国联民生：维持信达生物 “买入” 评级 盈利水平显著改善

According to Zhitong Finance APP, Guolian Minsheng released a research report stating that INNOVENT BIO (01801) has shown strong revenue growth, significant improvement in profitability, and its global pipeline is gradually entering the registration research stage. The bank expects the company's operating revenue for 2025-2027 to be RMB 11.788 billion / 15.256 billion / 20.516 billion, with year-on-year growth rates of 25.11% / 29.43% / 34.47%, and net profit attributable to the parent company to be RMB 604 million / 1.396 billion / 3.007 billion, with year-on-year growth rates of turning losses into profits / 131.07% / 115.45%. EPS is expected to be RMB 0.35 / 0.81 / 1.76 per share. As a domestically scarce innovative drug leader with global R&D and commercialization capabilities, the company has a clear strategy and efficient execution, and the bank maintains a "Buy" rating.

Guolian Minsheng's main points are as follows:

Event

INNOVENT BIO released its mid-year performance for 2025, achieving total revenue of RMB 5.953 billion in H1 2025, a year-on-year increase of 50.6%, with profits reaching RMB 834 million, significantly turning losses into profits. Non-IFRS profit was RMB 1.213 billion, and Non-IFRS EBITDA was RMB 1.413 billion, showing a significant improvement in profitability. The company's product portfolio has expanded to 16 marketed products, with synergy in oncology and comprehensive pipelines, and multiple new drugs successfully commercialized, while global layout continues to advance.

Outstanding financial performance, continuous optimization of operational efficiency

In H1 2025, product revenue reached RMB 5.234 billion (up 37.3% year-on-year), and revenue from licensing fees significantly increased to RMB 666 million (up 474% year-on-year) due to the upfront payment from the collaboration with Roche. Gross margin was 86.0% (up 3.1 percentage points year-on-year), R&D expenses were optimized to RMB 1.009 billion (down 28% year-on-year), and the sales expense ratio decreased to 39.9%. As of June 30, 2025, cash reserves were approximately RMB 11 billion, providing solid support for global innovation.

IBI363 (PD-1/IL-2α-bias) global phase III clinical trial launched

Core pipeline IBI363 announced breakthrough data at the ASCO annual meeting, showing excellent efficacy in cold tumors and IO-resistant populations. A key phase II study for melanoma has been initiated, and the U.S. FDA has approved the global phase III clinical trial (MarsLight-11) for squamous NSCLC, with plans to enroll patients from multiple countries. Its Ib/II phase studies for first-line NSCLC CRC and other indications have also been completed.

Significant progress in multiple pipelines, deepening global layout

CLDN18.2ADC (IBI343) has initiated a phase III study for pancreatic cancer, and HER2ADC (IBI354) is advancing to phase III clinical trials for ovarian cancer. The cornerstone product in the metabolic field, Masudutide, has added two phase III studies, and IBI112 (IL-23p19) for psoriasis is under NDA review, expected to be approved by the end of 2025. The company has reached a global collaboration with Roche for IBI3009 (DLL3ADC) and is advancing MRCT clinical studies in Australia, China, and the United States Risk Warning: Commercial sales are below expectations, clinical progress is below expectations, and market competition is intensifying