As an innovative long-acting growth hormone positioned for the Chinese market, Eftansomatropin Alfa has been committed from its inception to deeply serving the needs of Chinese patients. As China's growth hormone market accelerates its transition toward long-acting products, the ability to provide high-quality products with greater compliance and price competitiveness has become a key competitive factor, and localization has become an inevitable trend in the growth hormone industry.
TJ Biopharma's Hangzhou GMP manufacturing facility obtained its Drug Manufacturing License in August 2024. Technology transfer and process optimization for Eftansomatropin Alfa have been fully completed, and domestic production capacity is fully ready. Compared with the import model, domestic production will bring significant cost advantages, avoid uncertainties from overseas manufacturing supply chains and tariff-related factors, thereby providing patients with more accessible products. Importantly, thanks to proactive planning, the timeline for bringing locally-produced Eftan to market has been substantially optimized — significantly ahead of the original schedule — with a marketing application expected to be submitted in mid-2026.
As the first and only fusion protein long-acting growth hormone in China, Eftan employs the innovative hyFc® fusion protein technology, which greatly enhances the drug's stability and half-life by combining human growth hormone with a specially designed human immunoglobulin. This patented technology, while preserving the biological activity of growth hormone, enables the convenience of once-weekly dosing. In the previously completed Phase 3 clinical study, Eftansomatropin Alfa demonstrated excellent efficacy and is expected to bring improved treatment options to approximately 3.4 million Chinese children with growth hormone deficiency.
Dr. Qian Lili, General Manager of TJ Biopharma, stated: "As the flagship product in TJ Biopharma's first-tier pipeline, Eftan has been a product tailor-made for the Chinese market since its inception — localization is our established product positioning and strategy. Providing patients with high-quality, cost-advantageous treatment solutions has always been our core mission. The successful commissioning of our Hangzhou manufacturing facility and the smooth completion of the technology transfer give us the capability and confidence to bring this innovative product to market faster and at lower cost. Localization not only aligns with industry trends, but is also an important manifestation of TJ Biopharma's long-term strategy of deeply cultivating the Chinese market and serving Chinese patients."
Cao Wei, General Manager of JumpCan Pharmaceutical, stated: "The Eftan localization strategy is based on market development trends and patient needs. As one of China's leading pediatric pharmaceutical companies, JumpCan Pharmaceutical has always been committed to providing patients with high-quality innovative products. As the first fusion protein long-acting growth hormone, Eftan's technical advantages combined with the cost benefits of localization will provide more accessible treatment options for families with children in need. We will fully leverage our strengths in market access and commercialization to join hands with TJ Biopharma in bringing this innovative therapy to market as soon as possible."
Both parties will take locally-produced Eftan as a new starting point to explore deeper collaboration in the growth hormone field, including advancing the development of next-generation ultra-long-acting growth hormone formulations and exploring expanded indications such as idiopathic short stature (ISS), to jointly provide children with growth disorders with treatment options that are more accessible, higher-quality, and more convenient.
About Eftansomatropin Alfa
Eftansomatropin Alfa is the first and only fusion protein long-acting recombinant human growth hormone among products currently in the filing stage or already on the market in China, and is expected to provide innovative therapy for patients with growth hormone deficiency. The product employs the innovative hyFc® fusion protein technology, which significantly enhances the drug's stability and half-life by combining human growth hormone with a specially designed human immunoglobulin, enabling a breakthrough once-weekly dosing regimen.
In terms of its mechanism of action, Eftansomatropin Alfa substitutes for endogenous human growth hormone, stimulates liver cells, promotes the synthesis of insulin-like growth factor 1 (IGF-1) in the liver, elevates IGF-1 levels in human serum, and activates osteoblasts and chondrocytes in various tissues through IGF-1, thereby promoting skeletal growth and development.
In November 2021, TJ Biopharma and JumpCan Pharmaceutical entered into a strategic collaboration for the development, manufacturing, and commercialization of Eftansomatropin Alfa.
About TJ Biopharma
TJ Biopharma is a fully-integrated biotechnology company focused on innovative therapies in the fields of autoimmune diseases, tumor immunology, and metabolic diseases. Rooted in China and committed to global innovation, the company focuses on R&D, clinical trials, biologics manufacturing, and product commercialization and co-commercialization of globally innovative drugs. It has established a vertically-integrated industry chain encompassing R&D centers in Shanghai and Beijing and a GMP manufacturing facility in Hangzhou. Based on years of accumulation, the company has successfully built a dual-tier innovative drug pipeline with differentiated advantages: three first-tier products (Fizatuzumab, Eftansomatropin Alfa, and Etrasimod Alfa) have entered the marketing application acceptance stage; another five first-tier innovative products are in pivotal clinical stages or about to initiate Phase III studies. First-in-class programs developed on the company's proprietary AntibodyPLUS platform are poised to enter Phase I clinical trials or commence IND filings. Through collaborative development and commercialization partnerships with JumpCan Pharmaceutical, CSPC, Sanofi, and others, as well as diversified and sustainable revenue streams including innovative product licensing transactions, biologics CDMO services, and co-promotion arrangements, TJ Biopharma is accelerating the internationalization of its pipeline and the integrated R&D-to-commercialization process in China.
For more information, please visit: TJBio.com or follow TJ Biopharma's official WeChat account.
About JumpCan Pharmaceutical
JumpCan Pharmaceutical is a national-level high-tech enterprise and national technology innovation demonstration enterprise integrating product R&D, manufacturing, and commercial operations. It ranks among the Top 100 Chinese Pharmaceutical Industrial Enterprises and the Top 10 Most Valuable Listed Pharmaceutical Companies for Investment in China. Our main business covers pharmaceuticals and personal care, focusing on core therapeutic areas including respiratory, pediatrics, gastroenterology, women's health, dermatology, and cardiovascular diseases. We hold multiple nationally exclusive varieties and dosage forms with a leading market position.
Guided by the purpose of "Build a Joyful and Vibrant Life Together", we are oriented toward clinical medication needs and everyday health demands, providing accessible and diversified solutions to help improve people's lives and give back value to society.
For more information, please follow JumpCan Pharmaceutical's official WeChat account.
JumpCan Pharmaceutical: jcyy@jumpcan.com