After the PD-1 drug, which is also immunotherapy, cell therapy that is expected to cure cancer is considered to be the next outlet in the field of cancer treatment!
On March 3, Keji Pharmaceutical announced that the Drug Evaluation Center (CDE) of the State Drug Administration (NMPA) agreed to enter a confirmatory Phase II clinical trial of CT041, which mainly treats Claudin 18.2 (CLDN18.2) with positive expression of advanced gastric cancer/esophageal gastric-gastric-conjunctive adenocarcinoma (GC/GEJ) that has previously received at least second-line treatment failures.
At present, stomach cancer is the second largest cancer in mainland China, with limited advanced treatment drugs and poor prognosis. Founded in 2014, Coji Pharmaceutical, a biopharmaceutical company focusing on the research and development of CAR-T cell therapy for the treatment of hematological malignancies and solid tumors, was successfully listed on the Hong Kong Stock Exchange in June 2021 with the help of Hillhouse and Zhengxin Valley Capital.
According to the global cancer data in 2019, about 90% of cancer incidence is caused by solid tumors, but the current mainstream CAR-T cell therapy focuses more on hematological tumors, and Koji Pharmaceutical has chosen a different anti-cancer route.
Similar to the fiery PD-1 therapy, CAR-T cell therapy is also an immunotherapy for the treatment of tumors, but the mechanism is more complex than PD-1, which requires artificial modification of immune defender T cells to allow defenders to exert anti-tumor effects.
Although it is also through the body's own immune system to participate in the fight against cancer, but the immune cells modified by CAR-T therapy can not only accurately identify tumor cells, but also inspire autoimmune ability after discovering tumor cells, so this is also the most likely to cure cancer of a new tumor immunotherapy method.
At present, five CAR-T products have been approved for listing worldwide, namely two approved by Novartis in Switzerland and Kate Pharmaceutical in the United States in 2017, and Tecartus approved by Kate Pharmaceutical in 2020 and two CAR-Ts approved by Bristol-Myers Squibb in 2021.
Like many innovative biopharmaceutical companies, although Keji Pharmaceutical's R&D and targets are at the forefront, it has not yet commercialized products and is still in the stage of vigorously investing in research and development, with a cumulative R&D expenditure of nearly 500 million yuan in 2019 and 2020.
At present, Codji Pharmaceutical has obtained IND (Clinical Study Approval for New Drug) for 7 CAR-T therapies in China, the United States and Canada. Six of its product pipelines are in the clinical stage and 5 are in the preclinical stage.
However, continuous R&D investment has also led to further expansion of losses, Keji Pharmaceutical has expanded from a net loss of 265 million yuan in 2019 to 1.064 billion yuan in 2020, according to the 2021 performance forecast, the net loss of Keji Pharmaceutical in 2021 is about 4.73 billion yuan to 4.76 billion yuan, and the year-on-year loss has expanded by more than 3 times.
Even after adjusting profits, the net loss of Keji Pharmaceutical in 2021 was about 535 million yuan to 565 million yuan, an increase of about 60% year-on-year. According to this calculation, in three years, the net loss of Keji Pharmaceutical is at least as high as 1.8 billion yuan.
Coji Bio, which landed on the Hong Kong Stock Exchange in June 2021, did not escape the first day of the break, and the final closing price fell by 8.5% compared with the issue price of HK$32 per share. As of 3 March 2022, Keji Pharmaceutical reported HK$19.23 per share, down 40% from the issue price, with a market capitalisation of HK$11.1 billion (approximately HK$8.9 billion).
Although the CAR-T cell therapy track where Cody Pharmaceutical is located shows extraordinary potential in anti-cancer treatment, its high treatment costs are also showing an embarrassing situation of applause at present.
Due to the complex manufacturing conditions of CAR-T therapy and the high requirements of technical personnel, the previously approved products are comparable to the "sky-high price", with an average price of about 400,000 US dollars, even if the two CAR-T products listed by Fosun Pharma and WuXi Junuo in China are also priced at 1.2 million yuan.
According to Frost & Sullivan's forecast, the mainland CAR-T market size will be about 200 million yuan in 2021, will grow to 5.3 billion yuan by 2024, and the market size is expected to reach 28.9 billion yuan by 2030.
The choice of such an anti-cancer track is closely related to the vision of Li Zonghai, the founder of Keji Pharmaceutical, to "cure cancer".
Compared with the current founder of the bio-innovative pharmaceutical company who has the experience of "dr. returnee", Li Zonghai is a local doctor who has not stayed in the ocean. From a graduate student at Xiangya Medical College of Central South University (formerly Hunan Medical University) to a ph.D. in Shanghai Medical College of Fudan University, he joined the Shanghai Institute of Cancer after graduation in 2005, and finally chose to start his own business in 2014.
As the largest of the co-actors, Li Zonghai holds a 24% stake in Keji Pharmaceutical through Yijie Bio as of June 2021, with a net worth of approximately HK$2.1 billion (approximately HK$1.7 billion) based on the latest market capitalization.
(Author| Zeng Jiayi, Editor| Liao Ying)