Changchun High & New Technology Industries Group Inc

Changchun High-Tech Industries Group announced that its controlling subsidiary, Changchun GeneScience Pharmaceutical, has received clinical trial approval from the National Medical Products Administration for its GenSci133 injection, a Class 1 therapeutic biologic, for the treatment of osteoporosis. The drug is a fusion protein of a parathyroid hormone analogue and an anti-RANKL antibody, designed to promote bone formation and inhibit bone resorption through a dual mechanism, with an expected dosing frequency of once every three to six months. The company noted that osteoporosis represents an unmet clinical need in China, and if trials proceed smoothly, the drug will help strengthen its endocrine and metabolic product pipeline, though research and development involves uncertainty.

Changchun High-Tech announced that the clinical trial application for the domestically produced drug registration of its controlled subsidiary GeneScience Pharmaceuticals’ GenSci133 injection has been accepted by the National Medical Products Administration, with acceptance number CXSL2600814, for the indication of osteoporosis. GenSci133 is a PTH peptide and anti-RANKL antibody fusion protein independently developed by GeneScience Pharmaceuticals, classified as a therapeutic biological product Category 1, which inhibits bone resorption and promotes bone formation through dual pharmacological actions, aiming to increase bone mass. Non-clinical studies indicate the drug has the potential for subcutaneous injection once every three to six months. The company stated that this product aligns with its strategic plan in the endocrine field, but the subsequent clinical trial process and results are subject to uncertainty.

Changchun High-Tech subsidiary GeneScience Pharmaceuticals has received approval from the National Medical Products Administration for its clinical trial application for GenSci144 tablets for the chronic kidney disease indication. The drug is a chemical class 1 oral small-molecule inhibitor targeting the SLC6A19 protein. By reducing neutral amino acid absorption, it improves intrarenal metabolism, alleviates inflammatory fibrosis, and slows renal function decline. Its mechanism of action differs from existing drugs and is expected to cover all types of chronic kidney disease patients and be used in combination with existing therapies. There are approximately 674 million chronic kidney disease patients globally, with nearly 156 million adult patients in China. The drug previously received approval for clinical trials for phenylketonuria. The company cautions that the clinical trial process and outcomes are subject to uncertainty.

The investigational new drug application for GenSci136 for injection, intended for systemic lupus erythematosus, from Changchun High-Tech's controlled subsidiary GeneScience Pharmaceuticals, has been accepted by the National Medical Products Administration. The drug is a Category 1 therapeutic biological product independently developed by GeneScience Pharmaceuticals, employing a dual-target mechanism against BAFF and APRIL. Non-clinical studies have shown favorable pharmacological activity and an acceptable safety profile. Previously, clinical trials for this drug in generalized myasthenia gravis, IgA nephropathy, and ocular myasthenia gravis have been approved in China, and a clinical trial for myasthenia gravis has been approved by the U.S. FDA. The company cautions that there are uncertainties in the subsequent clinical trial process and outcomes.

The marketing application for Jintuoximab Injection from Changchun High-Tech's controlled subsidiary, Changchun GeneScience Pharmaceutical, has been accepted by the National Medical Products Administration. The drug is indicated for use in combination with paclitaxel for patients with advanced gastric or gastroesophageal junction adenocarcinoma who have failed prior first-line systemic therapy, with acceptance number CXSS2600110. Jintuoximab Injection is a recombinant anti-VEGFR2 human-mouse chimeric monoclonal antibody. Its pivotal Phase III clinical trial enrolled 754 subjects, and results showed that the primary endpoint of overall survival was successfully met with statistical significance. The company stated that after approval and launch, it will actively promote the drug in the domestic market, but market sales are subject to many factors and involve certain uncertainties.

The clinical trial application for the domestically produced drug registration of GenSci148 injection, developed by Changchun High-Tech subsidiary GeneScience Pharmaceuticals, has been accepted by the National Medical Products Administration. The indications are neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. GenSci148 is a VEGF multi-blocker independently developed by GeneScience Pharmaceuticals, classified as a Class 1 therapeutic biological product. Based on the proprietary ProlonXTM long-acting platform, it can simultaneously bind VEGF-A, VEGF-C, VEGF-D, and Ang-2, potentially extending dosing intervals and reducing treatment burden. The company stated that this acceptance aligns with its strategic plan in the ophthalmology field, but the subsequent progress and results of the clinical trial remain uncertain.