Novotech Supports Groundbreaking Approval of Anlotinib Combination Therapy for Advanced Soft Tissue Sarcoma

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.

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.

About NovotechNovotech-CRO.com

Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company trusted by biotech and small- to mid-sized pharmaceutical companies to guide drug development at every phase.

With a global footprint that includes 30+ offices across the Asia-Pacific region, North America, and Europe and partnerships with 5,000+ trial sites, Novotech provides clients an accelerated path to bring life-changing therapies to market by providing access to key clinical trial destinations and diverse patient populations.

Through its client-centric service model, Novotech seamlessly integrates people, processes, and technologies to deliver customized solutions that accelerate the path to market for life-changing therapies. By adopting a true partnership approach, Novotech shares a steadfast commitment to client success, empowering innovation, and advancing healthcare worldwide.

Recipient of numerous industry accolades, including the Frost & Sullivan CRO Company of the Year award for 19 consecutive years, Novotech is recognized for its excellence in clinical trial execution and innovation. Its deep therapeutic and regulatory expertise, combined with local market insights, ensures streamlined clinical trials, optimized data analytics, and accelerated patient recruitment strategies.

Together with clients, Novotech transforms scientific advancements into therapies that improve global health outcomes, embodying a mission of driving innovation and delivering impactful results

For more information or to speak to an expert team member visit www.Novotech-CRO.com

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