Kalbe Establishes Strategic Cooperation with Henlius for Lung Cancer Therapeutic Drug (Serplulimab) in MENA Territories

PT Kalbe Farma Tbk through its subsidiary PT Kalbe Genexine Biologicswith Shangai Henlius Biotech, Inc have entered into an exclusive license agreement for the development and commercialization of serplulimab injection in 12 Middle East and North African countries including Saudi Arabia, the United Arab Emirates, etc. 

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 commercialization 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 commercialization 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, and has been approved in China in March 2022. At present, serplulimab has been approved for 3 indications in China including MSI-H solid tumor, 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.