CSPC Pharmaceutical Group Gains NMPA Approval for Ustekinumab Biosimilar “Enyike” (恩益克)
Key Highlights
- CSPC Pharmaceutical Group Limited (Stock Code: 1093) announced that it has received marketing authorisation from the National Medical Products Administration (NMPA) for its biosimilar Ustekinumab Injection (brand name: Enyike (恩益克)).
- The product is a biosimilar to Stelara®, a blockbuster drug originally approved in China in 2017.
- The approval covers moderate to severe plaque psoriasis in adults and selected paediatric patients, as well as Crohn’s disease.
- This is a significant addition to CSPC’s pipeline in the autoimmune disease space, and may impact market share in China’s biologics sector.
Product and Market Details
Enyike (恩益克) is a fully human IgG1κ monoclonal antibody that targets the p40 protein subunit of interleukins IL-12 and IL-23. These cytokines are centrally involved in the pathogenesis of autoimmune conditions such as plaque psoriasis and Crohn’s disease. By binding to this subunit, Enyike disrupts IL-12 and IL-23 signaling, reduces disease symptoms, and delivers long-term clinical benefits for patients.
The originator drug, Stelara® (Ustekinumab), has become a mainstream therapy for autoimmune diseases in China since its launch, with broad recognition for its efficacy and safety. CSPC’s Enyike was developed as a Class 3.3 therapeutic biological product following NMPA’s biosimilar guidelines. The company conducted comprehensive pharmaceutical, non-clinical, and “head-to-head” clinical studies comparing Enyike to Stelara®. The trials confirmed a high degree of similarity in quality, pharmacokinetics, efficacy, and safety.
Indications:
- Treatment of adult patients with moderate to severe plaque psoriasis who have failed, are intolerant, or have contraindications to systemic therapies (including cyclosporine, methotrexate, or PUVA).
- Treatment of paediatric and adolescent patients aged 6 years or above (weighing 60–100 kg) with moderate to severe plaque psoriasis who have not responded to or are intolerant to other systemic therapies or phototherapy.
- Approval also covers Crohn’s disease, in line with Stelara®’s original label.
Clinical Validation and Publication
The efficacy and safety results from comparative clinical studies have been published in the Journal of the American Academy of Dermatology, the leading international journal in the dermatology field. This recognition further validates the robust clinical evidence supporting Enyike’s approval.
Shareholder Impact and Price Sensitivity
- This marks CSPC’s entry into the high-value autoimmune biologics segment with a biosimilar to a globally successful drug. Stelara®’s market presence and sales indicate significant commercial potential for CSPC’s Enyike.
- Expanding the company’s autoimmune portfolio is expected to enhance CSPC’s competitiveness and diversify revenue streams.
- Given the size of the Chinese biologics market and the established demand for Ustekinumab, this approval could be material and price sensitive for CSPC’s shares.
- Investors should note that biosimilar adoption in China is accelerating, and CSPC may capture meaningful market share from the originator and other competitors.
Corporate Governance
The announcement was signed by Chairman Cai Dong Chen. The Board is composed of a mix of executive and independent non-executive directors, indicating stable corporate governance.
Conclusion
The NMPA approval for Enyike (Ustekinumab injection) is a major milestone for CSPC Pharmaceutical Group, strengthening its position in the biologics and autoimmune disease market. Investors should closely monitor the market performance and uptake of this biosimilar, as it could drive significant growth and potentially move the share price.
Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own research and consult with professional advisors before making investment decisions. The information is based on the company’s public disclosures as of May 22, 2026, and may be subject to change.
石藥集團恩益克（Ustekinumab生物類似藥）獲NMPA批准上市
重點摘要
- 石藥集團有限公司（股份代號：1093）宣布，其生物類似藥Ustekinumab注射液（商品名：恩益克）已獲國家藥品監督管理局（NMPA）批准上市。
- 該產品為Stelara®的生物類似藥，Stelara®自2017年於中國上市以來，一直是治療自身免疫疾病的主流藥物。
- 批准適應症包括中至重度斑塊型銀屑病（牛皮癬）及克羅恩病，涵蓋成人及部分兒童患者。
- 此批准將強化石藥集團於自身免疫生物藥市場的競爭力，對中國生物藥市場份額或產生重大影響。
產品及市場詳情
恩益克是一種全人源IgG1κ單克隆抗體，針對IL-12及IL-23的p40蛋白亞基，這兩種細胞因子是銀屑病和克羅恩病發病的重要因素。恩益克通過阻斷IL-12/23信號傳導，有效減輕疾病症狀，並為患者帶來長期臨床益處。
參考藥Stelara®於2017年中國上市，憑藉其療效及安全性，已成為自身免疫疾病的主流治療選擇。恩益克作為3.3類治療性生物製品，嚴格按照NMPA生物類似藥指南開發，並進行了全面的藥學、非臨床及與Stelara®“頭對頭”臨床對比試驗，證明在品質、藥代動力學、療效及安全性方面高度相似。
適應症：
- 治療對其他全身治療（如環孢素、甲氨蝶呤、PUVA）無效、不耐受或有禁忌的中至重度成人斑塊型銀屑病患者。
- 治療6歲及以上、體重60–100公斤且對其他全身治療或光療反應不佳或不耐受的兒童及青少年斑塊型銀屑病患者。
- 亦涵蓋克羅恩病，與原研藥Stelara®標籤一致。
臨床驗證及學術發表
有關療效及安全性的臨床對比試驗結果已發表於國際權威期刊《美國皮膚病學會雜誌》，進一步證明產品的臨床價值。
對股東及股價敏感事項
- 此次批准標誌著石藥集團正式進軍高價值的自身免疫生物藥領域，市場潛力巨大。
- 豐富公司產品線，有望提升市場競爭力及收入來源多元化。
- 中國生物藥市場需求龐大，參考Stelara®的銷售表現，恩益克有望為公司帶來可觀業績，屬於具股價敏感性的重要消息。
- 生物類似藥在中國市場滲透率逐步提升，石藥集團有望爭取到原研藥及其他競爭產品的市場份額。
公司治理
公告由董事長蔡東晨簽署，董事會由多名執行及獨立非執行董事組成，反映公司管理架構穩健。
總結
恩益克（Ustekinumab注射液）獲批上市，是石藥集團於生物藥及自身免疫領域的重要里程碑。股東及投資者應密切留意該產品的市場推進及表現，因其有潛力帶動業績增長，對公司股價構成正面推動力。
免責聲明： 本文僅供參考，並不構成任何投資建議。投資者應自行調查及諮詢專業人士，方作出投資決定。以上信息根據2026年5月22日公司公告整理，可能隨時變動。
