Part of Gyre Therapeutics
Clinical Trials
11
9 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1997
Active, not recruiting
7
63.6%
Not yet recruiting
2
18.2%
Unknown
2
18.2%
No approval data available
- GNI Group has agreed to acquire 100% of Ayumi Pharmaceutical Holdings from shareholders led by Blackstone in a deal valued at approximately ¥44.8 billion. - Ayumi's flagship product Calonal® holds over 80% of Japan's domestic acetaminophen market, with the company reporting ¥38.5 billion in revenue for fiscal 2026. - The combined entity expects fiscal 2026 revenue of approximately ¥65.2 billion and will focus on fibrosis, pain management, rheumatology, oncology, and orthopedics. - The acquisition strengthens GNI Group's commercial infrastructure in Japan and enhances its ability to introduce biosimilars and innovative therapies into the Japanese market.
- Kelun-Biotech received Hong Kong Stock Exchange approval to remove the "B" marker from its stock code, effective April 14, 2026, signifying achievement of higher operating standards. - The company has secured approvals for 4 products across 8 indications within three years of listing, with 3 products covering 5 indications included in China's National Reimbursement Drug List. - MSD is evaluating 17 global Phase III clinical trials for sacituzumab tirumotecan (sac-TMT), with multiple studies approaching data readout stages. - The company operates leading ADC and novel conjugation drug platforms, positioning it for continued innovation from best-in-class to first-in-class therapeutics.
- Kelun-Biotech's SKB264 (sac-TMT) combined with pembrolizumab achieved primary endpoint in Phase III trial for first-line PD-L1 positive NSCLC, marking the world's first successful ADC-immunotherapy combination in this setting. - The company reported strong 2025 performance with revenue of RMB2.06 billion and four approved products, including three core assets entering China's National Reimbursement Drug List in January 2026. - SKB264 received FDA Commissioner Priority Review Voucher, reducing regulatory review time from 10-12 months to 1-2 months, with Merck planning first marketing application by 2026.
- Gyre Therapeutics announced a $300 million all-stock acquisition of Cullgen Inc., creating a fully integrated U.S.-China biopharmaceutical company with targeted protein degradation capabilities. - The combined entity will leverage Cullgen's protein degrader pipeline, including CG001419 for acute pain and CG009301 for blood cancers, alongside Gyre's commercial fibrosis treatments. - Gyre plans to submit a New Drug Application for Hydronidone liver fibrosis treatment in the first half of 2026 following regulatory support for conditional approval. - The transaction is expected to close in early Q2 2026, with Dr. Ying Luo becoming President and CEO of the combined company.
- Gyre Therapeutics completed a Pre-NDA meeting with China's CDE, achieving alignment on conditional approval pathway for Hydronidone based on existing Phase 3 clinical data. - The Phase 3 trial demonstrated that 52.85% of treated patients achieved ≥1-stage fibrosis regression at Week 52, compared with 29.84% in the placebo group (p=0.0002). - Hydronidone addresses a significant unmet medical need as there are currently no approved anti-fibrotic therapies for CHB-associated liver fibrosis patients. - The company plans to submit an NDA for conditional approval in the first half of 2026 and conduct a confirmatory Phase 3c trial to support full approval.
- China has accelerated drug development timelines by 50-70% through parallelized workflows and dense CRO ecosystems, capturing 39% of global clinical research share in 2023. - Major pharmaceutical companies are increasingly licensing Chinese assets not just for promising drugs, but to learn operational efficiency strategies that could transform their R&D processes. - While the FDA requires 20% of testing in the U.S. for drug approval, the remaining 80% can be conducted globally, creating opportunities for regions like China, Australia, and South Korea to attract clinical trials. - Chinese licensing deals have surged from 8% to 30% of global licensing activity in just two years, reflecting growing East-West collaboration in drug development.
- Kelun-Biotech and Crescent Biopharma announced a strategic partnership to develop CR-001, a PD-1 x VEGF bispecific antibody, and SKB105, an integrin beta-6-directed ADC with topoisomerase payload. - The collaboration grants Kelun-Biotech exclusive rights to CR-001 in Greater China while Crescent receives exclusive rights to SKB105 in the US, Europe and other global markets. - Both therapeutic candidates are expected to enter Phase 1/2 monotherapy clinical trials in Q1 2026, with combination studies to follow. - Crescent secured $185 million in private placement financing to support clinical development through multiple data readouts beginning in Q1 2027.
- Crescent Biopharma announced preclinical data for CR-001, a tetravalent PD-1 x VEGF bispecific antibody, demonstrating cooperative pharmacology with increased PD-1 binding in the presence of VEGF. - The experimental therapy showed potent anti-tumor activity in xenograft mouse models and was well-tolerated in non-human primates with robust PD-1 receptor occupancy. - The company plans to submit an IND application in Q4 2025 and initiate a global Phase 1 trial in solid tumor patients in Q1 2026. - CR-001's cooperative mechanism mirrors that of ivonescimab, another PD-1 x VEGF bispecific that demonstrated superior efficacy to pembrolizumab in Phase 3 non-small cell lung cancer trials.
- Crescent Biopharma remains on track to submit an IND application for CR-001, a PD-1 x VEGF bispecific antibody, in Q4 2025 to support a global Phase 1 trial in solid tumor patients. - Preclinical data presented at SITC demonstrates CR-001's cooperative pharmacology with increased PD-1 binding in VEGF presence and potent anti-tumor activity in xenograft models. - The company expects to report proof-of-concept clinical data from the Phase 1 trial in the second half of 2026, with $133.3 million cash runway through 2027. - CR-001 was designed to replicate ivonescimab's cooperative pharmacology, which showed superior efficacy compared to pembrolizumab in Phase 3 non-small cell lung cancer trials.
- Crescent Biopharma has appointed Jan Pinkas, Ph.D., as chief scientific officer, bringing over two decades of oncology drug development experience including expertise in antibody-drug conjugates. - The company expects to begin dosing patients in a global Phase 1 trial of CR-001, a PD-1 x VEGF bispecific antibody, in early 2026. - Crescent anticipates submitting an IND application for CR-002, a novel antibody-drug conjugate, in mid-2026. - Dr. Pinkas previously served as chief scientific officer at Pyxis Oncology and contributed to the development of ELAHERE, an approved ADC for platinum-resistant ovarian cancer.
