has been dramatically improved, which is critical for the pediatric population. GX-H9 is being co-developed with Handok under a strategic partnership and with I-Mab for development in greater China. I-Mab has partnered with Jumpcan for product launch and commercialization of eftansomatropin alfa in China. About Genexine Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on developing and commercializing immunotherapeutics 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-188E (tirvalimogene teraplasmid) for head and neck cancer and 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. Forward Looking Statements This press release contains forward-looking statements regarding the business of Genexine, Inc. ("Genexine"). Any statement describing Genexine's goals, expectations, financial or other projections, intentions or beliefs, development plans and the commercial potential of Genexine's drug development pipeline, including without limitation GX-I7 (efineptakin alfa), GX-188E, GX-H9 (eftansomatropin alfa), GX- E4 is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to risks and uncertainties, particularly those challenges inherent in the process of discovering, developing and commercialization of new drug products that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Genexine's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Genexine's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Genexine. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Genexine's programs are described in additional detail in Genexine's annual reports on the DART (Data Analysis, Retrieval and Transfer System) internet site ( ) of the Korean Financial Services Commission. Genexine assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.