CSPC Pharmaceutical Group Receives Approval for Dupilumab Injection Clinical Trials in China

CSPC Pharmaceutical Group has announced that its dupilumab injection has been approved for clinical trials in China by the National Medical Products Administration (NMPA). The injection is intended to treat atopic dermatitis, asthma, and other inflammatory diseases. The approval marks a significant milestone for CSPC, which is one of the largest pharmaceutical companies in China.

Connect Biopharma Holdings Limited (Nasdaq: CNTB) reported its financial results for the second quarter of 2025 and provided a business update. The company, focused on transforming care for inflammatory diseases, made significant progress in its clinical and corporate goals [1].

Key Highlights:

- Clinical Progress: Connect Biopharma initiated Phase 2 Seabreeze STAT studies evaluating rademikibart as an adjunct treatment for acute exacerbations in asthma and COPD. Positive data was presented at the American Thoracic Society (ATS) 2025 and the European Academy of Allergy and Clinical Immunology (EAACI) 2025 conferences, supporting rademikibart’s potential for differentiated efficacy and safety [1].

- Regulatory Milestones: The company’s exclusive licensee in China, Simcere, submitted a new drug application for rademikibart to the National Medical Products Administration (NMPA) for the treatment of atopic dermatitis (AD) in adults and adolescents [1].

- Corporate Updates: Connect Biopharma announced plans to terminate its American Depositary Receipt (ADR) program and directly list ordinary shares on the Nasdaq Global Market. This move aims to enhance institutional visibility, eliminate ADR depositary fees, and expand the investor base. Additionally, industry veteran Jim Schoeneck was appointed to the Board of Directors, bringing deep expertise in the development and commercialization of breakthrough products [1].

Financial Results:

- Cash and Investments: As of June 30, 2025, Connect Biopharma had $71.8 million in cash, cash equivalents, and short-term investments. The company expects these funds to be sufficient to support operations through 2027 [1].

- Revenue: License and collaboration revenues for the three and six months ended June 30, 2025, were $48,000 and $24.1 million, respectively, primarily from cost reimbursements and upfront license fees [1].

- Expenses: Research and development expenses were $8.8 million and $15.4 million for the three and six months ended June 30, 2025, respectively, reflecting increased costs for rademikibart-related clinical trials. General and administrative expenses were $4.7 million and $9.5 million for the same periods [1].

- Net Loss: The company reported a net loss of $12.9 million for the three months ended June 30, 2025, and $23.2 million for the six months ended June 30, 2025, compared to a net income of $14.8 million and $6.2 million for the same periods in 2024, respectively [1].

About Rademikibart:
Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). It aims to block the functions of IL-4 and IL-13, thereby blocking the T helper 2 (Th2) inflammatory pathway to treat Th2-related inflammatory diseases such as atopic dermatitis and asthma [1].

About Connect Biopharma:
Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. The company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target IL-4Rα. Connect Biopharma is conducting global clinical studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need [1].

References:
[1] https://www.biospace.com/press-releases/connect-biopharma-reports-second-quarter-2025-financial-results-and-provides-business-update