Main points of investment
The therapeutic effect of Claudin 18.2 target was confirmed by 3 phase studies.
In November, Anstailai announced that its Claudin 18.2 monoclonal antibody Zolbetuximab combined with chemotherapy as a phase 3 clinical study of first-line treatment for gastric cancer had positive results, and the progression-free survival time and overall survival time were significantly better than those of chemotherapy. The detailed results of the study will be presented at a follow-up oncology conference.
Osemitamab R & D progress is the first in China and the second in the world:
Osemitamab (TST001) is the second Claudin18.2 targeted antibody therapy candidate worldwide, developed by the company through its independently developed immune tolerance Breakthrough (IMTB) technology platform, with Best-in-class potential, and is expected to become the first Claudin18.2 targeted antibody therapy in China and the second in the world, covering gastric cancer or gastroesophageal junction cancer, pancreatic cancer, cholangiocarcinoma and other indications. Osemitamab was certified as an orphan drug for gastric cancer by FDA in July, 2021. In September 2022, the mid-term safety and efficacy data of the I/II phase clinical trial dose expansion cohort study of TST001 combined with CAPOX as first-line treatment for advanced and metastatic gastric cancer or gastroesophageal junction cancer was demonstrated at the 2022 ESMO conference. 15 patients achieved partial remission, accounting for 73.3% of the total population. The company has been conducting TST001 clinical trials in China and the United States, is currently in phase II development, and is expected to enter phase III clinical trials in 2023. It is estimated that the market size of Claudin 18.2 inhibitors in the United States and China will reach US $1.8 billion and US $1.7 billion respectively in 2030, and US $4 billion and US $3.7 billion respectively in 2035. TST001 is a candidate drug for the second generation of Claudin18.2 targeted antibody therapy. With the advantages of high affinity, stronger ADCC effect, declaration in China and the United States, simultaneous development of concomitant diagnosis, wide patient coverage and continuous perfusion production process, it has a broad market prospect in the treatment of gastric cancer, pancreatic cancer and cholangiocarcinoma.
Deep ploughing the field of tumor and chronic disease, the product pipeline differentiation is obvious:
The company's pipeline layout includes tumor and non-tumor treatment areas. In the tumor pipeline, Osemitamab is the potential best humanized antibody targeting Claudin18.2, and its research and development progress is the first in China and the second in the world. TST005, a dual-functional humanized antibody targeting PD-1/PD-L1 and TGF- β pathway, is currently in phase I trials, showing better anti-tumor activity and tolerable safety in preclinical studies. TST003 is the first anti-Gremlin1 monoclonal antibody in the world to enter the clinic and is expected to become a first-in-class product. MSB0254 is a humanized VEGFR2 monoclonal antibody, which has completed the phase I study; in the non-tumor pipeline, TST002 (Blosozumab) is used to treat osteoporosis, and the first patient has been administered in the phase I study in China. At present, the company's revenue mainly comes from CDMO business.
Continuous production technology to improve quality and efficiency, CDMO business revenue steady growth:
In the first half of 2022, the company added more than 15 customers to its CDMO business and expanded its services in IND declaration, analysis and testing, formulation research, particle investigation and drug filling. It is expected that the company will increase its ADC business by the end of 2022, thus further expanding its business growth potential.
Covering for the first time, firmly optimistic about the company's strong R & D capabilities and pipelines:
It is estimated that the company's operating income from 2022 to 2024 will be 7034 million yuan, 9707 million yuan and 126.19 million yuan. TST001 will generate revenue in 2025-26 and 260 million yuan and 640 million yuan in 2026-27 respectively. The company has outstanding R & D capability and rich pipelines. It is optimistic about the company's long-term development and covers it for the first time.
Risk hint
(1) the progress of product development is not as expected.
(2) Medical policy risk
(3) sales are not as expected.
