On December 24, Tasly Pharmaceutical Group Co.Ltd(600535) announced that the company's holding subsidiary Tasly Pharmaceutical Group Co.Ltd(600535) biomedical Co., Ltd. (hereinafter referred to as " Tasly Pharmaceutical Group Co.Ltd(600535) biology") obtained Sutro biopharma, Inc. (hereinafter referred to as "Sutro") exclusively develops and commercializes a targeted folate receptor in China (including Hong Kong, Macao and Taiwan) α (FR α) Antibody coupled drug (hereinafter referred to as "stro-002"), stro-002 is currently conducting clinical research on ovarian and endometrial cancer in Europe and America. Tasly Pharmaceutical Group Co.Ltd(600535) bio will pay Sutro a down payment of US $40 million and a potential milestone payment of up to US $345 million for development and commercialization, as well as an agreed proportion of sales commission.
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.
ADC drugs, namely antibody drug conjugate, have been growing rapidly since the breakthrough of key technologies in 2013, and have gradually become a hot field of international anti-tumor drug research. According to Kerui Weian, the global sales of ADC drugs currently on the market will exceed US $16.4 billion, about 100 billion yuan by 2026.
Although the market prospect is promising, the research and development of ADC drugs in China is still in the early stage. According to media reports, at present, only 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, which may lead to homogenization and excessive competition.
Stro-002 is the third generation ADC developed by Sutro company with global intellectual property rights, which can realize ADC fixed-point coupling and 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 cell-free protein synthesis technology (xpresscf), which can embed unnatural amino acids (xpresscf +) 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.
Now stro-002 is carrying out a phase I clinical study on recurrent ovarian cancer and endometrial cancer in the United States. The clinical data show positive preliminary efficacy, safety and good tolerance. Based on this, Sutro plans to communicate with FDA to accelerate the approval and listing of phase II single arm study as a registered clinical application.
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).
Among them, as the main carrier of the company's research and development of biological innovative drugs, Tasly Pharmaceutical Group Co.Ltd(600535) biological R & D pipeline has become increasingly rich in recent years. 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.
(Securities Daily)
