News and Events

Kalbe Launches Serplulimab, Lung Cancer Therapeutic Drug


PT Kalbe Farma Tbk (Kalbe) is currently the only domestic pharmaceutical company that markets the innovative immunotherapy product, Serplulimab. This product is combined with chemotherapy for first-line treatment of Extensive Stage Small Cell Lung Cancer (ES-SCLC).

Serplulimab, with the trademark Zerpidio, is the result of a collaboration between Kalbe and Shanghai Henlius Biotech, Inc., which is also proof of Kalbe's commitment to expanding access to health services for lung cancer patients and increasing innovation in the development of cancer immunotherapy in Indonesia. Serplulimab received a distribution permit from BPOM in Dec 2023, and was successfully launched on March 9 2024 through subsidiaries PT Kalbe Genexine Biologics (KGbio) and PT Global Onkolab Farma (GOF).

As part of Kalbe's initiative to support cancer management, ONE Onco is also presented as an integrated oncology ecosystem. ONE Onco provides comprehensive solutions to cancer patients starting from medical therapy, early detection, service directory, online consultation, healthy shopping and supportive therapy such as nutrition.

"Therefore, we welcome the availability of the Serplulimab immunotherapy innovation to open wider access to treatment for lung cancer sufferers in Indonesia." said Liliana Susilowati as President Director of GOF.

In the future, Kalbe, KGbio and Henlius will expand their exclusive development and commercialization licenses in Southeast Asia, the Middle East and North Africa.

"Through this strategic partnership, we will strive to utilize each other's resources and strengths to promote and commercialize Serplulimab to open access to this innovative drug for patients in those countries," said Sie Djohan, President Director of KGbio and Director of Kalbe.

KGM at a Glance

Kalbio Global Medika (KGM) is one of the first and the pioneer of biopharmaceuticals in Indonesia, established in 2014 and inaugurated officially in 2018 by the President of the Republic of Indonesia, Ir. Joko Widodo. KGM is part of the Kalbe Group, a subsidiary of PT Kalbe Genexine Biologics (KGbio), which is a clinical-stage biotechnology company focused on bringing biologics medical innovation to markets outside US/Canada, Western Europe, and China. KGM is an Innovative CDMO, equipped with CMC and scale-up capabilities plugged into Boston biotech ecosystem and state-of-the-art facility to enhance efficiency and productivity. With API manufacturing, formulation, fill and finish capabilities of biosimilar and novel biologics, averaging 10 million units of syringes, cartridges, and vials, KGM supplies local and international markets.

Kalbe at a Glance

PT Kalbe Farma Tbk (Kalbe) was established in 1966 and is one of the biggest public pharmaceutical companies in Southeast Asia. Kalbe has four main divisions that handle a portfolio of dependable and various brands: the prescription pharmaceutical division, the health products division that handles over-the-counter drugs, multivitamins, and ready-to-serve supplemental drinks, the nutritions division, and the distribution & logistics division.

Kalbe has also developed a B2B-based digital services ecosystem for the society: EMOS and KlikDokter, a B2C service. EMOS is an order management application system that helps distribution channels perform their stock or supply chain management actions. KlikDokter is a digital platform for healthcare services focusing on telemedicine, which provides health consultation and products that are needed by the society.

Kalbe now has more than 40 subsidiaries and 15 international-standard production facilities, supported by around 16,000 employees in 76 branches throughout Indonesia. Kalbe’s shares have been listed in Indonesia Stock Exchange/Bursa Efek Indonesia (IDX:KLBF) since 1991.

Henlius at a Glance

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 18 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centres and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®, the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

KGbio at a Glance

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.

GOF at a Glance

PT Global Onkolab Farma is one of the subsidiaries of PT Kalbe Farma that focuses on the development and creation of various kinds of cancer medicines, including prescription-based drugs, therapies, and supporting regimens.

Operating in Indonesia, this company is one of the first cancer drugs manufacturers that specialize in local manufacturing of high-quality affordable oncology products by utilizing advanced technology.

To serve cancer patients better, PT Global Onkolab Farma is committed in developing more effective cancer drugs and other cancer-related services, such as nutritional products and by collaborating with nearby cancer communities to provide support systems for cancer patients.