PT Kalbe Farma Tbk (Kalbe) through its subsidiary PT Kalbe Genexine Biologics (KGbio) together with Shangai Henlius Biotech, Inc (“Henlius”) have entered into an exclusive license agreement for the development and commercialisation of serplulimab injection in 12 Middle East and North African (“MENA”) countries including Saudi Arabia, the United Arab Emirates, Egypt, Qatar, Jordan, Morocco, etc. Serplulimab (HANSIZHUANG) is the first novel anti-PD-1 mAb for the first-line treatment of SCLC.
“We welcome the collaboration between KGbio and Henlius. With KGbio's network and operational capabilities in the Middle East and North Africa, this collaboration is an effort for the two companies to develop the products, especially for innovative biological products,” said Sie Djohan, President Director of KGbio, who is also the Director of Kalbe, KGbio's holding company.
Sie Djohan added that since 2019, KGbio has been granted exclusive rights to develop and commercialize this product in 10 Southeast Asian countries.
Kalbe believes that this strategic partnership is an opportunity to strengthen market penetration into the Middle East and North Africa territories. As a pioneer of biological medicines in Indonesia, with an integrated health ecosystem and new product innovations, Kalbe can provide wider access to medicines according to the needs of the community, not only in the country but also abroad with drug international standards quality.
“HANSIZHUANG is the first and only anti-PD-1 therapy approved for first-line treatment of small cell lung cancer. More than 30,000 Chinese patients have benefited from its excellent efficacy. We are excited to join forces with KGbio in MENA after the license granted in Southeast Asia,” said Jason Zhu, Chief Executive Officer, President, and Chief Financial Officer of Henlius.
Jason Zhu added that the aim is to continue supporting and improving the treatment outcomes and quality of life for local patients. Through KGbio's commercial network and operational capabilities in MENA, we firmly believe that serplulimab will bring new hope and health to patients in Southeast Asia and MENA.
In the future, the two companies will fully leverage their respective resources and advantages to promote the commercialisation of serplulimab in Southeast Asia and MENA. It is anticipated that this will enhance serplulimab accessibility in emerging markets and bring high-quality, affordable, and innovative medicines to more patients.
Serplulimab is Henlius’ first innovative product, has been approved in China in March 2022. At present, serplulimab has been approved for 3 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC). With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, serplulimab has earned wide recognitions and its pivotal clinical research results have been published in leading medical journals such as the Journal of the American Medical Association (JAMA). Its synergy with in-house products of the company and innovative therapies are being actively promoted and over 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications, such as lung cancer, esophageal carcinoma, gastric cancer, etc., covering full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,600 subjects globally. Its global clinical trial data will further support marketing applications in global markets and lay a foundation for clinical application all over the world in the future.
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.
Platforms of interest include Fc-fusion proteins, antibodies, bispecifics, ADCs, cell therapies and therapeutic vaccines. The company is backed by Asian pharma companies Kalbe, Genexine and US private equity giant General Atlantic.
PT Kalbe Farma Tbk. (“Kalbe”) was established in 1966 and is one of the largest publicly-listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions managing a broad and strong portfolio of brands; Prescription Pharmaceuticals Division, Consumer Health Division comprising over-the-counter drugs, as well as supplement drink and ready to drink products, Nutritionals Division, and Distribution & Logistics Division. Kalbe currently has more than 40 subsidiaries and 14 production facilities with international standards, employed around 16,000 employees and have 72 branches of distribution & logistics across Indonesia. Since 1991, Kalbe’s shares have been listed on the Indonesia Stock Exchange (IDX: KLBF). As of 31 December 2022, Kalbe has IDR 28.9 trillion total consolidated revenue and IDR 98.0 trillion market capitalization.
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.