Shanghai Bao Pharmaceuticals Co., Ltd. (Bao Pharma-B, 02659) announced that the National Medical Products Administration (NMPA) has cleared the company to initiate clinical trials of KJ101—its recombinant human chymotrypsin—for the dissolution and removal of gastric mucus during gastroscopy.

KJ101 is positioned as China’s first recombinant human chymotrypsin produced via synthetic biology. Developed with the company’s proprietary yeast-fermentation platform, the drug candidate is designed to eliminate animal-derived inputs, offering higher purity, no animal-origin virus risk, no allergenicity, and minimal batch variability.

Chymotrypsin, a protease capable of rapidly hydrolyzing proteins, is routinely applied in respiratory medicine, surgery, gastroenterology, and other departments to remove necrotic tissue and improve wound visibility. The new study focuses on enhancing visibility and efficiency during gastroscopy by clearing accumulated gastric mucus.

In February 2025, KJ101 secured its initial Investigational New Drug (IND) approval for wound-healing indications such as burns, surgical incisions, pressure ulcers, and diabetic foot ulcers, and a Phase II trial (CTR20252263) commenced in July 2025.

The company cautioned that clinical results, regulatory timelines, and eventual commercialization remain uncertain, and advised shareholders and potential investors to exercise prudence when trading its shares.