Rexroth bio plans to go to Hong Kong for listing, and the sales volume of puyouke, a heavyweight drug, has exceeded 220 million in 2018

On April 23, Tianshili announced that its subsidiary, Tianshili bio, would apply for independent listing on the Hong Kong stock exchange to form its independent financing capacity, support its future business development and release the value of the company's bio pharmaceutical sector The announcement disclosed the profit data of Tianshi in the last three years The net profits of the Company attributable to the owners of the parent company in 2016, 2017 and 2018 were about RMB 1176.42 million, RMB 1376.54 million and RMB 1545.16 million, respectively In recent three years, Tianshili has made profits continuously, and there is no horizontal competition with its subsidiary Tianshili bio, and its assets and finance are independent There are no cross positions among managers The listing of its subsidiary Tianshili bio in Hong Kong complies with the provisions of the CSRC Tianshili biomedical Co., Ltd was renamed from Shanghai Tianshili Pharmaceutical Co., Ltd in 2001 It is mainly responsible for biomedical research and development It is a biomedical commercialization platform covering multiple treatment fields The heavyweight product of Tianshili biological is the first class 1.1 innovative biological drug with independent intellectual property rights in China, i.e recombinant human urokinase for injection (trade name: puyouke) Among the biomedical enterprises in Hong Kong, tisley bio is one of the few enterprises that have mature products on the market Tianshili biology is also engaged in R & D layout in three fields: cardio cerebral vascular, digestion and metabolism, tumor and immunity, so as to rapidly promote the research pipeline with international competitive advantage Prior to the listing, Tianshili biology increased its capital and shares in July 2018 By introducing internationally renowned pharmaceutical companies and medical industry funds as strategic investors, the independent valuation of biological innovative drugs of Tianshili company was realized The capital increase brought in five institutions, four of which are overseas investment institutions and one international pharmaceutical enterprise, with a total investment of US $132.5 million A total of 75.71 million shares were subscribed for, accounting for 6.99% of the total shares of Tianshili bio after the completion of the capital increase Four overseas investment institutions, including Huiqiao capital, puke Cayman, BOCOM international and Jiaheng investment, contributed US $84.5 million in cash, accounting for 4.46%; transgenesa contributed US $48 million in non monetary way (50% equity and "T101 patent") accounting for 2.53% Transgenesa is a joint venture of chuangshijie (Tianjin) Pharmaceutical Co., Ltd under the company According to the agreement, the value of TSL bio before the expansion is USD 1.762 billion, and after the expansion is USD 1.895 billion Compared with other listed companies in Hong Kong, the valuation of TSL biology is generally between us $1 billion and US $1.5 billion, which is much higher Tianshili biological platform is a typical representative of Tianshili's innovative medicine which helps industrial layout with capital through minority equity investment Tiansili bio established tiansili chuangshijie (Tianjin) biopharmaceutical Co., Ltd through cooperation, acquired Shanghai Saiyuan Technology Co., Ltd., invested in Tianjing Biotechnology (Shanghai) Co., Ltd., Paige biology, Jianya biology and other research and development platforms, and also formed through cooperation with genexine and Geli pharmaceutical industries in South Korea The products under research mainly cover cardio cerebral blood vessels Three therapeutic fields are digestion and metabolism, tumor and immunity The sales volume of puyouke in 2018 has exceeded 220 million Puyouke is the only listed prourokinase product expressed by CHO cells in the world It is obtained from the expression of Chinese hamster ovary cells (CHO cells) constructed by genetic engineering method and used for thrombolytic treatment of acute ST segment elevation myocardial infarction, belonging to the third generation of thrombolytic agents Selective thrombolysis is mainly achieved by activating plasminogen on the surface of fibrin, which has been used in many clinical medication guidelines for cardiovascular diseases In 2017, through the price negotiation of the Ministry of human resources and social security, puyouke reduced the price by 11.5% and entered the national medical insurance catalog The payment price of medical insurance was 1020 yuan / piece In 2016, the sales volume of puyouke was RMB 38 million, and in 2017, the sales volume was RMB 99 million, with a rapid growth After entering the medical insurance, puyouke became the leading thrombolytic product, which stimulated the sales volume to continue to increase substantially in 2018 In 2018, the sales volume of puyouke exceeded 220 million yuan, an increase of 129.58% compared with 2017 The 2018 sales volume of puyouke is disclosed in the 2018 annual report of Tianshili PCI is the first choice in the treatment of myocardial infarction However, PCI intervention is very difficult for emergency patients District and county hospitals only completed 7.68% of PCI cases in China (data sharing of PCI in mainland China in 2016) Intravenous thrombolysis can be used in hospitals without PCI operation conditions The first generation of thrombolytic drugs, urokinase, has low opening rate and high bleeding rate, which has been rarely used in the international clinical practice The second generation thrombolytic agent, ateplase, has no basic promotion ability, short half-life and inconvenient use Prozac is the third generation of thrombolytic drugs At present, the mainstream drugs in the market are alteplase and urokinase, and the sales volume of alteplase accounts for 54.56% As a representative of the third generation thrombolytic drugs, puyouke has fibrin specificity and no antigen and allergic reaction The data of 2088 patients in phase IV clinical trial showed that the rate of opening blood vessels of patients with acute myocardial infarction reached 85.2%, the incidence of drug-related intracranial hemorrhage was only 0.19%, and the half-life reached 114 minutes, with high comprehensive cost performance In 2018, the production process validation and relevant data testing have been completed for the second capacity expansion and optimization process project of tiansili biological puyouke 20L reactor In the first half of 2018, the process was put into production successfully, and the maximum production capacity of puyouke can reach about 640000 pieces / year Puyouke 300L reactor project completed fat acceptance of main equipment and started the transformation of production workshop It is estimated that after completion, the output value will reach 2 million pieces / year, providing production capacity guarantee to meet the rapid growth market demand of puyouke products In addition to puyouke, the research pipeline of Tianshili biological medicine research and development pipeline of Tianshili biological medicine focuses on the research of 14 class I new biological drugs (including 2 new indications of puyouke), including common tumor targets, third-generation insulin, diabetes targets and other drugs In 2016, puyouke obtained two new indications clinical approval documents of ischemic stroke and acute pulmonary embolism (pulmonary infarction) Two therapeutic time windows of puyouke ischemic stroke indication (0-4.5h and 4.5h-6h) entered into phase III clinical trial, and the admission was successful The indication of acute pulmonary embolism entered the second phase Indications for stroke belong to the priority review sequence and are expected to be approved in 2019 At present, the number of cerebral infarction patients in China is far more than that of myocardial infarction After two new indications are approved, three indications of puyouke may bring more than 3 billion yuan of annual income Ammumumab, known as "recombinant all human anti EGFR monoclonal antibody", is a class 1 biological drug for colorectal cancer developed by Shanghai Salem biological Co., Ltd., a subsidiary of Tianshili The research and development of Tianshili biology is in the first echelon in China At present, phase I clinical trials are being carried out The preliminary results show that the efficacy of the drug is accurate, and its safety is higher than that of similar products on the market internationally T101 is the world's first therapeutic hepatitis B vaccine with adenovirus as carrier, which is jointly developed by TSL Chuangshi, a subsidiary of TSL biology, and transgene, a subsidiary of French merrier group In 2016, it was included in the list of CDE priority review varieties, and phase I clinical trials are currently under way Different from antiviral therapy, T101 can inhibit or even eliminate HBV or induce apoptosis of HBV infected hepatocytes by inducing patients' own HBV antigen-specific cytotoxic T lymphocytes (CTL), so as to control patients' condition continuously T601 (recombinant oncolytic vaccinia virus injection) has obtained the clinical approval, and two other products, lipoglycin (FGF21 analog injection) and anti PCSK9 all human antibody injection, are about to be applied for clinical research Tianshili bio invested in Pegatron, and obtained the market priority of Pegatron long-acting GLP-1 analog and glp-1glucogan double receptor agonist Among them, long-acting GLP-1 analogues are 1.1 innovative drugs for the treatment of type II diabetes At present, four phase I clinical trials have been completed in China and the United States at the same time, and the level of blood glucose reduction is better than that of GLP-1 drugs currently on the market in China Tianshili biology has invested 50 million US dollars in Gemini to obtain the sales priority of Gemini glargine insulin and lispro insulin in mainland China At present, Gemini is in the leading position in China's third generation insulin research and development office If TSL bio can successfully go to Hong Kong for listing, the bio pharmaceutical platform will achieve independent development The good sales situation of the listed drugs will ensure that the company has hematopoietic capacity, and the new financing will greatly alleviate the cash flow pressure of the parent company By using the funds raised for research and development, introducing new drug pipelines and daily operations, Tishi bio can effectively improve its own asset structure, promote its sound operation and sustainable development, and provide financing guarantee for the follow-up research and development of biological innovative drugs Reference materials: TSL's 2018 annual report CAITONG Securities - TSL bio Hong Kong stock listing is on the way, innovation and transformation comprehensively improve the company's valuation GF Securities - TSL bio pre IPO landing, ranking the top