Zhejiang Huahai Pharmaceutical (600521.SH) Subsidiary Receives Approval for Ruxolitinib Monoclonal Antibody Injection Marketing Authorization Application

Stock News10-09

Zhejiang Huahai Pharmaceutical Co.,Ltd. (600521.SH) announced that its subsidiary, Shanghai Huaotai Biopharmaceutical Co., Ltd. (referred to as "Huaotai"), has recently received an "Acceptance Notice" from the National Medical Products Administration for the domestic production drug registration and marketing authorization application of Ruxolitinib (development code: HB0034) injection. The declared indication is for the treatment of generalized pustular psoriasis (GPP) flares in adults.

Currently, no domestically developed anti-IL-36R antibody has been approved for marketing globally. As China's first self-developed innovative anti-IL-36R antibody, HB0034 can exert anti-inflammatory biological effects by inhibiting the IL-36 pathway.

According to research analysis results, compared to placebo, patients with GPP flares showed significant clearance of skin pustules within the first week after a single intravenous administration of HB0034, achieving the primary endpoint preset in the protocol. The safety profile was favorable, with no new safety signals identified.

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