SYDNEY– Novotech, a global full-service clinical research organization (CRO), announced its partnership with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ Pharma) in securing regulatory approval for Anlotinib Hydrochloride Capsules as a first-line treatment for unresectable locally advanced or metastatic soft tissue sarcoma (STS) in combination with chemotherapy. This marks the ninth indication for Anlotinib in China and the world’s first official approval of an Anlotinib-chemotherapy combination for first-line treatment of advanced or metastatic STS.
Anlotinib, previously recommended as a second-line monotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines, had been the only Grade I targeted therapy for STS. The new indication significantly expands treatment options for patients who have not previously received systemic therapy, offering more effective and targeted first-line care.
Novotech supported the development program with regulatory-compliant biostatistics services, including protocol review and design, statistical analysis planning, CDISC datasets generation, and post-database lock outputs of tables, figures, and listings. These services strengthened data transparency and interpretability, playing a pivotal role in the successful new drug application submission.
The Phase III trial demonstrated clear clinical benefits. Patients treated with the Anlotinib combination saw median progression-free survival improve by 5.6 months. The objective response rate rose to 17.8% compared to 2.9% in the control group, while the disease control rate reached 79.3%, underscoring the therapy’s potential.
“Novotech’s collaboration with CTTQ Pharma reflects our shared commitment to advancing outcomes for patients facing difficult-to-treat cancers,” the company said. “The expanded use of Anlotinib in combination with chemotherapy opens new possibilities for soft tissue sarcoma care and highlights the impact of Novotech’s partnership model in shaping the future of oncology research.”
