In 2018, Sansheng pharmaceutical's R & D investment increased by more than 40%, with multiple products under research

On March 20, 2019, China's leading biopharmaceutical company Sansheng Pharmaceutical (01530 HK) today announced its annual performance in 2018, which shows that the company continued to maintain strong growth in 2018, and accelerated the R & D layout and investment of innovative drugs According to the financial report data, in 2018, the company achieved a total operating revenue of about 4.584 billion yuan, an increase of 22.7% over the same period last year; gross profit of about 3.707 billion yuan, an increase of 21.2% over the same period last year; normalized EBITDA of about 1.782 billion yuan, an increase of 23.3% over the same period last year; normalized net profit of about 1.166 billion yuan, an increase of 29.0% over the same period last year; R & D investment of about 360 million yuan, an increase of 22.7% over the same period last year The same period last year saw an increase of 40.9% As of December 31, 2018, the company has 32 products under research, including 22 national first-class new drugs, covering 11 oncology, 12 autoimmune diseases, 6 nephrology, 2 metabolism and 1 dermatology In addition, after reaching cooperation agreements with Toray of Japan and refugebio technologies of the United States in 2018, at the beginning of 2019, the company has successively cooperated with Samsung bioepis of South Korea, versaeu of the United States, TLC of Taiwan and other companies to further enrich the existing products and product portfolio under research In 2018, the company's four core products, tebiao, yisepu, yibio and saibor, continued to maintain the leading position in the Chinese market According to IMS data, as the only commercialized recombinant human thrombopoietin product in the world, tebiao's sales increased by 71.3% in 2018, and its market share increased to 65.3%; its sales of yisaipu for rheumatoid arthritis, ankylosing spondylitis and silvercrumb disease increased by 9.7%, and its market share increased to 64.0%; these two products are still in production In the early stage of the product life cycle, the clinical demand is far from being met, and the market potential is huge in the future; while the sales volume of two recombinant human erythropoietin products of the company, ibio and saibor, increased by 4.8%, with a market share of 41.0% On May 25, 2018, the company and AstraZeneca's baidayan, as the first weekly antidiabetic drug in China, brought new treatment options for patients with type 2 diabetes In terms of rapid development of research pipeline, the company has made a number of significant progress in 2018: 302H, an anti HER2 monoclonal antibody drug for breast cancer treatment, has resubmitted the application for new drug marketing license to the State Food and drug administration, and has been included in the priority review; the third phase test of yisepu pre filled syringe has been completed, and is ready to apply to the State Food and Drug Administration for production approval in the first half of this year In 2018, tebiao won the ind approval for the treatment of children's immune thrombocytopenia Recently, the patients have been enrolled in the group, and the clinical trial of mobilization of liver dysfunction patients with thrombocytopenia risk in the perioperative period of surgery is under way Anti VEGF antibody 601a was obtained to treat macular edema and myopic choroidal vascular edema caused by retinal vein occlusion (RVO) The first phase clinical trial of DME patients will be started At present, patients in the neovascular amd trial are being enrolled The second generation recombinant human erythropoietin product nupiao (sss06) for the treatment of anemia has completed multiple phase I clinical trials and obtained the approval documents for phase II and phase III clinical trials; the polyethylene glycol long-acting erythropoietin rd001 for the treatment of anemia has completed phase I clinical trials and is now preparing phase II trials for the treatment of anemia; the humanized anti-tumor necrosis for rheumatoid arthritis (RA) patients Sss07 has completed the first phase of clinical trials for healthy volunteers and RA patients, and is preparing for the second phase of clinical trials for RA patients and other inflammatory diseases; anti epidermal growth factor receptor antibody 602 for tumor treatment has completed the first phase of clinical trials, and plans to carry out the third phase of clinical trials for colorectal cancer patients; pegsi for refractory gout patients with high uric acid level Ticase (sss11) has started the recruitment of patients in the first phase of clinical trials Partner selectabisciences, Inc is conducting the second phase clinical development of sel-212 in the United States Sel-212 is a combination of pegsiticase and SVP rapamycin In addition, on January 11, 2019, anti-pd1 antibody 609a, which is used to treat multiple cancers, was approved by the US Food and Drug Administration for new drug clinical (ind) and is submitting a new drug clinical application to the China food and drug administration In terms of foreign cooperation, in 2018, the company reached a cooperation agreement with Toray, Japan, to obtain the exclusive development and commercialization rights and interests of anti pruritus drug trk820 (remitch hydrochloride) in mainland China, and to acquire calcium acetate, a hyperphosphatemic product for the treatment of patients with chronic kidney disease, from a pharmaceutical company "BMT" in Beijing, and to cooperate with refugebio technologies, Inc ("refuge") initiated the cooperative research on the development of programmed cell therapy At the beginning of 2019, the company continued to accelerate the pace of external cooperation: cooperating with Samsung bioepis in South Korea to develop a number of bio similar drug products including sb8 bevacizumab; cooperating with Verseau to develop macrophage immunomodulator products for anti-tumor; cooperating with TLC to develop anti-tumor and anti infection micro fat body products These cooperation reflect the company's excellent professional ability in international development and operation, and lay a good foundation for the company's international strategy In the future, the company will continue to selectively seek opportunities for M & A and cooperation to enrich its existing product portfolio and maintain long-term growth Focusing on the development of high-quality innovative biopharmaceuticals and looking into the future, the company will continue to maintain the platform advantage integrating R & D, production and marketing, consolidate its leading position in China's biopharmaceutical industry, and solve unmet medical needs and benefit more patients by focusing on the development of innovative biopharmaceutical products The company will focus on the development of leading biopharmaceuticals, including nupiao, rd001, sss07, pegsiticase, 602, 601a, 609a and yisaipu's pre filled injection The company is developing a group of new biological drugs, including monoclonal antibody products, bispecific antibodies, fusion proteins and cell therapy, fully integrating multiple R & D platforms to promote the development of biological drugs, so as to bring a variety of treatment programs for patients With the company's about 38000 liter capacity of monoclonal antibody facilities, as well as the production facilities of mammalian cells, bacteria and small molecules, and more than 26 years of experience in the field of biomedical manufacturing, the company provides high-quality drugs with competitive cost and large-scale production capacity, and continues to build CMO business with the production capacity of monoclonal antibody products The company is actively and selectively looking for the opportunity to introduce biological drugs in the clinical trial stage to provide commercial production services At the same time, the company's existing products are being registered in new countries, and new products are registered in highly regulated markets through the approval of innovative or biological similar drugs, so as to further expand international business and benefit the vast number of patients around the world Dr Lou Jing, chairman and chief executive officer of Sansheng pharmaceutical, said: "in the era of continuous deepening of medical reform and rapid development of biopharmaceutical industry, Sansheng pharmaceutical has achieved strong growth for several years in a row, and has a successful research, production and marketing mature system of biopharmaceutical after time precipitation and market verification In the face of both opportunities and challenges in the market environment, Sansheng pharmaceutical will continue to be based on Biopharmaceutics and innovation, give full play to the advantages of the integration of R & D, production and sales At the same time, through strategic M & A and commercial cooperation, Sansheng pharmaceutical will build itself into a leading Chinese biopharmaceutical enterprise in the world, and constantly improve the accessibility of innovative biopharmaceuticals for the benefit of more patients "