Gyre Therapeutics affirms $100m+ guidance after Cullgen deal closes
Gyre Therapeutics has reported second-quarter 2026 revenue of $29.1 million, fractionally below the $29.7 million recorded in the same period a year earlier, and reaffirmed its full-year 2026 revenue guidance of $100.5 million to $111.0 million. The Nasdaq-listed company, which operates commercial and development-stage businesses across the United States and China, used the earnings release to update investors on a materially expanded pipeline following its acquisition of targeted protein-degrader specialist Cullgen in May.
The quarter's top-line figure was held up almost entirely by ETUARY (pirfenidone), the company's pirfenidone capsule approved in China for idiopathic pulmonary fibrosis, which generated $28.0 million in sales compared with $23.5 million a year ago. Two newer products, Etorel (nintedanib ethanesulfonate) and Contiva (avatrombopag maleate), contributed a combined $1.2 million, both below their prior-year comparatives, a decline the company attributed to the impact of China's national centralised procurement programme on pricing and volumes. The loss of collaboration revenue from an agreement with Astellas Pharma, which ended in March 2026, added a further $3.0 million headwind to the quarterly comparison.
Cullgen acquisition reshapes the pipeline
The close of the all-stock Cullgen acquisition on 4 May, valued at approximately $300 million, was the most consequential event of the period. The deal brought in a portfolio of targeted protein degraders (TPDs) and degrader-antibody conjugates (DACs), which the company is positioning as a next-generation successor to antibody-drug conjugates. Gyre's chief executive Ying Luo, who was Cullgen's CEO before being appointed to lead the combined group, said the transaction gives Gyre "a full-spectrum pipeline consisting of clinical and IND-enabling assets to address multiple therapeutic areas."
Two Cullgen assets are already in clinical evaluation. CG001419, a candidate being studied for cancer-induced bone pain and solid tumours, completed a Phase 1 study in Australia in December 2025 and is now being planned for a Phase 2 study in metastatic cancer pain; it is separately in Phase 1 in China for solid tumours. CG009301, a GSPT1 degrader for acute myeloid leukaemia, is in a Phase 1 dose-escalation trial in China. Two further degrader assets, CDK2-Cyclin E dual degrader CG923308 and TYK2-JAK1 dual degrader CG620953, are expected to reach IND filing in the United States or China in the first quarter of 2027.
The operational cost of this expansion was visible in the income statement. Research and development expense for the quarter rose 129% year-on-year to $19.1 million, driven partly by a $4.8 million milestone payment owed to GNI Group following China's NMPA acceptance of the NDA for F351 (hydronidone) in CHB-induced liver fibrosis. The operating loss widened to $14.4 million from $2.2 million in Q2 2025.
Regulatory and competitive context
The NMPA's acceptance of the F351 NDA, announced in May, is a meaningful near-term catalyst. F351 holds Breakthrough Therapy designation from China's Centre for Drug Evaluation and had already reported statistically significant fibrosis regression in a pivotal Phase 3 trial in chronic hepatitis B-associated liver fibrosis. If approved, it would represent Gyre's second commercial product in China alongside ETUARY.
The protein-degrader field has attracted substantial investment and competitive interest in recent years, with several larger pharmaceutical groups acquiring or partnering with TPD-focused companies. DAC platforms, which pair degraders with tumour-targeting antibodies, are at an earlier stage of validation, and Gyre will need to demonstrate clinical differentiation to establish relevance in what is becoming a crowded landscape. The company ended June with total liquidity of approximately $103 million, down from $116 million at year-end, providing near-term runway but leaving limited margin for programme delays.
Looking ahead, the key milestones investors will track include the NMPA's review decision on the F351 NDA, final data from the pneumoconiosis Phase 3 trial expected in Q4 2026, and the planned IND filings for the dual-degrader assets in early 2027.