HONG KONG, March 21, 2019 /PRNewswire/ -- Chinese leading biotechnology company 3SBio (01530.HK) today released its 2018 annual results, showing that the Company has been posting dramatic business growth, and has been gearing up R&D layout and investment in innovative drugs.
Financial highlights showed that the Company's revenue increased by approximately 22.7% to approximately RMB 4,583.9 million; gross profit rose by approximately 21.2% to approximately RMB 3,706.6 million; Normalized EBITDA added by approximately 23.3% to approximately RMB 1,781.8 million; Normalized net profit attributable to owners of the parent advanced by approximately 29.0% to approximately RMB 1166.1 million. R&D expenses soared over 40% to approximately RMB 362.7 million.
As of December 31, 2018, amongst the 32 product candidates within the Company's active pipeline, 22 were being developed as National Class I New Drugs in China, including 11 in oncology, 12 in immunology, 6 in nephrology, 2 in metabolic diseases and 1 in dermatology. After reaching separate partnerships with Japan's Toray and US-based Refuge Biotechnologies in 2018，the Company also announced partnerships with Samsung Bioepis, Verseau and TLC as part of efforts to enrich its existing product portfolio and pipeline at the beginning of 2019.
Market-Leading Products with Solid Growth
The Company's core products include TPIAO, Yisaipu, as well as recombinant human erythropoietin ("rhEPO") products EPIAO and SEPO. All the four products remained market leaders in China in 2018. According to IMS data, the China market share of TPIAO, which is the world's only commercialized recombinant human thrombopoietin ("rhTPO"), increased to 65.3% for the treatment of thrombocytopenia, and its sales jumped 71.3% in 2018. Yisaipu, a product to treat rheumatoid arthritis (RA), ankylosing spondylitis and psoriasis, owns a dominant market share of 64.0% in China, and its sales rose 9.7% in 2018. Two rhEPO products, namely EPIAO and SEPO, own a combined market share of 41.0% and their sales added 4.8% in 2018.
The Company launched the first once-weekly anti-diabetes drug Bydureon on May 25, 2018, providing a new treatment option for patients in China.
Rapid Advance in Product Pipeline
The Company made important progress in R&D in 2018: The Company resubmitted a New Drug Application (NDA) to the NMPA for the approval of 302H for the treatment of patients with HER2 over-expressing metastatic breast cancer, and the application was granted a priority review status by the NMPA. The Company completed Phase III trials of prefilled syringe of Yisaipu, and is preparing to apply for the manufacturing approval from the National Medical Products Administration (NMPA) in the first half of 2019.
In 2018, the Company was granted a new IND approval from the NMPA for clinical trials of TPIAO in pediatric ITP indication. Patient enrollment is expected to begin soon. Clinical trials for TPIAO in surgery patients with hepatic dysfunction at the risk of thrombocytopenia are ongoing. The Company has received IND approvals for an anti-VEGF antibody (601A) to conduct clinical trials in patients with RVO, mCNV and DME, and Phase I trial in DME patients is expected to begin soon. Patient enrollment in neovascular AMD trials is ongoing.
The Company completed multiple Phase I clinical trials of NuPIAO (SSS06, the second-generation rhEPO to treat anemia) and obtained an approval for Phase II and Phase III clinical trials. The Group has completed a dose-escalating Phase I safety and pharmacokinetics study on RD001 in healthy volunteers, and is planning for Phase II trials in anemic patients. The Company completed Phase I clinical trials of a humanized anti-TNF α antibody (SSS07) in both healthy volunteers and RA patients, and is preparing for Phase II trials in patients with RA and other inflammatory diseases. The Company completed Phase I trials of 602 (an anti-epidermal growth factor receptor antibody to treat cancer) and is planning Phase III pivotal trials in patients with colorectal cancer. The Company has started patient enrollment for the Phase I clinical trials for pegsiticase (SSS11) in refractory gout patients with high uric acid level. In the United States, the Company's business partner, Selecta Biosciences, Inc. ("Selecta") is actively pursuing Phase II clinical development for SEL-212 (consisting of pegsiticase, co-administered with SVP-Rapamycin to prevent the formation of anti-drug antibodies) as its lead program.
On January 11, 2019, the Company received an investigation new drug (IND) approval from the U.S. Food and Drug Administration for 609A, an anti-PD1 antibody, for clinical trials in patients with various cancers. The Company is submitting an IND application to the NMPA for clinical trial approval for 609A in China.
Global Partnerships and Co-operations
In 2018, the Company entered into an exclusive license agreement with Toray for the commercialization of TRK-820 ("Remitch"). The Company also achieved an agreement with BMT to acquire a calcium acetate tablet. In April 2018, the Company established research collaboration with Menlo Park, California-based Refuge Biotechnologies, Inc. ("Refuge") to develop Programmed Therapeutic Cells.
At the beginning of 2019, the Company revved up external collaborations, including the collaboration with Samsung Bioepis Co., Ltd. ("Samsung Bioepis") for the clinical development and commercialization of multiple biosimilar candidates developed by Samsung Bioepis, including SB8 bevacizumab biosimilar candidate ("SB8") in China; the partnership with Verseau Therapeutics, Inc. ("Verseau") for the development and commercialization of novel monoclonal antibodies in the field of immuno-oncology for a broad range of cancers; and the partnership with Taiwan Liposome Company, Ltd. ("TLC") to commercialize two liposomal products in the therapeutic areas of oncology and severe infectious diseases in China.
These collaborations demonstrated the Company's excellent expertise in international development and operation, while laying a key step-stone for its future globalization strategy.
The Company will continue to pursue selective mergers and acquisitions and collaboration opportunities to enrich its existing product portfolio, in a bid to achieve sustainable long-term growth.
Focus on Biopharmaceutical Innovation
In the future, the Company intends to reinforce its position as a leading biopharmaceutical company in China by leveraging its integrated R&D, manufacturing and commercial platforms. The Company will also focus on developing leading biologics products to address unmet medical needs to benefit more patients.
The Company will focus on developing leading biologics products, including NuPIAO, RD001, SSS07, Pegsiticase, product candidate 602, product candidate 601A, 609A,prefilled syringe of Yisaipu and other mAb products. The Company is developing a new set of biologics products, including monoclonal antibodies, bispecific antibodies, antibody fusion proteins, as well as cell therapies, by fully integrating multiple R&D platforms within the Company to promote product development and bring patients more treatment options.
With approximately 38,000-liter capacity in mAb facility, mammalian cell-based, bacteria cell-based and small molecule manufacturing facilities, and its over 26 years of experience in manufacturing biologics medicines, the Company is able to manufacture high quality pharmaceutical products with scalable monoclonal antibodies manufacturing capacity at competitive costs to deliver on its strategic objective of creating a profitable CMO business. The Company is actively and selectively seeking opportunities to bring in clinical trial stage biologic products in order to provide commercial manufacturing services.
At the same time, the Company's existing products are being registered in new countries, and new products are being registered in highly regulated markets through innovative or biosimilar-drug approvals, therefore further expanding its international business and benefiting patients worldwide.
Dr. Jing LOU, Chairman and CEO of 3SBio, commented: "With the ongoing healthcare reform and the booming bio-pharmaceutical industry, 3SBIO has achieved strong growth for several consecutive years, and we now have an established system covering research, manufacturing and commercial with a proven track record of success. As we embrace a market environment with opportunities and challenges, 3SBIO will continue to focus on biological medicine and innovation, fully leverage our advantages by integrating research, development, manufacturing and commercial, and, at the same time, make the best of strategic mergers and acquisitions and commercial cooperation. We aim to become a globally leading Chinese biopharmaceutical enterprise and improve the accessibility of biological medicines so as to benefit more patients."