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CSPC Wins China Approval for Ustekinumab Biosimilar Enyike, Expanding Autoimmune Portfolio

Story Highlights
  • CSPC secured Chinese marketing approval for Enyike, a ustekinumab biosimilar targeting IL-12 and IL-23 to treat plaque psoriasis and Crohn’s disease.
  • Head-to-head trials confirmed Enyike’s similarity to Stelara, and its approval strengthens CSPC’s autoimmune biologics portfolio and patient treatment options in China.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
CSPC Wins China Approval for Ustekinumab Biosimilar Enyike, Expanding Autoimmune Portfolio

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An update from CSPC Pharmaceutical Group ( (HK:1093) ) is now available.

CSPC Pharmaceutical Group has received marketing authorization in China for its ustekinumab biosimilar injection Enyike, a fully human monoclonal antibody targeting IL-12 and IL-23 for the treatment of plaque psoriasis, including paediatric patients, and Crohn’s disease. Developed as a Class 3.3 therapeutic biological product, Enyike demonstrated high similarity in quality, pharmacokinetics, efficacy and safety to originator drug Stelara in head-to-head trials, and its approval significantly enhances CSPC’s autoimmune disease portfolio while offering Chinese patients a new, locally developed treatment option in a major biologics segment.

The company followed established biosimilar development guidelines and published its comparative clinical results in the Journal of the American Academy of Dermatology, underscoring the scientific rigor behind Enyike’s development. This regulatory milestone is expected to bolster CSPC’s position in the competitive autoimmune biologics market in China, potentially improving access and affordability for patients who have failed or are intolerant to conventional systemic therapies and phototherapies.

The most recent analyst rating on (HK:1093) stock is a Buy with a HK$13.05 price target. To see the full list of analyst forecasts on CSPC Pharmaceutical Group stock, see the HK:1093 Stock Forecast page.

More about CSPC Pharmaceutical Group

CSPC Pharmaceutical Group is a Hong Kong-incorporated pharmaceutical company focused on developing and manufacturing innovative and generic drugs, including biologics, for the Chinese market. The group has been expanding its presence in high-value therapeutic areas such as autoimmune diseases, aiming to broaden its product portfolio and strengthen its competitive position in specialty medicines.

Average Trading Volume: 86,073,692

Technical Sentiment Signal: Hold

Current Market Cap: HK$85.01B

Learn more about 1093 stock on TipRanks’ Stock Analysis page.

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