3SBio announces 2020 annual results, tapping integrated platform advantages for steady growth

SHANGHAI, March 30, 2021 /PRNewswire/ -- Chinese leading biopharmaceutical company 3SBio (01530.HK) today unveiled its 2020 full-year results. The Company maintained stable profitability despite the huge challenge amid the COVID-19 pandemic, while ushering in new milestones. It once again demonstrated 3SBio's leading position in China's biopharmaceutical industry over the years, as well as the Company's strong growth momentum.

Core products maintain stable performance

In 2020, despite the COVID-19 impact, 3SBio continued to leverage its proven capability to maintain strong performance. According to the list of top 200 domestic pharmaceutical enterprises as of December 2020 released by IQVIA , 3SBIO jumped from 28th last year to 16th. In 2020, The full-year revenue was RMB 5.588 billion, an increase of 5.1% over the same period last year. Gross profit rose 3% year on year to approximately RMB 4.525 billion. Normalized net profit attributable to owners of the parent, after excluding the foreign

exchange differences, increased 5.3% to RMB 1,416.4 million. R&D costs totaled RMB 590.3 million, accounting for 10.6% of revenue. On July 22, 2020, Sunshine Guojian was listed on the STAR market of the Shanghai Stock Exchange. 3SBio's MSCI ESG rating has been continually improved from B initially in 2016 to A in 2020, surpassing 78% of companies in the global biotechnology industry.

3SBio's multiple core products maintained stable organic growth. According to IQVIA\CAP data, TPIAO, which is used to treat thrombocytopenia, posted a new high of RMB 2762.7 million in sales in 2020, an increase of 18.9% year on year. Sales of two recombinant human erythropoietin ("rhEPO") products, EPIAO and SEPO, jumped to RMB 973.9 million, marking a significant year-on-year increase of 30%. Yisaipu, a product to treat rheumatoid arthritis, ankylosing spondylitis, and psoriasis, had sales of RMB 615.3 million. Mandi's sales increased 46.9% year on year to RMB 3 67.6 million yuan. In general, several core products maintained their market-leading positions. Compared with Europe and the United States, the Chinese biopharmaceutical market still has big clinical demand and growth potential. The Company is actively adjusting and optimizing its market strategy to consolidate the leading position of its products.

In 2020, the new drug applications (NDAs) of three products under 3SBio were approved or accepted. On June 19, Cipterbin® (Inetetamab), which is independently developed by 3SBio's subsidiary, Sunshine Guojian, was approved by the National Medical Products Administration (NMPA) in China, and was added into the NRDL as well. The first approved indication is in combination with chemotherapy for the treatment of HER2-positive metastatic breast cancer. Only 12 days after the approval was granted, the first prescriptions were issued in five Chinese provinces and cities. According to the "China Consensus Guidelines for Advanced Breast Cancer 2020 (CABC3)" issued by the Breast Disease Research Center of China Medical Women's Association, inistuzumab (cyproterin) has become one of the preferred treatment options for patients with advanced breast cancer. According to the [2020] No. 1047 notice issued by the General Office of the National Health Commission, inistuzumab has been included in the "Guiding Principles for the Clinical Applications of New Anti-tumor Drugs (2020 Edition)."On August 19, Nadroparin calcium injection self-developed by 3SBio was approved by the NMPA for launch. On August 26, the NDA of Ampholipad™ (amphotericin B liposome for injection), which 3SBio was authorized by TLC to commercialize on China's mainland, was accepted by the NMPA.

In the updated 2020 national reimbursement drug list (NRDL), the blockbuster Cipterbin® was included for the first time. In addition, the Company's core product TPIAO was also added into the NRDL through negotiations.

Accelerating R&D pipeline

In 2020, the Company continued to focus on R&D and innovation. Amongst the 34 product candidates within the Company's active pipeline, 24 were being developed as National New Drugs in China, including 12 in oncology and 14 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.

In 2020, the Company obtained three new IND approvals. 611, an anti-IL4Rα antibody, received the IND approvals from the FDA and 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 involving major targets were progressing smoothly. For 610, the dose-escalating phase I clinical trial in healthy volunteers was completed. For 611, the dose escalation phase I clinical trial on healthy volunteers is now underway in the United States and is planned to be launched in China soon. The phase I head-to-head comparative clinical trial between anti-CD20 antibody 304R and Rituximab on safety and pharmacokinetics in patients with non-Hodgkin's lymphoma with zero tumor burden was completed. 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, completed the dose-escalating phase I clinical trial in healthy volunteers and is set to start the phase II clinical trial for the treatment of patients with plaque psoriasis. The dose-escalating phase I clinical trial for anti-VEGF antibody 601A for the treatment of AMD and DME patients completed, and the phase II clinical trial for patients with branch retinal vein occlusion and central retinal vein occlusion was initiated. Humanized anti-TNFα antibody SSS07 completed the phase I clinical trial for healthy volunteers and RA patients. The phase I clinical trial of anti-EGFR antibody 602 for healthy volunteers and patients with colorectal cancer was completed. HIF117 for the treatment of anemia started to enroll patients for the phase I clinical trial.

Significant progress has been made in clinical research on new formulations and indications of existing products, as well as next-generation products. An application for manufacturing approval of pre-filled aqueous injection solution of Yisaipu (301S) has been filed and accepted by the NMPA.TPIAO's phase III clinical trial for pediatric ITP indication started to enroll patients, and the phase I clinical trial in surgery patients with hepatic dysfunction at the risk of thrombocytopenia was completed. Long-acting erythropoietin SSS06 for the treatment of anemia completed the enrolment of patients for the phase II clinical trial, while RD001 is enrolling patients for the phase II clinical trial. The phase III head-to-head study between minoxidil foam formulation MN709 and Rogaine in male patients with hair loss completed patient enrollment.

In addition, clinical trials of various external cooperation projects were also progressing smoothly. TRK820, which was authorized from Japan's Toray, for the treatment of pruritus in hemodialysis patients completed the first part of bridging phase III clinical trial. SSS11 pegsiticase is now in the phase I clinical trial in refractory gout patients with high uric acid leve, and partner Selecta started the phase III clinical trial of the combination therapy SEL-212 containing pegsiticase for patients with chronic refractory gout, and made a milestone payment of US$4 million to 3SBio. Sunshine Guojian selected its partner Verseau's anti-VSIG-4 monoclonal antibody as the second authorized product.

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 500 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 is expected to file IND applications for multiple potential first-in-class or best-in-class candidates in China and the United States within 12 months.

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 28 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: "Since its establishment in 1993, 3SBio has been continuously growing in the past 28 years. The year 2020 was challenging amid the COVID-19 epidemic, but it was also a year with renewed vitality. The Company actively supplied urgently-needed medicines to the epidemic-hit areas, and contributed to the country's continuous fight against the epidemic. Leveraging our advantages with an integrated platform covering research, manufacturing, and commercialization with proven track record for many years, the Company maintained steady performance. In 2020, we ushered in the launch of Cipterbin®, the new treatment for breast cancer, and, at the same time, kicked off a new journey in the A-share capital market. Every milestone helps consolidate our position as an innovative biopharmaceutical company. As opportunities and challenges coexist in the industry, 3SBio will focus on core therapeutic areas and continue to address unmet medical needs. We will increase investment in the development of innovative biopharmaceutical products, make full use of the advantages of existing products through combination with follow-up pipeline, and drive research progress in major targets. While maintaining steady growth, we will continue to explore new candidates to empower our sustainable development and benefit human health."

Cautionary Note and Forward-Looking Statements

This press release contains forward-looking statements, such as those relating to business or products outlook, or Company's intent, plans, beliefs, expectation and strategies. These forward looking statements are based on information currently available to the Company and are stated herein on the basis of the outlook at the time of this press release. They are based on certain expectations, assumptions and premises, some of which are subjective or beyond our control. These forward-looking statements may prove to be incorrect or may not be realized in the future. With respect to any new product or new indication, we cannot guarantee that we will be able to successfully develop or eventually launch and market such product or indication. Underlying the forward-looking statements is a large number of risks and uncertainties. Further information regarding such risks and uncertainties may be found in our other public disclosure documents. The scientific information involved may only be preliminary and empirical. Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company.

SOURCE 3SBio