Ternary Gene (837344.BJ), one of the first listed companies on the Beijing Stock Exchange, released its 2023 annual report on the 15th. According to the report, the company's operating income reached 245 million yuan, an increase of 43.12% over the same period last year. This significant growth is the result of the company's active adaptation to market changes, optimization of sales strategies, and successful participation in centralized procurement. In addition, the company's non-net profit also achieved 29.0935 million yuan, a year-on-year increase of 40.41%, showing that the profitability of the company's main business has been significantly improved.
The financial report shows the company's resilience and innovation ability in the face of market challenges, and also marks the company's return to the track of revenue and net profit growth, providing confidence to investors and the market.
A biopharmaceutical company focusing on original interferon technology
Ternary Gene is a technology-original biopharmaceutical company focusing on interferon in the field of viral diseases and tumor treatment, the main product human interferon α1b, which is based on the breakthrough biomedical technology of the company's founder, Academician Hou Yunde, who has made outstanding contributions in the field of genetic engineering and clinical medicine, and won the 2017 National Science and Technology Award. This achievement marks a major breakthrough in the research and development of innovative drugs in biogenetic engineering, and also establishes the company's leading position in the field of interferon at home and abroad.
Over the years, the company's strategy has focused on deepening the technological iteration and product innovation of interferon products, successfully developed a number of exclusive dosage forms, formed a matrix product dosage form combination, and built a high competitive barrier. The company has obtained a number of international and domestic patents in aqueous solutions of highly stable protein drugs, high-efficiency, long-acting and safe interferon, genetic testing and nebulized inhalation technology for hepatitis B patients; The company has created China's first production line of genetic engineering drugs that has passed the national GMP certification; In 2024, the construction project of intelligent production and R&D base in the new plant area will be successfully completed and put into use, which is of milestone significance and provides a strong guarantee for the company's long-term development.
Existing products are expected to further expand their market share, and revenue is expected to maintain high growth
The company's existing core product, Yundesu ® (recombinant human interferon α1b injection), has significant characteristics in terms of broad-spectrum antiviral and safety of clinical use. According to the annual report, the sales volume of Yundesu in 2023 will reach 245 million yuan, a year-on-year increase of 43.1%, and the three-year compound growth rate will be as high as 10.01%, which not only significantly exceeds the industry growth rate of recombinant human interferon α1b, but also fully reflects the remarkable achievements of ternary gene in product business expansion.
With the continuous deepening of the medical insurance reform and the promotion of policies such as centralized procurement, three-medical linkage and "1+X" drug use model, the accessibility and efficiency of medical services have been significantly improved, and a unified national market has gradually taken shape. These changes provide a good condition for the rebalancing of supply and demand for previously unreleased medical needs. These changes indicate that interferon drugs with broad biological activity and strong immunomodulatory functions will usher in a wider market space, and further expand the application prospects of interferon and other drugs in the treatment of more diseases. The company's existing products are expected to further expand market share and achieve greater commercial value;
The production capacity of the new plant was upgraded to meet the explosive growth of sales
As a benchmark enterprise that has been leading the industry for high-quality production for a long time, Ternary Gene has entered a new level every time its production capacity is upgraded. With the first GMP certification passed in 2000, the company entered the stage of breaking the import monopoly from the stage of exploration of scientific research achievements transformation; In 2014, the company completed the expansion and transformation through the new GMP certification, the production line reached higher quality standards and higher production capacity, and the company's production capacity also caters to the changes in the disease spectrum, and innovates to meet the new clinical needs, and the company has entered the market-oriented stage.
Nowadays, in the face of the national unified market with volume procurement, ternary gene has ushered in an unprecedented market opportunity in history, but at the same time, it has also put forward higher requirements for the company's production capacity. In 2021, Ternary Gene has taken the lead in strategic layout and long-term planning, investing 700 million yuan to build a new factory.
The intelligent production and R&D base project of the new plant has designed and built a drug substance manufacturing and preparation production line for a variety of products including human interferon α1b, including powder injection, water injection, spray, eye drops, prefilled injection and blow-fill-seal integrated nebulization inhaler, with an annual output of more than 100 million multi-specification and multi-dosage products. In addition to the R&D and production platform for cytokine drugs, the intelligent production and R&D base of the company's new plant also has a cell therapy R&D and production platform, which will make a wider layout for the innovation and development of new cell therapy products and new treatment options in the future, provide sufficient production capacity support for existing products and new products that will be launched soon, and meet the company's market demand that is expected to grow explosively in the future.
The core pipeline of RSV new drugs is nearing commercialization and the cell therapy program has made important progress
Ternary Gene adheres to the professional development strategy, and the company has realized the seamless connection from basic research to drug development, manufacturing and clinical development by building a full-chain closed-loop R&D system, providing the company with the ability to rapidly evolve and accelerate the R&D commercialization process.
The company has established a rich and gradient R&D product line - the new product of the core pipeline RSV is about to be commercialized, and the other pipeline layout products cover a number of high-potential markets such as viral pneumonia, hepatitis, tumors, etc., and the company has targeted the layout of corresponding IVD products to form a closed-loop development of 'diagnosis' and 'treatment', which is in line with the development trend of precision medicine in the future. RSV virus is the most important pathogen causing respiratory infection, hospitalization and death in children under 5 years of age, and human interferon α1b developed by the company has outstanding clinical advantages in the treatment of pediatric RSV, such as definite efficacy and mild adverse reactions.
Human interferon α1b aerosol inhalation developed by ternary gene has the advantages of strong targeting, high efficacy, good safety, easy operation and high compliance in the treatment of RSV pneumonia virus infection in children. In 2023, the Phase III clinical study of this new product has been statistically analyzed after unblinding in accordance with the requirements of the clinical trial protocol and positive results have been obtained, and the trial has met the preset primary study endpoint. In accordance with the relevant requirements of registration review, the company has completed the preparation of registration materials for clinical trials and aerosol inhalation quality studies, and submitted an application for communication and exchange to the Center for Drug Evaluation of the State Food and Drug Administration. Relying on the company's professional commercial promotion team, combined with the admission dividend brought by the centralized procurement policy, it is expected that the interferon α1b nebulized inhaler will be rapidly commercialized after approval. This will also add a new milestone to the development of ternary gene in the field of biomedicine.
In addition, during the reporting period, the company made important progress in the tumor immune cell therapy program of γδT cells. The company has completed the confirmation of the optimization process of the activation and expansion stage of natural γδT cells, which has increased the expansion factor of γδT cells from 450 times to 16,000 times, and greatly increased the yield of cell preparations, providing an important guarantee for multiple infusions in clinical studies. In the future, it is expected to develop generic "off-the-shelf" cell therapy products through technological innovation, significantly reduce costs, and expand more clinical indications.