Hegen Bio CEO Dr. Lü Lulu on High-Quality Development and Innovation in Cell Therapy
Juventas
Innovative Cell Therapy Drug Developer
People's Daily, March 19, 2025 edition
[Lead-in]In the wave of accelerating breakthroughs in cell therapy technology, Juventas Biotechnology (Tianjin) Co., Ltd. has grown into a leader in China's cell drug industry, driven by independent innovation. It is committed to becoming a world-leading biopharmaceutical enterprise powered by next-generation cell and gene innovative technologies, setting an industry benchmark for promoting the development of new productive forces. Starting from March 18, the People's Daily consecutively published three special reports: "Ten State-Owned Enterprise Leaders Discuss Deepening State-Owned Enterprise Reform," "Ten Private Enterprise Leaders Discuss High-Quality Development," and "Ten Science and Technology Workers Discuss Innovation." These reports invited relevant individuals to share their confidence in development and prospects for the future. Dr. Lulu Lv, CEO of Juventas, as a representative of private enterprise leaders, was interviewed by the People's Daily to interpret the code of the company’s innovative development.
The following is an excerpt from the March 19, 2025 edition of the People's Daily
Lü Lulu, CEO of Juventas Biotechnology (Tianjin) Co., Ltd. ——
Targeting Cutting-edge Technologies, Increasing R&D Efforts
Cell Therapy as a Cutting-edge Medical Technology: A New Option for Treating Intractable DiseasesCell therapy, as a cutting-edge medical technology, is gradually becoming a new option for treating intractable diseases such as cancer and immune disorders. We are seizing the opportunity, leveraging our strengths, and taking multiple measures to promote the development of new productive forces, contributing to the high-quality and sustainable development of the cell therapy industry.
First, continuously increase investment in technology research and development to create more advanced cell therapy products. Juventas has established close cooperative relationships with multiple universities and research institutions to jointly conduct basic and applied research, launching the first cell therapy product with independent intellectual property rights produced in China.
Secondly, focus on the standardization and digital management of the production process. To ensure the quality of cell therapy products, monitor every step of the production process in real time. This efficient and precise management model not only reduces production risks but also provides a strong guarantee for production quality.
Moreover, we have invested substantial efforts in talent cultivation and team building. We are committed to establishing a high-quality R&D and management team. Through continuous hard work and tackling challenges, we have taken the lead internationally in R&D, technology, and production manufacturing. We have applied for 90 patents globally and have been honored with the title of "National Intellectual Property Advantage Enterprise."
With advanced technology, standardized production management, an excellent team of talents, and an open attitude towards cooperation, we are actively promoting the development of new quality productive forces in the cell therapy industry. In the future, we will continue to focus on developing new quality productive forces, providing patients with better treatment options, and contributing to the advancement of China's healthcare industry.
(Interviewed and compiled by Jin Bo, reporter of People's Daily)
About Juventas
Juventas, established in June 2018, has grown into a leading innovator in China's cell therapy industry, striving to become a globally recognized biopharmaceutical company driven by cutting-edge cell and gene technologies. The company’s first proprietary CAR-T product, Yuan Ruida® (Nageo-lun Cell Injection), received official approval for its New Drug Application (NDA) from the National Medical Products Administration in November 2023. This product is the first CAR-T drug in China’s leukemia treatment field and also the first fully self-innovated CD19 CAR-T drug developed in China. It was granted the designation of "Breakthrough Therapy" and included in the "Priority Review Process" by the National Medical Products Administration, as well as receiving "Orphan Drug" status from the U.S. FDA. In addition to being approved for treating adult patients with relapsed or refractory acute lymphoblastic leukemia, clinical research and new drug development for Yuan Ruida® are also progressing steadily for indications including relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, pediatric and adolescent relapsed or refractory B-cell acute lymphoblastic leukemia, and autoimmune diseases.
Yuanruida® (Najiolunsa Injection, CNCT19 Injection, Inaticabtagene Autoleucel Injection) is a CAR-T cell therapy product with proprietary intellectual property targeting CD19. It features a globally unique CD19 scFv (HI19a) structure and internationally leading manufacturing processes. It has received the "Breakthrough Therapy Designation" from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) and Orphan Drug Designation (ODD) from the U.S. FDA. In December 2022, the NMPA officially accepted the New Drug Application (NDA) for Najiolunsa Injection for the treatment of adult r/r B-ALL and granted it priority review. In March 2023, the Investigational New Drug (IND) application for Najiolunsa Injection for the treatment of adult r/r B-ALL was approved by the U.S. Food and Drug Administration (FDA). In November 2023, Yuanruida® (Najiolunsa Injection) was officially approved for marketing by the China National Medical Products Administration (NMPA).
Juventas closely collaborates with top national institutions such as the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, to build an international new drug R&D system centered on technology platforms like CAR and gene editing. It has over 10 pipeline products under research, covering multiple disease areas including hematological tumors, solid tumors, autoimmune diseases, and regenerative medicine.
Guided by clinical needs, the company is committed to creating safe, efficient, and accessible immune cell therapy products for patients through a strict production and quality system for cell therapy products. Juventas possesses world-class R&D technology platforms, process development platforms, quality control systems, and commercial-scale production bases. In June 2021, it obtained the first-ever "Drug Production License" for cell-based drugs in Tianjin, China. The company holds multiple invention patents and has been honored as a "National Intellectual Property Advantage Enterprise." It was approved to establish a national postdoctoral research workstation and selected for the National Key Research and Development Program under the Ministry of Science and Technology of China, specifically the "Science and Technology Supporting Economic 2020 Key Special Project."
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Shanghai FT1 Life Science Park (Abbreviation"Simbay Park, Star North · Free Trade Zone No.1") is located in the Waigaoqiao Bonded Area, the core of Shanghai Pudong New Area Free Trade Zone. It is an innovative service-oriented characteristic industrial park under the Star North Group, focusing on the incubation, cultivation, and transformation of medical enterprises.The park relies on the unique advantages of an outward-oriented economic zone with "Free Trade + Bonded" characteristics. By gathering the full range of service resources for the biomedical industry chain, including CRO+CDMO+CSO+EHS, government innovation and entrepreneurship support policies, and numerous well-known investment institutions, it provides enterprises with in-depth technical incubation within the medical industry. It acts as a steward for the transformation of corporate technological achievements and is committed to building an international biomedical industry innovation and entrepreneurship base.
