Events
Recently, the State Food and Drug Administration issued a new version of drug production quality management specifications – appendix to cell therapy products (Exposure Draft). Cell therapy product specifications are mainly formulated from seven aspects: personnel, plant and facilities, supplier and supplier material management, materials and products, production management, quality management and product traceability system. The standardization of the production end is conducive to the long-term and healthy development of the cell therapy industry.
Key investment points
There is huge room for the development of cell therapy industry. At present, the mainstream cell therapy refers to that the immune cells of the patients themselves will be isolated and transmitted back to the patients after genetic engineering transformation, because the transformed cells may have such characteristics as targeting, immune enhancement, etc. Therefore, it can identify tumor cells and kill them selectively, play the role of tumor treatment, and form memory immunity, which has significant advantages in preventing tumor recurrence and metastasis. Therefore, different from the traditional tumor treatment methods, cell therapy is more inclined to solve the problem with one shot. In 2017, the world’s first product for the treatment of hematoma was approved for listing. So far, 6 cell therapy products have been approved in the United States. In 2021, two products independently developed by China Fosun Kate and Yao Ming junuo were approved. By 2022, Nanjing legend biology and Keji biology will also be reported to the FDA for listing. In the future, with the gradual maturity of gene editing, vector transformation and other technologies, it will catalyze the listing of more products and the expansion of indications. As of November 2021, car-t alone had 392 clinical research projects in China, and 1890 cell therapy projects in the world (less than 400 in 2015). The industry may enter a period of rapid development, It is expected that the scale of China’s cell therapy market will increase from 1.3 billion yuan in 2021 to 58.4 billion yuan in 2030, with an average annual growth rate of 53%.
Focus on the improvement of cell therapy bottleneck: side effects + treatment cost + indication expansion. ① High treatment cost: Novartis priced at US $475000 in the United States and US $313000 in Japan. China Fosun Kate is priced at 1.2 million yuan. ② Indications are gradually developed. At present, cell therapy mainly focuses on the treatment of hematoma, which adopts personalized preparation process. However, American fat enterprises are using car-nk induced by universal stem cell IPSC for drug development. The preliminary clinical data have obtained good safety and efficacy. If the data can be repeated in later clinical practice, or lead cell therapy into an explosive era. ③ Higher requirements for side reaction management. Such as cytokine storm, off target toxicity and neurotoxicity. ④ The clinical therapeutic effect of solid tumor is still not ideal. The microenvironment of solid tumor is complex, including regulatory T cells, macrophages and inhibitory cytokines, which makes it difficult for reinfusion car-t cells to reach the tumor location. Therefore, the current treatment effect is poor.
Reagent consumables constitute the main cost, and domestic substitution is imperative. At present, the cost of preparing a cart cell is about USD 80000-120000. The most expensive are the reagents and consumables in the production process, as well as the consumables such as culture medium, plasmid, ribozyme and virus vector used for culture and transduction of car-t, accounting for about 55-70% of the total cost. In the internal subdivision structure of reagent consumables, lentivirus accounted for the highest proportion, accounting for 66%; Immunomagnetic beads accounted for 14.4%; Cytokines, disposable bags and pipelines and activating reagents account for about 6%. The cost of reagent consumables accounts for a high proportion, and localization is imperative from the perspective of cost reduction. At present, the proportion of domestic products is still low, but many listed companies in the industry have layout, and the product performance is gradually improving, such as Tofflon Science And Technology Group Co.Ltd(300171) , Zhejiangtailin Bioengineering Co.Ltd(300813) , Truking Technology Limited(300358) , Sensong international, Suzhou Nanomicro Technology Co.Ltd(688690) .
Investment suggestion: this time, the state issued the production management specification of key materials for cell therapy, which is intended to consider that there will be a batch of cell therapy products on the market in China in the future, and from the perspective of supply chain security, cell therapy products have not been commercialized on a large scale. Standardizing gene modified vectors or other starting biomaterials (including viruses, plasmids, RNA, antigenic peptides, antigenic proteins, protein RNA complexes, etc.) that will be directly used in the production of cell products in tal is also a guide to the production process and material end of the cell therapy industry, which is conducive to the long-term and healthy development of the industry.
Risk factors: industry competition intensifies, R & D progress is less than expected, and import substitution is less than expected
