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21, Sansheng Pharmaceuticals announced its first half 2019 results show that the company continued to maintain strong growth in the first half of 2019, research and development investment continued to increase. Currently, the company is working on bio-oncology drugs covering HER2, CD20, PD1, VEGF and EGFR and other important targets, autoimmune and inflammatory disease treatment biopharmaceuticals cover anti-TNFa, IL17A, IL5, IL4R, and IL1b antibodies, while the company also focuses on new next-generation biological therapies, including programmed cell therapy, immunosuppressants, macrophage checkpoint regulators, dual-specific antibodies and targeted antibody products.
first half of 2019, the company achieved total operating income of RMB2,643 million, up 21.6% YoY, and gross profit of RMB2.185 billion, up 25.1% YoY; EBITDA was RMB1,018 million, up 21.4% YoY, normalized net profit was RMB752 million, up 34.1% YoY, and research and development investment was RMB260 million, up 48.2% YoY.
As of the first half of 2019, the company has 32 products under study, of which 22 kinds of new drugs of the national class, covering 11 oncology, 12 autoimmune diseases, 6 kidneys, metabolism 2, dermatology 1. At the same time, the company continues to steadily expand foreign cooperation. In 2019, Samsung Bioepis of South Korea, Versaau of the United States and TLC of Taiwan have reached strategic partnerships with the company to seek more breakthrough therapies to further enrich existing products and research portfolios.
In the first half of 2019, the company's four core products, Tebio, Isepp, Ibio and Sebor, remained market leader in their respective therapeutic areas. According to IQVIA data, Tebio, the world's only commercially recombinant human plateocyte production product, increased sales by 42% to 72.5% in the first half of 2019; 13.2%, market share of 61.9%, these two products are still in the early stages of the product life cycle, penetration in China is low, clinical demand is far from being met, the future market potential is huge, while the company's two recombined human erythrene products Ereno and Saibor sales increased by 5.8%, market share increased to 41.3%.
On June 25, 2019, China's first approved single anti-recombinant humanized anti-CD25 monoclonal antibody injection kennixin obtained the Chinese drug GMP certificate issued by the State Drug Administration, the company is actively preparing the product for sale. The product is used to prevent acute excretation reaction caused by kidney transplantation, which can significantly improve the survival rate of transplanted organs and improve the quality of life of patients.
According to the recently released 2019 edition of the health insurance catalog, the company has included a number of products, including the treatment of a variety of skin diseases products fluorocardiosis cream (conneum), Isepp added for adult severe plaque psoriasis adaptation, Ibio added for non-bone marrow malignancies chemotherapy caused by anemia, refined zinc recombinant human insulin (Urin) from Medicare B to Class A. The company will also actively promote the process of other related products into the negotiating catalog.
In terms of research and development, the company made significant progress in the first half of 2019, completed the three-phase trial of the pre-charged Isep water needle (301S), and submitted the production batch to the State Drug Administration and received it.
In the study of bio-oncology drug products - HER2, PD1, Antibodies such as EGFR have been steadily advancing: the anti-HER2 monoclonal antibody drug 302H, which was resubmitted to the State Drug Administration last year for a new drug listing license for breast cancer, has now been completed by the National Drug Administration Review Center for technical review and on-site verification of clinical trial data; Clinical trials have been approved by the U.S. Food and Drug Administration in January this year and started in April patients, in June this year, China's State Drug Administration has accepted clinical approval of new drugs for the product;
On the other hand, the company's autoimmune, inflammatory and other diseases to treat biological drugs including anti-TNFa, IL-17A antibodies, etc. have also made significant progress: humanized anti-tumor necrotizing factors α anti-tumor necrotizing factors for patients with rheumatoid arthritis (RA) α antibody products (SSS07) have completed health volunteers and RA The first phase of clinical trials in patients is currently preparing for the second phase trial of RA patients and other inflammatory diseases, and the clinical trial of anti-IL-17A antibodies (608) for moderate-severe plaque-like psoriasis was approved by the National Drug Administration on July 31 this year.
NuPIAO (SSS06), a second-generation recombination human erythrin product for the treatment of anemia, has completed several Phase I clinical trials and has opened Phase II clinical trials for patients in the group. The first phase of clinical trials of polyethyl glycol long-acting erythytocytoplasmic RD001 for the treatment of anemia has been completed and is being prepared for the second phase of trials in anemia patients. Tebio has started a clinical trial of paediatric ITP adaptive disorders, is in the process of entering a group of patients with plates to reduce the risk of liver dysfunction in the surgical peri-surgical period mobilization of the first phase of clinical trials has been completed, the second phase of clinical trials is about to start.
In the first half of 2019, the company continued to accelerate the pace of external cooperation: in cooperation with Samsung Bioepis, South Korea, the development of several biosygenic pharmaceutical products, including SB8 Beval bead monoantigen, in cooperation with Verseau, the development of macrophage immunomodulation products for a variety of tumors, and the development of innovative microlipid products in the field of tumors, infections and other diseases with TLC. (U.S. News Agency)