Hualan Bio’s CTLA-4 mAb injection nodded for clinical trials in China



China-based Hualan Biological Engineering Inc., (002007.SZ) announced that subsidiary Hualan Genetic Engineering Co., Ltd, received clinical trial approval from the National Medical Products Administration (NMPA) relating to its recombinant human anti cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody (mAb) injection.

GBI SOURCE data indicates that the clinical study filing was accepted by the Center for Drug Evaluation (CDE) on May 21, 2018 (CXSL1800055) as a Category 2 therapeutic biologic.

As previously reported by GBI, there are no CTLA-4 mAb products currently available on the market in China. However, Beijing SL Pharmaceutical Co., Ltd received clinical trial approval for a biosimilar version of Bristol-Myers Squibb's CTLA-4 mAb Yervoy (ipilimumab) in May this year, while CStone Pharmaceuticals was cleared to start clinical develpoment of the novel CTLA-4 mAb CS1002 in August.

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China-based Beijing SL Pharmaceutical Co., Ltd (002038.SZ) announced receipt of China National Drug Administration (CNDA) clinical trial approval for its recombinant human anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody injection, a biosimilar version of Bristol-Myers Squibb (BMS)’s Yervoy (ipilimumab).
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