Tasly Pharmaceutical Group Co.Ltd(600535) announced on December 24 that targeted FR was introduced from Sutro company of the United States α ADC of (hereinafter referred to as "stro-002"). The cell-free protein synthesis technology used by stro-002 as a new generation ADC product and the ADC fixed-point coupling technology through unnatural amino acids have high technical barriers, which is expected to solve the problems of pharmaceutical quality and pharmacology caused by the non fixed-point coupling of traditional ADC. Its holding subsidiary Tasly Pharmaceutical Group Co.Ltd(600535) biology will realize the technical implementation and production of this leading technology in the cooperation area with the assistance of Sutro.
ADC drugs, i.e. antibody drug conjugates, have been in a rapid growth period since the breakthrough of key technologies in 2013, and have gradually become a hot field of international anti-tumor drug research. In 2020, the industry estimated that the global ADC drug market was US $4 billion.
Although the market prospect is promising, the research and development of ADC drugs in China is still in the early stage, and few Chinese pharmaceutical enterprises are involved in this field. It is reported that at present, more than 20 enterprises in China have applied for new ADC drugs, most of which are in phase I clinical trials. From the perspective of target R & D direction, most pharmaceutical enterprises take HER2 as the main attack direction. Tasly Pharmaceutical Group Co.Ltd(600535) interventional ADC selected less competitive target folate receptor α (FR α)。 The announcement shows that Tasly Pharmaceutical Group Co.Ltd(600535) biology has obtained the exclusive license of Sutro company of the United States to exclusively develop, register and commercialize stro-002 in Greater China. Stro-002 is currently conducting clinical research on ovarian and endometrial cancer in Europe and America.
Stro-002 is the third generation ADC developed by Sutro company with global intellectual property rights Stro-002 can realize ADC fixed-point coupling with high product uniformity; Target fr α It has tumor cell specificity, and there is no targeted FR in the world α ADC products of have been approved for marketing. There are three ADC products in clinical stage. Stro-002 is the only one that does not distinguish patients in clinical trials α Expression level products.
It was announced that stro-002 targeted fr α The antibody part of the synthesis process adopts the industry-leading acellular protein synthesis technology (Xpress CF), which can embed unnatural amino acids (Xpress CF +) at the specific protein location. The unnatural amino acid side chain of the antibody can be introduced into the cleavable linker small molecule load by clicking the chemical reaction site to realize the fixed-point coupling of ADC. The DAR value (drug antibody ratio) of stro-002 is 4 and the product uniformity is high. It is expected to solve the problems of pharmaceutical quality and pharmacology caused by non-point coupling of traditional ADC. In addition, the small molecular load of stro-002 is a derivative of marine extract hamitlin. It is a new microtubule inhibitor and a weak substrate of P-glycoprotein pump, which has the potential to resist drug resistance. Target fr of stro-002 α It is highly expressed in tumor tissues such as ovarian cancer, endometrial carcinoma, breast cancer and non-small cell lung cancer. It is not expressed in normal tissues or has a very low expression level, so it targets FR. α It is expected that specific treatments include ovarian cancer, non-small cell lung cancer (NSCLC), breast cancer and endometrial cancer.
Tasly Pharmaceutical Group Co.Ltd(600535) biology integrates complete research, production and marketing, and has built an R & D cluster of innovative medicine. The introduction of stro-002 will form differentiation advantages, further broaden its tumor treatment drug product pipeline and improve its product portfolio. The semi annual report shows that the company has made a precise layout in the field of tumor immunotherapy and tumor targeted therapy, with a total of 15 projects under research.
At present, Tasly Pharmaceutical Group Co.Ltd(600535) has 20 biopharmaceutical products, and the heavy product puyouke has increased rapidly in recent years. The product indications are expanding from acute ST segment elevation myocardial infarction (myocardial infarction) to the treatment of acute ischemic stroke (cerebral infarction) and acute pulmonary embolism (pulmonary infarction). Tasly Pharmaceutical Group Co.Ltd(600535) bio has rich research and development pipelines, which can cover advanced colorectal cancer, advanced malignant gastrointestinal solid tumors, chronic hepatitis B, type II diabetes and many other diseases.
(China Securities Journal · China Securities Network)
