Submission and acceptance of application for the production of new drug for Yisaipu(R)aqueous injection solution

3SBio Inc. (01530.HK), a leading biopharmaceutical company in the PRC, announces today that an application for the production of new drug has been submitted to the National Medical Products Administration for Yisaipu® pre-filled aqueous injection solution (common name: recombinant human type II tumor necrosis factor receptor-antibody fusion protein injection solution), an antibody fusion protein drug product that is self-developed by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., a subsidiary of 3SBio.

Yisaipu® aqueous injection solution is the first self-developed pre-filled fusion protein injection solution in the PRC. It is used for the treatment of three indications: active ankylosing spondylitis, moderate and severe active rheumatoid arthritis as well as moderate and severe plaque psoriasis in adults of 18 years old and above. According to research, the prevalence rates of such three diseases in the PRC are approximately 0.3%1, 0.4%2 and 0.1%3respectively. At present, patients' compliance with such biologics agent is not yet satisfactory. Poor patients' compliance is also one of the major causes of repeated disease onset.

Yisaipu® pre-filled aqueous injection solution has achieved significant breakthrough in the process of biologics agents in the PRC. Patients are no longer restricted to hospital treatment and can give self-injections at home. It is expected to greatly improve patients' compliance and enhance patients' quality of life.

Yisaipu® was launched as powder for injection in 2006 and has so far benefited more than 300,000 patients. It has received professional recognition from clinicians and trust from a wide range of patients. In 2017, it was included in the National Reimbursement Drug List as a Class B Drug. Yisaipu® pre-filled aqueous injection solution will bring more dosage forms and is expected to benefit more patients.

Dr. Lou Jing, Chairman and Chief Executive Officer of 3SBio, commented, "I am pleased to see that the application for the production of new drug for Yisaipu® pre-filled aqueous injection solution has been successfully submitted and accepted. 3SBio will continue to focus on the biopharmaceutical field and is committed to exploring and developing more therapeutic biologics agents in different dosage forms, so as to meet different medical needs and provide patients with more choices."

Sources of Data:

1. 2012 Chinese Journal of Orthopaedics 
2. 2018 Chinese Rheumatoid Arthritis Treatment Guide
3. 2018 Chinese Psoriasis Treatment Guide

About Yisaipu®

Yisaipu® (recombinant human type II tumor necrosis factor receptor-antibody fusion protein injection solution, rhTNFR: Fc) targets TNF-α, a major inflammatory mediator in the pathological process of rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis. It can combine with TNF-α and inhibit the biological activity of TNF-α to achieve therapeutic effect. Yisaipu® uses recombinant DNA technology to construct eukaryotic expression vector of fusion gene containing the extracellular coding region of human type II tumor necrosis factor receptor (P75) and the human IgG1 Fc coding region and transfect Chinese Hamster Ovary cell (CHO-K1 cell) to highly express rhTNFR: Fc.

About Sunshine Guojian

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. ("Sunshine Guojian"), a subsidiary of 3SBio, was established in 2002. Sunshine Guojian focuses on the R&D, pilot and industrialization of antibody drugs. The company owns the only "National Engineering Research Center of Antibody Medicine" (approved by the National Development and Reform Commission) in the PRC and operates the largest and most technologically advanced monoclonal antibody production base in the PRC with a production capacity of over 38,000 liters. Sunshine Guojian is a pioneer in Chinese antibody drugs and an absolute leader in the anti-TNF-α antibody market. The key therapeutic areas of the company's products include oncology, auto-immune diseases and others.

About 3SBio

3SBio is an integrated biotechnology company with market-leading biopharmaceutical business covering therapeutic areas such as oncology, auto-immune diseases, nephrology, metabolic diseases and dermatological diseases. 3SBio is committed to building an innovative product pipeline, and currently has more than 30 product candidates under development. 3SBio possesses the capability of producing recombinant proteins, monoclonal antibodies and chemically-synthesized molecular products, and has established R&D and production centers in Shenyang, Shanghai, Hangzhou, Shenzhen and Como, Italy. 

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, or 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 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 realised in 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 these risks and uncertainties may be found in our other public disclosure documents.Any scientific information discussed may be only preliminary and investigative.Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company.

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