宝济药业-B(02659)：KJ101新增适应症获得临床试验批准

智通财经

Mar 12

智通财经APP讯，宝济药业-B(02659)发布公告，公司自主研发、中国领先的经由合成生物学开发的重组人糜蛋白酶KJ101，已获中国国家药监局批准，可在中国开展用于胃镜检查时溶解去除胃内黏液的临床试验。

糜蛋白酶是一种能够迅速分解蛋白质，液化脓液及坏死组织的蛋白酶，凭借其特定的蛋白水解活性，它能有效分解积累在慢性或急性伤口的纤维蛋白、胶原蛋白碎片和其他蛋白质碎片。糜蛋白酶被广泛应用于唿吸科、外科、耳鼻喉科、妇产科、儿科、口腔科、眼科、皮肤科、消化科、肛肠外科等科室，特别是用在去除坏死组织、促进伤口愈合、改善胃镜视野等方面。

KJ101是通过公司合成生物学开发的中国领先的重组人糜蛋白酶，旨在全面替代动物源产品。KJ101基于该公司独特的重组酵母发酵技术构建，提供了一种纯净、更安全且更具可扩展性的替代方案，并具有高表达水平。KJ101具有纯度高、无动物源病毒污染的风险及无致敏性等核心优势。其生产原料来源广泛，原料供应不受上游畜牧养殖产业波动的影响，产品批间差极小，且不受原料品质变化的影响，确保了良好的临床安全性。

针对烧伤、外伤、手术切口、压力性溃疡及糖尿病足溃疡等伤口愈合适应症，该公司已于2025年2月获得国家药监局对KJ101的IND批准，并于2025年7月启动了其II期临床试验(CTR20252263)。

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