August 21, 2019, Hong Kong --- Chinese leading biotechnology company 3SBio（01530.HK) today released its 2019 interim results, showing that the Company maintained strong growth in the first half of 2019, and continued to boost R&D investment. The Company’s active pipeline of biological cancer therapies covers important targets such as HER2, CD20, PD1, VEGF and EGFR. The Company’s biological therapies for the treatment of autoimmune and inflammatory diseases cover anti-TNFa, IL17A, IL5, IL4R, and IL1b antibodies. Meanwhile, the Company also focused on developing new next-generation biotherapies, including programmed cell therapies, immunological checkpoint inhibitors, macrophage checkpointmodulators, bispecific antibodies, and combination therapies based on the Company’s comprehensive antibody product line.

Financial highlights showed that the Company’s revenue increased by 21.6% year on year to approximately RMB 2.643 billion in the first half of 2019; gross profit rose by 25.1% to approximately RMB 2.185 billion; Normalized EBITDA added by 21.4% to approximately RMB 1.018 billion; Normalized net profit advanced by 34.1% to approximately RMB 752 million. R&D expenses soared by 48.2% to approximately RMB 260 million.

As of the first half of 2019, 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. Meanwhile, the Company continued to expand external partnerships steadily. In 2019, the Company reached separate strategic partnerships with South Korea-based Samsung Bioepis, U.S.-based Verseau and Taiwan-based TLC to jointly explore more breakthrough therapies and further enrich its existing product portfolio and pipeline.

Maintain Market Advantages of Core Products

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 the first half of 2019. According to IQVIA data, sales of TPIAO, which is the world’s only commercialized recombinant human thrombopoietin (“rhTPO”), for the treatment of thrombocytopenia soared 42%, and its market share jumped to 72.5%. Yisaipu, a product to treat rheumatoid arthritis (RA), ankylosing spondylitis and psoriasis, had its sales increase 13.2% and its market share rise to 61.9%. These two products are still in the early stages of their life cycles, with low penetration rates in China, massive unmet clinical needs, and huge market potential. Two rhEPO products, EPIAO and SEPO, had their market share improve to 41.3% and their sales up 5.8%.

On June 25, 2019, the recombinant humanized anti-CD25 monoclonal antibody injection （“Xenopax”）was granted the Chinese GMP certificate issued by the National Medical Products Administration. The Company is actively preparing for the sale of the product. It is used for the prevention of acute rejection of kidney transplantation and can be used in combination with conventional immunosuppressive therapy to significantly improve the survival rate of transplanted organs and enhance the quality of life of patients.

According to the newly released 2019 National Reimbursement Drug List, several of the Company’s products have been added into the list, including Shinuo, a fluticasone propionate cream for the treatment of multiple skin diseases, the new indication of  Yisaipu for the treatment of adult patients with severe plaque psoriasis, and the new indication for EPIAO for the treatment of anemia caused by chemotherapy for non-myeloid malignant tumors. Humulin, a protamine zinc recombinant human insulin, has been upgrade from Category B to Category A in the list. The Company will also accelerate the NRDL negotiations for other products.

Comprehensive Layout for Product Pipeline with Multiple Targets

In research and development, the Company made key progress in the first half of 2019. It completed Phase III trials of pre-filled aqueous injection solution of Yisaipu (301S), and had its application for manufacturing approval accepted by the NMPA.

The Company’s best-in-class biotherapies for cancer that cover HER2, PD1, EGFR and other antibodies were being developed smoothly. Last year, the Company resubmitted a New Drug Application (NDA) to the NMPA for the approval of anti-HER2 monoclonal antibody 302H for the treatment of patients with breast cancer. The Center for Drug Evaluation under the NMPA has so far completed technical review and clinical trial site inspection. In January, 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 multiple cancers, and patient enrollment started in April. In June, the NMPA accepted an IND application for clinical trial approval for 609A in China. The Company also completed Phase I trials of 602, an anti-epidermal growth factor receptor antibody to treat cancer, and is planning late phase clinical trials in patients with colorectal cancer.

On the other hand, the Company’s biological therapies for the treatment of autoimmune, inflammatory and other diseases, including anti-TNFα and IL-17A antibodies, have also made significant progress. 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. On July 31, the Company received an IND approval from the NMPA for its anti-IL-17A antibody (608) for the treatment of moderate to severe plaque psoriasis, and patient enrollment will start soon.  

The Company was also actively developing new formulations, new indications and second-generation products for existing products. The Company completed multiple Phase I clinical trials of NuPIAO (SSS06, the second-generation rhEPO to treat anemia) and kicked off patient enrollment for Phase II clinical trials. The Company has completed Phase I clinical trials of RD001, a pegylated long-acting rhEPO for the treatment of anemia, and is planning for Phase II trials in anemic patients. The Company has started clinical trials of TPIAO in pediatric ITP indication and patient enrollment is ongoing. Phase I clinical trials for TPIAO in surgery patients with hepatic dysfunction at the risk of thrombocytopenia have been completed, and Phase II trials will start soon.

Accelerate Expanding External Partnerships

In the first half of 2019, the Company continued to accelerate external partnerships,  including the collaboration with Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) for the development of multiple biosimilar candidates, including SB8 bevacizumab; the partnership with Verseau Therapeutics, Inc. (“Verseau”) for the development of macrophage checkpoint modulatorsfor a broad range of cancers; and the partnership with Taiwan Liposome Company, Ltd. (Nasdaq: TLC, TWO: 4152) (“TLC”) for the development of liposomal products in the therapeutic areas of oncology and infectious diseases.

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.

Devoted to Develop High-quality Innovative Biologics Products

In the future, the Company intends to reinforce its position as a leading biopharmaceutical company in China by continuously leveraging its integrated R&D, manufacturing and commercial platforms. The Company will also focus on developing innovative 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 candidates 602, 601A, and 609A. The Company is developing a new set of biologics products, including bispecific antibodies, fusion proteins, as well as cell therapies. Meanwhile, the Company will continue to expand and strengthen its internal clinical development capabilities and improve its overall R&D abilities so as to 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.

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, companies that focus on innovation, production quality and market access will embrace more opportunities. After 26 years of development, 3SBio has grown into an attractive leading Chinese biopharmaceutical company that is committed to its mission and innovation. 3SBio will continue to focus on biological medicine and innovation, fully leverage our advantages by integrating research, development, manufacturing and commercial, and gear up the development of our pipeline in oncology, immunology and next-generation biotherapeutics. Meanwhile, we will also leverage external cooperation to complement our businesses and achieve synergies, while improving the accessibility of cutting-edge biological medicines in order to benefit more patients.”