Changchun High-tech: Announcement on the Acceptance of Subsidiary GenSci161 Injection’s Domestic Production Drug Registration Clinical Trial Application

Securities code: 000661 Securities abbreviation: Changchun High-tech Announcement number: 2026-082

Changchun High-tech Industry (Group) Co., Ltd.

Announcement on the Acceptance of Subsidiary GenSci161 Injection’s Registration Clinical Trial Application for Domestic Production of Drugs

The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete, and contains no false records, misleading statements or major omissions.

Recently, Changchun Jinsai Pharmaceutical Co., Ltd. (hereinafter referred to as "Kinsai Pharmaceutical"), a holding subsidiary of Changchun High-tech Industry (Group) Co., Ltd. (hereinafter referred to as the "Company"), received an "Acceptance Notice" approved and issued by the State Food and Drug Administration. Jinsai Pharmaceutical's domestically produced drug registration clinical trial application for GenSci161 injection was accepted. The relevant information is now announced as follows:

1. Basic information about drugs

Product name: GenSci161 injection

Application matters: Registration of clinical trials of domestically produced drugs

Acceptance number: CXSL2600927

Applicant: Changchun Jinsai Pharmaceutical Co., Ltd.

Approval conclusion: After review, it is decided to accept the application

Indications: Connective tissue disease-related interstitial lung disease

2. Other information about drugs

GenSci161 injection is a Class 1 therapeutic biological product independently developed by Kinsey Pharmaceuticals. It is intended to be used to treat interstitial lung disease related to connective tissue disease.

Connective tissue disease-related interstitial lung disease (CTD-ILD) is an important complication caused by systemic autoimmune diseases involving the lung interstitium. Common underlying diseases include systemic sclerosis (SSc), rheumatoid arthritis (RA), polymyositis/dermatomyositis (PM/DM), Sjogren's syndrome (pSS), and systemic lupus erythematosus (SLE). Its prevalence varies greatly depending on the underlying disease type and detection methods, ranging from about 3% to 70%. In recent years, studies have shown that some patients with CTD-ILD can progress to progressive fibrotic phenotype (PF-ILD), which is characterized by continued worsening of symptoms, progressive decline in lung function, increased risk of death, and poor prognosis. At the same time, CTD-ILD has significant clinical and biological heterogeneity. Different patients have significant differences in disease progression rate, imaging manifestations, and treatment response. Some patients may progress rapidly. Therefore, early identification of high-risk groups and timely intervention are of great clinical significance. Currently, there are no drugs approved for all patients with CTD-ILD, and there is a huge clinical need gap.

GenSci161 is a new type of fully human monoclonal IgG1 bispecific antibody that can simultaneously target two subtypes (IL-1α and IL-1β) of the key pro-inflammatory cytokine interleukin-1 (IL-1), thereby blocking the activation of inflammatory signaling pathways mediated by IL-1, inhibiting the production and release of multiple downstream pro-inflammatory cytokines, and achieving a more comprehensive regulation of inflammation. In recent years, studies have shown that inflammatory factors play an important role in the occurrence and development of CTD-ILD. Among them, interleukin-1 (IL-1) can play an important role in the inflammation-fibrosis transformation process by activating multiple inflammatory signaling pathways, promoting immune cell recruitment, inducing fibroblast activation, and promoting collagen deposition. Therapeutic strategies targeting IL-1 may provide new intervention approaches for CTD-ILD. GenSci161 injection has potential clinical value in treating CTD-ILD and is expected to provide new treatment options.

3. Impact on the company

If the subsidiary's clinical trial application progresses smoothly, it will help the company expand its business structure, optimize its product structure, enrich and improve the product line layout in strategic areas, and enhance the company's core competitiveness.

Since pharmaceutical products are high-tech, high-risk, and high-value-added, the early stage of drug research and development and the product development, clinical trial approval, and production have long cycles and many links, and are easily affected by some uncertain factors. There is still uncertainty in the follow-up process and results of this clinical trial. Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks.

The company will actively promote the above-mentioned research and development projects and perform its information disclosure obligations on the subsequent progress of the projects in a timely manner in strict accordance with relevant regulations.

Announcement hereby

Changchun High-tech Industry (Group) Co., Ltd. Board of Directors

September 1, 2026