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Estimated reading time: 7 minutes Recently, according to well-known domestic ** reports, the price of nakiautoleucel is 9990,000 yuan. Tianjin Radio and Television reported that the first prescription of CAR-T** (naciolleucel injection) for leukemia developed by Heyuan Biosciences was issued in the Blood Disease Hospital of the Chinese Academy of Medical Sciences.
On November 8, 2023, the marketing application of the CAR-T product nano-cel injection (formerly known as heki-leucelucel) submitted by Heyuan Biotechnology (Tianjin)**hereinafter referred to as Heyuan Biotech) has been approved by the China Food and Drug Administration (NMPA) for the treatment of *** or refractory B-cell acute lymphoblastic leukemia (Rr B-ALL). Only four days after the approval of nalkeleucel injection, the first prescription was issued at the Blood Disease Hospital of the Chinese Academy of Medical Sciences. At present, the patient has passed the preliminary assessment and examination, and is about to enter the stage of blood collection. Lv Lulu, CEO of Heyuan Biotechnology (Tianjin), said: "The day after we were approved, we entered the Huimin Insurance in Hebei (Province). Our first prescription in Tianjin has come out, and this patient has been included in 80% of the payment and reimbursement of commercial insurance. ”
As of 2022, 8 CAR-T projects have been approved worldwide, and in 2023, two new CAR-T projects have been approved, IASO Biotech and Heyuan Biotech, It is reported that Naki-autoleucel injection is the first CAR-T cell ** product in the field of leukemia in China. On November 8, 2023, Heyuan Biosciences announced that the National Medical Products Administration (NMPA) has officially approved the New Drug Application (NDA) for its CAR-T product Yuanruida (nal-cel injection) for the treatment of *** or refractory B-cell acute lymphoblastic leukemia (Rr B-ALL). According to reports, Naki-cel injection adopts the world's unique CD19 SCFV (Hi19A) structure and international leading manufacturing process, and the production success rate has reached 100% in the first-r-r-b-all registered clinical study. The NDA is based on a single-arm, open-label, multicenter pivotal clinical study in the treatment of B-cell acute lymphoblastic leukemia. The study was conducted in 10 clinical centers in China by Professor Wang Jianxiang from the Blood Disease Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) as the principal investigator. At the 2022 American Society of Hematology (ASH), Heyuan Biosciences reported pivotal clinical trial data of nalki-autoleucel injection (herkileucel injection)**r r b-all. Clinical data showed an overall response rate (ORR) of 821%, CR (complete response) rate of 667%。The negative rate of MRD in patients who achieved CR or CRI at 3 months and within 3 months was 92% and 100%, respectively. 
At present, 10 CAR-T products have been launched worldwide, and Fosun Kite's Axileucel injection** is 1.2 million injections on the domestic market; JW Therapeutics' Reggi Orencell Injection** is 1.29 million injections; Reindeer Bio's Ig-Orleucel Injection (trade name: Focosu)** is 11660,000 yuan. At present, from the perspective of commercialization, there are pain points that need to be solved urgently in the marketed CAR-T products: high production costs, preparation efficiency needs to be improved, and the preparation success rate is unstable, which also brings significant obstacles to the clinical application of CAR-T products, especially outside Europe and the United States. Therefore, reducing costs, improving accessibility and preparation processes have become important directions for researchers. Therefore, the nano-cel injection of Heyuan Biotech 99The ** of 90,000 falls within 1 million, and the cost of this in vitro gene editing ** is further compressed, approaching the ** of 300,000 yuan step by step. 
This product has been recognized as a "breakthrough drug" by the National Medical Products Administration, and its core is a unique structure with independent intellectual property rights and an international leading manufacturing process, which is superior to the existing first-class means. Lv Lulu said: "We are basically now a fully enclosed, fully automated production, the process is not only original, but also very leading in the world. "In the process of practical application, Heyuan Bio relies on the blood research institute and 30 blood centers and clinical centers across the country to extract blood components, prepare drugs, and reinfuse blood components for patients, and patients can complete the entire standardization process in 28 days. At present, relying on the commercial production base in Tianjin, Heyuan Biotech can achieve a production capacity of 2,000 copies per year, and the company is aiming at major clinical needs, and the indication population of CAR-T will be from ** to children, from the field of tumor diseases to the field of non-tumor diseases, Lv Lulu said: "The follow-up lymphoma acute lymphoblastic leukemia, including autoimmune diseases, will basically be completed in two years next year and the next year, and at the same time, our registration clinical trial in the United States will also be launched." The other is to benefit people's livelihood, and I believe that through the coverage of Huimin Insurance and a variety of payments, I hope that we are also the first Chinese original CAR-T product to enter the national medical insurance. ”
Lulu Lulu, CEO of Heyuan Biotech, said: "Heyuan Biotech is controlling costs step by step and expanding indications in order to further reduce costs through the increase in patients' demand for products. "We also believe that with the development of the domestic CAR-T industry, the cost of CAR-T products is expected to be greatly reduced when the key materials of CAR-T are replaced by localization and the preparation process is further upgraded, so as to bring this efficient way to more patients.
Heyuan Biology
Founded in June 2018, Heyuan Biosciences is a new generation of biopharmaceutical enterprises driven by cell and gene innovation technology, deeply cooperating with national first-class institutes and clinical research centers, building an international new drug R&D and innovation system with CAR technology platform, iPSCs technology platform and gene editing technology platform as the core, focusing on the R&D and commercialization of innovative drugs such as immune cells, and is committed to building a world-leading platform for the R&D, clinical transformation and commercialization of cell-based drugs.
The company's first core product, CNCT19 cell injection (inaticabtagene autoleucel), is a CAR-T cell ** product targeting CD19 with independent intellectual property rights, with a unique CD19 SCFV (Hi19A) structure and international leading manufacturing process, and has successively obtained three new drug clinical trial approvals (IND) from the National Medical Products Administration for the treatment of first-class or refractory acute lymphoblastic leukemia, **or refractory** aggressive B-cell non-Hodgkin lymphoma and **children and adolescents** or refractory B-cell acute lymphoblastic leukemia, and obtained "Breakthrough Drug**" designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration and orphan drug designation (ODD) from the US FDA. The National Medical Products Administration (NMPA) has officially accepted the New Drug Application (NDA) for CNCT19 cell injection*** or refractory B-cell acute lymphoblastic leukemia and included it in the priority review, which is expected to become the first CAR-T product marketed in the field of leukemia** in China and the first fully independent innovation targeting CD19 CAR-T product on the market. In March 2023, the application for CNCT19 cell injection for ***r r b-all ind was also approved by the U.S. Food and Drug Administration (U.S. Food and Drug Administrations.FDA).
The company adheres to the guidance of meeting clinical needs, creates safe, efficient and accessible immune cell products for patients through a strict production and quality system of cell products, and continues to build a highly scalable and internationally competitive innovation pipeline, covering non-tumor diseases such as hematological tumors, solid tumors and autoimmune diseases, covering more than 10 kinds of pipeline products such as innovative single-target and multi-target products and universal cell products. In addition, the company has a world-class R&D technology platform, process development platform, quality control system and commercial production base, and has obtained the first "Drug Production License" for cell drugs in Tianjin in June 2021. The company has a number of invention patents, and has been selected as a national key R&D project of the Ministry of Science and Technology, namely the "Key Special Project of Science and Technology to Help Economy in 2020".