Novotech, a globally recognized full-service clinical research organization (CRO), is proud to have partnered with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ Pharma) in achieving a significant regulatory milestone: the approval of Anlotinib Hydrochloride Capsules for a new indication as a first-line treatment for unresectable locally advanced or metastatic soft tissue sarcoma (STS) in combination with chemotherapy. This approval marks the ninth indication for Anlotinib in China and represents the world’s first official approval of an Anlotinib-chemotherapy combination for first-line treatment of advanced or metastatic STS.
Previously recommended as a second-line monotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines, Anlotinib was the only Grade I targeted therapy for STS. This new indication represents a significant advancement for patients who have not previously received systemic treatment, expanding access to more effective and targeted first-line therapeutic options.
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Novotech provided a comprehensive suite of regulatory-compliant biostatistics services in support of the development program, including protocol review and design, statistical analysis plans, CDISC datasets generation, and post-database lock outputs of TFL (Tables, Figures, and Listings). These contributions enhanced data transparency, improved result interpretability, and played a critical role in the successful NDA submission.
The Phase III study demonstrated compelling results:
- Anlotinib combination therapy improved median progression-free survival by 5.6 months.
- Delivered an objective response rate of 17.8% compared to 2.9% in the control group.
- The disease control rate climbed to 79.3%, underscoring the clinical potential of the new regimen.
Novotech’s expert biostatisticians and programmers provide end-to-end services, from protocol design and statistical consultation to comprehensive reporting, supporting clinical programs from first-in-human through Phase IV.
Our collaboration with CTTQ Pharma reflects a shared commitment to advancing outcomes for patients facing difficult-to-treat cancers. The expanded use of Anlotinib in combination with chemotherapy opens new possibilities for advancing care in soft tissue sarcoma and highlights the role Novotech’s partnership model plays in shaping the future of oncology research.
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Source- businesswire
