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Kalbe Launches Serplulimab in Indonesia, Lung Cancer Therapeutic Drug

Saturday, March 9, 2024

Jakarta, March 9th 2024 –  PT Kalbe Farma Tbk (Kalbe), through its subsidiaries PT Kalbe Genexine Biologics (KGbio) and PT Global Onkolab Farma (GOF), has launched Serplulimab to expand healthcare access for cancer patients. This initiative is aligned with Kalbe’s commitment to broadening access to healthcare and advancing innovation in cancer immunotherapy development in Indonesia. Serplulimab is an innovative immunotherapy product, combined with chemotherapy, for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Kalbe is currently the first and only local pharmaceutical company to market such an innovative immunotherapy product.


The launch of Serplulimab, in collaboration with Shanghai Henlius Biotech, Inc., took place on Saturday (March 9) following Kalbe’s market authorization approval from the Indonesian FDA (BPOM RI) in December 2023. “The availability of Serplulimab demonstrates Kalbe’s commitment to expanding access to healthcare services for lung cancer patients. This initiative also reflects our sustainability efforts in building an integrated healthcare ecosystem together with hospitals, healthcare professionals, medical associations, patients, and relevant stakeholders,” said Sie Djohan, President Director of KGbio and Director of Kalbe.


Cancer is one of the most pressing health issues in Indonesia and is the second leading cause of death after cardiovascular disease. According to GLOBOCAN 2022, there are approximately 408,000 new cancer cases annually, with 243,000 deaths.

“Lung cancer ranks as the third most common cancer, with more than 50% of patients dying within one year of diagnosis, and a survival rate of only 17.8%. Therefore, managing lung cancer requires a comprehensive approach—from promotive and preventive measures such as awareness and education programs, smoking avoidance campaigns, screening, and early detection, to curative treatments through precision medicine, including immunotherapy,” explained Dr. Tubagus Djumhana Atmakusuma, SpPD-KHOM, Chair of the Indonesian Society of Hematology-Oncology for Internal Medicine (PERHOMPEDIN).


Lung cancer is often diagnosed at an advanced stage, when treatment options are limited. This also applies to small cell lung cancer (SCLC), which accounts for 14% of all lung cancer cases. An estimated 250,000 patients are diagnosed with SCLC, and up to 80% do not survive. Due to its aggressive nature and difficulty to detect early, treatment is often delayed, resulting in low recovery rates.


“Cancer treatment includes a wide variety of methods—chemotherapy, radiation, surgery, and more recently, immunotherapy. Immunotherapy works by stimulating the body’s immune system to attack cancer cells or by providing immune components needed to help kill cancer cells. Based on clinical experience and published data, immunotherapy drugs like Serplulimab can serve as an important treatment option for patients with extensive-stage small cell lung cancer,” said Dr. Andhika Rachman, SpPD-KHOM, Hematology-Oncology Consultant at Cipto Mangunkusumo Hospital.


Kalbe’s continuous efforts to strengthen cancer management are further supported by the establishment of ONE Onco as an integrated healthcare ecosystem. “Through our subsidiary GOF, Kalbe has initiated the development of ONE Onco, an integrated oncology ecosystem offering comprehensive solutions for cancer patients—from treatment, early detection, service directories, online consultations, healthy living support, to supportive therapies such as nutrition. We warmly welcome the availability of innovative immunotherapies like Serplulimab to broaden treatment access for lung cancer patients in Indonesia,” said Liliana Susilowati, President Director of GOF.


Going forward, Kalbe, KGbio, and Henlius will expand their exclusive licensing for development and commercialization across Southeast Asia, the Middle East, and North Africa. “Through this strategic partnership, we aim to leverage our collective resources and expertise to promote and commercialize Serplulimab, expanding access to this innovative therapy for patients in these regions,” added Sie Djohan.


About Kalbe


PT Kalbe Farma Tbk (Kalbe), established in 1966, is one of the largest publicly listed pharmaceutical companies in Southeast Asia. Kalbe operates four main divisions: prescription pharmaceuticals, consumer health (over-the-counter medicines and multivitamins), nutrition, and distribution & logistics.

Kalbe has also developed B2B digital services such as EMOS, an order management system that streamlines distribution and supply chain management, and MOSTRANS, a B2B transportation solutions provider for logistics efficiency.


The company now has over 40 subsidiaries, 15 international-standard manufacturing facilities, and around 16,000 employees across 72 branches in Indonesia. Since 1991, Kalbe’s shares have been listed on the Indonesia Stock Exchange (IDX: KLBF).


About Kalbe Genexine Biologics (KGbio)


Founded in 2016, KGbio is a clinical-stage biotechnology company focused on bringing biologic innovations to markets outside the US/Canada, Western Europe, and China. Its business model involves licensing novel biologics and select biosimilars in oncology and specialty therapeutic areas (typically at pre-IND or early clinical stages), with the goal of licensing them in target geographies after clinical development and regulatory approval.


Its platform interests include Fc-fusion proteins, antibodies, bispecifics, ADCs, cell therapies, and therapeutic vaccines. KGbio is backed by Asian pharmaceutical company PT Kalbe Farma Tbk., South Korea’s Genexine, and US-based private equity firm General Atlantic.


About Global Onkolab Farma (GOF)


PT Global Onkolab Farma, a subsidiary of PT Kalbe Farma, focuses on the development and production of various oncology medicines, including prescription drugs, therapies, and supportive regimens.


Based in Indonesia, GOF is one of the first local manufacturers specializing in oncology production, using advanced technology to provide high-quality oncology products at affordable prices. To better serve cancer patients, GOF is committed not only to developing more effective cancer drugs but also to providing supportive care such as nutrition products and engaging with cancer communities to strengthen patient support systems.


[i] Science Direct, SCLC: Epidemiology, Risk Factors, Genetic Susceptibility, Molecular Pathology, Screening, and Early Detection, https://www.sciencedirect.com/science/article/pii/S1556086422018512#:~:text=The%20SCLC%20accounts%20for%20approximately%2014%25%20of%20all%20lung%20cancer%20cases.&text=Approximately%20250%2C000%20patients%20are%20diagnosed,200%2C000%20succumb%20to%20the%20disease, terakhir diakses 27 Februari 2024


[ii] Klikdokter, Kanker Paru Sel Kecil dan Gejalanya yang Mesti Diwaspadai, https://www.klikdokter.com/info-sehat/kanker/kanker-paru-sel-kecil-dan-gejalanya-yang-mesti-diwaspadai, terakhir diakses 27 Februari 2024


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