Heyuan BioTech Completes RMB 450 Million Series Financing Led by SDIC Capital to Advance Phase II Clinical Development of Proprietary CD19 CAR-T Therapy CNCT19

VCBeat (WeChat ID: vcbeat) learned that on November 19, 2020, Juventas Biotechnology (Tianjin) Co., Ltd. (hereinafter referred to as the “Company”) announced the completion of a new round of financing amounting to RMB 450 million. This round was led by SDIC Merchants Capital, with participation from new investors including Tianchuang Capital, Ruisheng Investment, Yizi Wealth, and Xiangrong Capital. Existing investors Jiadao Fanghua, ETP, Kaixin Biology, Daxie Pengchuang, and Daotong Investment continued to participate in this round. The support from this national-level industrial fund will accelerate the clinical translation and commercialization of the Company’s CD19-targeted CAR-T product, “CNCT19 Cell Injection,” and drive the research and development of subsequent pipeline products, including dual-target CAR-T therapies and TIL products.

The Company’s first independently developed CD19 CAR-T product, CNCT19 Cell Injection, stems from the long-term technological innovation and accumulation at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences). According to data from the National Medical Products Administration, CNCT19 Cell Injection officially received two Investigational New Drug (IND) approvals on November 29, 2019, for two indications: the treatment of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma and the treatment of relapsed or refractory acute lymphoblastic leukemia. Among these, the clinical trial for the treatment of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma has entered the Phase II registration stage, while subject enrollment for the Phase II registration trial for the treatment of relapsed or refractory acute lymphoblastic leukemia is imminent.

In recent years, China’s cell therapy industry has experienced robust growth, with particularly fierce competition in the CAR-T sector. Established international giants and emerging domestic players are competing on the same stage, frequently advancing R&D milestones. Clinical trial data, cost, and first-mover advantage are expected to be key determinants of successful product commercialization. Among fully domestically developed CAR-T products with independent intellectual property rights, Juventas (Tianjin) Biotechnology Co., Ltd.’s CNCT19 cell injection is at the forefront of clinical research progress. As a CD19 CAR-T product with independent intellectual property rights, it was among the first in China to enter Phase II registrational clinical trials and is poised to become the first independently developed CAR-T novel drug approved for market launch in China.

Dr. Lü Lulu, CEO of the company, stated, “Over the past two and a half years, the company has achieved breakthroughs in multiple significant milestones. Our first core product, CNCT19 Cell Injection, has officially entered Phase II registration clinical trials. Notably, the indication for adult relapsed or refractory acute lymphoblastic leukemia (ALL) has not yet been approved anywhere globally, representing an urgent unmet clinical need. The company will accelerate the progress of registration clinical trials to address the pressing clinical demands of patients in China and worldwide. Furthermore, we are committed to cost control and actively engaging with national medical insurance programs, striving to provide affordable immune cell therapy products that are accessible to the general public and deliver tangible benefits to patients. We are delighted to have gained the recognition and participation of new investors, and we extend our sincere gratitude to our existing investors for their longstanding and robust support. The successful completion of this financing round will continue to drive the company’s rapid development, accelerate technological innovation, clinical translation, and commercialization of cell therapies, and provide patients with safe, effective, and accessible innovative medicines.”

Mr. Xiao Zhi, Managing Director of SDIC Investment Promotion, stated, “Life sciences and the broader healthcare sector are key investment focuses for SDIC Investment Promotion. Cell therapies, represented by CAR-T, hold broad application prospects in oncology treatment. Cell therapy is a distinctive area in the development of innovative drugs in China, with the acceleration of innovation and clinical translation to meet clinical needs serving as the primary development goal for cell therapy products. SDIC Investment Promotion is optimistic about Juventas Biotechnology (Tianjin) Co., Ltd.’s capabilities in the development and rapid clinical translation of cell therapies. Its CNCT19 cell injection product has entered Phase II registration-based clinical trials. The company is one of the few enterprises that have truly advanced CAR-T products into the clinical stage. We look forward to the swift approval of its products to meet clinical demands. As an industry-leading cell therapy enterprise, the company demonstrates significant advantages in technological innovation, clinical translation, and commercialization layout. The SDIC Investment Promotion team will collaborate with the company and top-tier research institutions to support its healthy development and benefit patients in China.”

Guided by a commitment to meeting clinical needs, the Company leverages rigorous production and quality systems for cell therapy products to deliver safe, efficacious, and accessible immune cell therapies to patients. It continuously builds a highly scalable and internationally competitive innovative pipeline, covering hematologic malignancies, solid tumors, and forward-looking universal platform technologies. Furthermore, the Company boasts world-class R&D technology platforms, process development capabilities, quality control systems, and commercial-scale manufacturing facilities. It operates a 2,000 m² R&D center in Beijing and a nearly 10,000 m² GMP-compliant facility in Tianjin dedicated to the translational research, development, and commercial production of immune cell therapies.

Founded in June 2018, the company is a biopharmaceutical enterprise dedicated to the research, development, and commercialization of innovative therapies, including immune cell treatments. By establishing deep collaborations with top-tier national research institutes and clinical research centers, the company is committed to building an industry-leading platform for the clinical translation and commercialization of cell therapies, thereby accelerating technological innovation, clinical application, and market adoption in the field.

SDIC Merchants is a professional private equity management firm, with cumulative assets under management exceeding RMB 100 billion. Its investors include financial institutions, the National Social Security Fund, as well as state-owned and private capital. The management team has long been dedicated to investing in the advanced manufacturing industry, placing emphasis on technological innovation and the value of outstanding entrepreneurs and teams. It focuses on investments in intelligent manufacturing, smart and new energy vehicles, life sciences, and information and communications technology (ICT), committed to promoting the green, digital, and service-oriented development of the manufacturing sector.