3SBio Maintains Steady Growth in 1H 2020 More than 10 NDAs to be submitted in the next 3 years
August 17, 2020, Hong Kong--- Chinese leading biopharmaceutical company 3SBio（01530.HK) today unveiled its 2020 first-half results. The Company maintained steady growth in all business segments, and accelerated R&D pipeline, despite the influence from the global COVID-19 pandemic. In the future, 3SBio will continue to step up efforts to counter market challenges by leveraging its systematic advantages that integrate R&D, manufacturing, commercialization, and investment cooperation to lead the local biopharmaceutical industry and bring more benefits to patients and the society.
Maintain sustained profitability
In the first half of 2020, thanks to resuming operation in an orderly manner after the epidemic eased, 3SBio posted revenue of approximately RMB 2.695 billion, up 2.0% year on year. Gross profit increased by 1.5% to approximately RMB 2.217 billion. Net profit attributable to owners of the parent soared 118.6% to RMB approximately 703 million. Normalized earnings before interest, taxes, depreciation, and amortization (EBITDA) rose 3.1% to approximately 1.049 billion. The leverage ratio (excluding bonds) dropped to 4.1% from 13.7% in the same period in 2019.
Supported by an established commercialization team, 3SBio’s core products continued to receive stable revenue. According to IQVIA data, TPIAO, which is used to treat thrombocytopenia, posted sales of RMB 1.375billion in the first half of 2020, an increase of 15.2% year on year, and its market share rose to 72.8%. Yisaipu, a product to treat rheumatoid arthritis, ankylosing spondylitis, and psoriasis, had sales of RMB 331 million with a market share of 54.5%. These two products, which are still in the early stage of their product life cycles, with low penetration rates and huge unmet demand in China, will see significant growth potential in the future. Two recombinant human erythropoietin (“rhEPO”) products, EPIAO and SEPO, posted sales of RMB 462 million, with a market share of 41.2%. Sales of small molecule drugs increased to RMB 261 million in the first half of the year.
Several of the Company’s products and indications have been added into the updated 2019 National Reimbursement Drug List (NRDL), 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 of EPIAO and SEPO for the treatment of anemia caused by chemotherapy for non-myeloid malignant tumors. Humulin, a mixed protamine zinc recombinant human insulin injection, was upgraded to Category A from Category B in the NRDL. Byetta, a therapy for the treatment of patients with type 2 diabetes, was added into the NRDL through negotiations.
On June 19, 2020, the anti-HER2 antibody for injection, Inetetamab (Cipterbin®), which is independently developed by 3SBio’s subsidiary, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., was formally approved by the National Medical Products Administration in China. The first approved indication of Cipterbin® is for the treatment of HER2-positive metastatic breast cancer combining with chemotherapy. Only 12 days after the approval was given, the first prescriptions were issued in five provinces and cities across the country. On July 22, Sunshine Guojian was listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange.
Accelerate R&D pipeline
In the first half of 2020, the company continued to focus on R&D and innovation. Amongst the 32 product candidates within the Company’s active pipeline, 22 were being developed as National New Drugs in China, including 11 in oncology and 12 in autoimmune and other diseases. An application for manufacturing approval of pre-filled aqueous injection solution of Yisaipu (301S) has been filed and accepted by the NMPA. The company expects to submit new drug applications for more than 10 products in the next three years, together with IND applications for 10-15 new monoclonal antibodies and bispecific antibodies (simultaneous applications in China and the US).
In the first half of 2020, the Company obtained two new IND approvals. 611, an anti-IL4Rα antibody, received the IND approval from the FDA, and its IND application was accepted by the NMPA for the treatment of atopic dermatitis. 610, an anti-IL5 antibody, obtained the IND approval from the NMPA for the treatment of severe eosinophilic asthma.
Multiple clinical trials were progressing smoothly. 609A, an anti-PD1 antibody for the treatment of various cancers, wrapped up enrolling patients for the phase I clinical trial in the US and started the enrollment of Chinese patients. 608, an anti-IL-17A antibody for the treatment of moderate to severe plaque psoriasis, completed the enrolment of patients for the phase I clinical trial and was set to start the phase II clinical trial. TRK820 for the treatment of pruritus in hemodialysis patients completed the first part of the bridging study in the phase III clinical trial. HIF-117 for the treatment of anemia started to enroll patients for the phase I clinical trial. SSS11pegitiscase for the treatment of gout was in the phase I clinical trial. The phase I clinical trial for anti-VEGF antibody 601A for the treatment of AMD completed enrolling patients, and the patient enrolment in the phase I clinical trial for the treatment of DME was progressing as planned. Patient enrolment for SSS06 and RD02, two long-acting erythropoietins, was proceeding successfully for the phase II clinical trials. The phase III clinical trial of TPO for the treatment of children with ITP was conducted smoothly.
The Company also supplemented its research pipeline and international layout through external cooperation. At the beginning of 2020, the Company joined the MPM Oncology Innovations Fund (INV) as a limited partner. It has also agreed to make donation to the Dana-Farber Innovations Research Fund (IRF) to support early-stage oncology research.
Extremely competitive system platform
In the future, 3SBio intends to reinforce its position as a leading biopharmaceutical company in China by continuously leveraging its integrated R&D, manufacturing,commercialization and investment cooperation platforms. The Company will also focus on developing innovative biologics products to address unmet medical needs to benefit more patients.
The Company will fully integrate the R&D teams of more than 420 people on multiple R&D platforms, and actively develop innovative therapies including monoclonal antibodies, bispecific antibodies, antibody fusion proteins, and multiple small molecule drugs, thereby bringing a variety of treatment options to patients. The Company will kick off multiple phase III clinical trials this year.
The Company has approximately 38,000-liter capacity in mAb facility, mammalian cell-based, bacteria cell-based and small molecule manufacturing facilities, and more than 27 years of experience in manufacturing biologics medicines. With large-scale production capacity that meets international quality standards, the Company is able to continuously supply the market with high-quality biologics. With more than 3,000 professional sales personnel who cover over 2,500 Class 3 hospitals and over 14,000 Class 2 hospitals and lower-tier hospitals, the Company has business presence all over the country. Over nearly 3 decades, the Company has been well recognized for its strong commercial operation capabilities, which supports its sustainable growth.
Dr. Jing LOU, Chairman and CEO of 3SBio, commented: “The global economy faced a huge test during the COVID-19 pandemic in 2020. We proactively responded to challenges, fully supported the epidemic-hit areas, supported the country to overcome the difficulties, and maintained steady business growth. It fully demonstrated the Company’s systematic advantages in R&D, manufacturing, commercialization, and investment cooperation. In the future, we will continue to accelerate the IND applications and clinical trials for our drug candidates, further expand production capacity, and give full play to the advantages of our integrated platform. We aim to become a world-leading Chinese biopharmaceutical company, and continuously improve the availability of our innovative biologics to benefit more patients.”
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