3SBio's Breakthrough with Multiple Class 1 Innovative Biologics: Stirring a RMB 190B Market

According to the latest news from CDE and NMPA, 3SBIOINC's Class 1 new biologic drugs SSGJ-716 Injection and SSS55 Injection have been approved for clinical trials, intended for atopic dermatitis and periodontitis respectively; China's first domestically produced recombinant erythropoietin (EPO) innovative drug, Roxadustat Alfa Injection, has been approved for marketing to treat anemia caused by chronic kidney disease. Data from Menet shows that in 2025 Q1~Q3, the sales revenue of biologics in China’s three major terminals and six major markets exceeded 190 billion yuan, increasing by 8.86% year-on-year.

SSGJ-716 Injection is produced by3SBIO GroupA self-developed Class 1 new biologic drug, intended for the treatment of atopic dermatitis (AD). Data from Menet shows that the clinical application (CXSL2600014) of this new drug was accepted by the CDE in January 2026, and subsequently received its first implied permission for clinical trials in March this year.

SSS55 Injection, a Class 1 biological new drug developed by 3SBio Group, is intended for use in periodontitis. Prior to this, the new drug received clinical approvals in May and July 2025, respectively, for the potential treatment of paroxysmal nocturnal hemoglobinuria (PNH) and complement-related nephropathy.

3SBIOINC's Roxadustat Alpha Injection is a highly glycosylated, long-acting recombinant protein product used for anemia caused by chronic kidney disease. It is the first domestically produced innovative recombinant erythropoietin (EPO) drug approved for marketing in China. Data shows that the product has extended stability and a longer half-life while retaining its original biological activity, reducing the frequency of administration and facilitating clinical use.

In China's three major terminals and six major markets (for statistical scope, see the end of this article), the sales scale of biologics has been expanding year by year in recent years, surpassing 230 billion yuan in 2024 to reach a new high. From Q1 to Q3 of 2025, it continued to grow by 8.86% to exceed 190 billion yuan. In terms of channel structure, public hospital terminals account for over 80% of the market share. In terms of the overall category, anti-tumor and immunomodulatory agents account for approximately 45% of the market.

In the TOP10 of China's three major terminals and six major markets for biologics in 2025Q1~Q3, there are 6 multinational pharmaceutical companies and 4 local pharmaceutical companies listed. Among them, Novo Nordisk and Roche, both multinational companies, have sales exceeding 12 billion RMB, ranking first and second respectively; while Innovent Bio and Qilu Pharmaceutical, both local companies,Fosun PharmaceuticalBoth Innovent Bio and 3SBIOINC have sales exceeding 5.8 billion yuan, ranking third to sixth.

Top 10 Brands: Novo Nordisk's Semaglutide Injection, Innovent Bio's Sintilimab Injection,BeiGeneTislelizumab Injection from Innovent Bio, Bevacizumab Injection from Qilu Pharmaceutical, and Recombinant Human Thrombopoietin Injection from 3SBio Group ranked successively in the top five. The combined market share of the TOP5 brands is approximately 12%.

As a leader in China's biopharmaceutical field, 3SBIOINC consistently upholds the development philosophy of "leading innovation and continuous innovation." In recent years, its R&D expenditure has maintained a year-on-year growth rate in double digits, and the sustained investment in R&D has accelerated the transformation of its innovative achievements.

In terms of Class 1 innovative drugs, since 2026, the company has had one new product approved for marketing, one new product submitted for production and under review, and six new products approved for clinical trials. These products cover therapeutic categories including antitumor and immunomodulatory agents, drugs for blood and hematopoietic systems, genitourinary system and sex hormone drugs, as well as drugs for digestive system and metabolism.

Among them, Anmuchita Monoclonal Antibody Injection was approved for marketing in February 2026. It is used for moderate to severe plaque psoriasis suitable for systemic treatment or phototherapy and is the first domestically produced IL-17A inhibitor in China with a maintenance period requiring dosing only once every 8 weeks. The Recombinant Anti-IL-4Rα Humanized Monoclonal Antibody Injection was accepted for production filing in February this year for the treatment of moderate to severe atopic dermatitis. Its对标product, Dupilumab, achieved global sales of $18.291 billion in 2025.

Six Class 1 new drugs have received implied approval for clinical trials. In terms of the highest R&D progress, SSS50 for injection (androgenetic alopecia), HBT-708 for injection (advanced solid tumors), and SSS55 injection (paroxysmal nocturnal hemoglobinuria) have entered Phase I clinical trials, while SSS57 for injection (anemia), SSGJ-627 injection (intravenous infusion) (ulcerative colitis), and SSGJ-716 injection (atopic dermatitis) have been approved for clinical trials for the first time.