Press Release No. 032/KFCP-DIR/PR/VIII/20
Jakarta, 24 August 2020, PT Kalbe Farma Tbk (Kalbe) through its subsidiary Kalbe-Genexine Biologics (KGBio) today has enrolled the first patients as well as supplied the first dosage of the Ephepoetin Alpha (EPO-HyFc) medication for the global phase-3 clinical trial. The medication is designed to be used for anemia therapy for kidney patients who are chronic - non-dialysis. The research project that is dubbed as Helios is conducting the non-inferiority trial in comparison with methoxy polyethylene glycol-Epoetin Beta (Mircera).
"Kalbe through KGBio has developed the technology with HyFc® platform that is designed to encourage discoveries of a variety of agnostic protein therapy that is differentiated," said Sie Djohan, President Director of Kalbe Genexine Biologics. "Ephepoetin Alpha (EPO-HyFc, GXE4) is one of the primary products from the HyFc® platform that has conducted the pre-clinical, phase-1, and phase-2 of the clinical trials with patients with anemia that is linked to Chronic Kidney Disease (CKD)," Djohan continued.
Kalbe-Genexine Biologics (KGBio) is a joint-venture company between PT Kalbe Farma Tbk (Jakarta, Indonesia), and Genexine Inc (Seoul, South Korea) that was established in January 2016 to develop biotechnology-based products.
"The EPO-hyFc products have longer efficacy compared to the presently available EPO. The function is to expedite the forming of red blood cells that are damaged post-dialysis therapy, declining kidney function, and other conditions," Sie Djohan added.
The development of Ephepoetin Alpha (GXE4) product at present has arrived in the phase-3 clinical trials using the open, random, and multi-center design (Protocol No. GXE4KGBio-001) with Helios as its project name. The research is aiming to determine with Ephepoetin Alpha that is given is effective and can be better tolerated compared to Mircera (methoxy polyethylene glycol - epoetin beta) as medication for patients with chronic, non-dialysis kidney disease. Helios is a non-inferior study that involves CKD patients that have not received medications and CKD patients that have been medicated with ESA as well as not undergoing dialysis. At present the Phase-3 Clinical Trial of Helios is conducted in six countries: Indonesia, Australia, Taiwan, Filipina, Thailand, and Malaysia. The plan is to recruit 386 patients from 45 research centers that are coordinated by Novotech (Australia) Pty Ltd.
The protocol of Phase-3 Helios clinical trial has received permits from the Ethics Committee and health authorities from the countries that are participating in the research. On August 20, 2020, out of 45 research institutions that take part, 31 of which have started the patient recruitment activities, whereas the others will start their recruitment activities in the next few days to weeks.
On August 19, 2020, the first patient from the University Malaya Medical Center, Malaysia, has been registered and given the trial medication. The purpose of the research is to recruit the research population through the upcoming 4-5 months and complete the study in 2 years.
The detail of the research can be accessed through http://www/clinicaltrials.gov (NCT04155125).
PT Kalbe Genexine Biologics at a glance
PT Kalbe Genexine Biologics that established in 2016, is a joint venture between PT Kalbe Farma Tbk and Genexine Inc. of South Korea. Kalbe Genexine Biologics holds the purpose of the development of innovative- and biotechnology-based drugs, with a focus on the design of clinical and non-clinical trials, the CMC development process, and meeting established regulations and quality. At present, the company is developing the EPO hyFc: 3rd generation Long-Acting EPO from Genexine, and PD-1: HLX10 that is licensed by Henlius Biotech.
Genexine at a glance
Genexine, Inc, is listed in KOSDAQ (095700) since 2009, is a biotherapeutics company that is focused in immuno-oncology and orphan diseases.
Genexine has a strong product pipeline that is undergoing clinical phases, e.g.: Hyleukin-7, HyTropin (GX-H9), Papitrol-188 (GX-188E) that are based on long-acting Fc fusion technology and therapeutic DNA vaccine technology. Genexine has completed the phase II of the multinational trials and is gearing to present the IND Phase-3 Clinical Trial in the US for HyTropin (long-acting human growth hormone, hGH-hyFc), Papitron-188, therapeutic DNA vaccine that is undergoing Phase-2 clinical trials in Europe and Korea for Cervical Intraepithelial Neoplasia (CIN) II / III. Established in 1999, Genexine has more than 140 employees who are mostly scientists with MSc or Ph.D. degrees. Genexine is located at Pangyo Techno Valley near Seoul, South Korea.
Kalbe at a glance
PT Kalbe Farma Tbk ("Kalbe") was established in 1966 and is one of the largest listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions that handle reliable and varied brand portfolio: prescription medicines (Cefspan, Brainact, Broadced, etc.); health product division that handles over-the-counter medication (Promag, Mixagrip, Komix, Woods, Fatigon, etc.); multivitamins (Fatigon, H2, XonCe, Hevit-C, JossC1000, etc.); as well as supplement and ready-to-consume drinks (Hydro Coco, Extra Joss); nutrition division (ChilKid, Prenagen, Diabetasol, Zee, etc,); and distribution division. Kalbe currently has more than 40 subsidiaries, 14 production facilities with international standards, and employs approximately 17,000 employees, dispersed in more than 76 branches throughout Indonesia. Since 1991, Kalbe is listed on the Indonesia Stock Exchange (IDX: KLBF).