PT Kalbe Farma Tbk: KALBE LAUNCHES FIRST NOVOSIS, AN INNOVATIVE PRODUCT FROM BONGRAFT COMBINED WITH A GROWTH FACTOR, IN INDONESIA

Press release No. 022/KFCP-DIR/PR/III/22


Jakarta, April4th,2022. PT Kalbe Farma Tbk (Kalbe) collaborates withCGBio Koreato launch Novosis, the first innovative product in Indonesia that combines synthetic bone grafting with growth factor rhBMP-2 (recombinant human Bone Morphogenetic Protein-2)for the treatment of fractures.

This “dual action”combination of bone graft acts as a bone and rhBMPfilling material that can increase bone stimulation with clinically proven benefits and results. This is also proven from the intervention period and the bone healing process for patients, with a minimum risk of allergy and post-operative pain.

This innovation will help doctors and can influence the quality of life of patients. According to the head of Stem Cells and Tissue Engineering Center IMERI FKUI(the Faculty of Doctor of the University of Indonesia), Teacher. Dr. dr. Ismail Hadisoebroto Dilogo, Sp.OT. (K),clinical experience has shown that Novosis can speed up the operation in a specific surgical site.

Bone morphogenetic protein (BMP) is a protein that plays an important role in the formation and regeneration of bones and cartilage. Much research in the Cipto MangunkusumoOnly the hospital has set up BMP-IIas an osteoinductive agent”, as stated Teacher. Dr. dr. Ismail Hadisoebroto Dilogo, Sp.OT. (K).

He then explained, The implementation of BMP-IIas an osteoinductive agent has been shown to be safe and able to expedite surgery, decrease the risk of donor site complication or morbidity, and is effective in controlling fractures and chronic bone defects.

A 2018 basic health research finding by the National Institute of Health Research and Development said that Indonesians experienced about 5.5% of fracture cases caused by trauma, pressure and even pathological disorders like osteoporosis.

“The high rate of fracture cases in Indonesia requires appropriate action and therapy to expedite the grafting of the fractured bone. The operations also require bone grafting or replacement of the missing bone,” according to the chairman of the board of theIndonesian Medical association(PB IDI), dr. Muhammad Adib Khumaidi, Sp.OT.

Bone fusion or bone grafting and its degrees must be accelerated more than the autograft process, while trying to decrease the pain of patients. Thus, a collaboration between Kalbe andCGBio Korearemains committed to providing innovative products.

“Kalbe is committed to providing innovative products that are aligned with its missions, to improve health for a better life. Novosis will complete the series of bone grafting products created by the two Kalbe andCGBio Korea, Bongros (Hydroxyapatite) aDExcelos Inject (micro tricalcium phosphate beta),” according to Ridwan Ongthe TerribleDirector of Pharmaceutical MarketingPT Kalbe Farma Tbk.

He added, “CGBio is a South Korean company with experience in product development with regenerative medical technology, which focuses on developing and delivering innovative solutions for biological regenerative treatments.”

the CEOofCGBio, Hyun Seung Yu, said the company will continuously innovate and try to create new biological technology, with Novosis being the second product of the bone graft withBMP-2 growth factorwhich has received a distribution license to be marketed worldwide.

the BMP-2 itself has a role in facilitating faster grafting for newer bones, separating stem cells inside the body during fractures, and with better effects,” said Hyun Seung Yu.

He further stated, “Indonesia is very special for CGBioand we are grateful to launch Novosis in this country thanks to a collaboration with the best company such as Kalbe Farma.We hope that this collaboration can contribute to improving the health and quality of life of the Indonesian people.”

This strategic collaboration betweenKalbe aDCGBio,with Kalbe’s marketing infrastructure and nationwide distributions, it is hoped to easily provide Novosis to doctors and patients, which could also help them in their recovery process.

On the other hand, fractures remain one of the biggest health problems in the society which can also affect their economy, due to low productivity, possibility of disability, decreasing quality of life and consequences fatal. A 2018 The results of basic health research from the National Institute of Health Research and Development also revealed that Indonesia experienced 5.5% of fracture cases.

The primary goal of fracture management is to reposition a bone to its former location. In order to achieve such a condition, replacing a missing or broken bone with a bone graft is the appropriate action.

A Btransplant to replace missing or broken bones has been used in all fracture operation cases, including Indonesia, and can be obtained from a patient’s own bone (autograft) or from an animal or synthetic.

A synthetic btransplant has an advantage that minimizes the risk of transmitting contagious diseases, decreases time and prevents the risk of bleeding during the operation, and can be easily managed as a supply. The combination of bone grafting and growth factor could create a synergistic effect in the formation of new bone that could speed up a patient’s recovery.

A brief introduction toNovosis

Productct Name :Novosis

Compositiontions

Novosiscontains rhBMP-2(recombinant human BONE morphogenetic protein-2) as an active ingredient aa hydroxyapatite (HA) crystal as support.

rhBMP-2is a proteinmolecule This isgeneticspecially designed from a bacteria cell Escherichia coli a osteoinduactive: a sthereNThiswhich induces the formation of a bone in implantlocation.

hydroxyapatite (HA): a sthereNThisc with a high degree of purity, which can be implanted afrom a trabevswowthe structure similar to the human skeleton, with an interconnected three-dimensional porestructurevstowerand, and like a bearer ofrhBMP-2 as well as a skeleton by forming new bone tissue a osteovscorrugatedactive.

Indiancation

Indiancation to fill out a BONE faultcaused by surgery or traumatic injury on the skeleton (extremity, vertebral column and pelvis).

To dogrow old oneD Methods of implementation:

· NOVOSE must be prepared a few seconds before being Iimplanted.

· rhBMP-2 must be dissolved withWFI in a clear, colorless liquid with 1mg/1mL of focus (pH 4.5), before being also sprayed to allHA.

· NOVOSE is implanted after surgeon locates aimplantlocation.

· Yes NOVOSE is not used in2 hours later DvsconstituteyouIto, it must be eliminated immediately.

· NOVOSE cannot be re-sterilized.

Constrainedcation

· Htherepersensitivitythere towards NOVOSEComponents

· Pregnancy

· Active malignancy or Pennsylvaniayoufineyou who suffer malignancy therapies

· Active infection on a operayouIsite

· Ppersistt compartment syndrome

· Uncontrolled DM with severe vsfulfilledcations

· Patologicalfracture callus likePagetdisease or metastasis

· Severe degenerative bone diseases(T-score

Warning & Caution :

· Women potentially at birth are recommended not to become pregnant after NOVOSIS therapy for one year.

· Nursing mothers.

· I ammatureth bone.

· Use aDDvsconstituteyou the productside as indicated.

· NOVOSE is intended for one-time use.

· Pennsylvaniacustomers with kidney disorder, livermetabolismc bone diseasesAutomatiquemUNand diseasesaDI ammunosupPresidentfive diseases.

· ApoweryouIall of immuneresponseare towards NOVOSEComponents.

Side effects

· Jthere are no reports of serious side effects in a clinical trial of NOVOSE 1mg/1ml

Storage room

· Store it in the refrigerator(For about 2-8°VS).

· Don’t freeze it.

· Store it in its original packaging to protect it from direct sunlight.

Packaging

A box of 1 vial of rhBMP-2 0.25mg, a Flaskof HA 1 gramaD a Flaskof WFI 1ml

A brief introduction toKalbe

Founded in 1966, PT Kalbe Farma Tbk (Kalbe) is one of the largest public pharmaceutical companies in Southeast Asia. The company has four main divisions which engage in a portfolio of reliable and diverse brands, such as prescription drugs division, health products division which handles free medications, multivitamins and ready-to-drink beverage supplements , and the distribution and logistics divisions. .

Kalbe has also developed an ecosystem of digital services for the company, both in B2B with EMOS and in B2C with KlikDokter. EMOS is an order management application system that facilitates distribution channels when starting inventory or supply chain management, while KlikDokter is a digital platform for healthcare services, in particular telemedicine, which provides consultations and health products needed by society.

Today, Kalbe has more than 40 subsidiaries and 15 production sites with international standards, employing approximately 16,000 employees in 76 branches across Indonesia. Kalbe shares have been listed on the Indonesian Stock Exchange (IDX) since 1991 (IDX: KLBF).

Comments are closed.