1. Introduction to the Project

1.1 Introduction to technical achievements

The CAR-NK cell tumor treatment products developed in this project include BCMA-CAR-NK cell products and CD19-CAR-NK cell products. The BCMA-CAR-NK cell product has completed CAR-NK research and development for multiple myeloma (the second highest incidence cancer in the hematological system), and has been clinically explored in Shaanxi Provincial People’s Hospital. Three patients with recurrent multiple myeloma accompanied by extramedullary infiltration have been treated, achieving excellent treatment results with an effective rate of 100%. It has completed the development of CAR-NK cell products, CD19-CAR-NK, targeting B-cell leukemia and lymphoma (the highest incidence cancer in the hematological system), and will soon conduct clinical exploratory research.

1.2 Technical analysis and advantages

1.2.1 Core technical analysis

CAR-NK cell tumor therapy produces immune cell therapy: the immune cell therapy refers to the collection of immune cells from the human body, followed by in-vitro gene editing to increase their targeted killing ability, cell expansion and culture, and then re-infused into the patient’s body to achieve the goal of killing blood cancer or solid tumors.

1.2.2 Technological innovation and advantages

This project has been applied for 7 national invention patents, covering the entire CAR-NK preparation process, solving the industry pain points and difficulties of low NK cell amplification factor and low CAR-NK cell transduction rate. The technological innovation and advantages of this project are as follows:

In response to the difficulty of NK cell expansion and low purity, the patented technology can increase the amplification factor of NK cells from 100 times to nearly 10000 times without the use of serum, resulting in a purity of up to 98%. Solved the difficulty of large-scale production of CAR-NK cells.

It selects a specific target (BCMA scFv) for multiple myeloma, with independent intellectual property rights and a value of 50 million yuan. In-vitro and extra-vivo experiments have demonstrated its excellent specificity and ability to mediate excellent tumor killing effects.

The difficulty in NK cell virus transduction is the biggest challenge in the industry. The technical team of this project has independently developed a fake virus packaging system, which has increased the transduction rate from less than 10% in the industry to an incredible 90%. This is a world-class invention with a commercial value of hundreds of millions of dollars. By now, the technical team has applied for a patent and registered a trademark for the system.

A method has been invented to significantly improve the viral transduction rate of CAR-NK cells, which ensures that CAR-NK cell products have very high product quality and achieve excellent therapeutic effects.

The process of preparing CAR-NK cells has a high technological content, and this method has been patented to ensure that its technological and industry-leading advantages not be surpassed.

1.3 Main products and applications of technical achievements

The CAR-NK cell tumor treatment products developed in this project include BCMA-CAR-NK cell products and CD19-CAR-NK cell products.

BCMA-CAR-NK cell products are used for the treatment of multiple myeloma (the second highest incidence cancer in the hematological system), and CD19-CAR-NK cell products are used for the treatment of B-cell leukemia and lymphoma (the first highest incidence cancer in the hematological system).

1.4 Technical achievement commercialization stage

The project has completed product development, which is the small-scale trial stage. By now, it has entered the pilot stage and it is collaborating with CDMO to determine the process flow. It is about to produce the pilot batch of products.

1.5 Technical team

Changchun Ruigeli’an Biotechnology Co., Ltd. is an innovative company focused on tumor treatment, relying on the new generation of immune cell therapy technology to develop and research NK cell tumor treatment products.

Changchun Ruigeli’an Biotechnology Co., Ltd. is a holding company of Beijing Qimaiyonghua Biotechnology Co., Ltd., which was established in December, 2021, founded by two individuals who have returned from studying in the United States. They have applied for 5 invention patents and 1 registered trademark. The founder of the company has been focusing on cell immunotherapy for nearly 20 years and has been working in the United States for many years, with a profound accumulation of technology. In November ,2023, Beijing Qimaiyonghua Biotechnology Co., Ltd. has been awarded the title of Zhongguancun New and High-tech Enterprise. The founder is also listed as an expert talent in Changchun City.

Mr. Lu Zhihua is the Founder and Executive Director of Changchun Ruigeli’an Biotechnology Co., Ltd. and Beijing Qimaiyonghua Biotechnology Co., Ltd., Doctor of Medicine from Peking Union Medical College, visiting scholar at Stanford University in the United States, chief physician and professor at a well-known 3A hospital in China.

2. Market Potential Analysis

(1) Domestic and foreign policy support, with broad market prospects.

Immune cell therapy is a high-tech industry supported by the state. The cell therapy industry in China started relatively late compared to foreign countries, but the market demand for tumor cell immunotherapy in China is huge. At present, cell therapy belongs to individualized treatment. The industry as a whole is in line with the foreign environment and is in the stage of experimental research and layout development. The market size of China’s cell immunity industry has reached 3.5 billion yuan. Currently, the number of malignant tumor patients continues to increase, and the demand for anti-cancer treatment and drugs is growing. Affected by various factors such as economic, social, environmental, and lifestyle changes, the number of malignant tumor patients in China has been increasing year by year. Immune cell therapy, as an emerging cancer treatment model, has attracted much attention compared to traditional cancer treatment methods due to its safety, specificity, persistence, systemic, thoroughness, and wide indications. Immune cell therapy has made significant progress and has shown good therapeutic effects in the treatment of various cancers, bringing hopes to people. The development of future biotechnology will definitely further improve its efficacy and specificity, expand the scope of indications, and bring hopes to more patients.

(2) The patented technology is excellent, and the technological level is expected to be leading in the industry.

The efficacy and safety of the product has been determined; a clinical exploratory study (IIT experiment) has been completed, and it is 100% effective for 3 patients without any side effects.

The R&D team has invention patents, independent intellectual property rights, and complete domestic substitution, without any bottleneck issues.

(3) Compared to similar competitors, the product has a cost advantage.

In 2017, CAR-T products were first approved for sale in the United States, and 2021 marks the first year of commercialization of CAR-T products in China. However, the price of CAR-T drugs themselves is too high (1.2 million yuan per injection), which makes it difficult to fully release the patients’ acceptance and market size.

With the excellent therapeutic effects demonstrated by CAR-NK therapy, as well as the characteristics of allogeneic infusion and large-scale production, the market space of immune cell therapy will be fully opened up.

After large-scale production, the cost of CAR-NK products will be one percent or even one thousandth of that of the existing CAR-T products, promoting CAR-NK’s entry into medical insurance and upgrading from the current third line medication to the first line medication. This will greatly expand the market space of CAR-NK products, reaching a level of 100 billion yuan.

(4) The product conversion cycle is short, and the R&D team has the experience in implementing traditional Chinese medicine.

Cellular drugs do not require Phase III clinical trials. There are 100 Phase I/II clinical cases, and the drug can be launched within six months.

3. Financing Needs and Financing Purposes

The project is planned to raise 5 million yuan in financing. After the funds are in place, they will be used for clinical research and pilot plant construction. It is expected that:

Initiate Phase I clinical research in the second quarter of 2026, determine clinical units and study PI;

Start the construction of the pilot workshop in the first quarter of 2027;

Phase II clinical research will be launched in the second quarter of 2028.

With the support of funds, the project aims to build the largest cell storage center in Northeast China, apply for the first stem cell IND and immune cell (NK cell) IND in Northeast China, and apply for the first BCMA-CAR-NK cell drug targeting multiple myeloma (the second highest incidence cancer in the hematological system) in China.

4. Analysis of Technical Achievements and Benefits

4.1 Economic benefits

Multiple myeloma is the second largest malignant tumor in hematology. This disease usually occurs in the elderly, and as the aging population in China becomes increasingly severe, the number of patients with multiple myeloma is expected to increase to 167200 in 2024 and have further increased to 266300 by 2030.

B-cell lymphoblastic leukemia/B-cell lymphoma is the largest malignant tumor in hematology. It is expected that the number of NHL patients in China will increase to approximately 610900 in 2024, and have further increased to approximately 730000 by 2030. The compound annual growth rate from 2024 to 2030 will be 3.0%.

Based on CAR-NK cell tumor treatment products priced at 500000 yuan per injection, with a penetration rate of 20%, the number of patients treated will reach 150000 and 200000, and the sales revenue will reach 75-100 billion yuan.

The company is in a leading position in the industry, accounting for approximately 40% of the market share. It is expected that two CAR-NK products will reach a peak sales revenue of 30-40 billion yuan.

4.2 Social benefits

Immune cell therapy is an emerging cancer treatment method that has been proven to be very effective in the treatment of certain types of cancer. With the continuous development of technology and the deepening of research, the application scope of immune cell therapy will become increasingly widespread.

The cell therapy industry is a typical new industry and a high-tech industry that can bring the huge market potential.

The project construction helps to build a healthy China, increase people’s well-being, and become a driving force for economic growth.

5. Contact Method

Contact person: Lu Zhihua

Tel: 15948030707