KALBE LAUNCH THE FIRST NOVOSIS, AN INNOVATIVE PRODUCT OF BONGRAFT COMBINED WITH GROWTH FACTOR, IN INDONESIA

Jakarta, April 4th, 2022. PT Kalbe Farma Tbk (Kalbe) collaborates with CGBio Korea to launch Novosis, the first innovative product in Indonesia that combines a synthetic bonegraft with growth factor rhBMP-2 (recombinant human Bone Morphogenetic Protein-2) for treating fractures. This “dual action” combination of the bonegraft acts as a bone and rhBMP filling material that can increase the bone stimulation and is clinically proven to have satisfying benefits and results. This is also proven from the period of operation and the bone healing process for patients, with a minimum alergy risk and post-operative pain. This innovation will help the doctors and can influence the life quality of the patients. According to the Head of Stem Cell and Tissue Enginering Cluster IMERI FKUI (the Faculty of Doctor of the University of Indonesia), Prof. Dr. dr. Ismail Hadisoebroto Dilogo, Sp.OT. (K), the clinical experience showed that Novosis could accelerate the operation in one specific surgical location. “Bone morphogenetic protein (BMP) is a protein that has an important role in forming and regenerating bones and cartilages. Many researches in the Cipto Mangunkusumo Hospital alone have implemented the BMP-II as an osteoinductive agent,” as stated by Prof. Dr. dr. Ismail Hadisoebroto Dilogo, Sp.OT. (K). He then explained, “The implementation of BMP-II as an osteoinductive agent is proven to be safe and capable to accelerate surgery, decrease the risk of complication or donor-site morbidity, and is effective in governing the fractures and chronic bone defects.” A 2018 Basic Health Research result by the National Institute of Health Research and Development stated that Indonesian people experienced around 5.5% cases of factures caused by trauma, pressure, and even pathological disorders like osteoporosis. “The high rate of fracture cases in Indonesia requires the proper action and teraphy in order to accelerate the grafting of the fractured bone. Operations also require a bonegraft or replacing the missing bone,” according to the Chairman of the Executive Board of the Indonesian Medical Association (PB IDI), dr. Muhammad Adib Khumaidi, Sp.OT. The bone fusion or bone grafting and its degrees must be accelerated more than the autograft process, while trying to decrease the pain from the patients. Therefore, a collaboration between Kalbe and CGBio Korea stays committed in providing innovative products. “Kalbe has committed to provide innovative products that are aligned its missions, to increase health for a better life. Novosis will complete the series of bone graft products created by both Kalbe and CGBio Korea, Bongros (Hydroxyapatite) and Excelos Inject (micro Beta Tricalcium Phosphate),” according to Ridwan Ong, the Director of Pharmaceutical Marketing of PT Kalbe Farma Tbk. He added, “CGBio is a South Korean company that has experiences in developing products with a regenerative medical technology, which focuses on developing and providing innovative solutions for biological regenerative treatments.” The CEO of CGBio, Hyun Seung Yu, stated that the company would continuously innovate and attempt to create a new biological technology, with Novosis being the second product of the bone graft with growth factor BMP-2 that received a distribution permit to be commercialized worldwide. “The BMP-2 itself has a role in facilitating a faster grafting for newer bones, by separating stem cells inside the body during fractures, and with better effects,” said Hyun Seung Yu. He furtherly stated, “Indonesia is very special to CGBio and we are grateful to launch Novosis in this country through a collaboration with the best company such as Kalbe Farma. We would hope that this collaboration can assist in increasing health and quality of life for the Indonesian people.” This startegic collaboration betwee Kalbe and CGBio, through marketing infrastructures and national distributions by Kalbe, is hoped to easily provide Novosis for both doctors and patients, which could also help in their recovery process. On the other hand, fractures remain one of the greatest health issues in the society that can also affect their economy, due to low productity, the possibility of disablity, the decreasing quality of life, and the fatal consequences. A 2018 Basic Health Research result by the National Institute of Health Research and Development also revealed that Indonesia experienced 5.5% of fracture cases. The main objective of governing a fracture is to reposition a bone to its former location. In order to achieve such condition, replacing a missing or broken bone with a bonegraft is the proper action. A bone graft to replace missing or broken bones has been utilized in every fracture operation case, including in Indonesia, and can be obtained from either a bone of a patient itself (autaograft) or an animal or synthetic one. A synthetic bonegraft has an advantage that minimalizes the risk of contagious disease transmission, decreases the time and prevents the risk of hemorrhaging during operation, and can be easily managed as a supply. The combination of bone graft and growth factor could create a sinergic effect in forming a new bone that could accelerate a patient’s recovery. Novosis at a glance Product Name  : Novosis Compositions   Novosis contains rhBMP-2 (recombinant human bone morphogenetic protein-2) as an active material and a hydroxyapatite (HA) crystal as a carrier. rhBMP-2 is a protein molecule that is genetically engineered from a cell of bacteria Escherichia coli à osteoinductive: a synthetic that inducts the forming of a bone in the implant location. Hydroxyapatite (HA): a synthetic with a high rate of purity, which can be implanted and has a trabeculae structure similar to human skeleton, with a three-dimensional, interconnected pore structure, and as a carrier of rhBMP-2 as well as a skeleton in forming a new bone tissue à osteoconductive. Indication        Indication to fill a bone defect caused by a surgery or a traumatic injury on the skeleton (extremity, spine, and pelvis). Dosage and Ways of Implementation: ·         NOVOSIS must be prepared seconds before being implanted. ·         rhBMP-2 must be dissolved with WFI into a clear, colorless liquid with 1 mg/1mL of concetration (pH 4,5), before being equally sprayed to the entire HA. ·         NOVOSIS is implanted after a surgeon locates an implant location. ·         If NOVOSIS is not utilized in 2 hours after reconstitution, it must be disposed immediately. ·         NOVOSIS cannot be resterilized. Contraindication          ·         Hypersensitivity towards NOVOSIS components ·         Pregnancy ·         Active malignancy or patients that undergo malignancy therapies ·         Active infection on a operating location ·         Persistent compartment syndrome ·         Uncontrolled DM with severe complications ·         Patological fracture such as Paget disease or metatases ·         Severe degenerative bone diseases (T score <-3,0) Warning & Caution      : ·         Women potentially on birth are recommended not to pregnant after the NOVOSIS therapy for a year. ·         Breastfeeding mothers. ·         Immature bones. ·         Use and reconstitute the product as instructed. ·         NOVOSIS is meant to be utilized once. ·         Patients with kidney disorder, liver, metabolic bone diseases, autoimmune diseases, and immunosuppresive diseases. ·         A potential of immune responses towards NOVOSIS components. Side Effects                  ·         There are no reports of serious side effects during a clinical test of NOVOSIS 1mg/1mL Storage                        ·         Store it in the refrigerator (for about 2-8°C). ·         Do not freeze it. ·         Store it in its original package to protect it from sunlight. Packaging                    A box of 1 vial of rhBMP-2 0,25 mg, a vial of HA 1 gram, and a vial of WFI 1 mL Kalbe at a glance Founded in 1966, PT Kalbe Farma Tbk (Kalbe) is one of the largest open pharmaceutical companies in Southeast Asia. The company has four main divisions that engage in a portfolio of reliable and diversed brands, such as the prescription medicine division, the health product division which handles free medicines, multivitamins, and ready-to-drink supplement beverages, and the distribution and logistics divisions. Kalbe has also developed a digital service ecosystem for the society, both in B2B with EMOS and in B2C with KlikDokter. EMOS is an order management application system that facilitates the distribution channels in commencing stock management or supply chain, while KlikDokter is a digital platform for health services, specifically telemedicine, which provides necessary health consultations and products for the society. Now, Kalbe has more than 40 subsidiaries and 15 production facilities with international standards, employing around 16.000 employees who are being stationed in 76 branches all around Indonesia. Kalbe’s shares has been recorded in the Indonesia Stock Exchange (IDX) since 1991 (IDX:KLBF).

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