PT Kalbe Farma Tbk

YONGIN, South Korea, Sept. 10, 2024 /PRNewswire/ -- GC Cell, a leading innovator in cell therapy, has officially announced the execution of a landmark 'Technology Transfer and License Agreement' with PT Bifarma Adiluhung (Bifarma), a premier stem cell therapy company in Indonesia. This strategic partnership, which began in June, solidifies approximately three months later with the signing of the final license agreement. Under the terms of the agreement, Bifarma will be granted the exclusive rights to develop, manufacture, and commercialize Immuncell-LC for 15 years. Continue Reading GC Cell and PT Bifarma Adiluhung sign a licensing agreement for Immuncell-LC to expand access in Indonesia (PRNewsfoto/GC Cell) Bifarma is recognized for operating Indonesia's first GMP-certified cell therapy production facility and possesses a comprehensive sales and marketing infrastructure focused on oncology, specializing in a cold chain distribution network that spans across Indonesia. This infrastructure is expected to maximize the accessibility and commercial success of Immuncell-LC. James Park, CEO of GC Cell, expressed his enthusiasm about the partnership's potential, stating, "The initiation of technology transfer concurrent with the signing of the license agreement sets us on a path to introduce Immuncell-LC in Indonesia by next year, leveraging both our expertise and a firm partnership with Bifarma. This milestone is pivotal as we work to introduce Immuncell-LC, South Korea's first anticancer drug cell therapy, to a global audience, offering new treatment avenues to a broader patient demographic." The Indonesian pharmaceutical market, the largest in Southeast Asia, is rapidly expanding with an average growth rate exceeding 8% annually, representing a significant opportunity for innovative treatments like Immuncell-LC. The introduction of the product is expected to mark a significant advancement in Indonesia's cancer treatment landscape, particularly for Hepatocellular Carcinoma (HCC), which affects approximately 23,000 new patients annually in the country. Dr. Sandy Qlintang, MBiomed., President Director of PT Bifarma Adiluhung said, "We are excited to announce our collaboration in Immuncell-LC with GC Cell, focusing on innovative treatments for hepatocellular carcinoma (HCC) in Indonesia. By combining our expertise, we aim to enhance therapeutic strategies and bring groundbreaking advancements to liver cancer treatment through cutting-edge immune cell therapies. Together, we are committed to make a significant impact in the fight against HCC." Immuncell-LC, an anti-cancer immune cell therapy, has demonstrated significant efficacy in solid tumors, particularly liver cancer, and has been recognized as an FDA-designated orphan drug. It consists primarily of autologous blood-derived T lymphocytes enhanced to improve cancer cell killing capabilities. The therapy has proven its effectiveness in large-scale Phase 3 clinical trials for early-stage Hepatocellular Carcinoma (HCC) patients, significantly reducing recurrence risk and mortality with a favorable safety profile. As GC Cell continues to engage with major pharmaceutical entities across emerging markets, the partnership with Bifarma is poised to set a precedent for the introduction of innovative therapies in underserved regions, promising enhanced clinical outcomes and increased accessibility to cutting-edge treatments. About GC Cell With a core focus on cell therapy, GC Cell offers complete bio healthcare solutions from diagnosis to treatment, and the brand's comprehensive value chain spans R&D, production, commercialization, and distribution. More info: About PT Bifarma Adiluhung PT Bifarma Adiluhung, through its cell therapy division Regenic, is Indonesia's first and largest cell-based therapy provider, holding GMP certification from Indonesia's FDA and an operating license from Ministry of Health for clinical-grade manufacturing of stem cells and their metabolites. Regenic services encompass autologous and allogeneic stem cells and their derivatives, a stem cell education center, and an R&D center focused on innovative cell therapy products. Regenic is dedicated to advancing healthcare through pioneering cell-based therapies to enhance the quality of life for all individuals. SOURCE GC Cell

GC Cell and PT Bifarma Adiluhung announced a strategic partnership to facilitate the entry of 'Immuncell-LC', the only approved autologous T-cell therapy for HCC into the Indonesian market. YONGIN, South Korea, June 19, 2024 /PRNewswire/ -- GC Cell, a fully integrated cell and gene therapy pioneer, is proud to announce the establishment of an MOU for strategic partnership with Bifarma, a frontrunner in stem cell therapy within Indonesia with comprehensive capabilities in R&D, GMP-compliant manufacturing, and the commercialization of cell therapies. Bifarma is a Subsidiary of Southeast Asia's Leading Pharmaceutical, PT Kalbe Farma Tbk. Continue Reading This strategic partnership marks a significant step towards entering the Indonesian market and expanding into the innovative cell therapy sector, particularly to facilitate the entry of 'Immuncell-LC', the only approved autologous T-cell therapy for liver cancer surgery in Korea. The MOU also includes discussions on technology transfer and broad cooperation on the development of additional NK cell therapy pipelines. Furthermore, GC Cell recently unveiled its Blueprint 2.0 strategy, emphasizing a company-wide strategic shift towards future growth drivers. A pivotal component of this strategy is the global market entry of its proprietary cell therapy products, Immuncell-LC, Korea's pioneering cell therapy, along with securing the foundation for NK cell therapy pipelines across the Asia-Pacific region. Indonesia, known for its large population and robust growth rate coupled with the advent of universal healthcare, presents a promising market for autologous cell therapies. Such therapies are increasingly accessible through medical procedures that are supported by substantial clinical data, similar to those in Japan. Through this strategic partnership with Bifarma and leveraging the Kalbe Group's extensive local infrastructure, including cold chain logistics and a broad hospital network, GC Cell anticipates the accelerated launch of its Immuncell-LC beyond Korea. James Park, CEO of GC Cell, commented, "This partnership is a testament to the global recognition of our cell therapy expertise, first established in Korea. By combining GC Cell's integrated value chain in cell and gene therapy with Bifarma's strong market presence and capabilities in Indonesia, we are poised to rapidly capture a leading position in the burgeoning field of anti-cancer cell therapies." "We are pleased to announce that Bifarma, through our cell therapy division ReGeniC, has entered into a MOU with GC Cell, a pioneering biopharmaceutical company from Korea. This strategic collaboration represents a significant milestone for both organizations and reinforces our mission to offer advanced, safe, and high-quality cell therapy," said Dr. Sandy Qlintang, MBiomed., President Director of PT Bifarma Adiluhung. This MOU represents a significant milestone for both organizations in their pursuit to transform patient care and fortify their positions in the global healthcare landscape. About GC Cell With a core focus on cell therapy, GC Cell offers complete bio healthcare solutions from diagnosis to treatment, and the brand's comprehensive value chain spans R&D, production, commercialization, and distribution. More info: About PT Bifarma Adiluhung PT Bifarma Adiluhung, through its cell therapy division Regenic, is Indonesia's first and largest cell-based therapy provider, holding GMP certification from Indonesia's FDA and an operating license from Ministry of Health for clinical-grade manufacturing of stem cells and their metabolites. Regenic services encompass autologous and allogeneic stem cells and their derivatives, a stem cell education center, and an R&D center focused on innovative cell therapy products. Regenic is dedicated to advancing healthcare through pioneering cell-based therapies to enhance the quality of life for all individuals. About PT Kalbe Farma Tbk 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 B2B-based digital services ecosystems for the society: EMOS and MOSTRANS. EMOS is an order management application system that helps distribution channels perform their stock or supply chain management actions. MOSTRANS is a B2B transportation solution provider for the easy management and the efficiency of transportation. Kalbe now has more than 40 subsidiaries and 14 international-standard production facilities, supported by around 16,000 employees in 71 branches throughout Indonesia. Kalbe's shares have been listed in Indonesia Stock Exchange/Bursa Efek Indonesia (IDX:KLBF) since 1991. For more information, please visit SOURCE GC Cell

In a significant milestone, the Chinese biopharmaceutical company Henlius (Henlius) has announced the shipment of its self-developed and manufactured biosimilar drug Trastuzumab® (Hanquyou) from its Xuhui production base to Saudi Arabia. This marks the first time the company has commercially supplied its product to the Middle East North Africa (MENA) region, positioning Trastuzumab® to become the first Chinese-origin monoclonal antibody biosimilar to enter the Middle Eastern market. The achievement is the result of Henlius' exclusive commercial collaboration with its international partners Intas and its subsidiary Accord, which covers markets in Europe, North America, parts of the Middle East and North Africa, as well as some CIS countries. Trastuzumab® (marketed as HERCESSITM in the US and Zercepac® in Europe) is a biosimilar to the reference product Herceptin®, and has already been approved and launched in over 40 countries and regions across Asia, Europe, Latin America, North America, and Oceania. Henlius' Xuhui production base, which is the first facility in China to obtain both Chinese and European GMP certifications for the manufacture of self-developed antibody biologics, has been the site for the Trastuzumab® shipment to the Middle East. This production site and its quality management system have undergone extensive audits and inspections by various regulatory bodies, including China's NMPA, the European EMA, Indonesia's BPOM, Brazil's ANVISA, as well as Henlius' international business partners. With the successful entry into the Middle Eastern market, Henlius continues to expand the global commercialization of Trastuzumab® and its other products, collaborating with leading biopharmaceutical companies such as Accord, Abbott, Eurofarma, Elea, and KGbio to serve patients across approximately 100 countries worldwide.